Project Title (100 words max):
Lead Researcher/Investigator:
Lead Unit (i.e., Department, Organized Lead Unit, Center or Institute):
Kuali Research (KR) follows the KFS Organizational Unit Hierarchy.
ATTENTION! For new submissions, Department Chair (DC) or Organized Lead Unit Director (OLUD) sign-off in KRP is required before final committee approval will be granted. For more information, visit the listserv.
Submission Type:
IMPORTANT! Be sure to select the correct 'Submission Type'. When 'Submission Type' is changed, the contents of the form will be cleared and replaced with a set of new questions specific to the submission type.
Choose one that applies:
Submission for Administrative Determination or Registration:
Choose one that applies:
Lead Researcher's primary school/department/program is:
Choose one that applies:
Select the level of review for this protocol:
Choose one that applies:
STOP! UCI does not permit reliance for exempt research.
UCI IRB review required.
Is this expanded access, humanitarian use device, or right to try?
Choose one that applies:
Select the expanded access type:
Choose one that applies:
STOP!! UCI does not permit reliance for Right to Try.
UCI IRB review required.
Specify who initiated/authored the project:
Choose one that applies:
Is this study an extension of a UCI IRB approved study (e.g., resubmission of ongoing exempt research; open label extension) or is it otherwise related to a UCI IRB approved study?
Choose one that applies:
If yes, provide the protocol number for the UCI IRB approved protocol (enter multiple protocol numbers if appropriate):
Is the project limited to review of records (e.g., medical, educational, prison, etc.) and/or biospecimens (e.g., discarded tissues) without subject contact?
Choose one that applies:
Is the project limited to review of records (e.g., educational) and/or biospecimens (e.g., discarded tissues) without subject contact?
Choose one that applies:
List only UCI individuals who are engaged in human subjects research below:
REQUIRED! All study team members must complete the following Collaborative Institutional Training Initiative (CITI) trainings:
For more information, visit HRP Training and Education.
List only UCI individuals who are engaged in human subjects research below:
REQUIRED! Edit the Lead Researcher/Investigator profile to address all unanswered prompts. Failure to complete the profile will delay approval.
REQUIRED! All study team members must complete the following Collaborative Institutional Training Initiative (CITI) trainings:
Incomplete or expired CITI training will delay IRB approval. For more information, visit HRP Training and Education.
List only individuals who are involved in the treatment below:
REQUIRED! All study team members must complete the following Collaborative Institutional Training Initiative (CITI) trainings:
Incomplete or expired CITI training will delay IRB approval. For more information, visit HRP Training and Education.
List only UCI individuals who are engaged in human subjects research below:
REQUIRED! Edit the Lead Researcher/Investigator profile to address all unanswered prompts. Failure to complete the profile will delay approval.
REQUIRED! All study team members must complete the following Collaborative Institutional Training Initiative (CITI) trainings:
Incomplete or expired CITI training will delay IRB approval. For more information, visit HRP Training and Education.
List only UCI individuals who are engaged in human subjects research below:
REQUIRED! Edit the Lead Researcher/Investigator profile to address all unanswered prompts. Failure to complete the profile will delay approval.
REQUIRED! All study team members must complete the following Collaborative Institutional Training Initiative (CITI) trainings:
Incomplete or expired CITI training will delay IRB approval. For more information, visit HRP Training and Education.
IMPORTANT! For greater than minimal risk research that involves an investigational drug, device or surgical procedure, only a United States (US) licensed medical doctor or US licensed nurse practitioner may finalize the consent process.
Some Departments may have specific policies related to consent that may be more restrictive. Researchers should be aware of these policies and adhere accordingly.
For more information, see UCI HRP Policy 31 Documentation of Informed Consent for Human Subjects.
KRP NOTE! If an individual does NOT appear in the search, they are not listed with a formal affiliation in UC Path and cannot be added to the study team. Please contact the Department's Human Resources to add researchers, including contract workers, to UC Path as "contingent".
Researcher:
Email:
Financial Interest:
hSCRO RESEARCHERS:
IMPORTANT! Please mark "No" for this question. COI does NOT apply to hSCRO research.
IRB RESEARCHERS:
To promote the objectivity of the research, all researchers are required to disclose their related disclosable financial interests, per the IRB COI Policy. If you have any questions about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to comply:
?Do you, your spouse/registered domestic partner, and dependent children have any disclosable financial interests* (i) that would reasonably appear to be affected by this research study; or (ii) in entities whose financial interests would reasonably appear to be affected by this research study?"
Choose one that applies:
Training:
hSCRO RESEARCHERS:
IMPORTANT! Please ignore the training column. It is only relevant for IRB researchers. hSCRO researchers are NOT required to take CITI training courses.
IRB RESEARCHERS:
IMPORTANT! Incomplete or expired CITI training will delay IRB approval. For more information, visit HRP Training and Education.
All study team members must complete the following Collaborative Institutional Training Initiative (CITI) trainings:
Degree:
Choose one that applies:
Position/Title:
Affiliation:
Choose one that applies:
Specify other UCI affiliation:
Researcher Role:
Choose one that applies:
Permissions:
Select all that apply:
Duties (check all that apply):
Select all that apply:
Specify which research procedures:
Specify relevant training and experience for the referenced duties/responsibilities:
Does the Lead Researcher (LR) meet the criteria for a Principal Investigator (PI) by virtue of their University status?
Choose one that applies:
STOP! A Faculty Sponsor is required to oversee the conduct of this study.
Add a Faculty Sponsor to the study team who is eligible to serve as PI.
Are RP tracked outside the approved protocol, in accordance with the RP Heat Map?
Choose one that applies:
At UCI, a single IRB (sIRB) will be required for the following types of non-exempt cooperative (multisite) research carried out within the United States:
Are UCI researchers engaged in human subjects research activities (e.g., interact with subjects; have access to identifiable information) at a non-UCI site?
Select all that apply:
Are non-UCI researchers engaged in human subjects research activities (e.g., interact with subjects; have access to identifiable information)?
Select all that apply:
Specify location(s) where non-UCI personnel are engaged in research:
Is the non-UCI investigator and/or the non-UCI site located in the United States?
Choose one that applies:
IMPORTANT! UCI will not serve as the IRB of Record for international investigators. They must secure their own ethics board approval.
Does the UCI researcher(s) have a dual affiliation with the non-UCI site?
Choose one that applies:
STOP! UCI does not permit reliance for Exempt Research and will not serve as the IRB of Record.
The non-UCI investigators must obtain their own IRB approval.
In an effort to avoid administrative delays related to establishing sIRB agreements, it is strongly recommended that the sIRB process be addressed via an Amendment, after initial approval is granted for the UCI site.
Does the sIRB request need to be addressed at this time?
Choose one that applies:
In an effort to avoid administrative delays related to establishing sIRB agreements, it is strongly recommended that the sIRB process be addressed via an Amendment, after initial approval is granted for the UCI site.
Does the sIRB request need to be addressed at this time?
Choose one that applies:
For more information, visit: Single IRB Process.
Specify rationale for the request for UCI to serve as the IRB of Record:
Choose one that applies:
UCI utilizes the SMART IRB, which is free resource that enables IRB reliance for multisite studies across the nation, regardless of funding status. When UCI is the IRB of Record, it does not utilize the SMART IRB Online Reliance System.
Does the non-UCI site participate with SMART IRB?
Choose one that applies:
REQUIRED! Submit the Individual Investigator Agreement (IIA) in the Attachments section.
Does the non-UCI site have their own IRB?
Choose one that applies:
Will medical records [i.e., Protected Health Information (PHI)] at the non-UCI site be created, access, used, or disclosed?
Choose one that applies:
The UCI IRB will consider serving as the HIPAA Privacy Board when the research is within California and the non-UCI investigator does not have a privacy board. Exceptions may be considered.
Is the non-UCI investigator requesting that the UCI IRB also serve as their HIPAA Privacy Board?
Choose one that applies:
IMPORTANT! The UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. The non-UCI investigator may use the Relying Site HIPAA Research Authorization template. Each institution will retain their own Privacy reporting responsibilities should a breach of privacy occur.
REQUIRED! The non-UCI entity must register as a Participating Institution of SMART IRB.
Once registered, submit the signed SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record) in the Attachments section.
REQUIRED! The non-UCI entity must register as a Participating Institution of SMART IRB.
Once registered, submit the signed SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record) in the Attachments section.
REQUIRED! The non-UCI entity must register as a Participating Institution of SMART IRB.
Once registered, submit the signed SMART IRB - Letter of Acknowledgement (UCI is IRB of Record & HIPAA Board) in the Attachments section.
REQUIRED! Submit the signed SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record) in the Attachments section.
The non-UCI site must be a Participating Institution or in the process of joining the SMART IRB.
REQUIRED! Submit the signed SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record) in the Attachments section.
The non-UCI site must be a Participating Institution or in the process of joining the SMART IRB.
REQUIRED! Submit the signed SMART IRB - Letter of Acknowledgement (UCI is IRB of Record & HIPAA Board) in the Attachments section.
The non-UCI site must be a Participating Institution or in the process of joining the SMART IRB.
REQUIRED! Submit the Institutional Authorization Agreement (IAA) - (UCI is IRB of Record) in the Attachments section.
REQUIRED! Submit the Institutional Authorization Agreement (IAA) - (UCI is IRB of Record) in the Attachments section.
REQUIRED! Submit the Institutional Authorization Agreement (IAA) - (UCI is IRB of Record & HIPAA Board) in the Attachments section.
Justify the request for UCI to serve as the HIPAA Board:
Specify the name of the non-UCI site requesting to rely on the UCI IRB:
Provide the Name, Title & Degrees for the Site Investigator:
Provide the Site Investigator's department:
Provide the Site Investigator's email:
Provide the Site Investigator's phone:
Site Investigator's Duties (check all that apply):
Select all that apply:
IMPORTANT! For greater than minimal risk research that involves an investigational drug, device or surgical procedure, only a United States (US) licensed medical doctor or US licensed nurse practitioner may finalize the consent process.
Some Departments may have specific policies related to consent that may be more restrictive. Researchers should be aware of these policies and adhere accordingly.
For more information, see UCI HRP Policy 31 Documentation of Informed Consent for Human Subjects.
List the research activities/procedures to be performed and the individual?s relevant qualifications (training, experience):
Are there additional researchers at the non-UCI site engaged in human subjects research?
Choose one that applies:
REQUIRED! The Site Investigator's must verify that all trainings have been completed by their study team prior to their engagement with human subjects.
Has the Site Investigator (or their study team reported) a financial conflict of interest related to this study that has resulted in a management plan?
Choose one that applies:
REQUIRED! Submit the non-UCI site's conflict of interest management plan in the Attachments section.
How is the Site Investigator provided with a copy of the UCI IRB approved study documentation (i.e. protocol, recruitment, consent, etc.) throughout the duration of the study?
Will research activities be performed ONLY at UCI locations?
Choose one that applies:
Will research be performed at Children?s Health of Orange County (CHOC) Children's or MemorialCare Health System (MHS) facilities (check all that apply)?
MHS facilities include:
IMPORTANT! If a MemorialCare investigator, also wants to include private offices (PO) that are not covered under the MemorialCare FWA, a separate non-UCI entity row is required for each PO.
Select all that apply:
Will subjects be consented at CHOC Children's facilities?
REQUIRED! Submit one of the following in the Attachments section:
NEXT STEPS:
For additional information on how to obtain a signed SMART IRB LOA, please contact CHOC Office of Research Compliance: orc@choc.org
Will subjects be consented at MHS?
Revise the UCI consent template with the MHS Consent Language inserted where applicable. The consent must be submitted to MHS for approval prior to submitting to UCI.
REQUIRED! Submit the MHS revised UCI consent form in the Attachments section.
REQUIRED! Submit an email from MHS acknowledging their reliance on UCI in the Attachments Section.
For additional information on how to obtain an email confirmation, please contact:
Will research activities be performed outside of California?
Choose one that applies:
Specify if there are any applicable state or local laws, regulations, policies, or ancillary review processes as are relevant to the research (Type 'None' if not applicable):
Will this study require emergency resources?
Choose one that applies:
Specify the resources available at the non-UCI site to treat emergencies resulting from study-related procedures (check all that apply):
Select all that apply:
Specify 'Other' emergency resources:
Pharmacy: How will the drugs/agents used in the study be managed at the non-UCI site?
Choose one that applies:
Specify name and title of the pharmacist/responsible person for the drugs/agents at the non-UCI site:
Specify how this individual is provided with a current copy of the protocol:
Radiation Safety Committee (RSC): Does this study involve the human use of radioactive materials (e.g., PET scans, radioimmunotherapy, nuclear medicine procedures, lymphoscintigraphy) and/or radiation-producing equipment (e.g., CT scans, X-rays, fluoroscopy, but not MRI or laser procedures)?
Choose one that applies:
REQUIRED! Submit the non-UCI site's RSC approval in the Attachments section.
Institutional Biosafety Committee (IBC): Do research procedures involve recombinant and synthetic nucleic acids, materials or microorganisms modified using recombinant and synthetic nucleic acids or infectious agents and human materials including cells into human subjects?
Choose one that applies:
REQUIRED! Submit the non-UCI site's IBC approval in the Attachments section.
UCI promotes and engages in Single IRB Review (sIRB) agreements that allow one IRB review for multi-site research and for cooperative research (45 CFR 46.114). The goal is to reduce duplication in review and increase efficiency.
These agreements vary in scope (a single project agreement versus master agreement), in type of research (all types of human research versus limited to industry-authored clinical trials), and nature of the IRB (central IRB such as NCI CIRB, an independent IRB such as Western IRB; or a collaborative IRB model where any one IRB partner to the agreement can be the reviewing IRB such as the UC IRBs).
For more information visit, UCI as the Relying IRB or contact: IRBReliance@uci.edu.
IMPORTANT! All UCI human research activities approved through a sIRB process must be registered with UCI IRB and must comply with applicable UCI policies and procedures, regardless of funding or location of performance sites.
Provide the rationale for the request to cede IRB review to a non-UCI entity (check all that apply):
Select all that apply:
Identify the sIRB collaboration and the Reviewing institution:
Advarra/WCG - UCI has established IRB Agreements with several independent IRBs for industry-authored, multi-site clinical trials and clinical research where the sponsor or Clinical Research Organization has chosen the independent IRB as the IRB of Record for the study.
The NCI Adult CIRB - Late Phase Emphasis reviews Phase III Cooperative Group studies from ACOSOG, GOG, NSABP, RTOG, and SWOG.
Choose one that applies:
Specify whether the non-UCI IRB has received accreditation:
Select all that apply:
STOP!! UCI will not rely on a non-UCI IRB that does not have accreditation/certification.
UCI IRB review required.
Specify accrediting body:
Specify anticipated accreditation date:
Does the non-UCI IRB use the SMART IRB Online Reliance System?
Choose one that applies:
Does the non-UCI IRB use IRB Reliance Exchange (IREx)?
Choose one that applies:
Please provide the ORS tracking number (optional):
A protocol specific Institutional Authorization Agreement will need to be established with the another entity.
Specify the non-UCI IRB:
REQUIRED! Submit the IRB of Record's Institutional Authorization in the Attachments section.
Is this Emergency or Non-Emergency Use?
Choose one that applies:
Does this involve an IND or IDE?
Choose one that applies:
REQUIRED!
REQUIRED!
Within five working days after the use of an investigational drug or biologic, provide a follow-up report via an Amendment, summarizing the consent process (if applicable), the date, and results of the emergency use must be submitted to the IRB. This is a federal requirement.
The report will be reviewed by the IRB at a convened meeting. IRB review is not merely confirmation of the emergency use but is an assessment of the circumstances, the appropriateness of the emergency waiver, and the consent process employed.
Following the meeting, the physician will be provided confirmation of IRB review and any noted concerns or requests for additional information. This confirmation should be maintained with the physician's records for audit purposes.
For additional information, view the FDA guidance:
Select the expanded access type:
Choose one that applies:
Is it a Single Patient IND with Form 3926?
Choose one that applies:
Does Form 3926 allow for alternative IRB review procedures (i.e. item 10.b. on the form)?
Choose one that applies:
REQUIRED! Submit Form 3926 in the Attachments section.
REQUIRED! Submit the following documents in the Attachments section:
REQUIRED! Submit the following documents in the Attachments section:
Is this Right to Try cancer-related patient care?
Choose one that applies:
REQUIRED! All cancer-related patient care must undergo Tumor Board review. To submit a study for review, download the application. Email the completed application to CancerCenter_Committees@hs.uci.edu
Does this study include a Sponsor's Master Protocol (MP)?
Choose one that applies:
List the Master Protocol, Investigator Brochures, Sponsor Consent Form Templates and other supplemental documents (as applicable) below.
Document:
Choose one that applies:
Specify IB drug/device:
Version #:
Version Date:
Select the funding source(s) (check all that apply):
Select all that apply:
Specify non-cash support:
Specify funding and/or Sponsor:
Select the sponsor type(s) (check all that apply):
Select all that apply:
STOP! DOJ funded/supported studies are NOT eligible for 2018 Common Rule Exemptions.
STOP! DOE funded/supported studies are NOT eligible for self-determination.
IRB review is required.
STOP! DOE funded/supported studies are NOT eligible for self-determination.
Please contact irb@uci.edu for additional instruction/guidance.
Has UCI received an award (i.e., prime recipient) through a grant, contract or cooperative agreement directly from HHS entities or signatories of the Common Rule for non-exempt human subjects research and all activities involving human subjects are carried out by employees or agents of another institution (i.e. Subaward involved)?
Choose one that applies:
STOP! Based on your answer to the above question, the proposed activity as described constitutes human subjects research.
UCI IRB review may be required.
Contracts/Grants:
List below all extramural proposals or awards that will support the project:
Sponsor Name:
Title of Proposal/Award:
Proposal/Award #:
Is UCI the prime recipient of the award?
Choose one that applies:
Specify the prime recipient of the award:
REQUIRED! Upload a completed copy of the DoD Supplement Form in the Attachments section.
For more information, visit:
ATTENTION! IRB Fee Schedule
An IRB review fee is assessed for new clinical research protocols partially or fully supported by industry sponsors. The IRB fee is a single fee* to support the administrative costs of the protocol review process. The fee is charged to the funding source after IRB approval, once the contract is finalized.
IRB fee rates generally increase annually.
For the current rate and more information, visit: IRB Review Fees
Is it unclear whether you need to submit a new hSCRO protocol for research activities performed at UCI?
Choose one that applies:
Do you intend to use:
Choose one that applies:
Do you intend to generate new human embryonic stem cells (hESCs) or new human Induced pluripotent stem cells (hiPSCs) lines?
Do you intend to transplant neural stem cells into humans?
Do you intend to introduce human adult pluripotent, human fetal tissue, human fetal stem cells, human embryonic stem cells, or their neural derivatives into nonhuman animals at any stage of embryonic, fetal, or postnatal development?
Will the research include the use of blastocysts, gametes, or somatic cells whose identity is readily ascertainable or might become known to the investigator?
Do you plan on using only adult tissue?derived multipotent cells such as hematopoietic cells, mesenchymal stem cells, bone?marrow stromal cells?
Will the research include in vitro or in vivo use of non?neural cells that are already differentiated/no longer pluripotent derived from human induced pluripotent stem cells?
Choose one that applies:
Will the research include only in vitro use of neural cells derived from human induced pluripotent stem cells?
Do you plan on using neural stem cells only in vitro?
STOP! hSCRO review is REQUIRED.
Please go back to the hSCRO screener question and change your answer to 'No, I confirm hSCRO review is required for my research activities' and continue with the application.
STOP! hSCRO review is NOT REQUIRED.
Please click 'Abandon' at the top right and exit the application.
The UCI Exempt Self-Determination Tool is used to self-determine certain types of exempt research at UCI, including exempt research conducted through the Undergraduate Research Opportunities Program (UROP). Exceptions do apply. Please refer to the Exempt Self Determination webpage on this topic.
For studies that are eligible for Exempt Self-Determination, UCI IRB review is not required and will not be provided.
IMPORTANT!
Complete the following screening tool to determine whether the study is eligible for Exempt Self-Determination.
Are University of California / UC Irvine records (e.g., medical, employment, student applications, etc.) disclosed to the research team?
CA Civil Code §1798 ? California Information Practices Act (CIPA)
§1798.3 (c) The term disclose means to disclose, release, transfer, disseminate, or otherwise communicate all or any part of any record orally, in writing, or by electronic or any other means to any person or entity.
Choose one that applies:
Do the records include ?personal information??
§1798.3 (a) The term personal information means any information that is maintained by an agency that identifies or describes an individual, including, but not limited to:
Choose one that applies:
Does this study involve the creation, access, use, or disclosure of medical records; or observations of clinical care [i.e., Protected Health Information (PHI)]?
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Choose one that applies:
Does the research involve targeted recruitment of any of the following populations?
Are research subjects and/or performance sites located outside the United States? Is this international research?
Choose one that applies:
Does this research involve a request for UCI to serve as IRB of Record for a non-UCI investigator and/or site engaged in human subjects research?
Choose one that applies:
Does the Lead Researcher or any study team member have a Disclosable Financial Interest?
Choose one that applies:
STOP! The research is NOT eligible for Exempt Self-Determination.
UCI IRB review is required.
IMPORTANT! If all research activities qualify for one or more of the categories below, the study is eligible for exempt self-determination.
Select the category(ies) that apply to the research:
Category 1: Education (the following criteria must be met)
Select all that apply:
Category 2: Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria are met:
One of the following criteria must be met:
Select all that apply:
Category 3i: Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
One of the following criteria must be met:
Select all that apply:
Category 4: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if the following criterion is met:
Select all that apply:
STOP! The research is NOT eligible for Exempt Self-Determination.
UCI IRB review is required.
The responses, as indicated above, meet the criteria for Exempt Self-Determination.
UCI IRB review is not required and will not be provided. Research activities may begin as soon as the form is submitted in KRP.
A confirmation of registration will not be sent. The study status in KRP will remain as "submitted" or "resubmitted".
Should the study sponsor require evidence of IRB review for an exempt self-determination, please provide the sponsor this letter along with a printout/PDF of the submission in KRP.
NEXT STEPS:
Is the research a clinical investigation?
A clinical investigation is any experiment that involves a test article and one or more human subjects, and that meets any one of the following:
An individual becomes a human subject for FDA purposes if their data or specimens are used as the recipient of the test article or control. For example, when retrospective data are used as the control, the individuals become human subjects. Likewise, when an individual?s blood sample is used to test an assay, the individual becomes a human subject.
Choose one that applies:
Registration on ClinicalTrials.gov may be required if one (or more) of the following is true:
Registration on ClinicalTrials.gov may be required if one (or more) of the following is true:
IMPORTANT! The manufacturer of the drug/device must adhere to Clinicaltrials.gov.
For more information, visit: Clinical Trials Registration and Results Information Submission.
Does this research meet the definition of a clinical trial that requires adherence to Clinicaltrials.gov (CT.gov)?
Choose one that applies:
Specify the rationale for CT.gov registration (check all that apply):
Select all that apply:
Specify 'Other' Clinicaltrials.gov rationale:
Specify the Entity who will be registering / has registered the study on clinicaltrials.gov:
Provide the CT.gov registration NCT # (Enter 8-digit sequence of numbers only):
ATTENTION!
School of Medicine (SOM) Researchers: All clinical trials must be performed under the auspices of an Organized Lead Unit (OLU).
Alpha Stem Cell Clinic (ASCC)
Center for Clinical Research (CCR)
Chao Family Comprehensive Cancer Center (CFCCC)
Institute for Memory Impairments and Neurological Disorders (MIND)
Go to Project Details -> Lead Unit and verify the appropriate OLU for the trial.
IMPORTANT! For an industry funded clinical trial, please submit a proposal to SPA via Kuali Research to trigger contract negotiation.
The UCI Non-Human Subjects Research (NHSR) Self-Determination is used to determine if a project involves Activities that Require IRB
For studies that are eligible for NHSR Self-Determination, UCI IRB review is not required and will not be provided.
IMPORTANT!
Complete the following screening tool to determine whether the study is eligible for NHSR Self-Determination.
Does the proposed activity involve a systematic approach?
Choose one that applies:
Is the intent of the proposed activity to develop or contribute to generalizable knowledge? (e.g., Is it Quality Improvement (QI) research?)
Activities designed to develop or contribute to generalizable knowledge are those activities designed to draw general conclusions, inform policy, or generalize outcomes beyond the specific group, entity, or institution (i.e., to elaborate, to be an important factor in identifying or expanding truths, facts, information that are universally applicable). The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that never is published is still research.
IMPORTANT! Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.
Consider the following questions:
Choose one that applies:
Is the research about living individuals?
Choose one that applies:
Does the research collect factual information about a place or thing (i.e., not a person)?
Choose one that applies:
Does the research use California-produced death data files containing personal identifying information (i.e., state issued death certificates and indices)?
Choose one that applies:
Does this study involve the creation, access, use, or disclosure of the medical records [i.e., Protected Health Information (PHI)] of deceased individuals?
Choose one that applies:
All of the following must be true:
Explain why the research is not about living individuals:
Institutions Engaged in Human Subjects Research [Scenario A.(1)]
Does the research involve obtaining information or biospecimens through intervention or interaction with individuals (e.g., conduct research interviews or administer questionnaires, collect saliva or blood, administer drugs or other treatments; surgically implant medical devices)?
Choose one that applies:
Institutions Not Engaged in Human Subjects Research [Scenario B.(1)]
Will employees or agents only perform commercial or other services for investigators provided that:
Choose one that applies:
Institutions Engaged in Human Subjects Research [Scenario A.(2)]
Will researchers intervene with any human subject by manipulating the environment (e.g., control environmental light, sound, or temperature; orchestrate social interactions)?
Choose one that applies:
Institutions Engaged in Human Subjects Research [Scenario A.(5)]
Will the study team obtain the informed consent of human subjects for the research?
Choose one that applies:
Institutions Not Engaged in Human Subjects Research [Scenario B.(4)]
Employees or agents will only perform the following:
Select all that apply:
Will researchers obtain identifiable private information or obtain identifiable biological specimens?
Examples:
Choose one that applies:
Are UCI researchers the recipients of a limited data set (LDS)?
A limited data set (LDS) is protected health information that excludes direct identifiers of the individual or of relatives, employers, or household members of the individual.
An LDS provided by a 3rd party to a UCI researcher must exclude the following direct identifiers of the individual or of relatives, employers, or household members of the individual:
IMPORTANT! A Data Use Agreement (DUA) is required, please contact Grace J. Park at parkgj@uci.edu.
Choose one that applies:
Will UCI researchers will have direct access to the medical record to generate the LDS?
Choose one that applies:
Does the research involve the use of coded private information/specimens?
Choose one that applies:
The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information/specimens pertain (Confirm one of the following):
Choose one that applies:
Institutions Not Engaged in Human Subjects Research [Scenarios B.(5) - B.(11)]
Specify whether employees or agents will do the following activities, check all that apply:
Select all that apply:
Select all that apply:
Is the activity a clinical investigation?
A clinical investigation is any experiment that involves a test article and one or more human subjects, and that meets any one of the following:
An individual becomes a human subject for FDA purposes if their data or specimens are used as the recipient of the test article or control. For example, when retrospective data are used as the control, the individuals become human subjects. Likewise, when an individual?s blood sample is used to test an assay, the individual becomes a human subject.
Test article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act.
A human subject is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
A medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, including software applications that are either:
Specimen includes the use of leftover specimens that are not individually identifiable (e.g., a remnant of a human specimen collected for routine clinical care or analysis that would otherwise have been discarded).
Choose one that applies:
STOP! UCI IRB review is required for clinical investigations.
STOP! The proposed activity constitutes human subjects research.
UCI IRB review may be required.
STOP! The proposed activity constitutes human subjects research.
UCI IRB review is required.
The University of California, Irvine (UCI) Human Research Protections (HRP) Program complies with all review requirements defined in 45 CFR Part 46 and 21 CFR 50.3.
45 CFR 46.102(l) defines research as ?a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; and 45 CFR 46.102(e)(1) defines a human subject as ?a living individual about whom an investigator conducting research obtains (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
21 CFR 50.3(c) defines a clinical investigation as ?any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.?
The responses, as indicated above, meet the criteria for Non-Human Subjects Research (NHSR) Self-Determination.
The activities do not constitute human subject research. UCI IRB review is not required and will not be provided. Project activities may begin as soon as the form is submitted in KRP.
A confirmation of registration will not be sent. The study status in KRP will remain as "submitted" or "resubmitted".
Should the study sponsor require evidence of a NHSR determination, please provide the sponsor with a printout/PDF of the KRP submission.
NEXT STEPS:
Is the research subject to the NIH Genomic Data Sharing (GDS) Policy?
Choose one that applies:
IMPORTANT! NIH has strict standards for IRB review and informed consent for the data they will accept for inclusion in GDS data repositories.
If UCI Institutional Certification is required, please contact the Education and Quality Improvement Program (EQUIP) at equip@uci.edu to discuss the project.
Does the research involve human/primate blood, tissue, fluids or primary cells?
Choose one that applies:
Institutional Biosafety training may be required.
Does this research require review by the Human Stem Cell Oversight (hSRCO) Committee?
Specify the hSCRO approved protocol number (hSCRO #):
Indicate the source and how the study team will access the de-identified information and/or de-identified biospecimens (Check all that apply):
Select all that apply:
Were the information/specimens originally collected for research purposes?
Select all that apply:
Explain how the information/biospecimens were originally collected (e.g., clinical care):
Provide the UCI IRB number(s) for the approved study(ies):
Confirmation:
Select all that apply:
Confirmation:
Select all that apply:
Confirmation:
Select all that apply:
Specify internet sources:
Confirm that internet site?s privacy statement does not prohibit use of their information:
Select all that apply:
UCI Health Enterprise Data & Analytics (Honest Broker) records include:
The information below is required for the Honest Broker data request specifications.
Specify subject eligibility factors (inclusion/exclusion criteria) and include timeframes for each criterion:
Anticipated or maximum number of subjects:
Provide the UCI IRB number(s) for the approved study(ies):
Enter entity/vendor:
Enter clinic/operating room:
IMPORTANT! Per HRP Policy 15 and the UCI Health Anatomical Pathology/Surgical Pathology - Procedure Number: S-23, all biospecimens removed from clinic or the operating room must be sent to UCI Health Pathology for review and documentation by a pathologist, with the exception of biospecimens specifically listed as exempt or biospecimens obtained from Dermatopathology.
To obtain Pathology clearance, contact Dr. Robert Edwards (redwards@uci.edu) or Delia Tifrea (dtifrea@hs.uci.edu).
Select all that apply:
Explain here:
Provide a non-technical summary of the project that can be understood by non-scientists (250 words max):
Investigator-authored research involving greater than minimal risk to subjects (full board review) requires scientific/scholarly merit prior to IRB review - with few exceptions.
The following options identify the scientific merit process for the proposed research and the order of IRB review. Researchers should work with their Departments and the applicable committee (e.g., PRMC) to coordinate the review of their projects, as necessary.
The proposed research qualifies as minimal risk research.
The Department Chair, Division Chief, or Institute Director provides assurance that the research uses procedures consistent with sound research design, the study design can be reasonably expected to answer the proposed question, and the importance of the knowledge expected to result from the research is known.
The proposed research qualifies as greater than minimal risk, sponsor-initiated research.
The sponsor is an industry sponsor, a federal sponsor, or a non-profit, private sponsor. It is assumed that scientific merit has been conducted. Available peer review comments may be requested by the IRB for consideration.
The proposed research qualifies as greater than minimal risk, investigator-initiated biodmedical research.
REQUIRED! Review from the Biostatistics, Epidemiology and Research Design (BERD) unit of the Institute for Clinical and Translational Science (ICTS) is required. The UCI IRB staff will coordinate the review in conjunction with the expertise of the BERD.
Please click on the following link to arrange a consultation with one of the ICTS BERD Statisticians: ICTS BERD Statisticians - Consultations.
Is the research cancer-related?
Choose one that applies:
Chao Family Comprehensive Cancer Center (CFCCC)?s Protocol Review and Monitoring Committee (PRMC) Review Required
Submit your PRMC application to the CFCCC by emailing CancerCenter_Committees1@hs.uci.edu.
Note the following submission timing requirements:
To ensure all required research is submitted and help facilitate their review process, Cancer Center staff may review your IRB protocol documentation in KR Protocols.
The proposed research qualifies as greater than minimal risk, investigator-initated social, behavioral, or educational research.
The Department Chair, Division Chief, or Institute Director assures that the research uses procedures consistent with sound research design, the study design can be reasonably expected to answer the proposed question, and the importance of the knowledge expected to result from the research is known.
Research involving human subjects sometimes requires the approval or authorization of Other Reviews Required by UCI (e.g., School of Medicine Review Committees).
Additional Review by the following Committees may be required prior to IRB review:
For a list of all ancillary committees, their requirements and how they relate to the IRB review process, refer to the Other UCI Required Reviews Chart.
Research involving human subjects sometimes requires the approval or authorization of Other Reviews Required by UCI.
For a list of all ancillary committees, their requirements and how they relate to the IRB review process, refer to the Other UCI Required Reviews Chart.
For studies utilizing a Reliance Agreement (sIRB), additional review by the following Committees are required (as applicable) prior to the IRB submission:
Be sure to upload evidence in the Attachments section.
Is the research cancer-related?
Choose one that applies:
All cancer research is monitored by UCI's Chao Family Comprehensive Cancer Center (CFCCC). The Cancer Center staff may review your IRB protocol documentation in KR Protocols.
Specify if any of the following hazardous materials are used for research-related purposes (i.e., not for standard of care) (check all the apply):
Select all that apply:
Does the research involve human/primate blood, tissue, fluids or primary cells?
Choose one that applies:
List human/primate blood, tissue, fluids or primary cells here:
Institutional Biosafety training may be required.
Does this research require review by the Human Stem Cell Oversight (hSRCO) Committee?
Choose one that applies:
California law, pursuant to Health & Safety Code Sections §11480 & §11481, requires proposed research studies using certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II Controlled Substances as their main study drug(s), to be reviewed and authorized by the Research Advisory Panel of California in the Attorney General's Office.
See the Guidelines <https://oag.ca.gov/research/guide> page for specific criteria. In addition, please refer to UC Policy: https://policy.ucop.edu/doc/3520503/BFB-BUS-50
List carcinogens here:
List etiologic agents or infectious agents here:
List recombinant DNA (including human gene transfer, a.k.a. "gene therapy") here:
List regulated toxic chemicals here:
List toxins here:
Review the Radiation Safety Committee (RSC) Research Application to determine the level of RSC review. If you have additional questions contact the Radiation Safety Officer at 714-456-5607.
IMPORTANT! If all procedures using radiation are ?standard of care? RSC approval is NOT required. Standard of care procedures are procedures the participant would receive even if they were not enrolled in the research study. Go to the Potentially Hazardous Materials section and uncheck the radiation/radioactive option(s).
Specify if the use of radiation machine(s) or material(s) qualifies for RSC subcommittee review or require full committee review:
Choose one that applies:
Specify Radiation Machine (check all that apply):
Select all that apply:
Specify the 'Other' radiation machine not listed above:
Specify the radioactive material (check all that apply):
Select all that apply:
Specify nuclear medicine procedures:
Specify radiopharmaceutical(s):
Specify the number of PET scans required for the research (i.e., not for standard of care) and the frequency:
Specify radioactive material:
Check all ancillary committees that apply:
Select all that apply:
Indicate the status of the IACUC review:
Choose one that applies:
IACUC protocol number:
IACUC Approval Date:
IACUC Expiration Date:
All research involving the use of human stem cells must be reviewed and approved by the IBC before beginning research procedures
For UCSB: This approval may also be called Biological Use Authorization
Indicate the status of the IBC review:
Choose one that applies:
IBC protocol/or BUA number:
IBC Protocol Approval Date:
IBC Expiration Date:
Indicate the status of the IRB review:
Choose one that applies:
IRB protocol number:
IRB Approval Date:
IRB Expiration Date:
Provide a non-technical summary of the project that can be understood by non-scientists (250 words max):
IMPORTANT! Do NOT reference the Master Protocol.
Insert the abstract from the corresponding grant application (if available).
Insert/paste relevant information from the grant application in the applicable questions below.
Describe the purpose, specific aims or objectives and specify the hypotheses or research questions to be studied:
Provide the scientific or scholarly rationale for the research and describe the relevant background information and the specific gaps in current knowledge that this study intends to address:
Provide relevant preliminary data (animal and/or human):
Describe the primary outcome variable(s), secondary outcome variables, and predictors and/or comparison groups as appropriate for the stated study objectives/specific aims:
List up to ten relevant references/articles to support the rationale for the research:
Describe the purpose, specific aims or objectives and specify the hypotheses or research questions to be studied:
Not required. Please refer to Master Protocol.
Provide the scientific or scholarly rationale for the research and describe the relevant background information and the specific gaps in current knowledge that this study intends to address:
Not required. Please refer to Master Protocol.
Provide relevant preliminary data (animal and/or human):
Not required. Please refer to Master Protocol.
Describe the primary outcome variable(s), secondary outcome variables, and predictors and/or comparison groups as appropriate for the stated study objectives/specific aims:
Not required. Please refer to Master Protocol.
List up to ten relevant references/articles to support the rationale for the research:
Not required. Please refer to Master Protocol.
Date(s) test article will be administered/utilized:
Dosage:
Name of the investigational drug/biologic or device (test article):
IND/IDE/HDE #:
REQUIRED! Upload a copy of the FDA IND/IDE/HDE approval letter in the Attachments section.
If no IND/IDE exists, contact the FDA for an Emergency Use IND/IDE.
Manufacturer:
Describe the patient's condition and explain why the use of the test article is required:
Indication for Emergency Use:
Will informed consent be obtained from the patient or the patient?s legally authorized representative?
Choose one that applies:
REQUIRED! Submit the Emergency Use Physician Attestation Form in the Attachments section.
REQUIRED! Submit the Expanded Access Consent in the Attachments section.
REQUIRED! Submit the UCI Right to Try Attestation and Consent Template in the Attachments section.
If this study includes a Non-English Speaking Patient:
Confirm the English version of the consent materials will be translated for non-English speaking participant or their LAR once IRB approval is granted.
Select all that apply:
Targeted subject populations/data sources (check that apply):
Select all that apply:
Targeted subject populations/data sources (check that apply):
Select all that apply:
STOP!! UCI does not permit reliance for neonate research.
UCI IRB review required.
Indicate 'Other' population group:
Will UCI interact/intervene with subjects?
Choose one that applies:
Provide site/institution specific information:
Choose one that applies:
Specify 'Other' subject populations/data source:
Eligibility Criteria
Not required. Please refer to Master Protocol.
When utilizing UCI Health Enterprise Data & Analytics services (e.g., pre-screening, data pull), the following additional information is required:
Example Entry:
Eligibility Criteria:
Eligibility Criteria:
IMPORTANT! When utilizing UCI Health Enterprise Data & Analytics services (e.g., pre-screening, data pull), the following additional information is required:
Example Entry:
Is eligibility based on age, gender, pregnancy/childbearing potential, social/ethnic group, or language spoken (e.g., English Speakers only)?
Choose one that applies:
Example: Eligibility Group: Age 70+, Rationale: Disease that affects the elderly
REQUIRED! This study does NOT include Non-English Speaking Participants (NESP) Revise the above question to 'Yes', and add a scientific justification/rationale for the exclusion of NESP.
Specify the tribal name:
Specify whether there is an applicable Tribal Law that provides additional protections for research subjects:
IMPORTANT! If the study includes both pregnant women and their child after it is born, complete, "§ 46.204 Research Involving Pregnant Women or Fetuses" below and be sure to select 'Children' as an additional study population in the Subject Populations Checklist question.
For more information, visit: Vulnerable Populations: Pregnant
Permissible Research Involving Pregnant Women or Human Fetuses
Confirm that all of the following are true [§46.204(h),(i),&(j)]:
Choose one that applies:
Is the risk to the fetus caused solely by interventions or procedures that hold out the prospect of a direct benefit to the pregnant woman or the fetus [§46.204(b)]?
Choose one that applies:
Is the risk to the fetus not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means [§46.204(b)]?
Justify why the risk to the fetus is not greater than minimal [§46.204(b)]:
Justify why purpose of the research is the development of important biomedical knowledge, which cannot be obtained by any other means:
Explain why the proposed research is scientifically appropriate; include descriptions of pre-clinical studies conducted on pregnant animals and any clinical studies conducted on non-pregnant women that provide useful data to assess the potential risks to pregnant women and fetuses [§46.204(a)]:
Explain why the risks to the pregnant woman and fetus are the least possible for achieving the objectives of the research [§46.204(c)]:
Please acknowledge the following regulatory requirements for who will be required to consent to this research by checking each box [§46.204(d-e)]:
Even where the IRB determines that the participants are capable of consenting, the IRB may still waive the consent requirement under circumstances in which consent may be waived in accord with IRB Policy 32 and federal regulations.
Select all that apply:
Explain how each individual providing consent under the previous question will be fully informed regarding the reasonably foreseeable impact of the research on the fetus [§46.204(f)]:
Will the research involve subjects who are pregnant and meet the definition of "children" (Under the laws of the jurisdiction in which the research is to take place, the subject is under the age required to consent to the treatment or procedures involved in this research)?
Exception: ?A minor may consent to medical care related to the prevention or treatment of pregnancy, except sterilization.? If the IRB determines that the study involves the prevention or treatment of pregnancy and it is appropriate for the minor to consent to the treatment or procedures involved in the study, parental permission is not required (California Family Code 6925).
Choose one that applies:
Is the research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women or fetuses (§46.207)?
Choose one that applies:
Explain why the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women or fetuses:
Provide justification for the assumption that the research will be conducted in accordance with sound ethical principles:
The IRB must also determine whether informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.
STOP! Research with pregnant women or fetuses is not approvable.
Will the research involve neonates of uncertain viability [§46.205(a)&(b)]?
Choose one that applies:
Will the research involve nonviable neonates [§46.205(a)&(c)]?
Choose one that applies:
Will the research involve viable neonates (§46.205(d))?
Choose one that applies:
Will individuals engaged in the research have any part in determining the viability of a neonate [§46.205(a)(3)]?
Choose one that applies:
Explain why the proposed research is scientifically appropriate and provide a description of any pre-clinical and clinical studies that have been conducted which provide data for assessing potential risks to neonates [§46.205(a)(1)]:
Neonates of Uncertain Viability
Does the research hold out the prospect of enhancing the probability of survival of the neonate to the point of viability, AND any risk is the least possible for achieving that objective [§46.205(b)(1)(i)]?
Is the purpose of the research development of important biomedical knowledge, which cannot be obtained by other means AND there will be no added risk to the neonate resulting from the research [§46.205(b)(1)(ii)]?
Justify that the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability [§46.205(b)(1)(i)]:
Justify that any risk is the least possible for achieving that objective [§46.205(b)(1)(i)]:
Justify that the purpose of the research is the development of important biomedical knowledge, which cannot be obtained by other means [§46.205(b)(1)(ii)]:
Justify that there will be no added risk to the neonate resulting from the research [§46.205(b)(1)(ii)]:
Explain the procedures that will be used to obtain legally effective informed consent of either parent of the neonate [§46.205(b)(2)]:
Consent is Required. If neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative may be obtained. The father's informed consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
Explain how each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate [§46.205(a)(2)]:
Nonviable Neonates
Are ALL of the following true [§46.205(c)(1),(2),(3)&(4)]?
Choose one that applies:
Explain the procedures that will be used to obtain legally effective informed consent of both parents of the neonate [§46.205(c)(5)]:
Consent is required. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice for this type of research.
If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
Explain how each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate [§46.205(a)(2)]:
REQUIRED! Select 'Children' as an additional group in the Subject Populations Checklist question.
Is the research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of neonates (§46.207)?
Choose one that applies:
Explain why the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of neonates:
Provide justification for the assumption that the research will be conducted in accordance with sound ethical principles:
The IRB must also determine whether informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.
Is the research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of neonates (§46.207)?
Choose one that applies:
Explain why the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of neonates:
Provide justification for the assumption that the research will be conducted in accordance with sound ethical principles:
The IRB must also determine whether informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.
STOP! Research with neonates is not approvable.
When conducting research with prisoners, additional requirements to ensure the protection of human subjects are required. It is the expectation of the IRB that UCI Researchers intending to conduct research with prisoners understand these additional requirements by reviewing the following:
Does the target population meets the definition of a prisoner per (§46.303(c))?
Choose one that applies:
Provide protocol specific justification for this determination:
STOP! Research with prisoners is not approvable.
Does this research involve no greater than minimal risk to subjects?
Choose one that applies:
Provide protocol specific justification for this determination, including documentation of why the research will pose no more than inconvenience to the subject:
Provide protocol specific justification for this determination:
Based on your funding source answer, this research supported by HHS (or an agency under HHS).
REQUIRED! This study must be submitted to the Secretary of HHS (through OHRP) for approval as required by the regulations (45 CFR 46.305(c) and 46.306(a)(1)).
Are there any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, that are of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prisoner is impaired? (§46.305(a)(2))
Choose one that applies:
Explain the possible advantages that can be expected for prisoner subjects:
Justify that the possible advantages are NOT of such a magnitude that the prisoner's ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prisoner is impaired:
Are the risks involved in the research commensurate with the risks that would be accepted by non-prisoner volunteers / subjects? (§46.305(a)(3))
Choose one that applies:
Explain the possible risks that can be reasonably expected for prisoner subjects:
Justify that the risks involved in the research are commensurate with the risks that would be accepted by non-prisoner subjects:
Are the procedures for the selection of subjects within the prison fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners?
Choose one that applies:
Explain how prisoners will be selected for participation in this research study:
Are prisoners the targeted population?
Choose one that applies:
Explain the importance of continuing to intervene, interact, or collect identifiable private information during a participant's incarceration:
Will the control subjects be selected randomly from the group of available prisoners who meet the characteristics needed for the research project?
Choose one that applies:
Explain why the procedures for the selection of subjects within the prison will be fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners:
Explain how you will insure that the information to be presented will be in a language that is understandable to the subject population (§46.305(a)(5)):
Will there be parole considerations? (§46.305(a)(6))
Choose one that applies:
Explain what steps will be taken to insure that parole boards will not take into account a prisoner's participation in the research when making decisions regarding parole (45 CFR 46.305 (6)):
Explain what steps will be taken to insure that each prisoner will be clearly informed in advance that participation in the research will have no effect on his/her parole (45 CFR 46.305 (6)):
Will there be a need for follow-up examination or additional care of subjects after the research procedures have concluded taking into account the varying lengths of individual prisoners' sentences (§46.305(a)(7))?
Choose one that applies:
Explain what provisions have been made for the follow-up:
Explain how you will communicate this to the prisoner subjects:
Select the category of research under 45 CFR 46 ? Subpart C:
Choose one that applies:
Provide protocol specific justification for this determination:
Explain the condition/s that will be studies and provide the rationale:
Explain the research practices used in this study and how they are intended to improve the health and well-being of the subjects:
Select the type of epidemiologic research for this study:
Choose one that applies:
Describe the epidemiologic research:
Provide protocol specific justification to support that prisoners are not the particular focus of the research:
Additional considerations in the State of California:
1) The California Department of Corrections and Rehabilitation (CDCR) must approve research involving state prisoners. Note that county or local jails may detain state prisoners.
2) Committee for the Protection of Human Subjects (CPHS) approval may apply to prisoner research. CPHS is the institutional review board (IRB) for all of the departments under the California Health and Human Services Agency (CHHSA). CPHS is also the IRB required to review all research-related requests for state personal information to the University of California and non-profit educational institutions. (CPHS must also approve research requests for birth and death data from the California Department of Public Health.)
Additional considerations OUTSIDE the State of California:
1) If research activities under the jurisdiction of the UCI IRB will involve prisoners held outside of California, the investigator is responsible for identifying and ensuring compliance with the laws and regulations of the applicable jurisdictions. The IRB application should specify the jurisdictions involved and measures to ensure compliance.
Confirm by checking the box below indicating the Lead Researcher is aware:
Select all that apply:
Is the type of prisoner research biomedical (CA Penal Code 3500(b)) or social-behavioral (CA Penal Code 3505) in nature?
Choose one that applies:
Provide protocol specific justification for this determination:
Indicate the proposed consent process:
Choose one that applies:
Will pregnancy testing be involved for minors?
Choose one that applies:
Select the category that best describes the proposed research (45 CFR 46 - Subpart D):
Select all that apply:
Indicate why the proposed research poses no greater than minimal risk to children:
Explain why the risk is justified by the anticipated benefit to the child:
Explain why the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches:
Justify why the risk represents a minor increase over minimal risk:
Explain why the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations:
Identify the subjects' disorder or condition:
Explain why the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition, which is of vital importance for the understanding or amelioration of the subjects' disorder or condition:
Explain why the proposed research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children:
If there is more than one group of children being enrolled in the research (e.g., patients, healthy controls) and the groups fall into different risk/benefits categories, describe the groups below listing the applicable category for each group:
Indicate how parental permission will be obtained (check all that apply):
Select all that apply:
Explain how/why the research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects:
Describe the alternative appropriate mechanism for protecting the children who will participate as subjects in the research. The choice of an appropriate mechanism should consider the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition:
REQUIRED! In the Informed Consent Process section, select 'No informed consent/assent (no direct contact)'. Identify the waiver processes as applicable for each participant population.
The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine one of the following:
Choose one that applies:
Justify the selection:
Explain why if parental permission were required, the research could not practicably be carried out:
Select which best describes how you will be obtaining assent and answer the corresponding questions:
Select all that apply:
Indicate how assent will be obtained (check all that apply):
Select all that apply:
If more than one assent method is indicated above, provide a breakdown of when each method will be used:
REQUIRED! Submit a Assent Script in the Attachments section.
REQUIRED! Submit the Child Assent Form in the Attachments section.
REQUIRED! Submit the following documents in the Attachments section:
UCI IRB requires the eIC process adheres to the OHRP guidance: Use of Electronic Informed Consent: Questions and Answers.
Describe the child assent process:
Explain which children will not be asked for assent:
Explain the limitations of the children?s ability to assent based on their ages, maturity, and psychological state:
Explain how/why the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research:
Justify that the research involves no more than minimal risk to the subjects:
Explain how/why the waiver or alteration will not adversely affect the rights and welfare of the subjects:
Explain why if assent were required, the research could not practicably be carried out:
Is it appropriate to provide children with additional pertinent information after participation?
Choose one that applies:
Explain how/why, whenever appropriate or not, the children will be provided with additional pertinent information after participation:
The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine one of the following:
Choose one that applies:
Explain why if parental permission were required, the research could not practicably be carried out:
Will people under the age of 18 who are permitted under California law to consent for themselves be enrolled in this study?
Choose one that applies:
Describe the people under 18, able to consent for themselves, to be enrolled in the study:
Do you intend to enroll wards of the state or any other agency, institution, or entity? (45 CFR 46.409; 21 CFR 50.56)
Choose one that applies:
Explain why it is appropriate to enroll wards in this study:
Describe the plans for appointing advocates and explain what their duties will be:
The mere presence of a cognitive impairment should not lead to a presumption that a person is incapable of making a decision regarding participation in research. All adults are presumed competent unless determined to be incompetent. Cognitively impaired and medically incapacitated persons are considered vulnerable research populations because their mental or medical disability may compromise their capacity to make a reasoned decision about participation in research.
When competency of the subject is in question, a decision-making capacity assessment should be performed. When surrogate consent will be used, investigators must attempt to obtain informed consent directly from the subject whenever possible. If the subject expresses resistance or dissent to participation or to use of surrogate consent (by word or gesture) the individual shall be excluded from the study. In addition, a subject who regains the cognitive ability to consent must be re-consented using standard consenting procedures.
Surrogate consent to participate is not permitted for persons in a State of California mental health facility inpatient psychiatric ward, or persons on psychiatric hold.
IMPORTANT! UCI researchers should follow the UCOP Guidance on Surrogate Consent for Research and use the Investigator Certification of Surrogate Decision Makers for Potential Subject Participation in University of California Research Form as appropriate. Details of how to obtain consent from a surrogate are provided on the Use of Surrogate Consent in Research webpage.
For additional guidance, please visit Use of Surrogate Consent in Research webpage.
Indicate the populations included in the research (check all that apply):
Select all that apply:
Provide a compelling and scientifically sound rationale for inclusion of cognitively impaired or medically incapacitated subjects:
Describe in detail the plan for assessing the decision-making capacity of each subject in order to determine whether the individual is capable of providing informed consent:
Specify who will be performing the decision-making capacity evaluation. Provide the credentials, experience, and expertise of the individual(s) performing the evaluation:
Is it reasonable to expect that during the course of the study subjects may lose their capacity to consent or their ability to withdraw consent (e.g., research involving administration of or withdrawal of antipsychotic drug)?
Choose one that applies:
Explain why. Also what provisions will be put in place to protect the subject?s rights (e.g., ongoing informed consent; use of surrogate consent)?
Explain why:
Surrogate consent may be considered only in research studies relating to the cognitive impairment, lack of capacity or serious or life-threatening disease and conditions of the research subjects (check all that apply):
Select all that apply:
Does the surrogate consent method include all subjects?
Choose one that applies:
Specify cohort:
Develop a plan that outlines the sequence of steps that will be employed by the study team to acquire and document surrogate consent provided by a legally authorized representative:
Explain how you will solicit the assent of the cognitively impaired individual:
Describe how you will evaluate the subject's resistance or dissent to participate or to the use of surrogate consent:
Under the revised Common Rule, an IRB may approve a proposal for the investigator to obtain information or biospecimens to screen, recruit, or determine eligibility of prospective subjects for a research study without informed consent. In other words, the revised Common Rule removes the pre-2018 Common Rule requirement for an IRB to approve a waiver of informed consent for these types of activities. This change harmonizes with FDA.
[Refer to 45 CFR 46.116(g) of the revised Common Rule.]
Will the study team obtain information or biospecimens to screen, recruit, or determine eligibility of prospective subjects?
Choose one that applies:
Pre-Screening Activities (check all that apply):
Select all that apply:
Pre-Screening Activities (check all that apply):
Select all that apply:
Explain Other Pre-Screening Activity:
REQUIRED! Submit the pre-screening script in the Attachments section.
UCI IRB requires the pre-screening script meets the Recruitment Requirements.
34 CRF 99: Family Educational Rights and Privacy Act (FERPA) applies to this research
REQUIRED! Submit evidence of FERPA compliance from the school/institution/district in the Attachments section. The school/institution/district should verify that signed permission is not required to screen school records.
34 CRF 99: Family Educational Rights and Privacy Act (FERPA) applies to this research
REQUIRED! Maintain evidence of FERPA compliance from the school/institution/district in the research record. The school/institution/district should verify that signed permission is not required to screen school records.
Enter the name(s) of Non-UCI Entity/Entities:
How will the study team request Non-UCI Health records and abstract data directly from those records?
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple protocol numbers if appropriate):
Provide assurance that the release of information to the UCI study team is permitted under the IRB approved protocol:
Select all that apply:
Provide a complete list of ALL data points, variables, and/or information that will be collected/recorded (i.e. data abstraction form) for pre-screening/recruitment purposes:
IMPORTANT! Data collected/recorded from student or medical records must be limited to the contact information unless justified otherwise.
Example Entry:
IMPORTANT! Under a partial waiver of HIPAA authorization, only the minimum necessary information should be accessed for pre-screening/recruitment activities (i.e., determining eligibility and contacting the subject). The information should not be further accessed, used, or disclosed above and beyond pre-screening/recruitment activities until a signed consent form (and signed HIPAA authorization, as applicable) is obtained.
Explain why pre-screening/recruitment activities could not be done without access to the information listed above:
Indicate how the study team will access the biospecimens (check all that apply):
Select all that apply:
Enter the commercial entity/vendor:
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple protocol numbers if appropriate):
Specify 'Other' biospecimen source:
Specify 'Other' UCI health entity:
Were the biospecimens originally collected for research purposes?
Select all that apply:
Explain how the biospecimens were originally collected (e.g., clinical care):
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple protocol numbers if appropriate):
UCI IRB requires the IRB approved consent does not preclude the research.
REQUIRED! Submit a copy of the Non-UCI IRB approval and consent form for the original research collection in the Attachments Section.
UCI IRB requires the vendor?s policy does not preclude the research.
REQUIRED! Submit a copy of the Vendor Policy/Letter attesting that the sharing of biospecimen is ethical in the Attachments Section.
IMPORTANT!
For more information, visit this HRP Webpage.
Does the study involve recruitment at UCI?
Choose one that applies:
Indicate all methods that will be used to recruit subjects for this study:
Recruitment Methods:
Choose one that applies:
Specify 'Other' recruitment methods:
Specify Where Posted:
Type of Space:
Select all that apply:
REQUIRED! Applicable consent documents must include reference to the use of SONA.
REQUIRED! The ClinicalTrials.gov statement must be in all applicable consent documents.
Specify how contact information will be obtained:
Examples:
REQUIRED!
Specify the precautions taken to avoid compromised objectivity:
IMPORTANT! Colleagues may provide a copy of the consent and other UCI IRB approved materials, but do NOT obtain subjects? consent for the research or act as representatives of the investigators.
Indicate all methods that will be used to recruit subjects for this study:
Recruitment Method:
Choose one that applies:
Specify 'Other' recruitment methods:
Specify Where Posted:
Type of Space:
Select all that apply:
REQUIRED! Applicable consent documents must include reference to the use of SONA.
REQUIRED! The ClinicalTrials.gov statement must be in all applicable consent documents.
IMPORTANT! Only clinical trials that are eligible to be registered on ClinicalTrials.gov may be listed on the Center for Clinical Research (CCR) Find a Trial web page.
Specify how contact information will be obtained:
Examples:
REQUIRED!
Specify the precautions taken to avoid compromised objectivity:
IMPORTANT!
IMPORTANT! Colleagues must NOT obtain subjects? consent for the research or act as representatives of the investigators.
REQUIRED!
Does this study involve the creation, access, use, or disclosure of medical records; or observations of clinical care [i.e., Protected Health Information (PHI)]?
Choose one that applies:
Identify the Health Insurance Portability and Accountability Act (HIPAA) Authorization process (check all that apply):
Select all that apply:
Identify the Health Insurance Portability and Accountability Act (HIPAA) Authorization process (check all that apply):
Select all that apply:
The patient's signed HIPAA Research Authorization is required (check below).
Select all that apply:
Will non-UCI covered components access Protected Health Information (PHI)?
Choose one that applies:
The patient's signed HIPAA Research Authorization is required (check below).
Select all that apply:
The Health Insurance Portability and Accountability Act (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) address medical confidentiality and access to medical information for research studies that use, create, or disclose health care related data and records, termed ?personal health information.?
For more information, visit: Protected Health Information.
A Partial Waiver of HIPAA Authorization is Requested.
A Total Waiver of HIPAA Authorization is Requested.
Provide assurance that the research meets all of the waiver criteria listed below:
Select all that apply:
Specify why the research could not practicably* be conducted without the waiver [164.512(h)(i)(2)(ii)(B)] (check all that apply):
*Practicably means capable of being done; it should not be determined by considerations of convenience, cost, or speed.
Select all that apply:
Explain why research could not be done if signed authorization was required:
When a partial and/or total waiver of HIPAA authorization is granted by the IRB, the Lead Researcher, members of the Study Team, and as applicable, the Sponsor and Contracted Research Organization, as approved in the waiver application, may access, use, or disclose a research subject?s personal health information for the research study without seeking the specific authorization for that use or disclosure.
Will entities outside the UCI study team access, use, or disclose a research subject?s PHI?
Select all that apply:
Explain why the entity(ies) listed above need PHI to conduct the study:
IMPORTANT! All studies under the 2023 NIH Data Management and Sharing Policy must insert Consent Language: NIH Data Management and Sharing (DSM) in the appropriate sections of the Biomedical / Social Behavioral Informed Consent Template, see: IRB Forms.
For more information about NIH DSM requirement, see: NIH 2023 Data Management and Sharing Plan (DMSP) Guidance and Resources.
Select the informed consent process:
Choose one that applies:
Specify how informed consent/assent will be obtained from subjects (check all that apply):
Select all that apply:
Describe the setting where the consent/assent discussion will take place?
How much time will the potential study subject have to review the consent/assent document before a response is required, including time to take the consent document home?
Beginning with the approach of potential human subjects, describe how potential human subjects will be oriented to the protocol, who will engage in the consent discussion, ensuring that there is a sufficient understanding of what participation will entail, including the solicitation of open ended questions, and then finalization of the consent process (either with or without a signature).
Describe the consent/assent process:
No Subject Contact (check the box below):
Select all that apply:
Exempt Category 4: Secondary research for which consent is not required.
Identify the methods of Informed Consent or assent process as applicable for each participant population (check all that apply):
Select all that apply:
Identify the methods of Informed Consent or assent process as applicable for each participant population (check all that apply):
Select all that apply:
Explain why the research could not be conducted, if parental permission were required:
Identify the methods of Informed Consent or assent process as applicable for each participant population (check all that apply):
Select all that apply:
Identify the methods of Informed Consent or assent process as applicable for the patient population (check all that apply):
Select all that apply:
REQUIRED! Submit the Expanded Access Consent in the Attachments section.
REQUIRED! Submit the Consent for use of Humanitarian Use Device in the Attachments section.
If this study includes Non-English Speaking Patients:
Confirm the English version of the consent materials will be translated for non-English speaking participants or their LAR once IRB approval is granted.
Select all that apply:
Is this consent method used for all subjects?
Choose one that applies:
Specify cohort:
Indicate the waiver of signed informed consent/assent (check all that apply):
Select all that apply:
Is this consent method used for all subjects?
Choose one that applies:
Specify cohort:
REQUIRED! Submit a Study Information Sheet in the Attachments section.
UCI IRB requires ALL of the following:
REQUIRED! Develop and use a Study Information Sheet.
UCI IRB requires ALL of the following:
Indicate the paper-based signed informed consent/assent (check all that apply):
Select all that apply:
Is this consent method used for all subjects?
Choose one that applies:
Specify cohort:
REQUIRED! Submit the Adult Consent Form, Child Assent Form and/or Parental Permission Form in the Attachments section.
REQUIRED! Develop and use an Adult Consent Form.
Indicate the electronic signed informed consent/assent (eIC) (check all that apply):
Select all that apply:
Is this consent method used for all subjects?
Choose one that applies:
Specify cohort:
REQUIRED! Submit the following documents in the Attachments section:
UCI IRB requires the eIC process adheres to the OHRP guidance: Use of Electronic Informed Consent: Questions and Answers.
REQUIRED! Develop and use an Adult Consent Form
Maintain on file:
UCI IRB requires the eIC process adheres to the OHRP guidance: Use of Electronic Informed Consent: Questions and Answers.
REQUIRED! Submit the following documents in the Attachments section:
UCI IRB requires the eIC process adheres to the OHRP guidance: Use of Electronic Informed Consent: Questions and Answers.
Indicate the location where the consent process will take place (check all that apply):
Select all that apply:
Specify 'Other' location:
Specify how the research team will assure that subjects, their parents, or their legally authorized representative (LAR) have sufficient time to consider whether to participate in the research:
Choose one that applies:
Specify hours, days or weeks for subjects, parents or their LAR will be allowed to consider whether to consent:
Specify 'Other' timeframe:
Beginning with the approach of potential human subjects, describe how potential human subjects will be oriented to the protocol, who will engage in the consent discussion, ensuring that there is a sufficient understanding of what participation will entail, including the solicitation of open ended questions, and then finalization of the consent process (either with or without a signature).
Describe the adult consent process:
Describe the parental permission process:
Indicate the location where the consent process will take place (check all that apply):
Select all that apply:
Specify 'Other' location:
Specify how the research team will assure that subjects, their parents, or their legally authorized representative (LAR) have sufficient time to consider whether to participate in the research:
Select all that apply:
Specify hours, days or weeks for subjects, parents or their LAR will be allowed to consider whether to consent:
Specify 'Other' timeframe:
Describe the parental permission process:
Describe the parental permission process:
Describe the child assent process:
Describe the child assent process:
Beginning with the approach of potential human subjects, describe how potential human subjects will be oriented to the protocol, who will engage in the consent discussion, ensuring that there is a sufficient understanding of what participation will entail, including the solicitation of open ended questions, and then finalization of the consent process (either with or without a signature).
Describe the adult consent process:
Indicate the location where the consent process will take place (check all that apply):
Select all that apply:
Specify 'Other' location:
Specify how the research team will assure that subjects have sufficient time to consider whether to participate in the research:
Select all that apply:
Specify hours, days or weeks for subjects will be allowed to consider whether to consent:
Specify 'Other' timeframe:
Beginning with the approach of potential human subjects, describe how potential human subjects will be oriented to the protocol, who will engage in the consent discussion, ensuring that there is a sufficient understanding of what participation will entail, including the solicitation of open ended questions, and then finalization of the consent process (either with or without a signature).
Describe the adult consent process:
What type of consent process will be used for Non-English Speaking Participants?
Select all that apply:
For what languages will consent/assent translations be provided?
Please read the HRPP webpage for more information on the use of the short form consent process.
When the short form method is approved by the IRB of Record, the UCI policy must be followed:
The Short Form Consent Process should be used for the occasional and unanticipated non-English speaking subject. To use a Short Form Written Consent process, the research must meet all of the requirements established in 45CFR46.117(b)(2) and 21 CFR 50.27(b)(2). In addition, a description of how an Investigator will obtain informed consent using the Short Form process should be explained in Informed Consent Process Section.
How Does the Short Form Consent Process Work?
When the short form method is approved by the IRB, the following should occur:
Please read the HRPP webpage for more information on the use of the short form consent process before completing this section.
The short form process will be used for the following languages:
Choose one that applies:
Specify 'Other' languages:
Indicate why the short form informed consent process is necessary for the research study (i.e., provide a compelling and sound rationale). If you believe that enrollment of certain language speaking participants is not expected due to the disease or condition being studied and the anticipated study enrollment, please include study specific justification:
Explain who will be performing the oral translation of the English-approved consent form. Specify the credentials, experience, and expertise of the individual(s) performing the translation:
Indicate how non-English speaking subjects or their LAR will be consented in their language and who will be responsible for interpreting and facilitating the informed consent discussion for the non-English speaking subjects:
Select all that apply:
Specify 'Other' method in which non-English speaking subjects or their LAR will be consented in their language and who will be responsible for interpreting and facilitating the informed consent discussion for the non-English speaking subjects:
Select the option for the Waiver or Alteration of the Consent:
Choose one that applies:
General Waiver or Alteration of Consent [45 CFR 46.116(f)(3)]:
Provide assurance that the research meets all of the waiver criteria listed below:
(i) The research involves no more than minimal risk to the subjects;
(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
Select all that apply:
Explain why the research could not practicably* be conducted without the waiver [45 CFR 46.116(f)(3)(ii)] (check all that apply):
*Practicably means capable of being done; it should not be determined by considerations of convenience, cost, or speed.
Select all that apply:
Explain why research could not be done if signed consent was required:
Waiver or Alteration of Consent in Research Involving Public Benefit and Service Programs
Will the research or demonstration project be conducted by or subject to the approval of state or local government officials?
Choose one that applies:
Provide the rationale on how the research or demonstration project is to be conducted by or subject to the approval of state or local government officials:
STOP! Answer must be 'YES' to meet criteria for a waiver of informed consent.
The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine (Check all boxes that are true; at least ONE option must be checked): [45 CFR 46.116(e)(3)(i)]
Select all that apply:
Provide the rationale on how the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
Could the research practicably be carried out without the waiver or alteration? [45 CFR 46.116(e)(3)(ii)]
Choose one that applies:
Provide the rationale on why the research could NOT practicably be carried out without the waiver or alteration:
Select the option for the Waiver of Documentation (Signed) Informed Consent:
Choose one that applies:
Would the ONLY document linking the subject and the research be the signed consent form?
Choose one that applies:
Would the principal risk of the research be potential harm resulting from a breach of confidentiality?
Choose one that applies:
Provide the rationale on why the primary risk of the research would be potential harm resulting from a breach of confidentiality:
STOP! Answer must be 'Yes' to meet criteria for a waiver of documentation of informed consent.
Wil the subject be provided with a Study Information Sheet or other document that addresses the basic elements of informed consent?
Choose one that applies:
Will each subject, parent or LAR be asked whether the subject wants documentation linking the subject with the research, and the subject?s wishes govern?
Choose one that applies:
Does the research involve no more than Minimal Risk? [45 CFR 46.116(f)(3)(i)]
Choose one that applies:
STOP! Answer must be 'Yes' to meet criteria for a waiver of documentation of informed consent.
Will the subject be provided with a Study Information Sheet or other document that addresses the basic elements of informed consent?
Choose one that applies:
Would the research procedures normally require a signed consent form outside the research environment?
Choose one that applies:
STOP! Answer must be 'No' to meet criteria for a waiver of documentation of informed consent.
Select the following research procedures that do not normally require signed consent (Check all that apply):
Select all that apply:
Specify and provide the rationale for 'Other' research procedures:
As Protected Health Information (PHI) is to be used, created, or disclosed as part of the research study, check the box below to confirm that the following information will be conveyed to the participant (i.e., included in Study Information Sheet):
Select all that apply:
Will the research involve no more than Minimal Risk? [45 CFR 46.116(f)(3)(i)]
Choose one that applies:
Are subjects or LARs members of a distinct cultural group or community in which signing forms is NOT the norm?
Choose one that applies:
Specify the distinct cultural group or community and provide the rationale on why signing forms is not the norm:
Is there an appropriate alternative mechanism for documenting that informed consent was obtained?
Choose one that applies:
Provide the alternative mechanism:
STOP! Answer must be 'Yes' to meet criteria for a waiver of documentation of informed consent.
Will the subject be provided with a Study Information Sheet or other document that addresses the basic elements of informed consent?
Choose one that applies:
IMPORTANT! Researchers access will be limited to the sample size numbers provided below. Should researchers need access beyond these numbers, an amendment must be approved by the IRB.
TIP! UCI has multiple tools that allow researchers to perform cohort identification analyses for their research with de-identified patient data from the UCI Health Enterprise Data Warehouse.
For more information, please contact Health Enterprise Data & Analytics.
Provide sample size numbers in the table below:
Pre-Screen Number:
Maximum Number:
Expected / Target Number:
Category/Group:
Age Range:
Pre-Screen Number:
Maximum Number:
Expected / Target Number:
Provide sample size numbers in the table below:
Maximum Number:
Expected / Target Number:
Category/Group
Age Range
Maximum Number:
Expected / Target Number:
Pre-screen Number Determination:
Explain how the pre-screen number was determined (e.g., cohort discovery, anticipated rate of enrollment):
Sample Size Determination:
Sample Size Determination:
Will this study take place only at UCI (i.e., does NOT involve other non-UCI sites)?
Choose one that applies:
Overall Study Sample Size:
Specify total number of subjects across all sites.
Specify the activities that require hSCRO review (check all that apply):
Select all that apply:
Cell Tracking Table
Complete the below table for each human cell line to be used during this research protocol.
+Add Line for multiple cell lines, as necessary.
Material
Indicate from one of the following:
Choose one that applies:
Cell Line Name/Tissue ID #
Supplier:
Provenance / Source Information (Stem Cell Registries, UCI/non-UCI IRB-approved collection protocol or Company & Catalog number for somatic cells used to generate iPSCs, etc. (Hyperlinks to registries or catalog entries are also allowed)):
For Embryonic Stem Cell lines, Provide the Registry #
(NIH, CIRM, UK Stem Cell Registry) or hyperlink:
Is the cell line/specimen anonymous or de-identified?
Choose one that applies:
Complete the below table describing the location of research procedures and storage of the cell line materials used in this study.
+Add Line for multiple locations, as necessary.
Building Name/Room Number for research procedures or storage of the cell line materials:
Research Procedures or Storage:
Select all that apply:
Enter Research Procedure:
Generation, Use, and Sharing of Stem Cells
Indicate how the biospecimens (cells, tissues) will be maintained should the responsible investigator leave UCI (or UCSB):
Choose one that applies:
Indicate how the biospecimens will be maintained should the responsible investigator leave UCI:
If you wish to maintain the cells after the completion of the research, please explain how and where the cells will be maintained:
Provide a concise description of the study design to include all experiments to be performed. Briefly describe the rationale behind the experiment or the hypothesis being tested (i.e., the reason for performing the procedure). Provide precise definitions of the measures and outcome variables and include tables and charts where needed or applicable:
Check all sites where UCI investigator(s) will conduct research activities (e.g., recruitment, informed consent, and research procedures including accessing identifiable, private information about participants):
Select all that apply:
Indicate where the research will be performed (check all the apply):
Select all that apply:
Is the location(s) public or private?
Select all that apply:
Specify the location where UCI IRB approved research will occur (check all that apply):
Select all that apply:
Specify location(s) or specify group name & provide website link if virtual:
Verify IRB approval for personnel at the non-UCI location(s) who are engaged in human subjects research activities:
Choose one that applies:
REQUIRED! Maintain on file a copy of the non-UCI IRB approval letter and approved consent form, as applicable.
Will UCI serve as the Coordinating Center of a multi-site study (i.e., the UCI researcher is the lead investigator of a multi-center clinical investigation or UCI is the lead institution of a multi-site study)?
Choose one that applies:
Describe the plan to manage the research project to ensure that the research is carried out in an ethical manner and to ensure adequate human research protections at all participating sites:
Confirm all of the following:
Select all that apply:
Describe the plan to ensure that following applicable information relevant to the protection of human participants will be recorded and shared between the participating sites:
The following information relevant to the protection of human participants will be recorded and shared between the participating sites (check all that apply):
Select all that apply:
Please describe other information that may impact risks to subjects:
Research conducted by UCI researchers falls under the University's purview and guidelines even when conducted elsewhere. Review HRP Policy # 27, which addresses conducting international human subject research.
Specify the international location:
Choose one that applies:
REQUIRED! Explicit consent is required. This may take the form of signed consent, audio-recorded oral consent, consent documented with a check-box or equivalent method involving a statement or clear affirmative action indicating consent.
Insert the Consent Language: General Data Protection Regulation (GDPR) template into the applicable consent form(s).
REQUIRED! Explicit consent is required. This may take the form of signed consent, audio-recorded oral consent, consent documented with a check-box or equivalent method involving a statement or clear affirmative action indicating consent.
Insert the Consent Language: China?s Personal Information Protection Law (PIPL) template into the applicable consent form(s).
IMPORTANT! Research cannot begin until a license is obtained. (This process can take several months.)
Name of Country:
Is an international investigator and/or an international site engaged in human subjects research activities (e.g., interact with subjects; have access to identifiable information)?
Choose one that applies:
Specify the international investigator(s) / site(s) and their level of engagement:
Does the location indicated above have an Institutional Review Board (IRB) or an equivalent ethics committee?
Choose one that applies:
REQUIRED! Submit IRB / ethics committee approval letter and approved consent form, if applicable; or a letter from the IRB / ethics committee waiving the requirement for IRB review in the Attachments section.
Will UCI researchers (including medical faculty, as applicable) be physically present at the international location?
Choose one that applies:
Describe how UCI researchers (including medical faculty, as applicable) will actively oversee the research project, including supervision of the research team (e.g., the lead researcher will hold bi-weekly Skype meetings with the study team to review research data, answer questions, etc.):
Specify who will be physically present at the research site, their role in the research and how long they intend to be present at the location:
Describe the researcher(s) qualifications (e.g., relevant coursework, past experience/research, and / or training) to conduct human subjects research in an international setting:
Does the researcher(s) speak/read/write the language of the potential subjects?
Choose one that applies:
Explain how recruitment, the informed consent discussion and data collection will take place:
Explain how the researcher(s) have knowledge of local community attitudes to mitigate the cultural norms and remain in compliance with U.S. regulations for research:
Explain how the cultural norms differ compared with U.S. culture in respect to research autonomy, consent, recruitment, confidentiality, etc. Include an explanation of the cultural sensitivities that will be required to conduct this study; consider current events (include additional documentation if necessary):
Has the researcher(s) been invited into the community?
Choose one that applies:
Explain:
Does the research involve access to patient medical records?
Choose one that applies:
Explain whether the country has regulations that protect access to medical records for research purposes (i.e. HIPAA in the U.S) and explain how the researcher(s) will adhere to the country?s requirements:
Is this research therapeutic?
Choose one that applies:
Describe what provisions have been made to provide continued access to the therapeutic intervention after completion of the study:
Does this research involve clinical care?
Choose one that applies:
Describe how the research may address an important scientific question regarding the host community/ country. If applicable, describe how the proposal is responsive to local health needs of the host community/ country. Be sure to describe both the standard of care in the USA and the available standard of care / alternatives in the host community/ country:
If UCI medical students / residents are performing clinical procedures, is it within the guides of what they would be allowed to do as a medical student / resident?
Research may provide subjects with beneficial care. In some countries, the type and level of clinical care provided to participants may not be available to them outside of the research context. As such, how will the research team minimize the likelihood subjects will believe mistakenly that the purpose of the research is solely to provide treatment rather than to contribute to scientific knowledge?
Clarify whether there has been an effort to secure continued access for all participants to needed experimental interventions that have been proven effective at the conclusion of the project:
Explain whether, if proven effective, the procedures will be available to some or all of the host country population:
Also explain either:
1. Why the research procedures (if effective) will NOT be made available to the host country's population:
OR
2. How the research procedures (if effective) will be made available to the host country's population. Please include a description of any pre-negotiations among sponsors, host country officials, and other appropriate parties aimed at making interventions available after the research:
Is there a reasonable way for the research team to collect, store and transfer the research data, including specimens (if applicable)?
Describe how any incidental findings will be handled ? including who will confirm the findings and how results will be conveyed to the subject:
What arrangements (if any) will be in place for the study data to be available to the subject population at the conclusion of the study?
Include an explanation of the study design (e.g., randomized placebo-controlled, cross-over, cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification/ randomization/blinding scheme:
Is this a study for which a statistical analysis plan is appropriate (e.g. quantitative study design)?
Choose one that applies:
Specify a non-statistical analysis plan for assessing study results:
Describe the statistical methods for the stated specific aims and hypotheses. The analysis plans should match the stated study specific aims and hypotheses:
Provide precise definitions of the study endpoints and criteria for evaluation; if the primary outcomes are derived from several measurements (i.e., composite variables) or if endpoints are based composite variables, then describe precisely how the composite variables are derived:
Describe the statistical method(s) that will be used to analyze the primary outcome(s) or endpoints:
If appropriate describe secondary or post hoc analyses of primary outcome(s) or other exploratory analysis and if necessary, provide a breakdown of the methods used per outcome or endpoint:
Include an explanation of the study design (e.g., randomized placebo-controlled, cross-over, cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification/ randomization/blinding scheme:
Not required. Please refer to Master Protocol.
Is this a study for which a statistical analysis plan is appropriate (e.g. quantitative study design)?
Not required. Please refer to Master Protocol.
Specify a non-statistical analysis plan for assessing study results:
Not required. Please refer to Master Protocol.
Describe the statistical methods for the stated specific aims and hypotheses. The analysis plans should match the stated study specific aims and hypotheses:
Not required. Please refer to Master Protocol.
Provide precise definitions of the study endpoints and criteria for evaluation; if the primary outcomes are derived from several measurements (i.e., composite variables) or if endpoints are based composite variables, then describe precisely how the composite variables are derived:
Not required. Please refer to Master Protocol.
Describe the statistical method(s) that will be used to analyze the primary outcome(s) or endpoints:
Not required. Please refer to Master Protocol.
If appropriate describe secondary or post hoc analyses of primary outcome(s) or other exploratory analysis and if necessary, provide a breakdown of the methods used per outcome or endpoint:
Not required. Please refer to Master Protocol.
UCI IRB requires that all clinical investigations involving greater than minimal risk to subjects develop a data and safety monitoring plan to assure the safety and welfare of the research subject/patient.
This is aligned with with NIH requirements and with federal regulations that require that IRBs assure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects/patients.
For clinical protocols involving a test article, it is common to have an independent Data Safety Monitoring Board (DSMB).
Please read the applicable HRP webpage for further guidance.
Does this protocol require a Safety Monitoring Plan?
Choose one that applies:
Provide details of those individuals who will be responsible for the safety oversight of your protocol, including the relevant experience/expertise of each individual (for UCI investigator initiated studies conducted only at UCI, provide the names and titles as well):
Indicate how frequently accumulated protocol data will be reviewed and evaluated for participant safety, protocol conduct and progress, and, when appropriate, efficacy:
Describe the events that would trigger an unscheduled review. Also include stopping guidelines and un-blinding rules if applicable:
List who will be locally monitoring and collecting information on adverse events and/or unanticipated problems (e.g., UCI Lead Researcher, Research Coordinator, etc.).
Include the name, title and experience of the individual(s) and further describe each individual?s role in the oversight of subject/patient participating in the protocol.
Describe the plan for annual reporting of the participants? safety, and the protocol's conduct, progress, and efficacy, when appropriate:
Does this protocol require a Safety Monitoring Plan?
Choose one that applies:
Provide details of those individuals who will be responsible for the safety oversight of your protocol, including the relevant experience/expertise of each individual (for UCI investigator initiated studies conducted only at UCI, provide the names and titles as well):
Indicate how frequently accumulated protocol data will be reviewed and evaluated for participant safety, protocol conduct and progress, and, when appropriate, efficacy:
Describe the events that would trigger an unscheduled review. Also include stopping guidelines and un-blinding rules if applicable:
List who will be locally monitoring and collecting information on adverse events and/or unanticipated problems (e.g., UCI Lead Researcher, Research Coordinator, etc.).
Include the name, title and experience of the individual(s) and further describe each individual?s role in the oversight of subject/patient participating in the protocol.
Describe the plan for annual reporting of the participants? safety, and the protocol's conduct, progress, and efficacy, when appropriate:
Treatment Procedures (check all that apply):
Select all that apply:
Provide a detailed chronological description of the procedures.
Will data be collected for this intermediate use/widespread IND beyond just reporting of adverse events?
Choose one that applies:
IMPORTANT! Effective December 31, 2023, all data collection forms/instruments must adhere to the University of California policy for Gender Recognition and Lived Name.
What kind of data will be generated/ collected/ shared and how?
Explain what the data will be used for:
Is the data collection going to be onerous on the patient? Explain:
Does the patient have the option to refuse data collection and still get the desired treatment? Explain:
Will there be Quality Assurance for data being collected? Explain:
Research Procedures (check all that apply):
Select all that apply:
Research Procedures (check all that apply):
Select all that apply:
Research Procedures (check all that apply):
Select all that apply:
Research Procedures (check all that apply):
Select all that apply:
Research Procedures (check all that apply):
Select all that apply:
Indicate 'Other' type of procedure:
Indicate the phase(s) of the study (check all that apply):
Select all that apply:
Specify whether UCI will participate in all phases of the clinical trial:
Will the research procedures differ from the Master or IRB-approved research protocol?
Choose one that applies:
Provide a description of any research procedures that will differ from the Master or IRB-approved protocol:
Provide a detailed chronological description of the procedures:
Provide a detailed chronological description of the procedures:
Not required. Please refer to Master Protocol.
Specify the total duration of a subject?s participation in the study and clearly outline the duration of participation for each study visit and sub-study, as applicable:
IMPORTANT! Effective December 31, 2023, all data collection forms/instruments must adhere to the University of California policy for Gender Recognition and Lived Name.
List all data collection tools (e.g., measures, questionnaires, observational tool) below; include citations for standardized/validated measure(s):
Are all data collection tools standardized or validated?
Choose one that applies:
REQUIRED! For data collection tools that are not standardized or not validated, submit a copy of the draft or final tool in the Attachments section.
The final version must be submitted for IRB approval via an amendment application prior to subject enrollment.
IMPORTANT! For data collection tools that are not standardized or not validated, maintain a copy of the final version on file in the researcher's record.
List all procedures involving the use and/or collection of photographs, or audio/video recording:
Will this study require clinical items/ services from UC Irvine Health?
Choose one that applies:
List the research procedure (e.g. phlebotomy for blood draws, pharmacy for dispensing study drug(s), radiation services for X-rays, lumbar punctures, MRIs, CT Scans), and identify the unit/department that will perform the procedure:
Research that is NOT under CCR, CFCCC, ASCC:
Click here to start UCI Center for Clinical Research (CCR) Study Activation Request Form.
Indicate the types/sources of identifiable private information (check all that apply):
Select all that apply:
Indicate the types/sources of identifiable private information (check all that apply):
Select all that apply:
Indicate the types/sources of identifiable private information (check all that apply):
Select all that apply:
Indicate whether the information was originally collected for research purposes:
Select all that apply:
UCI IRB must confirm that the original IRB approved consent does not preclude the research.
REQUIRED! Submit a copy of the Non-UCI IRB approval and consent form for the original research collection in the Attachments section.
Explain how the information were originally collected (e.g., clinical care):
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple numbers if appropriate):
Specify California prisoner record source:
Specify entity/vendor:
UCI IRB must confirm that the vendor?s policy does not preclude the research.
REQUIRED! Submit a copy of the Vendor Policy/Letter attesting that the sharing of information is ethical in the Attachments section.
UCI IRB requires that the vendor?s policy does not preclude the research.
REQUIRED! Maintain on file a copy of the Vendor Policy/Letter attesting that the sharing of information is ethical.
IMPORTANT! Access to UCI health data is facilitated through data stewards identified by the Health Data Governance Committee (HDGC).
Specify how UCI-Health medical records will be obtained:
Select all that apply:
Specify 'Other' medical records:
Specify Non-UCI Entity:
Explain how the study team will obtain Non-UCI Health records:
Specify the types of Non-UCI Student education records:
REQUIRED! Submit the FERPA (34 CRF 99) compliance letter from the local school/district site in the Attachments section.
REQUIRED! Maintain on file the FERPA (34 CRF 99) compliance letter from the local school/district site.
Specify the image(s)/recording source:
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple numbers if appropriate):
Specify the types of UCI student education records:
REQUIRED! Submit the FERPA (34 CRF 99) compliance letter from the UCI Registrar in the Attachments section.
REQUIRED! Maintain on file the FERPA (34 CRF 99) compliance letter from the UCI Registrar.
Specify the types of UCI student health medical records:
REQUIRED! Submit the FERPA (34 CRF 99) compliance letter from the UCI Registrar in the Attachments section.
Specify 'Other' record source:
Specify the date-range of the data used for the project (e.g. January 2002 to January 2020):
UCI Health Enterprise Data & Analytics records include:
The information below is required for the data & analytics request specifications.
Provide a complete list of ALL data points, variables, and/or information that will be collected (i.e. data abstraction form):
Specify the date-range of the data used for the project (e.g. January 2002 to January 2020):
Not required. Please refer to Master Protocol.
Provide a complete list of ALL data points, variables, and/or information that will be collected (i.e. data abstraction form):
Not required. Please refer to Master Protocol.
Indicate the source of the biospecimens and explain how the biospecimens will be obtained:
Select all that apply:
Indicate the source of the biospecimens and explain how the biospecimens will be obtained:
Select all that apply:
Indicate whether the biospecimens were originally collected for research purposes:
Select all that apply:
Explain how the biospecimens were originally collected (e.g., clinical care):
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple numbers if appropriate):
UCI IRB requires that the IRB approved consent does not preclude the research.
REQUIRED! Maintain on file a copy of the Non-UCI IRB approval and consent form for the original research collection.
UCI IRB must confirm that the original IRB approved consent does not preclude the research.
REQUIRED! Submit a copy of the Non-UCI IRB approval and consent form for the original research collection in the Attachments section.
Specify entity/vendor:
UCI IRB must confirm that the vendor?s policy does not preclude the research.
REQUIRED! Submit a copy of the Vendor Policy/Letter attesting that the sharing of information is ethical in the Attachments section.
UCI IRB requires that the vendor?s policy does not preclude the research.
REQUIRED! Maintain on file a copy of the Vendor Policy/Letter attesting that the sharing of information is ethical.
Specify UCI Health clinic or operating room:
Per HRP Policy 15 and the UCI Health Anatomical Pathology/Surgical Pathology - Procedure Number: S-23, all biospecimens removed from clinic or the operating room must be sent to UCI Health Pathology for review and documentation by a pathologist, with the exception of biospecimens specifically listed as exempt or biospecimens obtained from Dermatopathology.
To obtain Pathology clearance, contact Dr. Robert Edwards (redwards@uci.edu) or Delia Tifrea (dtifrea@hs.uci.edu).
Provide the protocol number for the UCI IRB Approved Protocol study (enter multiple numbers if appropriate):
Specify 'Other' biospecimens source:
This section must be completed for studies that involve the collection of specimens for genetic research and/or testing. This includes any studies involving the study of the genetic mechanisms of human disease and health.
Genetic specimens include blood, saliva, solid tumors, and any other tissues or body fluids used for genetic testing.
The IRB is responsible for reviewing genetic testing to protect the privacy of subjects by ensuring that appropriate mechanisms are in place to assure the confidentiality of the specimens and testing results. Some testing results could have the potential to define genetic traits or mechanisms belonging to an individual or population that have the potential to cause harm to study subjects.
Specify the type of specimens collected:
Specify the type of genetic testing to be performed (check all that apply):
Select all that apply:
Will a Clinical Laboratory Improvement Amendment (CLIA) approved lab be used to process/analyze the specimens?
Choose one that applies:
Will pedigree analysis and/or family linkage studies be performed?
Choose one that applies:
Will participants be informed of the results of genetic testing?
Choose one that applies:
Will the results of genetic testing become a part of the subjects? medical record?
Choose one that applies:
Is the research subject to the NIH Genomic Data Sharing (GDS) Policy (see policy FAQs)?
Choose one that applies:
IMPORTANT! If UCI Institutional Certification is needed, an Amendment is required to execute the certification prior to the distribution of genomic data sharing.
REQUIRED! Insert the appropriate language into the consent form, see: Consent Addendum: Language for Genomic Data Sharing (GDS). NIH has strict standards for IRB review and informed consent for the data they will accept for inclusion in GDS data repositories.
Deception is defined as providing intentionally misleading information.
Incomplete Disclosure, in the context of research, can be defined as withholding information about the real purpose of the research or giving subjects false information about some aspect of the research.
Deception or incomplete disclosure in research is only permitted if the research presents no more than minimal risk to subjects.
Explain the scientific rationale for use of deception or incomplete disclosure in the study. Could the research be conducted without the use of deception or incomplete disclosure?
Which aspects of study procedures will be withheld from the subjects?
Explain why the deception involves no more than minimal risk to subjects:
Explain whether the subjects would consider the information being withheld from them important when making a decision about whether to participate in the research. Does withholding the information adversely affect the rights and welfare of the subjects?
REQUIRED! UCI IRB requires the consent document to disclose the use of deception or incomplete disclosure.
UCI IRB also recommends that you develop and submit a copy of the debriefing script, as applicable in the Attachments section.
REQUIRED! UCI IRB requires the consent document to disclose the use of deception or incomplete disclosure.
UCI IRB also recommends that a debriefing script be used and that a copy of it be maintained on file.
Exempt Research Confirmation:
Select all that apply:
REQUIRED! UCI IRB requires completion of the Waiver or Alteration of the Consent section.
UCI IRB also recommends that you develop and submit a copy of the debriefing script, as applicable in the Attachments section.
Explain when and how the subjects will be told of the deception/incomplete disclosure:
Indicate who will inform subjects of the deception/incomplete disclosure:
Will subjects be given an opportunity to withhold use of their data given that they will not be fully informed about the purpose of the study until after data collection?
Choose one that applies:
Provide justification for not providing the opportunity to subjects:
Research conducted by UCI researchers falls under the University's purview and guidelines even when conducted elsewhere.
Who is responsible for giving permission/consent to conduct research in this setting/culture?
How will you handle situations in which permission from the group is provided but individuals do not want to participate and vice versa?
Will you consult with the people who gave you permission to collect data before you publish? Explain:
Generic Name:
Trade Name/Biologic:
Article Manufacturer:
Is the article a drug as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1))?
Choose one that applies:
Is the article a dietary supplement?
Choose one that applies:
Under DSHEA, a dietary supplement is not a drug if the intended use for which it is marketed is only to affect or evaluate the effect of the structure or any function of the body (i.e., not intended to be used for a therapeutic purpose).
Is the intent of the study to evaluate the dietary supplement?s ability to diagnose, cure, mitigate, treat, or prevent a disease?
Choose one that applies:
Is the article a Biological Product?
Is it a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings?
Choose one that applies:
Explain why the article is not a drug, citing any regulatory guidance, as applicable:
Explain why the article is not a drug, citing any regulatory guidance, as applicable:
Identify the regulatory status of the article to be used in this study:
Choose one that applies:
REQUIRED! Submit a copy of the FDA determination letter in the Attachments section.
REQUIRED! Provide a copy of the FDA determination letter if available. Acknowledgement Evidence of the IND number on the Master Protocol serves as a protocol ? specific reference and is acceptable evidence of the IND. Note: Researchers must provide documentation of a valid IND number prior to IRB approval. If the study is not externally funded or if a UCI investigator holds the IND, a copy of the FDA IND Application is required prior to IRB review. Upload copies in the Attachments Section.
IND Number:
Holder of the IND:
Choose one that applies:
Enter IND Lead Researcher:
Other IND Holder (e.g., NIH, GOG, CTEP):
Does the IND allow billing of subjects?
Choose one that applies:
Is the investigation intended to support FDA approval of a new indication or a significant change in the labeling of the article?
Choose one that applies:
Is the investigation intended to support a significant change in the advertising of the lawfully marketed agent?
Choose one that applies:
Does the investigation involve a route of administration or dosage level or use in a patient population or other factor (e.g., formulation) that significantly increases the risks to subjects (or decreases the acceptability of the risks) associated with the use of the article?
Choose one that applies:
Is the investigation intended to promote or commercialize the article (i.e., make promotional claims of safety or effectiveness)?
Choose one that applies:
Does the study require any change in the approved formulation, dosage, or route of administration of the article?
Choose one that applies:
REQUIRED! An IND application must be filed with the FDA.
For Cancer therapies only: Does the investigation involve a new use, dosage, schedule, route of administration, or new combination of marketed cancer articles in a population with cancer where based on the scientific literature and generally known clinical experience, there is no significant increase in the risk associated with the use of the article?
Choose one that applies:
IMPORTANT! For Cancer therapies only, an IND may NOT be required.
You may reference the section title and page number(s) of the Investigator Brochure or Package Insert rather than pasting or transcribing the relevant information in the following article information questions.
REQUIRED! Submit the Investigator Brochure or Package Insert in the Attachments section.
Specify the article description:
Specify the clinical pharmacology:
Specify the indications for use:
Specify the dosage and guidelines for administration (optional):
Specify the dosage and administration in this investigation (if different from approved):
Specify the toxicity and known side effects:
Specify the precautions and contraindications:
Describe how the investigational article will be prepared, controlled and who will be responsible for management of the article:
Choose one that applies:
IMPORTANT! All investigational articles/products utilized at UCI Health must be under the control of UCI Health Investigational Drug Services (IDS) Pharmacy. This includes storage, control, and distribution of investigational articles/products.
IMPORTANT! For Investigator Initiated Trials (IIT), evidence of UCI IDS pharmacy clearance is required in order to release IRB approval.
Describe your plan to ensure that the investigational article is used only in accordance with the UCI IRB approved protocol:
Describe who will access to the agent and how access will be controlled to secure the drug/biologic:
Specify how records for control of the article will be recorded:
Choose one that applies:
REQUIRED! Submit Sponsor Drug/Biologic Log in the Attachments section.
Specify why no log will be used:
Specify whether investigational article is prepared or manufactured in UCI research labs:
Choose one that applies:
Identify the lab:
Please read the HRPP webpage for information about the use of devices in clinical investigations.
Name of Device or Product:
Device Manufacturer:
Description of the device:
Specify the proposed use of the device for this study:
Does this device have an Instructions for Use/User Manual/Product Brochure?
Choose one that applies:
REQUIRED! Submit the Instructions for Use, User Manual or Product Brochure in the Attachments section.
Include information to describe how it works and the foreseeable risks associated with its use:
Is the device a medical device?
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent/in vitro diagnostics (IVD), or other similar or related article, including a component part, or accessory which is:
Choose one that applies:
If ?no?, for minimal risk studies and the device is intended to be used in a clinical setting, provide justification for selecting ?no?, citing any regulatory guidance as applicable:
Are you testing the safety and/or efficacy of this device?
Please view the FDA clinical investigation definition to determine if this device will be required for use in this study.
Choose one that applies:
If ?no?, for minimal risk research and if the device is the object of the investigation, provide justification for selecting ?no?, citing any regulatory guidance as applicable:
Is the device approved for marketing in the United States?
Choose one that applies:
How is the device approved in the United States?
Choose one that applies:
Select one of the following:
Choose one that applies:
Is the device authorized for use under an FDA Emergency Use Authorization (EUA)?
Choose one that applies:
Is the device being used in this study according to its approved indication?
Choose one that applies:
Is the Device Exempt from the Investigational Device Regulations (21 CFR 812)?
Choose one that applies:
Is the Device Exempt from the Investigational Device Regulations (21 CFR 812)?
Choose one that applies:
Select the device exemption that meets one of the following categories:
Choose one that applies:
Clarify how the device meets the category selected:
Is this device a Significant Risk (SR) device?
Significant Risk is:
Choose one that applies:
Has the investigator or sponsor of this research obtained an Investigational Device Exemption (IDE) from the FDA for the use of this device for this research?
Choose one that applies:
REQUIRED! Submit the IDE Authorization Letter in the Attachments section.
IDE Number:
Holder of the IDE (check all that apply):
Select all that apply:
Specify Lead Researcher:
Specify 'Other' IDE Holder:
Does the IDE allow billing of subjects?
Does the IDE cover a combination use (e.g., combination of an investigational drug and device)?
Specify the combination use:
Specify why an IDE has not been obtained yet:
Choose one that applies:
Specify 'Other' reason:
Based on the criteria for a significant risk device listed in the link below, explain why the device as it is used in this study, qualifies as Non-Significant Risk (NSR) device:
Has the FDA or another IRB determined the device to be non-significant risk as it is used in this study?
Choose one that applies:
Indicate who will be responsible for the management of the device during the study:
Explain the plan to ensure that the investigational device is used only in accordance with the UCI IRB approved protocol:
Indicate who will have access to the device and how access will be controlled to secure the device (or device stock):
Specify how records for control of the device (or device stock) will be recorded:
Choose one that applies:
REQUIRED! Submit the Sponsor Device Log in the Attachments section.
Specify why no log will be used:
Indicate whether the investigational device is manufactured in a UCI facility:
Choose one that applies:
Identify the lab and location:
The medical device form is completed. Click the 'Done' button.
If you need to add more devices, click on the + Add Line button above the table to enter additional devices.
Does your research involve the use of a placebo or sham procedure?
Choose one that applies:
Does a proven standard treatment/therapy exist to treat the disease/condition being studied?
Explain the answer:
Is the standard treatment/therapy considered to be effective?
Explain the answer:
Provide compelling and scientifically sound methodological reasons for use of placebo or sham procedure (e.g., the toxicity of the therapy is such that patients commonly refuse it):
Explain whether standard therapy is given to mitigate permanent harms (e.g., psychological harm, disfigurement or other serious adverse sequelae) or whether it is given to treat symptoms that constitute inconvenience or discomfort only:
Does the disease/condition being treated have the potential to progress to a higher risk condition if not actively treated (i.e., if assigned to placebo)?
Explain the answer:
Explain whether the natural fluctuation of the disease/condition is significant enough to necessitate the use of placebo or sham comparison to determine if the observed changes are due to treatment or natural history:
Explain whether it would be possible to predict the placebo or sham response rate in this study with a reasonable degree of accuracy:
Clarify whether subjects in the placebo group would be exposed to an increased risk of death, severe morbidity or disability, severe discomfort, or other long-term negative effects:
Explain how the study design will minimize risks to subjects:
Does your research involve the use of use of a placebo washout period?
Choose one that applies:
STOP! Research with a placebo, sham procedure, or placebo washout period is not applicable.
Provide compelling and scientifically sound methodological reasons for use of placebo-washout:
Explain whether the disease/condition being treated has the potential to progress to a higher risk condition if not actively treated:
Indicate the duration of the washout period:
Describe the risks specific to the placebo-washout phase of the study:
Explain how the study design will minimize risks to subjects:
Will Individual results be shared with subjects?
Choose one that applies:
Explain what information will be shared and how the results will be shared:
Will overall study results will be shared with subjects?
Choose one that applies:
Specify how overall study results will be shared with subjects:
Exempt - No more than minimal risk to subject
Select the applicable category(ies) (check all that apply):
Select all that apply:
The research involves educational tests, survey/interview procedures, or observation of public behavior, select criteria:
Choose one that applies:
Note: For Category 2iii, any disclosure of the human subjects' responses outside the research would reasonably* place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
The research involves benign behavioral interventions with adult subjects, select criteria:
Choose one that applies:
Note: For Category 3iC, any disclosure of the human subjects' responses outside the research would reasonably* place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, select criteria:
Choose one that applies:
Note: Category 4i applies to secondary research use of archives in a public library, for example, or to government or other institutional records where public access is provided on request, or from a commercial entity if the information is provided to members of the public on request or if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor to an archive. It would also apply if a commercial entity made identifiable biospecimens publicly available to anyone on request or for a fee.
IMPORTANT! For 4ii, identifiers are NEVER collected/recorded. If identifiers are collected/recorded, choose Expedited Category 5 instead.
Taste and food quality evaluation and consumer acceptance studies; specify:
Choose one that applies:
ATTENTION! The Level of Review may qualify for Exempt Self-Determination.
Step 1: Assess whether the research qualifies for Exempt Self-Determination.
Step 2: If eligible for self-determination, go to Project Screener > 'Submission Type' > ?Administrative Determination or Registration? > 'Exempt Self-Determination'
Minimal Risk - No more than minimal risk to subjects
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Select the applicable category(ies) (check all that apply):
IMPORTANT! All procedures must be accounted for under applicable categories and must fit within the limitations of those categories; otherwise, Full Committee review is required.
Select all that apply:
Expedited Category 1 - Clinical Studies of:
Select all that apply:
Expedited Category 2 - Blood sample as follows:
Select all that apply:
Expedited Category 5¹ - Materials that:
Select all that apply:
Expedited Category 8 - Continuing review where:
Choose one that applies:
Risks and Discomforts
1. Describe and assess any reasonably foreseeable risks and discomforts associated with each procedure for each subject population ? physical, psychological, social, legal or other.
2. If this study will involve the collection of identifiable private information, even temporarily, for which the disclosure of the data outside of the research could reasonably place the subjects at risk, include the risk of a potential breach of confidentiality.
A bullet point list is recommended.
EXPEDITED/FULL COMMITTEE ONLY: Include an assessment of their expected frequency (e.g., common ? 65%, less common ? 40%, unlikely ? 5%, rare - <1%) and the seriousness (mild, moderate, severe).
Discuss what steps have been taken and/or will be taken to prevent and minimize any risks/potential discomforts to subjects:
Discuss what steps have been taken and/or will be taken to prevent and minimize any risks/potential discomforts to subjects:
Not required. Please refer to Master Protocol.
Specify whether a confidentiality certificate has been issued for the study:
Effective October 1, 2017, all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH that was commenced or ongoing on or after December 13, 2016 is deemed to be issued a certificate.
For more information, review this guidance.
Select all that apply:
REQUIRED! Ensure that the requisite certificate language is in consent document; see template: Consent Forms
REQUIRED! Submit the certificate or application for the certificate in the Attachments section.
NIH may issue a Certificate for this study; however, issuance is discretionary.
The study topic (e.g., purpose, objectives, aims) must fall within a mission area of the NIH or the Department of Health and Human Services.
Indicate in what situations identifiable private information protected by a certificate will be disclosed (check all that apply):
Select all that apply:
Specify the situation(s) where identifiable private information protected by a certificate will be disclosed:
Is there the prospect of a direct benefit anticipated for subjects?
Choose one that applies:
Describe the potential benefits subjects may expect to receive from participation in this study:
Specify the expected potential societal/scientific benefit(s) of this study:
Describe the alternatives to participation in the study available to prospective subjects. Include routine (standard of care) options as well as other experimental options, as applicable (check all that apply):
Select all that apply:
Describe the alternatives to participation in the study available to prospective subjects (check all that apply):
Select all that apply:
Is the alternatives to earn extra course credit verified by SONA?
Choose one that applies:
Specify alternatives to earn extra course credit:
Specify 'Other' alternatives to study participation:
Specify the routine standard of care:
Compensation is when participants are paid for their time & efforts in research.
For more information see: Compensation Info.
Are participants compensated?
Choose one that applies:
Compensation method:
Choose one that applies:
Specify amount:
Compensation schedule:
Choose one that applies:
Specify 'Other' schedule:
Will the cash compensation method include all subjects?
Choose one that applies:
Specify compensation cohort:
Is the total monies participants receive greater than or equal to $600?
REQUIRED! The confidentiality sections of the protocol and the consent document must disclose that participant names and social security numbers must be collected and reported to UCI Accounting for tax-reporting purposes.
Does compensation involve the use of lotteries, raffles, or drawings?
Choose one that applies:
The California Department of Consumer Affairs requires additional considerations when using lotteries, raffles, and drawings, see UCI Lottery Guidance.
Is total value of the prize greater than or equal to $600?
Choose one that applies:
STOP! To use lotteries, raffles, or drawings, the prize must be valued at less than $600.
Change the prize value or do not use this compensation method.
Will the lotteries, raffles, and drawings be used for all compensation methods listed above?
Choose one that applies:
Specify the compensation(s) that will use lottery, raffle, or drawing:
Specify the procedures for the inclusion of an individual who is not asked to participate in the study, but wishes to be included in the lottery, raffle, and/or drawing:
Specify a fair method of choosing the winner and explain how the winner will be notified:
Specify the approximate chance of winning (e.g., no less than 1 in 1000):
REQUIRED! Ensure that the consent/assent document specifically informs individuals that they are not guaranteed to win any prize in the drawing and that the only compensation they will receive is the ?1 in X? chance of winning. Also, include that participation in the research is not required to be included in the lottery, raffle, or drawing.
Will subjects pay for the expanded access treatment, RTT or HUD?
Choose one that applies:
Provide details:
Will subjects or their insurers be charged for study procedures?
Choose one that applies:
Identify and describe those costs:
Will subjects be reimbursed for out-of-pocket expenses?
Choose one that applies:
Describe any requirements for reimbursement (e.g., receipt):
Check all measures that will be used to maintain the study subject?s privacy:
Select all that apply:
Specify 'Other' measure to protect privacy:
Check all measures that will be used to maintain the confidentiality of identifiable information:
Select all that apply:
Specify 'Other' measure to protect confidentiality:
Specify who will establish and manage the repository:
Choose one that applies:
Specify non-UCI Entity:
Indicate how the stem cell line information and biospecimens are obtained, stored, and secured (check all that apply):
Select all that apply:
Specify how 'Other' stem cell line information and biospecimens are obtained, stored, and secured:
Indicate how stem cell line electronic data is obtained, stored, and secured (check all that apply):
Select all that apply:
Specify how 'Other' stem cell line electronic data is obtained, stored, and secured:
Indicate the Protected Health Information (PHI) identifiers be collected or retained for data analysis, recruitment, consenting and/or compensation (check all that apply):
Select all that apply:
Will any identifiable private information be collected or retained for data analysis, recruitment, consenting and/or compensation?
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record information). Private information must be individually identifiable.
Identifiable is where the identity of the subject is or may be ascertained by the researcher, or will be associated with the information. The could involve the use of coded data.
List the subject identifiers that will be collected or retained:
Will a code be used to link subject/patient identifiers with the information and/or biospecimens?
Choose one that applies:
Provide the rationale for the above response:
Specify how identifiers are attached:
Will any identifiable photos or audio/video recordings be collected or used (check all that apply)?
Select all that apply:
Will the identifiable photographs/digital images be de-identified?
Choose one that applies:
Provide rationale on why identifiable photographs/digital images will not be de-identified:
Specify timeframe for the photographs/digital images de-identification and how will the photographs/digital images be de-identified:
How will the audio recordings be transcribed?
Choose one that applies:
Provide rationale on why identifiable audio recordings will not be transcribed:
Specify timeframe for the audio transcription:
Provide the service for the audio transcription:
Will the identifiable audio recordings be de-identified?
Choose one that applies:
Provide rationale on why identifiable audio recordings will not be de-identified:
Specify timeframe for the audio recordings de-identification and how will the recordings be de-identified:
How will the video recordings be transcribed?
Choose one that applies:
Provide rationale on why identifiable video recordings will not be transcribed:
Specify timeframe for the video transcription:
Provide the service for the video transcription:
Will the identifiable video recordings be de-identified?
Choose one that applies:
Provide rationale on why identifiable video recordings will not be de-identified:
Specify timeframe for the video recordings de-identification and how will the recordings be de-identified:
Specify whether subject/patient identifiers will be disclosed in presentations and/or publications:
Choose one that applies:
Specify how long all subject/patient identifiers will be retained. This includes identifiers stored in paper format, stored electronically as well as video recordings, audio recordings, photographs, etc.:
Choose one that applies:
Please provide the rationale on why all subject/patient identifiers will be maintained indefinitely:
Specify 'Other' time frame and provide rationale:
Are University of California / UC Irvine records (e.g., medical, employment, student applications, etc.) disclosed to the research team?
CA Civil Code §1798 ? California Information Practices Act (CIPA)
§1798.3 (c) The term disclose means to disclose, release, transfer, disseminate, or otherwise communicate all or any part of any record orally, in writing, or by electronic or any other means to any person or entity.
Choose one that applies:
Indicate whether the records include personal information (check all the apply):
§1798.3(a): The term personal information means any information that is maintained by an agency (i.e., UCI) that identifies or describes an individual, including, but not limited to the information listed below.
Select all that apply:
Specify the 'other' personal information:
Explain why the personal information is needed to conduct the research:
Specify how disclosure of UC/UCI records to the study team is permitted:
Select all that apply:
Explain how the disclosure of personal information is relevant and necessary in the in the ordinary course of the performance of the study team?s UC duties:
Explain how the disclosure of personal information is related to the purpose for which the information was acquired:
Explain a plan to destroy or return all personal information as soon as it is no longer needed for the research project. OR
Demonstrate an ongoing need for the personal information for the research project and has provided a long-term plan sufficient to protect the confidentiality of that information.
Check the box below to provide assurance that the personal information will not be reused or disclosed to any other person or entity, or used in any manner, not approved in the research protocol, except as required by law or for authorized oversight of the research project.
Select all that apply:
Indicate how information and/or biospecimens (including signed consent forms) will be stored (check all that apply):
Select all that apply:
Specify where the biospecimens will be stored in a locked lab/refrigerator/freezer:
Specify where the information will be maintained electronically:
Specify where the information will be maintained in hard copy:
For enterprise cloud storage, select the location that adheres to the UCI Protection Level required for the research information:
Select all that apply:
Specify 'Other' storage method:
Specify 'Other' storage location:
Will subject identifiers be transported or maintained on portable devices (e.g., laptop, smartphone, external hard drive, etc.)?
IMPORTANT! Only the ?minimum data necessary? should be stored on portable devices or transported as doing so makes it susceptible to loss or theft.
Choose one that applies:
Specify the device(s) or method(s) of transportation:
Explain why transporting or maintaining subject identifiable data/biospecimens on portable devices is necessary:
Indicate how long research information/biospecimens will be retained:
Choose one that applies:
Specify time frame and provide the rationale for research information and/or biospecimens retention:
The research team, authorized UCI personnel, the study sponsor (as applicable) and regulatory entities such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP), may have access to participants' study records to protect their safety and welfare.
The research team, authorized UCI personnel, the study sponsor (as applicable) and regulatory entities such as the Office of Human Research Protections (OHRP), may have access to participants' study records to protect their safety and welfare.
Will research materials (information/ biospecimens) be shared with collaborators (i.e., researchers not covered under the UCI project), for purposes within the scope of the current project?
Choose one that applies:
IMPORTANT! UCI IRB requires that the protocol team will remove all of the identifiers listed in the previous 'Participant Identifiers' section prior to distribution.
Specify researcher/entity for shared identifiable information/biospecimens:
List of all identifiers to be shared:
Provide rationale to share identifiers:
IMPORTANT! UCI IRB requires that all appropriate data use agreements will be finalized before sharing and other site IRB Approval or IAA/IIA request documentation if actively engaged in human subjects research
Specify who will establish and manage the repository:
Choose one that applies:
Will identifiers be retained to manage the UCI biorepository?
Choose one that applies:
Indicate the minimum subject identifiers that are required to manage the biorepository (check all that apply):
Select all that apply:
Indicate the minimum subject identifiers that are required to manage the biorepository (check all that apply):
Select all that apply:
Will biospecimens be retained in the biorepository?
Choose one that applies:
Specify 'Other' unique identifier:
Describe the type(s) of information/biospecimen to be stored:
Describe for what purpose the information/biospecimens will be stored:
Explain any specific future benefits that might be expected to accrue to families or groups. Indicate what scientific, medical, and social benefits are likely to accrue as a result of research performed on information/biospecimens in this biorepository:
Specify who on the current research team will be responsible for the management of the biorepository (i.e., person responsible for maintaining the repository, stripping identifiers, coding and/or distributing information/biospecimens):
Specify how much time will elapse between the time of collection and storage of information/biospecimens in the biorepository:
Describe the acquisition, logging in, and tracking of information/biospecimens:
Specify how the information/biospecimens will be prepared for storage (i.e. describe the process):
Describe how the information/biospecimens will be labeled while in storage (e.g., with a unique, random number or code, in order to protect the confidentiality of research subjects, de-identified after specified time):
Since identifiable information will be retained, participants must be given the opportunity to withdraw their information/biospecimens from the biorepository. Describe the procedures for honoring participant withdrawal requests:
Provide the physical location where the information/biospecimens will be stored (i.e. building and room number, indicate if freezer is involved, etc.):
Describe the security plan for the biorepository. Indicate if there are automated backup security systems to monitor storage equipment, including a backup power source in the event of a freezer failure or other emergency situation:
Indicate how long information/biospecimens will be stored in the biorepository:
Choose one that applies:
Information/biospecimens will be maintained until:
Indicate how the biorepository will be maintained should the responsible investigator leave UCI:
Choose one that applies:
Please describe:
Indicate who may request access to the stored Information/biospecimens (check all that apply):
Select all that apply:
Specify topics that researchers at UCI are studying:
Specify topics that researchers at another institution are studying:
Specify the formal process in which researchers would request to use information/biospecimens stored in this research biorepository:
Information can be cut and pasted from standard operating procedures, if established (strongly recommended).
Indicate how information/biospecimens will be shared with others (check all that apply):
Select all that apply:
IMPORTANT! All studies of investigational IVDs that will support applications to FDA are subject to 21 CFR Parts 50 and 56, even if they are not subject to most requirements of 21 CFR Part 812. For more information see the FDA Guidance on In Vitro Diagnostic Device Studies - FAQs.
Confirmation Required:
Select all that apply:
List the subject identifiers that may be provided to researchers and provide justification:
Confirmation:
Select all that apply:
Specify how the biorepository managers will be trained on the appropriate manner to ship the information/biospecimens to ensure that the integrity of the material is maintained. Information can be cut and pasted from standard operating procedures, if established (strongly recommended):
Specify how the biorepository managers will verify that the information/biospecimens were properly shared/delivered:
For UCI IRB templates, visit IRB Forms.
For hSCRO templates, visit Applications & Forms.
To access approval documents where UCI will rely on another IRB, including commercial IRBs, visit their respective online portals. Frequently used commercial IRB portals include:
ATTENTION! If requisite documentation is not attached, the submission will be returned as incomplete.
Maximum file size is 30MB
Attachment Type
Choose one that applies:
File Comments
File Name
Status (HRP Use Only)
Choose one that applies:
Agenda (HRP Use Only)
Choose one that applies:
STOP! Please upload the DoD Supplement Form
STOP! Please upload the Emergency Use Physician Attestation Form
STOP! Please upload the Expanded Access Consent
STOP! Please upload the Expanded Access Consent
STOP! Please upload the 3926 form
STOP! Please upload FDA IND/IDE Letter or documentation
STOP! Please upload the HUD Consent
STOP! Please upload the FDA HDE Letter or documentation
STOP! Please upload the HUD Brochure
STOP! Please upload the Right to Try Attestation and Consent Template
STOP! Please upload the Non-UCI IRB's SMART Letter of Acknowledgement (LOA) or Institutional Authorization Agreement (IAA)
STOP! Please upload the Non-UCI entity?s conflict of interest management plan
STOP! Please upload the Non-UCI entity?s RSC approval
STOP! Please upload the Non-UCI entity?s IBC approval
STOP! Please upload the SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record)
STOP! Please upload the SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record)
STOP! Please upload the SMART IRB - Letter of Acknowledgement (UCI is IRB of Record & HIPAA Board)
STOP! Please upload the SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record)
STOP! Please upload the SMART IRB ? Letter of Acknowledgement (UCI is IRB of Record)
STOP! Please upload the SMART IRB - Letter of Acknowledgement (UCI is IRB of Record & HIPAA Board)
STOP! Please upload the Institutional Authorization Agreement (IAA) - (UCI is IRB of Record)
STOP! Please upload the Institutional Authorization Agreement (IAA) - (UCI is IRB of Record)
STOP! Please upload the Institutional Authorization Agreement (IAA) - (UCI is IRB of Record & HIPAA Board)
STOP! Please upload the Individual Investigator Agreement (IIA)
STOP! Please upload the CHOC consent form
STOP! Please upload the email from MHS acknowledging their reliance on UCI
STOP! Please upload your Master Protocol
STOP! Please upload your Investigator Brochure(s)
STOP! Please upload your Package Insert
Please upload your Package Insert
STOP! Please upload the Consent Form
STOP! Please upload the Assent Form
STOP! Please upload documentation on why the prisoner research will pose no more than inconvenience to the subject and select 'Other' as the attachment type.
STOP! Please upload your FERPA evidence
STOP! Please upload your FERPA evidence
STOP! Please upload the Non-UCI IRB approval and consent form for the original research collection
STOP! Please upload the Vendor/Policy Letter
STOP! Please upload your Recruitment Materials
STOP! Please upload your Recruitment Materials
STOP! Please upload the HIPAA Research Authorization Form
STOP! Please upload the HIPAA Research Authorization Form
STOP! Please upload the HIPAA Research Authorization Form
STOP! Please upload the Study Information Sheet
STOP! Please upload your Pre-Screening Script
STOP! Please upload your Pre-Screening Script
STOP! Please upload the Paper-based Consent Form
STOP! Please upload the Paper-based Parental Permission Form
STOP! Please upload the Paper-based Assent Form
STOP! Please upload the Paper-based Assent Form
STOP! Please upload the Electronic Consent Form
STOP! Please upload the Electronic Parental Permission Form
STOP! Please upload the Electronic Assent Form
STOP! Please upload the Electronic Assent Form
STOP! Please upload a copy of the draft or final data collection tool/instrument
STOP! Please upload the FERPA compliance letter from the UCI Registrar
STOP! Please upload the FERPA compliance letter from the local school/district site
STOP! Please upload the FERPA compliance letter from the UCI Registrar
STOP! Please upload the FERPA compliance letter from the UCI Registrar
STOP! Please upload the FERPA compliance letter from the local school/district site
STOP! Please upload the FERPA compliance letter from the UCI Registrar
STOP! Please upload the Non-UCI IRB approval and consent form for the original research collection
STOP! Please upload the Vendor/Policy Letter
STOP! Please upload the Vendor/Policy Letter
STOP! Please upload the Non-UCI IRB approval and consent form for the original research collection
STOP! Please upload the Vendor/Policy Letter
STOP! Please upload the FDA Determination Letter
STOP! Please upload the IND Acknowledgement Letter
STOP! Please upload the Sponsor Drug/Biologic Log
STOP! Please upload the medical device instructions for use, user manual or product brochure
STOP! Please upload a picture of the medical device
STOP! Please upload FDA documentation for the marketed device
STOP! Please upload the IDE Authorization Letter
STOP! Please upload the Sponsor Device Log
STOP! Please upload the certificate application (CoC Documentation)
STOP! Please upload the certificate application (CoC Documentation)
STOP! Please upload the certificate that has been issued (CoC Documentation)
STOP! Please upload the certificate that has been issued (CoC Documentation)
STOP! Please upload the UCI RSC approval
STOP! Please upload the UCI IBC approval
By checking the box below, the Investigator:
Select all that apply:
Investigator's Assurance
As Lead Researcher, I have ultimate responsibility for the performance of this study, the protection of the rights and welfare of the human subjects, and strict adherence by all co-investigators and research personnel to all Institutional Review Board (IRB) requirements, federal regulations, and state statutes for research involving human subjects.
I hereby assure the following:
I and all co-investigators and research personnel agree to comply with all applicable requirements for the protection of human subjects in research including, but not limited to, the following:
Select all that apply:
Investigators' Disclosure of Financial Interest
In order to inform research subjects of circumstances that may affect their decision to participate in this study, all researchers are required to disclose their financial interests with outside institutions.
The Lead Researcher of the protocol must ask the following question of all study team members:
?Do you, your spouse/registered domestic partner, and dependent children together have any disclosable financial interests (i) that would reasonably appear to be affected by the research; or (ii) in entities whose financial interests would reasonably appear to be affected by the research?"
A member of the study team who answers in the affirmative will be contacted by the Conflict of Interest Oversight Committee (COIOC) to obtain additional information regarding their specific financial interest(s).
IMPORTANT! If there has been a change in the financial disclosures of the LR or the study team, please also request a 'Change in Financial Interests'.
Select all that apply:
As Primary Lead Researcher and Faculty Sponsor, we have ultimate responsibility for the performance of this study, the protection of the rights and welfare of the human subjects, and applicable UCI policies, as well as state statutes for research involving human subjects.
I hereby assure the following:
Select all that apply:
Select all that apply:
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Contact the Office of Research
For KRP technical questions or issues:
For IRB questions and regulatory or institutional guidance:
For KRP technical questions or issues:
For hSCRO questions and regulatory or institutional guidance: