UC Davis IRB Members have superior knowledge, experience and dedication. We appreciate their hard work and thorough review of proposed research. The following are useful resources for conducting IRB reviews.
In This Section
- Meeting Dates
- Reviewer’s Guide
- Choosing Determinations
- Definition of Minimal Risk
- Reviewer’s Checklist
- Committee Member Placemat
The biomedical/clinical committees both meet twice each month. The social and behavioral committee meets monthly.
Requesting Rush Review
Requests for rush review or document processing will be evaluated on a case-by-case basis. Please use the Project Mail or submission comment box in IRBNet to contact IRB Administration with a rush request. Include the justification for the rush, a date by which the determination is needed, and any possible impacts on subjects’ rights or welfare in your message.
Reportable New Information
- HRP-306 Drugs
- HRP-307 Devices
- HRP-314 Criteria for Approval and Additional Considerations
- HRP-314B Requirement for Informed Consent
- HRP-315 Advertisements
- HRP-316 Payments
- HRP-318 Additional Federal Agency Criteria
- HRP-325 Clinical Trials Contraception
Approval or Approval with Administrative Comments
An “approval” or “approval with administrative comments” is issued when the committee has no questions or concerns about the current submission. The IRB members may provide comments about the approval or recommendations for future submissions. These comments will be included in the approval letter.
Modifications Required to Secure Approval
Granted when the submission does not meet the criteria for approval, Worksheet: Criteria for Approval (HRP-314), but committee recommends approval contingent on required directed revisions to the protocol or consent document. When this determination is made, the response does not need to go back to Committee for review. The required revisions will be described in the letter of action. The investigator must provide a separate, point-by-point response. The revisions must be made exactly as described in the letter of action in order for the study to be approved by a designated reviewer without additional review by the committee. If the revisions submitted in the response are not exactly as described in the letter of action, or if the response contains revisions in addition to those requested, the response will be assigned to an agenda for full committee review.
Determination for research that does not meet the criteria for approval, Worksheet: Criteria for Approval (HRP-314), and new information or clarification is needed to determine that one or more of the criteria are satisfied. This determination is made when serious concerns are raised about the risk/benefit ratio or other issues of human subject protection and the members of the committee agree that additional information, justification, or changes are needed before approval can be reconsidered. The investigator’s response to the committee’s requirements will be reviewed by the full committee.
The committee has found that the study design, research risks and benefits, consent process, and/or documentation of consent are inappropriate or inadequately described, such that the committee cannot specify changes necessary to meet the criteria for approval, Worksheet: Criteria for Approval (HRP-314). This determination is made very rarely. The investigator’s response to the committee will typically require major revision to the study’s procedures, inclusion/exclusion criteria, or aims and will need to be reviewed by the full committee.
- Failure to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects, and/or with the requirements or determinations of an IRB.
- In the case of research funded or conducted by the Department of Defense (DOD), Non- Compliance includes failure of a person, group, or institution to act in accordance with Department of Defense (DOD) instruction 3216.02, its references, or applicable requirements.
Noncompliance that adversely affects the rights or welfare of participants. For Department of Defense (DOD) research Serious Non-Compliance includes failure of a person, group, or institution to act in accordance with Department of Defense (DOD) Instruction 3216.02 and its references such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.
A pattern of noncompliance that indicates an inability or unwillingness to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects and/or with the requirements or determinations of an IRB.
Unanticipated Problem Involving Risks to Subjects or Others
An incident, experience, or outcome that meets all of the following criteria:
- Unexpected (in terms of nature, severity or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.
None of the Above (Acknowledgement)
None of the Above (Acknowledgement)
The probability and magnitude of harm or discomfort anticipated in the research that 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.
Federal regulations require the IRB to make specific determinations for waivers of consent or documentation of consent, for inclusion of certain vulnerable populations and for investigations of drugs and devices. UC Davis IRB uses a checklist to document these determinations in a manner acceptable to regulators. Members are asked to complete the following documents, when applicable.
- HRP- 410 Waiver or Alteration of the Consent Process
- For use when consent will be waived or when deception is used.
- HRP- 411 Waiver of Written Documentation of Consent
- For use when the requirement for a signature on a consent form is waived.
- HRP-412 Pregnant Women
- HRP-416 Children
- For use when individuals who meet the definition of “child” will be included in the research.
- Children means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.
- HRP-417 Cognitively Impaired Adults
- For use when individuals who lack capacity to personally consent are included in the research.
- HRP-418 Non-Significant Risk Device
- For use with clinical investigations of medical devices
- HRP-441 HIPAA Waiver of Authorization
- For use when identifiable medical records will be accessed without authorization