Office of Research IRB Member Resources - Office of Research

IRB Member Resources

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

The biomedical/clinical committees both meet twice each month. The social and behavioral committee meets monthly.

Meeting Dates: 2021, 2020, 2019, 2018, 2017

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.

 

Reviewer’s Guide

Initial Submissions

Renewal Submissions

Modification

Reportable New Information

Consent Template

Worksheets

 

Choosing Determinations

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.

Deferral

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.

Disapproval

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.

Non-Compliance

  • 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.

Serious Non-Compliance

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.

Continuing Non-Compliance

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)

 

Definition of Minimal Risk

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.

 

Reviewer’s Checklists

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.

 

Committee Member Placemat

Reviewer placemat