Committee Actions and IRB Approval Process
IRB Actions
May 2024
45 CFR 46. 111
Criteria for IRB approval of research (DHHS)
21 CFR 56.111
Criteria for IRB approval of research (FDA)
1.
The Primary Reviewer presents their summary/concerns.
2.
The Secondary Reviewer presents their summary/concerns (if
applicable)
3.
The committee discusses the study following the presentation of
the primary and secondary reviewers’ evaluation and comments.
4.
The Primary Reviewer includes a recommendation for a motion in
their written review and shares it with the board.
5.
Following the committee discussion, a final motion is made…
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45 CFR 46. 111
Criteria for IRB approval of research (DHHS)
21 CFR 56.111
Criteria for IRB approval of research (FDA)
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Approve
Approve with Contingencies, Designated Reviewer
Approve with Contingencies, Staff Verifiable
Defer
Disapprove
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The study as written
meets all criteria for approval
with no further changes
Approve
Committee Actions
USC HRPP Policies, Chapter 7.8
45 CFR 46. 111
Criteria for IRB approval of research (DHHS)
21 CFR 56.111
Criteria for IRB approval of research (FDA)
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Approve with Contingencies,
Designated Reviewer
Committee Actions
USC HRPP Policies, Chapter 7.8
The board finds that the application is “approvable” with
modifications, clarifications, and/or verifications, examples:
1)
confirmation of specific assumptions or understandings on the
part of the IRB regarding how the research will be conducted;
2)
submission of additional documentation;
3)
precise language changes to protocol or informed consent
documents; or
4)
substantive changes to protocol or informed consent
documents along with
clearly stated parameters
that the
changes must satisfy.
This may be a chair, committee
member, or IRB analyst with
appropriate experience or expertise
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Approve with Contingencies,
Staff Verifiable
Committee Actions
USC HRPP Policies, Chapter 7.8
If changes proposed are
administrative/editorial
in nature,
NOT
part of the approval criteria then no additional IRB review is
needed, and the changes can be reviewed as part of the
verification process.
The contingency cannot be tied to a judgement or justification.
Examples: confirmation of ancillary approvals, site permission,
HRPO approval, check a box, very precise changes to a document,
CTO.
This is less about “who” reviews as it is
about the nature of the contingency
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Defer
Committee Actions
USC HRPP Policies, Chapter 7.8
The board has concerns about the study or significant information
or modifications are needed that are directly relevant to the criteria
for approval.
Examples:
Questions about the risks, research design/methodology, statistical
analysis, data safety monitoring plan, provisions for protecting
participant’s safety and privacy, and informed consent documents.
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Disapprove
Committee Actions
USC HRPP Policies, Chapter 7.8
The protocol describes research activities that may pose
significant concerns for human participant safety with
minimal prospect of benefit
The risk to benefit ratio is deemed unfavorable
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1)
Clarify the time points at which participants will be
evaluated to determine imminent risk in the suicide plan.
2)
Confirm that the IP address will not be recorded.
3)
Please revise the exclusion criteria to specify what score
on the Montreal Cognitive Assessment (MoCA) will result
in a participant being excluded.
4)
Please upload the HRPO review document once
obtained.
5)
Please revise the exclusion criteria to explain if and how
you will exclude those with diminished capacity.
Approve
Approve w/ contingencies,
designated reviewer
Approve w/contingencies,
staff verifiable
Defer
Disapprove
Designated
Reviewer
Staff
Verifiable
Defer
Approve with Contingencies, Designated Reviewer
Defer
Approve with Contingencies, Staff Verifiable
Approve with Contingencies, Designated Reviewer
Approve with Contingencies, Staff Verifiable
Committee Actions
USC HRPP Policies, Chapter 7.8
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?
•
USC HRPP Website
Policies
IRB Member Toolbox
•
IRB Member Regulatory Reference Guide
(attached with meeting agenda)
•
Code of Federal Regulations
45 CFR 46.111
21 CFR 56.111
•
IRB Member Handbook (Amdur/Bankert)
IRB Review Actions
May 2024
Thank You!
Guidelines and steps involved in the committee actions towards research approval by Institutional Review Boards (IRBs). Includes possible outcomes, criteria for approval, and actions with contingencies. The process involves primary and secondary reviewers, committee discussions, motions, and final approvals or modifications.
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Presentation Transcript
IRB Actions May 2024
Order of operations toward a committee action Order of operations toward a committee action 1. The Primary Reviewer presents their summary/concerns. 2. The Secondary Reviewer presents their summary/concerns (if applicable) 3. The committee discusses the study following the presentation of the primary and secondary reviewers evaluation and comments. 4. The Primary Reviewer includes a recommendation for a motion in their written review and shares it with the board. 5. Following the committee discussion, a final motion is made 45 CFR 46. 111 Criteria for IRB approval of research (DHHS) 21 CFR 56.111 Criteria for IRB approval of research (FDA)
Possible Committee Actions Possible Committee Actions Approve Approve with Contingencies, Designated Reviewer Approve with Contingencies, Staff Verifiable Defer Disapprove 45 CFR 46. 111 Criteria for IRB approval of research (DHHS) 21 CFR 56.111 Criteria for IRB approval of research (FDA)
Committee Actions Committee Actions Approve The study as written meets all criteria for approval with no further changes 45 CFR 46. 111 Criteria for IRB approval of research (DHHS) 21 CFR 56.111 Criteria for IRB approval of research (FDA) Committee Actions USC HRPP Policies, Chapter 7.8
Committee Actions Committee Actions Approve with Contingencies, Designated Reviewer The board finds that the application is approvable with modifications, clarifications, and/or verifications, examples: This may be a chair, committee member, or IRB analyst with appropriate experience or expertise 1) confirmation of specific assumptions or understandings on the part of the IRB regarding how the research will be conducted; 2) submission of additional documentation; 3) precise language changes to protocol or informed consent documents; or 4) substantive changes to protocol or informed consent documents along with clearly stated parameters that the changes must satisfy. Committee Actions USC HRPP Policies, Chapter 7.8
Committee Actions Committee Actions Approve with Contingencies, Staff Verifiable If changes proposed are administrative/editorial in nature, NOT part of the approval criteria then no additional IRB review is needed, and the changes can be reviewed as part of the verification process. This is less about who reviews as it is about the nature of the contingency The contingency cannot be tied to a judgement or justification. Examples: confirmation of ancillary approvals, site permission, HRPO approval, check a box, very precise changes to a document, CTO. Committee Actions USC HRPP Policies, Chapter 7.8
Committee Actions Committee Actions Defer The board has concerns about the study or significant information or modifications are needed that are directly relevant to the criteria for approval. Examples: Questions about the risks, research design/methodology, statistical analysis, data safety monitoring plan, provisions for protecting participant s safety and privacy, and informed consent documents. Committee Actions USC HRPP Policies, Chapter 7.8
Committee Actions Committee Actions Disapprove The protocol describes research activities that may pose significant concerns for human participant safety with minimal prospect of benefit The risk to benefit ratio is deemed unfavorable Committee Actions USC HRPP Policies, Chapter 7.8
Is it a designated reviewer contingency, staff verifiable Is it a designated reviewer contingency, staff verifiable contingency, or deferral? contingency, or deferral? Designated Reviewer 1) Clarify the time points at which participants will be evaluated to determine imminent risk in the suicide plan. Approve with Contingencies, Designated Reviewer 2) Confirm that the IP address will not be recorded. Approve with Contingencies, Staff Verifiable Staff Verifiable 3) Please revise the exclusion criteria to specify what score on the Montreal Cognitive Assessment (MoCA) will result in a participant being excluded. Approve with Contingencies, Designated Reviewer Defer 4) Please upload the HRPO review document once obtained. Approve with Contingencies, Staff Verifiable 5) Please revise the exclusion criteria to explain if and how you will exclude those with diminished capacity. Defer Approve Approve w/ contingencies, designated reviewer Approve w/contingencies, staff verifiable Defer Disapprove
Where Can I Find More Information? Where Can I Find More Information? USC HRPP Website Policies IRB Member Toolbox IRB Member Regulatory Reference Guide (attached with meeting agenda) Code of Federal Regulations 45 CFR 46.111 21 CFR 56.111 IRB Member Handbook (Amdur/Bankert) Committee Actions USC HRPP Policies, Chapter 7.8
IRB Review Actions Thank You! May 2024
