SOP #28 Controverted Issues

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 28 
Effective Date: 10/8/2021

 

Policy

The College of St. Scholastica (CSS) IRB will record issues of controversy in the IRB Minutes as recommended by the regulations of The Food and Drug Administration (FDA) and The Office for Human Research Protections (OHRP).

Purpose

The purpose of this policy is to address the sensitive topic of documenting controverted or disputed issues and their resolution in the meeting minutes.

Definitions

OHRP defines controverted issues as those that cause controversy and dispute among the IRB membership during a convened meeting and are usually the result of opposition to some aspect of the proposed research.

Controverted Issues and Their Resolution

A controverted issue is an issue discussed at an IRB meeting for which there is a disagreement between some IRB members or there are opposing viewpoints among IRB members that are voiced during the IRB’s deliberations. In the absence of such disagreement or opposing viewpoints, it is unlikely that the discussion of an issue would be a discussion of a controverted issue. Federal regulations require a summary of controverted issues and their resolution to be included in IRB meeting minutes (45 CFR 46.115(a)(2)). Two statements are often sufficient to summarize a controverted issue:

  • Statement #1: Description, discussion, and disagreement.
  • Statement #2:  Resolution

Controverted issues that arise during the convened meeting usually are the result of opposition to some aspect of the proposed research.  Some research, by its very nature, is considered to be controversial (e.g., emergency research where informed consent may not be obtained for all subjects or some research involving vulnerable populations).

IRB members may resolve controverted issues and concerns with continued discussion and deliberation, decide to seek further clarification from the investigator or sponsor of the proposed research, or decide to settle the issue by vote.  The minutes of IRB meetings must be in sufficient detail to show a written summary of the discussion of controverted issues and their resolution (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

The controverted issue should be recorded in the IRB meeting minutes in such a way that anyone who later reads the IRB minutes (perhaps even years later) should be able to recreate the history of the review and know what decisions were made and why. For example, why were pregnant women included or excluded from a clinical trial or why the specific age range was approved for the treadmill study. These may become important issues to know at continuing review. In the future these decisions may be reconsidered due to changing information or circumstances, but the knowledge of the original decisions is an important part of that discussion. Thus, the documentation of controverted issues in the IRB minutes is of vital importance, both because the regulations require it and the knowledge related to the decisions must be recorded. The IRB minutes should include:

  1. A description of the controverted issue that is being debated.
  2. A description of the various sides or points of view related to the controverted issue.
  3. A summary of the essence of the discussion of the issues.
  4. Documentation of the specific final resolution of the controverted issue including the vote, if taken.

EXAMPLES of Summaries of Controverted Issues for IRB Meeting Minutes

Example 1. The IRB discussed whether the proposed payment of $75 to each child would be an undue influence on the children or their parents. Some members thought this was inappropriate. The IRB decided that a $10 gift certificate for a toy would be more appropriate as payment because it would not be unduly influential.

Example 2. The IRB members disagreed whether the risks associated with this study of children’s responses to a laboratory “bullying” experience are “no greater than minimal risk” or “greater than minimal risk, though only a minor increase over minimal risk, and no prospect of direct individual benefit.” The IRB decided to ask the researcher for additional details about (1) the nature, intensity and direction of the bullying, and (2) the de-briefing, in order to determine the appropriate category.

Example 3. The IRB debated the scientific merit and design of the study.  The majority (but not unanimous) opinion was that the merit and/or benefits did not justify the risks to individual subjects. The IRB decided to ask the researcher to consider adding an “active” control condition (such as a series of educational materials or lectures) in addition to the “no intervention” control group, in order to provide more meaningful comparisons with the intervention condition.

Example 4. The IRB had different viewpoints over the likelihood of some subjects becoming incarcerated during the study and decided to approve the study except for the use of prisoners. The researcher will be told to submit a Modification if she anticipates subjects becoming incarcerated so that prisoner involvement and procedures can be reviewed by the IRB and a prisoner advocate.

Resources

See also, CSS IRB SOP #04 CSS IRB Meeting Management, Function and Operations and CSS IRB SOP #17 IRB Meeting Minutes (Expedited/Exempt Approval Form)

Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs – Guidance https://www.hhs.gov/ohrp/minutes-institutional-review-board-irb-meetings-guidance-institutions-and-ir bs.html-0

Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs (September

2017.) https://www.fda.gov/media/94686/download

IRB EasyEd. Controverted Issues.  Volume 2 Number 3.  © 2017 Apex Ethical

This is a new policy per the 2018 Common Rule Requirements.

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