recording reasons for dissent in the minutes

[siardem]

I am new to this discussion forum, but the question I have involves a far reaching consequence. The U.S. system for protection of human subjects of research is overseen by a federal office ( the Office for Human Subjects Protection.) The procedural rules are state in 45 CFR 46 and a version of that regulation has been adopted by 16 federal agencies under the heading of the Common Rule)http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html

The regulations specify a number of issues that must be documented in the meetings of the Institutional Review Board (IRB).

I was a member of the federal body that developed the regulations published by the Secretary of Health and Human Services and adopted formally by the agency heads.

I had accepted the view that member(s) who did not vote in favor of approval of an IRB motion were required to state the reasons) for disagreement. My personal experience,  in addition to overseeing the implementation of the regulations at thousands of institutions world wide, has involved decades of experience serving in various capacities as member of an IRB and chair of several.

In answer to a question from an administrator of an IRB, I searched carefully both the regulations and implementing guidelines . However, I was not able to identify any explicit requirement for inclusion ( without attribution) in the minutes a statement of a member/members of reasons for disagreement with the majority view.

I was not able to find a similar provision in Robert's.

Is anyone able to assist in identifying the basis for the requirement to include a statement of reasons for dissenting from the majority vote?   Minutes of the IRB meetings are limited in circulation, but are not restricted. The findings of the IRB are to be communicated to the researchers whose proposed research activities are subject to review and approval by the IRB. But the identities of the individuals voting are not recorded

.

Thanks for any light that can be shed on this practice, believed universally to be a requirement, but not supported by any provision in the Common Rule and implementing guidelines.

 

[George Mervosh]

I was not able to find a similar provision in Robert's.

Is anyone able to assist in identifying the basis for the requirement to include a statement of reasons for dissenting from the majority vote? 

 

RONR has no such requirement.

[Gary Novosielski]

Quite the contrary.  RONR says that it improper even to offer a reason for voting a particular way, at least at the time of voting.  Doing so is tantamount to debate, and debate ends before voting begins.

 

A member who opposes or supports a motion can of course express the reason for holding this opinion in the course of debate, but certainly cannot be compelled to do so.  

 

Another question sometimes arises about whether a member who abstains from voting must offer a reason for abstaining.  Same answer: No.

[siardem]

Many thanks. I will try to trace the origin of this common practice.