Comments on Institutional Review Blog: Must Employees Consent?

Thanks for this comment. I should have said earli...

2011-11-02T10:55:41.914-04:00

Thanks for this comment.

I should have said earlier that I agreed with you about the "massive flaw in the Common Rule itself," and only disagreed about your reading of the Belmont Report. Both documents cause headaches, and those headaches are aggravated the National Commission's failure to reconcile the Belmont Report with its IRB recommendations, which formed the basis of the Common Rule.

The ANPRM represents an overdue acknowledgment of many of the flaws in the Common Rule, but it fails to ask about the Belmont Report. In my personal comments on the ANPRM, I suggested that "the Belmont Report should be retired and replaced with a statement on research ethics that can be updated to reflect current thinking and experience."

I won't disagree with you on the Belmont Repor...

2011-11-02T10:34:39.199-04:00

I won't disagree with you on the Belmont Report, though the document itself does not acknowledge the limitations you point out. The essential point I was trying to make is that the Common Rule is unambiguous that informed consent is required if there is more than minimal risk to the subjects. Hence, any research on employees that could lead to their firing is presumptively illegal under the rule. Given the almost unbounded scope of activities that count as "research" under the Common Rule, OHRP was essentially fulfilling its bureaucratic mission. The problems (plural) lie with the Rule, not with with some major misinterpretation by bureaucrats. One could certainly argue that in this case the employees weren't really the "subjects" of the research, or that it wasn't really "research" and I don't disagree with those arguments. But if the employees were research subjects, then voluntary informed consent was required. That is a crazy result, and one created by the text of the Rule.

Also, please see Tom Beauchamp's comments on t...

2011-10-27T11:35:51.085-04:00

Also, please see Tom Beauchamp's comments on this matter:

Because the definition is so nonspecific, regulatory requirements that use the definition may judge that some activities that are questionably research involving human subjects nonetheless must be treated as such. Government requirements are today commonly applied even if 'human subjects' may not need to be protected by the rules of human-subjects research. A sweeping – that is, all-inclusive conception – of 'human-subjects research' can have immediate and unjustifiable practical impact on attempts to upgrade medical care . . ."

Beauchamp Derides Federal Definition of Research

Thanks for this comment. I cannot agree that the ...

2011-10-27T11:13:01.153-04:00

Thanks for this comment.

I cannot agree that the Belmont Report is "very clear" on this issue, particularly since it does not conform to the sentiments the commissioners expressed in their deliberation. And rather than specifying "a very narrow range of circumstances" in which consent is not needed, the Belmont Report confesses ignorance about a vast and undefined realm called "social experimentation."

I disagree with your conclusion. Both the Belmont ...

2011-10-27T11:07:56.579-04:00

I disagree with your conclusion. Both the Belmont Report and the Common Rule are very clear that subjects of research must give informed consent in all but a very narrow range of circumstances. Being an employee is not an exception. OHRP is simply following the legal standard set out in the Common Rule. The problem is not its interpretation, but a massive flaw in the Common Rule itself. There are many kinds of research where informed consent should not be required, and it should not be mandated or even presumptively preferred in those cases. This is one of the obvious categories where the rule is wrong and needs to be changed.