Thank you for your comment. I fear I don't unders...

2009-07-14T08:38:52.780-04:00

Thank you for your comment.

I fear I don't understand your claim that "FWAs are worthless." Many regulations require that persons or institutions sign promises to obey them. Drivers' licenses, tax returns, and building permits, for example, all serve this function.

And as you point out, FWAs serve an additional purpose: they allow OHRP regulators to extend their power beyond the scope of 45 CFR 46, by extracting additional promises. Regulators have been playing this game since 1981. See E. L. Pattullo, "How General an Assurance?," IRB: Ethics and Human Research 3 (May 1981): 8-9.

OHRP would also need to modify the terms of FWAs (...

2009-07-13T13:49:38.193-04:00

OHRP would also need to modify the terms of FWAs (or finally admit that FWAs are worthless- why does there need to be an additional promise to follow regulations by which an institution is already bound?). While the terms do not explicitly require review of exempt research, the terms could easily serve as the basis for OHRP to hold an institution accountable for an exempt project that was not sufficiently "guided" by the Belmont Report (emphasis added below)...

"A. TERMS OF THE FEDERALWIDE ASSURANCE (FWA) FOR INSTITUTIONS WITHIN THE UNITED STATES

1. Human Subjects Research Must be Guided by Ethical Principles

All of the Institution’s human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles..."

Comments on Institutional Review Blog: Menikoff to Critics: "Yes, We Hear You"

Thank you for your comment. I fear I don't unders...

OHRP would also need to modify the terms of FWAs (...