Checking the Box

As some of you know, for many years I was a major proponent of institututions applying the Federal-Wide Assurance (FWA) to all research regardless of funding. I have recently changed my position on that and now recommend that that institutions limit their FWA to federally-funded research. Here are some of my thoughts as to why I've taken that position.

All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any federal department or agency that has adopted the Common Rule must be covered by an OHRP-approved assurance of compliance.The form for applying for a FWA presents institutions with the option of voluntarily applying either the Common Rule or the Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR 46 to all research, regardless of source of support. Institutions indicate with an [x] which, if any, of the options they chose to elect.The question is whether institutions should “check the box” or only have their FWA apply to federally-funded research.

First of all, except for FDA-regulated research, the federal government has no authority to regulate non-federally-funded research.In the past, OHRP strongly encouraged institutions to apply their FWA to all research, but this was a recommendation only.The reason for this recommendation was that most institutions had no formal policy on human subjects research and the only institutional authority for the IRB to review human subjects research was the FWA.Therefore, unless the FWA applied to all research regardless of funding, the IRB had no authority to review non-federally-funded research.This could result in a double standard with federal regulations applying to federally-funded research and a different standard, or no standard, applying to non-federally-funded research.Officials from OHRP have informally agreed that, if an institution has an institutional policy at least equivalent to the federal regulations that applies to all human subjects research, there is no need to apply the FWA to all research.

Although applying the FWA to all research may not be required, the question remains as to what harm would be done by “checking the boxes”.The basic problem with applying the FWA to all research is that it gives OHRP oversight over all of the research conducted by the institution.By limiting the FWA to federally-funded research, OHRP’s oversight is similarly limited.When problems arise with non-federally-funded research it is the institution’s responsibility to deal with and OHRP has no authority to intervene.Let me give you an example of how OHRP oversight over non-federally-funded research can be a problem for an institution.OHRP received a complaint regarding some research at an institution which had elected to apply the FWA to all research.The research in question was primarily chart-review research which was not federally funded.Because they had “checked the box”, OHRP did an investigation and the institution spent considerable time and effort to respond.After several months and considerable institutional stress and anxiety, OHRP terminated their investigation but reserved the right to conduct a site visit in the future.If the institution had limited its FWA to federally-funded research OHRP would have had no authority to investigate this research and all of this could have been avoided.

In addition, at least one part of the federal regulations (Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research) has language which makes it difficult to apply to social and behavioral research. Therefore, applying the FWA to all research creates inherent compliance problems for that research.

So, if an institution has a strong institutional policy that applies to all human subjects research regardless of funding, then, in my opinion, it should not apply the FWA to all research. This is in the institution's best interest and, if the institutional policy is adequate, does not diminish the protection of human subjects.