Friday, January 19, 2018

Revised Common Rule Delayed at Least 6 Months

The new Common Rule was supposed to go into effect today, but OHRP has declared a six month delay in the implementation of most of its parts. This apparently includes a delay in the redefinition of research and the liberation of oral history.

The official announcement is set to his the Federal Register on January 22, but an unpublished rule is online at–00997.

Here’s the justification for delaying the new definitions of research and the new exemptions:

The 2018 Requirements include four explicit categories of activities that have been deemed not research for the purposes of the Common Rule. In the absence of guidance, it would be difficult for institutions to fully take advantage of the exclusion of activities from the definition of research; therefore we now assume that many institutions would not have used these categories without guidance.

The 2018 Requirements also include five new exemption categories, and modify all but one exemption that exists in the pre–2018 Requirements. We have received feedback from SACHRP that many of the exemption categories will require significant guidance in order to be implemented. Areas where significant guidance is needed include: applying the categories of the new exemptions themselves, conducting limited IRB review (as required in four exemptions), developing and using broad consent (as required in two exemptions), utilizing the exemption for certain HIPAA covered activities, and understanding which federally supported or conducted nonresearch information collections qualify for exemption. Because the guidance necessary to implement these provisions has not yet been developed, we now assume that 50 percent of the regulated entities would not have taken advantage of the expansion in exemptions or the revised definition of research during the six-month delay.

OHRP essentially argues that in the six and a half years from the 2011 ANRPM through today, it has been unable to craft regulatory language or accompanying guidance clear enough that institutions can use it to oversee research.

The truth is, since the crackdown of 1998, universities have spent twenty years guessing what OHRP wants from them. As Robert Klitzman writes in The Ethics Police:

The fact that federal agencies at times communicated in limited, incomplete, or frustrating ways appeared to compound these problems. Committees may request clarifications from OHRP and the FDA, but find the answers “unhelpful.” Interviewees said that sometimes the agencies simply didn’t respond; and at other times, did so unsatisfactorily, merely reiterating the regulations without offering clarification. ”If they don t want to say much,” Liza said, “they’ll just repeat the regulations in five different ways.”

In not issuing definitive official opinions, federal agencies leave committees to wrestle alone with these vagaries. Working in this interpretive vacuum without guidance can generate stress and discrepancies. “The Feds often seem to back away from taking a stand;’ Troy, the chair, reported. "They’ll turn it back to us, and say, ‘Its up to the IRB.’ They’ll come in and criticize us later.” Stephen concurred:

Many times when you call for advice; they essentially just read back the regulations. You basically have to make your own decision, which is great, until you have an audit, and then you’re told you didn’t make the right decision.

Does anyone expect that another six months is going to fix this problem?

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