Friday, July 20, 2018

OHRP Draft Guidance on Oral History; No Mention of Examples

OHRP has posted draft guidance on “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”

The draft reiterates the distinctions made in the January 2017 Federal Register announcement of the new Common Rule, stating:

It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups. 

Unlike the June 22 video, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.

Thursday, July 19, 2018

OHRP Video: Oral History of "Specific Leaders" Would Qualify as Research

On June 22, OHRP posted a video to YouTube, dated March 2018 and entitled “When Does the Common Rule Apply?,” featuring Misti Ault Anderson, Senior Advisor for Public Health Education at OHRP. The video includes a passage stating that while an oral history interview of “one individual” will no longer be considered research under the new Common Rule, a project about “specific leaders” would still be regulated.

I consider this statement to be at odds with the 18 January 2017 Federal Register announcement of the revised rule. However, Anderson tells me the video is an “education tool,” not official guidance, and that “we will be seeking public comment for consideration before developing the final guidance.”

Monday, April 23, 2018

Feds Say New Common Rule Will Reduce Burdens and Offer Guidance—But Not Yet

In a new notice of proposed rulemaking, published in the Federal Register on April 20, HHS and other Common Rule Agencies identify three provisions of the new Common Rule as “burden-reducing.” Among them is the redefinition of research to exclude historical research. Yet the notice gives institutions either three or nine months to implement the reforms.

[“Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period,” 83 Federal Register 17595 (April 20, 2018).

The “burden-reducing” label correctly implies that the corresponding provisions of the current Common Rule are unnecessarily burdensome. Yet rather than reducing the burdens immediately, the new NPRM gives institutions the choice of eliminating them in July 2018 or January 2019.

The notice presents this as a recognition of “entities’ possible inclinations to make all transitions at once.” To be sure, federal agencies seem to favor massive, comprehensive, and infrequent change to incremental improvement, but I wonder if research institutions feel the same. And it’s telling that the notice considers “entities” as the primary stakeholders in the decision. Recall that the 2011 ANPRM aimed at “Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” (Emphasis added.) The new notice does not speculate how investigators might feel about the pace of transition.

The notice also states,

We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution’s decision to elect to implement the three burden-reducing provisions or not.

In February 2007, OHRP promised such guidelines “by the end of the year.”

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.