Blog Archives

HHS May Delay Common Rule Implementation

On October 7, the White House Office of Information and Regulatory Affairs issued a notice that it is reviewing a rule that would delay the implementation date for most of the changes to the Common Rule, the set of regulations governing research involving human participants, by one year, pushing the effective date for the changes from January 2018 to January 2019 (see COSSA’s analysis of the changes, which were announced in January of this year). The delay would still allow “the use of three burden-reducing provisions during the delay year,” but there is little clarity on what those provisions are or when more details will be made available.

One hint may be found in a letter sent by four higher education associations in June that asked for a year-long delay in the compliance date for most of the changes to the regulations, while allowing burden-reducing provisions to move forward. The letter identified those provisions as “certain exclusions and exemptions, elimination of the continuing review requirement for certain types or stages of research and elimination of IRB [internal review board] review of grant applications.” If the Department of Health and Human Services (HHS) concurs with the recommendations in the letter, the provisions allowed to go into effect as originally scheduled may well include several of the changes that aim to make research involving human participants less burdensome for low-risk social and behavioral research.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

Human Subjects Advisory Committee Seeking New Members

The Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body to the Health and Human Services (HHS) Secretary and the Office of Human Research Protections (OHRP), is soliciting nominations to fill four vacancies in 2017. SACHRP provides scientific expertise and recommendation on matters related to the protection of human subjects in scientific research. The Committee will likely play an important role as OHRP implements the revisions to the Common Rule (see COSSA’s coverage). Experts are sought from fields including “public health and medicine, behavioral and social sciences, health administration, and biomedical ethics.” Nominations must be received no later than September 18, 2017. More information is available in the Federal Register notice.

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Posted in Issue 16 (August 8), Update, Volume 36 (2017)

HOT TOPIC: HHS Announces Final Changes to Human Subjects Research Regulations

During the final days of the Obama Administration, the U.S. Department of Health and Human Services (HHS) released the final text for its changes to the Common Rule, the regulations that govern research with human subjects, completing a revision process started in 2011. The Common Rule, which was last updated in 1991, affects research supported by 16 federal departments and agencies, including the Departments of Health and Human Services, Agriculture, Defense, Education, Commerce, Labor, and Veterans Affairs, as well as the National Science Foundation.

Overall, the changes look to be a positive development for the social and behavioral science research community. According to the executive summary, “The final rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research.” The rule maintains several proposals from the earlier Notice of Proposed Rulemaking (NPRM) that aimed to reduce the oversight burden on researchers conducting studies that pose no or minimal risk to participants (like a lot of social and behavioral science research). It also declines to adopt several provisions that were controversial in the biomedical research community (although supported by some in the social sciences), including consent requirements surrounding work with de-identified biospecimens, which is likely to lead to a less contentious reception overall.

Read on for COSSA’s full analysis of the changes.

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Posted in Issue 2 (January 24), Update, Volume 36 (2017)

Academies Report Recommends Abandoning Proposed Changes to the Common Rule

On June 29, the National Academies of Sciences, Engineering, and Medicine released part 2 of its report Optimizing the Nation’s Investment in Academic Research (the first part had been released in 2015). Of particular significance to the social and behavioral science research community is a chapter within the report on the “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” In it, the panel issues a stinging criticism of the Department of Health and Human Services’ (HHS) September 2015 Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects. The chapter argues that the NPRM should be abandoned and that it “would impose additional burdens that could be detrimental to important areas of research.”

COSSA’s comment on the NPRM, submitted jointly with the American Educational Research Association (AERA) and the Inter-university Consortium for Political and Social Research (ICPSR), was largely supportive of the proposal, particularly those provisions that made the regulations less burdensome for low-risk social and behavioral research. What is more, the recommendations made in this latest report are in many ways inconsistent with those of the National Research Council’s (NRC) 2014 report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.   (more…)

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Posted in Issue 14 (July 12), Update, Volume 35 (2016)

Human Subjects Advisory Committee Seeking New Members

The Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body to the Health and Human Services (HHS) Secretary and the Office of Human Research Protections (OHRP), is soliciting nominations to fill four vacancies in 2016, including the position of Chair. SACHRP provides scientific expertise and recommendation on matters related to the protection of human subjects in scientific research. The Committee will likely play an important role as OHRP finalizes its announced revisions to the Common Rule (see COSSA’s coverage). Experts are sought from fields including “public health and medicine, behavioral and social sciences, health administration, and biomedical ethics.” Nominations must be received no later than March 21, 2016. More information is available in the Federal Register notice.

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Posted in Issue 3 (February 9), Update, Volume 35 (2016)

COSSA and Members Comment on Proposed Revisions to the Common Rule

COSSA, in conjunction with the American Educational Research Association (AERA) (a COSSA governing association) and the Inter-university Consortium for Political and Social Research, submitted comments on the Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects or the “Common Rule” (click here for context on the NPRM). Overall, the comments are supportive of the proposed changes affecting the social and behavioral sciences and urge that “major and substantial improvements… not be delayed or deferred even if it is determined that some issues require further analysis before some rule changes can be made.” The comments also points out several sections where additional clarification would be useful.

The American Psychological Association (APA), Population Association of America (PAA) (COSSA governing associations), and the Society for the Psychological Study of Social Issues (SPSSI) (a COSSA member), also submitted comments on the NPRM, which are available on regulations.gov (docket ID HHS-OPHS-2015-0008).

Now that the window for public comment has closed, the Office of Human Research Protections will review all submitted comments and release a final rule. However, if the pace of the Common Rule revision process thus far is any indication, it will likely be several months, if not longer, before we see a final rule.

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Posted in Issue 1 (January 12), Update, Volume 35 (2016)

Deadline for Comments on Common Rule NPRM Extended

The Department of Health and Human Services has announced that it will extend the period for public comment on the Notice of Proposed Rule Making (NPRM) for the Federal Policy for the Protection of Human Subjects (otherwise known as the Common Rule) by 30 days. The new deadline is January 6, 2016. A summary of the major changes to the regulations proposed in the NPRM is available here.

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Posted in Issue 22 (December 1), Update, Volume 34 (2015)

HHS Releases Proposed Updates to the Common Rule

The Department of Health and Human Services has released its proposal to update the regulations that govern research involving human subjects (the Common Rule). The long-awaited Notice of Proposed Rulemaking (NPRM) explains the proposed changes and poses a number of questions for which the department is seeking public comment, to be submitted within 90 days of the NPRM’s publication. The Office of Human Research Protections (OHRP) plans to hold several webinars in the coming weeks to explain the changes as well as an in-person town hall meeting in Washington, DC in October.

The Common Rule has not been updated since 1991. The NPRM is the next step in a process that began in 2011 with the issuance of an Advanced Notice of Proposed Rulemaking (ANPRM) that asked for input. In response, COSSA, along with 21 other organizations, submitted a white paper that gave the perspective of the social and behavioral science community. The National Academies also issued a consensus report in 2014 that discussed proposed revisions to the Common Rule in the context of the social and behavioral sciences. A number of the proposed changes attempt to address concerns raised by the social and behavioral science community, particularly those that attempt to make the level of review proportional to the potential level of harm. The NPRM states the drafters’ intention to “more thoroughly addresses behavioral and social science research perspectives and the broader types of research conducted or otherwise supported by the other Common Rule agencies” and cites the consensus report as a source of guidance. (more…)

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Posted in Issue 16 (September 8), Update, Volume 34 (2015)

PCAST Hears Interim Report on Precision Medicine Initiative

On May 15, the President’s Council of Advisors on Science and Technology (PCAST) received an interim report on the President’s proposed Precision Medicine Initiative (PMI). Opening the meeting, PCAST co-chair and director of the White House Office of Science and Technology Policy (OSTP) John Holdren discussed the ongoing budget process and the challenges associated with the FY 2016 budget. Despite these challenges, Holdren noted, there are a number of exciting initiatives in progress, including the Precision Medicine Initiative. (more…)

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Posted in Issue 9 (May 19), Update, Volume 34 (2015)

Senate HELP Committee Examines “U.S. Leadership in Medical Innovation”

On March 10, the Senate Health, Education, Labor and Pensions (HELP) Committee held its first in a series of anticipated hearings on “U.S. Leadership in Medical Innovation.” Opening the hearing, HELP Committee Chairman Lamar Alexander (R-TN) announced that he and Ranking Member Patty Murray (D-WA) intend to focus on three major actions over the next two years: (1) “fixing” the No Child Left Behind Act; (2) simplifying and reauthorizing the federal government’s supervision of higher education in America; and (3) dealing with the “exciting new era of medicine.” Regarding the latter, Alexander noted that the House is moving on a parallel track via its 21st Century Cures initiative (see Update, February 24, 2015). (more…)

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Posted in Issue 5 (March 24), Update, Volume 34 (2015)

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