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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)

FDA, OHRP Seek Comment on Proposed Guidance on Electronic Consent

The Food and Drug Administration (FDA) has released draft guidance on using electronic media and processes to obtain informed consent in FDA-regulated clinical investigations. The guidance covers how and when electronic informed consent information should be presented, how to ensure subjects’ understanding of the information, how to maintain confidentiality and security, and how to keep appropriate documentation of the consent process.

FDA is seeking public comment on the draft guidance by May 8, 2015. Instructions and more information are in in the Federal Register notice.

The Office of Human Research Protections (OHRP) is soliciting comments on whether the FDA’s draft guidance is appropriate for research under the Office’s purview (regulated under 45 CFR 46). As part of an effort to harmonize agencies’ regulations and guidance for human subjects research, OHRP is considering issuing the final guidance as a joint FDA-OHRP document. The Office will consider comments received from the public in its decision making.

Comments to OHRP are also due on May 8, 2015. More information and instructions are available in a separate Federal Register notice.

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Posted in Issue 4 (March 13), Update, Volume 34 (2015)

SACHRP Seeks Nominations for New Members

The Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body of the Office of Human Research Protections (OHRP), is seeking nominations to fill two spots that will become vacant in July 2015. The Committee provides guidance on matters “relating to the responsible conduct of research involving human subjects with particular emphasis on special populations such as neonates and children, prisoners, the decisionally impaired, pregnant women, embryos and fetuses, individuals and populations in international studies, populations in which there are individually identifiable samples, data or information; and investigator conflicts of interest.”

Qualified candidates will possess expertise and experience in a field relevant to human subjects protection, including “public health and medicine, behavioral and social sciences, health administration, and biomedical ethics.” Nominations should consist of a letter of nomination as well as the candidate’s CV and contact information. They must be received by February 12, 2015. More information is available in the Federal Register notice.

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Posted in Issue 1 (January 13), Update, Volume 34 (2015)

SACHRP Considers Consent in Low-Risk Online Studies

At its meeting on October 30, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) heard a presentation from B.R. Simon Rosser, University of Minnesota School of Public Health, on “The Evolution of Consent in Low-Risk Studies: Lessons from Online Survey Research.” He suggested that SACHRP rethink how researchers handle informed consent for low-risk studies conducted over the internet. (more…)

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Posted in Issue 20 (November 3), Update, Volume 33 (2014)

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