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Full Implementation of Common Rule Delayed through January 2019

On June 19, the Office of Human Research Protections (OHRP) within the U.S. Department of Health and Human Services issued a final rule adopting a proposal released in April to delay the compliance date for revisions to the Common Rule (the set of regulations governing research involving human participants) by six months. COSSA submitted comment on this proposal asking that the implementation of the new regulations not be delayed any further than is necessary. The new compliance date for the majority of the new regulations is now January 21, 2019. However, beginning on July 19, 2018, institutions (on a study-by-study basis) may choose to adopt three “burden-reducing” provisions early (so long as the studies move into full compliance with the new regulations after they go into effect in January 2019). The burden-reducing provisions include: the revised definition of research; the elimination of requiring annual continuing review for certain categories of research; and elimination of requiring IRBs to review grant applications and funding proposals. See COSSA’s previous summary of this proposal for a comparison of the text of the current and new provisions.

While the fate of the revisions to the Common Rule has been in limbo since the Presidential transition in 2017 (see COSSA’s previous coverage), barring some unforeseen intervention by the Administration, the issuance of this final rule appears to be the last step before the regulations can go into effect. In its response to comments submitted, OHRP notes, “We do not believe a delay of the general compliance date beyond January 21, 2019 is necessary.”

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Posted in Issue 13 (June 26), Update, Volume 37 (2018)

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)

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)

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 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)

OHRP Solicits Comments on Draft Guidance on Risk Disclosure in Research Evaluating Standards of Care

The Office of Human Research Protections (OHRP) has issued draft guidance on “Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”  As more and more comparative effectiveness research is conducted to evaluate different treatments commonly used by medical practitioners (“standards of care”), the guidance is an attempt to assist researchers in determining how to disclose potential risks of the different treatments they are studying. (more…)

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

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