human subjects

OHRP Issues Guidance on Human Subjects Protections for Coronavirus Actions

The Office of Human Research Protections (OHRP) within the Department of Health and Human Services has issued guidance for institutions and investigators conducting research in response to the COVID-19 pandemic. The guidance covers the following topics: (1) Public Health and Clinical Activities; (2) Excluded Public Health Surveillance Activities; (3) Legally Required Reporting; (4) Research Changes to Eliminate Apparent Immediate Hazards; (5) Proposing and Reviewing Study Changes; and, (6) Whether Suspensions of Research Must be Reported.  The guidance document can be accessed at on OHRP’s website. Back to this issue’s table of contents.

OHRP Releases Draft Guidance for Transitioning Studies to Revised Common Rule; Comments Requested

The Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) has released draft guidance for transitioning studies to the revised Common Rule. The Common Rule is the set of regulations governing research involving human participants. After a lengthy revision process (see COSSA’s previous coverage), changes to the Common Rule updating a number of its provisions took effect on January 21, 2019. The draft guidance released by OHRP gives details on how an institution may voluntarily transition a study initiated before the implementation date to the new regulations. The complete draft guidance can be accessed…

OHRP Releases Information on Clinical Trial Consent Form Posting, GDPR Guidance

As part of the revisions to the Common Rule (the set of regulations that govern research involving human participants) going into full effect in January 2019 (see COSSA’s coverage for more details), clinical trials covered by these regulations must publicly post copies of the consent forms used to enroll participants. The Office of Human Research Protections (OHRP) has announced that these consent forms must be posted either on clinicaltrials.gov or to a docket folder on regulations.gov (docket ID: HHS-OPHS-2018-0021). OHRP has also made available guidance related to the European General Data Protection Directive (GDPR) to assist stakeholders conducting human subjects…

Draft Guidance Documents Related to Revised Common Rule Released

On July 20, the Office for Human Research Protections (OHRP) the Department of Health and Human Services (HHS) released three draft guidance documents that relate to the three provisions in the revised Common Rule that institutions may choose to implement during the period between July 19, 2018 and January 20, 2019, when the revised Common Rule becomes effective (see COSSA’s coverage of the delay). The three draft guidance documents are: Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019:…

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…

Common Rule Agencies Release Proposal for 6-Month Delay of Revisions, Optional Implementation of “Burden-Reducing” Provisions; Comments Sought for 30 Days

On April 20, the 17 agencies regulated under the Common Rule, the set of regulations governing human subjects research, released a Notice of Proposed Rulemaking (NPRM) that would delay implementation of revisions to the Common Rule by an additional six months, setting a new compliance date of January 21, 2019. The stated rationale for the delay is to “provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements.” The Obama-era changes had been originally scheduled to go into effect on January 19, 2018 but were delayed by an Interim Final Rule announced in January 2018…

Common Rule Implementation Delayed Six Months; Further Delays Likely

The 16 U.S. federal agencies subject to the Common Rule, the set of regulations governing research involving human subjects, announced a six-month delay on the implementation of revisions originally announced in January 2017 (see COSSA’s analysis of the changes). The delay was announced as an Interim Final Rule in a Federal Register notice published on January 17, 2018, two days before the changes were scheduled to go into effect. According to the notice, federal agencies subject to the Common Rule are “in the process of developing a proposed rule to further delay implementation of the 2018 requirements,” and the six-month…

Delay to Common Rule Implementation Likely

On January 4, the Department of Health and Human Services submitted a final rule for approval by the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA), which would indefinitely delay implementation of revisions to the Common Rule, the set of regulations governing research involving human participants (see COSSA’s analysis of the changes, which were announced in the final days of the Obama administration). This rule replaces an earlier proposal to delay implementation that was submitted in October but never approved by OIRA (see COSSA’s discussion), which would have allowed certain “burden-reducing” provisions of the Rule…

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…

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…

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…

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…

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.”…

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…

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. Back to this issue’s table of contents.

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…

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.

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…

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…

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…

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