OHRP

HHS Seeking Nominations for Advisory Committee on Human Research Protections

The Office for Human Research Protections (OHRP) at the Department of Health and Human Services (HHS) is soliciting nominations for the Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body to the HHS Secretary on policies protecting the safety of human participants in research. OHRP is seeking nominations for four positions on the Committee that will be opening during the 2021 and 2022 calendar years. More information and nomination instructions are available in the Federal Register.

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OHRP Releases Draft Guidance for Transitioning Studies to Revised Common Rule; Comments Requested

The Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) has released draft guidance for transitioning studies to the revised Common Rule.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 The draft guidance released by OHRP gives details on how an institution may voluntarily transition a study initiated before the implementation date to the new regulations. The complete draft guidance can be accessed…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…

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…

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…

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.”…

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 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.

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.

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