Open Mike

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Proposed Changes to Human Subjects Regulations Are Open for Comment

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name. Today I’d like to give you some background on how these regulations – and the conversation around these regulations – have evolved since 1991, and let you know about an opportunity to provide feedback on the modernization of these important rules.

In July 2011, the Department of Health and Human Services (HHS) issued an Advance Notice of Proposed Rulemaking (ANPRM). As noted by some authorities, the ANPRM appeared after a time when the clinical research landscape dramatically changed, with less emphasis on single-center small-number studies and greater emphasis on multi-center (often international) projects, health services research, and research leveraging existing data registries and biospecimens.1 Other thought leaders have described emerging challenges as investigators and other stakeholders work to integrate clinical research into learning health care systems.2 Reflecting our interest in human subjects protection and informed consent, the NIH-funded Health Care Systems Research Collaboratory just published a series of articles in the journal Clinical Trials on ethical and regulatory issues specifically related to pragmatic clinical research.3

In September 2015, the Department of Health and Human Services (HHS) published proposed changes to the Common Rule through a Notice of Proposed Rulemaking (NPRM), which is now open for public comment through December 7, 2015.

The NPRM contains many wide-ranging changes to the Common Rule, with the aim of modernizing the current regulations to reflect how research is done today.

Some of the proposed changes include:

  • A requirement that in most cases research being conducted at more than one institution (multisite research) must rely on a single Institutional Review Board (IRB).
  • Applying the Common Rule regulations to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency.
  • Implementing new data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.
  • Defining secondary use of non-identified biospecimens as “human subjects” for research purposes.
  • Expansion of consent requirements, including written consent for use of an individual’s biological samples, for example blood or urine, for research with the option to consent to their future use for unspecified studies.

I encourage you, the research community, to submit your comments as described on the NPRM website at regulations.gov. (While we welcome discussion in the comments below related to this topic, these won’t be submitted as formal comments to HHS). While I have highlighted just a few of the potential changes proposed with this draft NIH would like the research community to consider the document in its totality. You should keep in mind how this may affect your current and future studies.

The HHS Office of Human Research Protections has also published a number of resources on their website to help you review the proposed changes and submit comments.

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3 thoughts on “Proposed Changes to Human Subjects Regulations Are Open for Comment

  1. We are in Australia, and participate in multiple collaborations with US (and other) countries funded by NIH. Does the first bullet point above imply that our study would need to be approved by a US IRB?

    • The NPRM proposal for single IRB review for multisite research states that any institution located in the United States that is engaged in cooperative research covered by the regulations must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. Thus, foreign sites in multisite research will be able to rely on their local IRB for approval of research at their site.

  2. With respect to the “expansion of consent requirements, including written consent for use of an individual’s biological samples, for example blood or urine, for research with the option to consent to their future use for unspecified studies.”
    It is suggested that studies conducted before this rule be “grandfathered out” if this requirement as there are myriad studies with valuable stored specimens that are well characterized often emanating from expensive and detailed clinical studies. As this was not a requirement 5-10 years ago and the development of new assays and approaches would greatly extend these studies, it would be a shame for investigators to not avail themselves of these samples and studies.

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