Article | February 24, 2017

Health and Human Services (HHS) Revisions To The Common Rule: What You Need to Know

Health and Human Services (HHS) Revisions To The Common Rule

By Shann Williams, Senior Director, Operations, Rho

On January 18, 2017, the Department of Health and Human Services (HHS) announced revisions to the Common Rule. The intent of the revision is to enhance protection for research participants, while reducing the administrative burden associated with oversight.  Stakeholders will need to be compliant by January 19, 2018. This article provides a summary of the changes – including which proposals from the review period were not incorporated – so you can be prepared for the changes and ready for the impacts of the final rule.

Background of the Common Rule

The Federal Policy for the Protection of Human Subjects, generally known as the Common Rule, was released in 1991. Originally, the rule was based on the Belmont Report of 1974 that sought to outline the following:

  1. The boundaries between biomedical/behavioral research and the accepted routine practice of medicine.
  2. The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects.
  3. Appropriate guidelines for the selection of human subjects for participation in such research.
  4. The nature and definition of informed consent in various research settings.

The most recent revision to the rule occurred in 2005, and a notice of proposed revisions was published in September 2015. After HHS received more than 2,100 comments, the most recent changes were established, excluding some of the initially proposed changes.

The Common Rule applies to research using human subjects that is conducted or supported by HHS or 15 other federal agencies. Pharmaceutical industry studies not conducted or supported by HHS may still fall under similar and largely redundant Food and Drug Administration (FDA) regulations (e.g. 21 CFR 50, 21 CFR 54, 21 CFR 56). Studies conducted or supported by HHS that need to comply with investigational new drug (IND) regulation would be subject to both the Common Rule and FDA regulations (for example, a study that will support changes to the label for an approved product). 

Purpose of the Revisions

The latest round of revisions is “intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay and ambiguity for investigators,” according to the rule summary. Additionally, the revisions demonstrate an effort to “modernize, simplify and enhance” the current system.

Research involving human subjects has grown and developed substantially over the last two decades – including the number and type of clinical trials, the use of electronic heath data and other electronic data elements, and large data combined with more sophisticated analytical techniques. These advances – which were not imaginable when the Common Rule was first adopted or even during previous revisions – were not being matched by a comprehensive oversight system. The revision cites “the sheer volume of data that can be generated,” as well as the “ease with which it can be used to identify individuals,” as important factors to the changes.

In addition, the revision references the Precision Medicine Initiative as a consideration for proposed changes, with the central tenant that participants in research should be active partners and not merely passive subjects.

What you Need to Know: The Changes

The revision to the Common Rule includes the following:

  • Enacts new policies for what research subjects should be informed of during the informed consent process, including:
    • A statement added to the consent form regarding whether a subject’s biospecimens – even if non-identified – may be used for commercial profit and whether the subject will or will not share in this profit.
    • Whether or not clinically relevant research results will be disclosed to subjects and, if so, how they will be disclosed.
  • Requires that one version of the informed consent form used during enrollment be posted for studies conducted or supported by the federal government on a federal website no later than 60 days after last patient, last visit. Responses to the revision suggested using as the website to post these forms, but the federal website that will be used has not been determined.
  • Creates an expectation that informed consent forms include a succinct summary at the beginning of the document covering information that would be most important to the person considering participation in the study. This includes potential benefits and risks, alternative treatments they should consider, and the purpose of the research.  According to Jerry Menikoff, Director of the Office of Human Research Protections (OHRP) at HHS, the revision is intended to both provide needed information to potential subjects, while maintaining institutional protections from potential lawsuits.
  • Allows obtaining a broad consent from subjects for unspecified future research as an option for investigators and requires that 12 elements be included (6 of these are specific to a broad consent).
  • Identifies new categories of research that may be exempt from a full IRB review based on the study’s risk profile. 
  • Requires that multi-center research use a single Institutional Review Board (IRB) for research that takes place within the United States. This will become effective in 2020, 3 years after publication of the final rule.
  • Enforces regulatory compliance for IRBs that are not operated by a Federal Wide Assurance (FWA) holding institution. Previously, the rule held that institutions holding the FWA would be held responsible, thus increasing the reluctance of clinical sites to use a central IRB.
  • Alleviates the need for IRB continuing review of ongoing research for studies that were under expedited review, those studies that have completed study interventions and are in analysis, or are in observational follow-up combined with standard of care.

Which Proposals Were Not Adopted?

The final rule did not adopt several proposals, including:

  • Requiring that non-identified biospecimens be subject to the Common Rule and require consent to be obtained for such specimens, as well as imposing further restrictions under which a waiver of consent could be obtained for biospecimen research.  The proposed changes that received the most comments were regarding how the rule would impact biospecimens, including the expanded definition of “human subject.”
  • Requiring that this policy expand to cover clinical trials that are not federally funded.
  • Enforcing standard privacy practices for identifiable health information and biospecimens.
  • Adding a list of activities that would meet the definition of “minimal risk” to provide more clarity around this definition.
  • Requiring that the study exemptions to IRB review be documented and determined in a specific way (e.g., using a specific tool).

What Remains to Be Seen?

The Common Rule document includes projections for quantitative savings and qualitative benefits from years 2017 – 2026. A primary theme of the public comments – which led to the abandonment of the more controversial proposed changes – was the lack of details. With a lack of quality deliverables and ambiguity about the underlying tools, templates and concepts, only time will tell if the streamlined nature of the final rule will result in measurable deliverables and the projected quantitative and qualitative benefits.

Ideally, in executing the new rule, the requirement for multi-state U.S. research to use a single IRB would reduce costs and expedite the research. Notably, the NIH also recently issued their policy on the use of single IRBs for these types of studies. However, at Rho, we’ve had first-hand experience following this recent mandate, and have found that some clinical sites have been reluctant or unable to relinquish control over their research to a central IRB authority. Some of the studies we’ve worked on have had to go through both a central IRB and institutional site IRB, thereby increasing study costs and timelines in direct contradiction to the goal of the revision.

Since the requirement change for the central IRB not held by a FWA-holding institution to be in compliance with the rule will not be made effective until next year, there seems to be high potential that there will be increased costs and burden in the short-term.

Similarly, some clinical site IRBs may continue their current practices for full- and continuing-reviews regardless of whether those studies meet the revised definition of being exempt from requiring them. Hopefully the changes will provide long-term benefits as more clinical sites become comfortable implementing the revisions and amending their institutional guidelines.

In addition to these uncertainties, it remains to be seen what opinions are held by the new presidential administration and what impact those opinions might have.   

As the revisions are enacted, we look forward to seeing their impact on protection for research participants and lessening the administrative burden associated with oversight.