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By Lynn L. Bergeson and Margaret R. Graham

On January 19, 2017, the U.S. Environmental Protection Agency (EPA), together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.  82 Fed. Reg. 7151.  The Federal Register publication states that this final rule is intended to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators, and “these revisions are an effort to modernize, simplify, and enhance the current system of oversight.”  The rule will become effective on January 19, 2018.  The compliance date is also January 19, 2018, with some exceptions.

The final rule differs in important ways from the proposed rule issued on September 8, 2015; most significantly, several proposals are not being adopted.  Other minor changes have been to improve the rule and for purposes of clarity and accuracy.  Some of the changes include:

  • It does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
  • To the extent some of the proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
  • It does not expand the policy to cover clinical trials that are not federally funded.
  • It does not adopt the proposed new concept of ‘‘excluded’’ activities.  Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The proposed revisions to the exemption categories have been modified to better align with the longstanding ordering in the final rule. It does not include the proposed requirement that exemption determinations need to be made in specified ways.
  • It does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens.
  • It does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.

The final rule makes the following significant changes to the Common Rule:

  • Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.  Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
  • Establishes new exempt categories of research based on their risk profile.  Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
  • Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective three years after publication of the final rule.
  • Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.

More information on the Federal Policy for the Protection of Human Subjects is available on the U.S. Department of Health & Human Services’ website