PRIM&R’s Comments on the FDA’s Proposed Rule, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations”

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which was published in the Federal Register on November 15, 2018. Comments are due February 13.

In our comments, we applaud the FDA for taking steps to harmonize their human subject regulations with the Common Rule as this will reduce the burdens of redundant regulations that do not add up to better human subject protections. Harmonizing the provisions on waiver or alteration of informed consent will be especially beneficial for researchers who must comply with both the FDA rules and the Common Rule. This move towards harmonization will also be helpful for researchers conducting certain types of cluster randomized and pragmatic trials, and research involving “big” health data, which heretofore have been ineligible for waivers of consent, even when they qualify as minimal risk.

However, PRIM&R raises two areas of consideration for the FDA.

First, we ask the FDA to explain why it is not adopting the new fifth waiver criterion in the revised Common Rule, which says that the IRB may waive or alter informed consent if it finds and documents that, in addition to meeting the original four waiver criteria, “if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.” Furthermore, we request that if the agency does ever adopt the fifth criterion or otherwise allow waiver or alteration of consent for the use of identifiable data or specimens, it provide more justification than has currently been offered by the Common Rule agencies as to the types of qualifying research.

For example, as it becomes easier to link together personal data sources and therefore identify individuals, it becomes harder for IRBs to confidently determine which research uses of identifiable biospecimens or identifiable private information are truly minimal risk, and thus waiver eligible. The FDA could offer guidance on the types of information IRBs should obtain before making such a determination.

Second, we urge the FDA to issue additional guidance on the standard of “practicability” as it pertains to the criteria for waiving or altering informed consent. We point out that current guidance does not adequately emphasize that IRBs’ waiver of consent decisions—in particular, determinations that getting consent would make the research impracticable should take into account the importance of the research in question. If the FDA were to issue guidance for IRBs on how to make determinations of “practicability” using a standard of importance , there might be more uniformity in how the regulations are interpreted.

Currently, there is considerable variability in how IRBs interpret the “practicability” standard: where some IRBs might say “impracticable” means it is impossible to conduct the research with consent, others might cite an investigator’s resistance to seeking informed consent as something that meets the “impracticability” standard. PRIM&R believes that “impracticable” should be understood to mean that the burdens of getting consent are too high, considering the benefits, or value, promised by the research.

In 2008, the Secretary of Health and Human Services’ Advisory Committee on Human Research Protections (SACHRP) issued “Recommendations related to waiver of informed consent and interpretation of ‘minimal risk.” There they note that “practicability” should not be determined solely on the grounds of cost, speed, or convenience, and instead IRBs making such determinations should consider ethical concerns that would be raised if consent were required, such as creating additional risks related to psychological or social harms. PRIM&R suggests that both the FDA and those who are interested in commenting on the FDA’s proposed rule consult SACHRP’s thoughtful recommendations.

The FDA recently extended the public comment period on the proposed rule to February 13, 2019, and comments may be submitted at (search for Docket No. FDA-2018-N-2727 and then select the “Comment Now” button). We encourage the community to cite PRIM&R’s comments or borrow any of the points we make if that would be useful to you in crafting your own comments. Please let us know in the comment section below if you take such an approach.