Recently, PRIM&R submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan. The RFI was issued as part of the agency’s response to new Congressional requirements in the 21st Century Cures Act dictating that NIH consult with experts regarding:

• Appropriate age groups to be included in research studies involving human subjects; and
• Acceptable justifications for excluding participants from a range of age groups from human subject research studies.

In its comments, PRIM&R endorses NIH’s efforts to promote research involving pediatric and elderly populations—groups who have, despite repeated efforts, remained under-represented in research—but emphasizes and provides examples of the ethical complexities that must be considered when including such groups in research.

Rather than address these issues de novo, we encourage NIH to review the robust body of scholarship and policy recommendations found in the work of a number of national bioethics advisory groups who have taken up the ethical grounds as well as the practical barriers and opportunities for including a wide range of under-represented groups in research. We draw NIH’s attention in particular to the following reports: the National Bioethics Advisory Commission’s report, Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, the Presidential Commission for the Study of Bioethical Issues’ report on Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society, and the Secretary’s Advisory Committee on Human Research Protections, Recommendations Regarding Research Involving Individuals with Impaired Decision-Making. 

PRIM&R also suggests that NIH bear in mind two points as they move forward. First, chronological age alone does not indicate susceptibility to risk or vulnerability to undue influence; at any age, an individual’s ability to engage in the informed consent process, for example, will vary depending on situational factors and cognitive abilities. Second, inclusion of populations who have historically been under-represented due to likelihood of impairment in capacity to consent will require appropriate additional safeguards as part of the review process, consent procedures, and the design of clinical research itself.

In conjunction with their request for information, NIH also convened a two-day workshop on how to facilitate appropriate inclusion of pediatric and older populations in human subjects clinical research.

Based on the input received from both the RFI and at the workshop, NIH plans to re-evaluate their policies accordingly. PRIM&R looks forward to seeing what comes of this process.

We encourage and welcome you to share your thoughts on our comments or the RFI document by leaving a comment below.