Some IRB Policies Unfairly Exclude People with Uncertain Decision-Making Capacity

By Stacey Kusterbeck

Some institutional review board (IRB) policies may be unfairly excluding people with uncertain or impaired decision-making capacity from participating in research, according to a recent study.¹ “There are no federal regulations of policies that focus specifically on protection of adults with impaired or uncertain decision-making capacity in research. We wanted to see what kind of guidance IRBs provide,” says David B. Resnik, JD, PhD, one of the study authors and a bioethicist at the National Institutes of Health.

Resnik and colleagues analyzed IRB policies at 94 U.S. research institutions on the guidance they offer to researchers who recruit populations with a wide range of decision-making capacity. Some key findings were:

• 41.5% of policies required exclusion of people with uncertain or impaired decision-making capacity unless inclusion was scientifically justified.
• Few (5.3%) institutions had policies requiring inclusion of these populations unless exclusion was scientifically justified.
• In 54.3% of policies, eligibility criteria depended on the risks of the research. For instance, one IRB policy distinguished between minimal-risk studies and more-than-minimal risk studies (both with or without the prospect of direct benefit for participants).
• Most (77.7%) policies included guidance on obtaining consent or assent.
• Less than half (44.7%) of policies included guidance on assessing decision-making capacity.
• About one-third (30.9%) of policies required IRBs to include a member who is knowledgeable about the concerns and needs of people with uncertain or impaired decision-making capacity when the IRB is reviewing research pertaining to that population.

“Research that would be relevant might include studies on how well people with uncertain or impaired decision-making understand the information that is conveyed to them, how they use that information to make decisions, and the factors that may impede or enhance their decision-making abilities,” says Resnik. IRB members with relevant knowledge could be anyone with substantial professional or personal experience working with this population, adds Resnik. IRBs might obtain input from a healthcare provider who treats patients with uncertain or impaired decision-making, from scholars (including ethicists) who do research on this population, or even from laypeople with relevant experience.

Putting the burden solely on researchers to justify inclusion of this population is ethically problematic. “In some cases, researchers assume that it is easier not to include this population because, for example, they don’t have to worry as much about issues related to consent or finding a legally authorized representative,” explains Resnik.

IRBs should assess their policies for people with uncertain or impaired capacity and make sure they are not in violation of civil rights or disability rights laws, according to Resnik. Researchers must carefully consider the benefits and risks of the research for members of this population and the participants’ ability to consent. “Exclusion can be justified when the risks are significant, the participant is not likely to receive any direct medical benefits from participating, and the person is not able to consent to participating,” says Resnik. According to the study authors, IRB policies should require:

• that adults with uncertain or impaired decision-making capacity be included, unless exclusion is ethically or scientifically justified; and
• that decisional capacity be reassessed if the study participant’s medical status changes.

It is ethically problematic whenever researchers exclude entire populations based on erroneous beliefs, warns Katherine E. McDonald, PhD, associate vice president for research and professor of public health at Syracuse University. Researchers should not make blanket assumptions that a given population is uninterested in participating, or cannot consent, or cannot complete study procedures.

“Many adults with developmental disabilities, for example, have a strong desire to be included in research, have decision-making capacity, and are able to complete study procedures when appropriately accommodated,” says McDonald. Research suggests that bias, rather than empirically supported evidence, contributes to widespread exclusion of adults with intellectual disability and other populations.^2,3 Researchers can use these approaches to ensure study participants are not unfairly excluded, offers McDonald:

• Helping adults with intellectual disability to understand consent disclosures. Researchers can do this by using everyday words, referring to everyday experiences, reading information aloud, or encouraging the potential participant to have someone with them to offer support.
• In general, assuming that potential participants have consent capacity unless there is reliable, substantial evidence that they lack capacity.
• Ensuring that the threshold of consent capacity required is based on the risks of the study in question. For example, consenting to an observational study with biobanking is considered not greater-than-minimal risk. In contrast, consenting to an invasive, potentially therapeutic biomedical clinical trial may entail more significant risks. “Greater confidence in a potential participant’s consent capacity is warranted for the latter, but perhaps not the former. Evaluators should keep in mind most people struggle to comprehend all consent disclosures,” recommends McDonald.
• Remembering that if someone is determined to lack consent capacity for a research study, it still may be possible to enroll that person via a legally authorized representative with meaningful assent. “In such cases, consideration should be given to whether characteristics of the study are such that it is ethical to enroll individuals therein via proxy consent,” says McDonald. For example, when considering enrollment in studies that involve more substantial risks without the prospect of direct benefit, it may not be determined appropriate to allow participation decisions to be made by a third party.
• Providing specific scientific or ethical rationales for any exclusion criteria. A blanket statement that those who lack consent capacity are ineligible lacks rationale and may be discriminatory or unfounded. “A statement that those who lack consent capacity are ineligible because the study’s risk-benefit profile may make it undesirable to cede decision-making authority to another individual may be more ethical,” explains McDonald.

IRBs can take these steps to address enrollment of adults with impaired or uncertain decision-making capacity, says McDonald:

• Scrutinize consent materials and protocols to ensure researchers are meeting their responsibilities to foster understanding;
• Require standardized, individualized, and valid approaches to determining consent capacity that are responsive to the risk-benefit ratio of the study under review; and
• Review institutional policies to determine if those reflect unfound bias toward particular groups.

“IRBs can be excellent partners in facilitating greater inclusion in research,” emphasizes McDonald.

For researchers, the biggest challenge with including individuals with impaired decision-making capacity is that it takes a lot of time and, potentially, extra resources to do it appropriately. “In the current resource-limited environment, it is often viewed as most convenient to just exclude this population — which, of course, is ethically problematic,” says Benjamin Silverman, MD, senior IRB chair at Mass General Brigham and director of ethics for the McLean Institute for Technology in Psychiatry. People with disabilities, including those with impaired decision-making capacity, have the right to equal opportunity to consider participation in clinical research, but often are excluded without appropriate justification, notes Silverman. “In response to a long history of exploitation and mistreatment of vulnerable populations, the research community, including investigators, sponsors, and IRBs, inclines toward exclusion of people with disabilities from clinical research in the spirit of protection. However, such protectionism can deprive people with disabilities of access to research, including important benefits. It can also contribute to denial of individual autonomy, compromise the generalizability of research, and can be a form of discrimination,” asserts Silverman.

When reviewing study protocols, IRBs should ask these two questions about capacity assessment, says Silverman:

• How will capacity will be assessed? “If you are checking capacity, it is a one-time assessment. For longitudinal research, you have to think about this over time,” says Silverman. If it is a study of people with mild cognitive impairment who have dementia, researchers would assess capacity at the time of enrollment and then reassess throughout the study, for example.
• How will research staff handle questions of capacity that arise at the point of care? “If someone comes in for a research visit and seems confused or altered or changed from baseline, researchers have to do something about that in real time,” explains Silverman.

Exclusion can be justified under these circumstances, says Silverman:

• if someone has been given appropriate reasonable accommodations (including supported decision-making) and, with those accommodations in place, has had an individualized and methodical assessment of their capacity to consent and is found to not have capacity to consent; and
• the IRB has not approved surrogate consent (for example, because the study is greater than minimal risk without benefit and could be conducted in other individuals not lacking capacity).

For researchers, it is important to understand methods and approaches for assessment of decision-making capacity. That includes ensuring the provision of necessary accommodation during the capacity assessment processes. “Researchers should also be aware of implicit and explicit bias regarding the capacity of people with cognitive disabilities,” underscores Silverman.

Stacey Kusterbeck is an award-winning contributing author for Relias. She has more than 20 years of medical journalism experience and greatly enjoys keeping on top of constant changes in the healthcare field.

References

1. Nguyen E, Appiah D, Ne’eman A, et al. An analysis of institutional review board policies for enrollment of adults with impaired or uncertain decision-making capacity. J Empir Res Hum Res Ethics. 2025;20(3):123-130.

2. McDonald KE, Schwartz AE, Sabatello M. Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in? Disabil Health J. 2022;15(4):101368.

3. DeCormier Plosky W, Ne’eman A, Silverman BC, et al. Excluding people with disabilities from clinical research: Eligibility criteria lack clarity and justification. Health Aff (Millwood). 2022;41(10):1423-1432.