Speakers

Emily A. Largent, JD, PhD, RN
Emanuel & Robert Hart Assistant Professor of Medical Ethics and Health Policy
Department of Medical Ethics and Health Policy
University of Pennsylvania Perelman School of Medicine

Slides

Keywords

Ethics, Vulnerable Populations

Key Points

• Vulnerability guidelines and regulations often refer to groups such as pregnant people, children, and prisoners. But this might obscure heterogeneity within groups, intersecting sources of vulnerability, and other vulnerable participants, such as people with dementia.

• One definition of vulnerability is “an identifiably increased likelihood of incurring additional or greater wrongs,” as a result of research participation. We need to ask how might researchers wrong participants, and one way to think about this is how might researchers fail to discharge duties to them?

• The Belmont Report lays out three principals of duties researchers have: respect for persons, beneficence, and justice. What is entailed by each of these duties? Respect for persons involves seeking voluntary informed consent or, if participants lack capacity, seek permission from a surrogate, and respect privacy. Beneficence involves minimizing risks, and ensuring they stand in reasonable relation to potential benefits. Justice involves ensuring the burdens and benefits of research are fairly distributed.

• In a review of studies, researchers identified the ways participants in a particular study might be wronged and identified corresponding protections, such as conducting a capacity assessment if we are worried about participants having an inadequate understanding in informed consent. Going through this process helps researchers see where vulnerabilities might arise and how to address them.

• The issue of informed consent comes up often with vulnerable populations that have dementia. Researchers seeking to enroll people living with dementia need a plan for assessing participants’ capacity to consent to research participation. When prospective participants lack capacity, researchers should identify a surrogate to give permission for enrollment and still find ways of involving the person with diminished capacity in research-related decision-making. Caregivers may also need to be enrolled and give their own consent as they may be more involved as the participant’s cognitive impairment worsens.

• Many pragmatic clinical trials are conducted with waivers of informed consent, but when vulnerable populations are subjects in research, there may still be additional important considerations, such as outreach, identifying caregivers through the medical record, and being certain a diagnosis of dimension has already been disclosed to the patient.

• It is ethically acceptable and imperative to enroll vulnerable subjects in research, but when they are enrolled it is important that we think about their vulnerability in systematic ways so that we know not only what they are vulnerable to but how we can protect them. Issues of consent and considerations for waivers of consent are particularly important for this population.

Learn more

Ethical Challenges in Conducting Research Using a Waiver of Informed Consent with People Living with Dementia.

Discussion Themes

- You noted that the criteria of waivers and alterations gets left out. How do you think about the fact that people are uncomfortable with waivers and that notification may turn people off? Any time we are not notifying because we might upset people is a sign we need to think more carefully how we are going to approach it. When you use a waiver, you need to go in and explain why a waiver is being used and why there was no meaningful way to opt out. Hopefully you can share what has been learned.

- Sometimes consenting in a “good moment” feels stressful because they may forget that they consented. You need to have a plan in place for assessing capacity and ability to consent. Take time to check in with the participant and caregiver to make sure they are on board and assess their continued willingness to participate.

-What if a patient has capacity to consent but their surrogate disagrees? That’s difficult. Take the individual’s consent as word; however, if they are dependent on the surrogate for transportation, etc., it can be a barrier.

Tags

#pctGR, @Collaboratory1