By Courtney Jarboe, CIP
What does it mean to be vulnerable?
When researchers begin to learn about vulnerability, it’s usually with a conversation about cases such as the United States Public Health Service Syphilis experiments, the Nazi experiments, and the many other historical examples of unethical research with vulnerable populations. We also tend to look to the regulations 45 CFR 46 and 21 CFR 56, which offer this limited list of vulnerable participants:
- Human fetuses
- Persons with physical handicaps
- Persons with mental disabilities
- Persons who are disadvantaged economically or educationally
The Belmont Report also describes racial minorities, the very ill, and the institutionalized as vulnerable. Even with this guidance, there is always a question of exactly who should be considered a member of a vulnerable population, and how to handle those situations.
Vulnerability in Research by James M. Dubois provides the pros and cons of two approaches to addressing vulnerability: group-based and analytic. The group-based approach, Dubois states, “makes it easier to identify individuals as vulnerable.” However, he also argues that, “such an approach may become unwieldy if we seek to craft special regulations for every group that may be vulnerable,” adding:
The National Bioethics Advisory Committee (NBAC) recommends the analytic approach to addressing vulnerability. Although my institution does not review bioethical research, the approach may be useful when reviewing institutional review board (IRB) applications. The NBAC has identified six traits of vulnerability that may “interfere with an individual’s ability to protect themselves in research especially during the informed consent process.” The vulnerability traits are:
- Cognitive or communicative
Just in the past several weeks, the National Transgender Discrimination Survey (NTDS) results were shared with the public. This survey included more than 6,450 responses from participants. “The NTDS is the first large-scale national study of discrimination against transgender and gender non-conforming Americans, and paints a more complete picture than any prior research to date.”
This study shows the complexity of vulnerability in the transgender and gender non-conforming individuals. Researchers can utilize the study’s results to better understand the population’s vulnerability.
No matter what approach researchers take the question remains: What is the definition of vulnerability?
It’s important to remember that IRBs are responsible for reviewing research in relation to ethical conduct and for ensuring that participants can make an informed decision about their participation. In addition, the IRB reviewer or committee should acknowledge what, if any, special accommodations need to be made in order to protect the population without indirectly scrutinizing the population (implication of stereotypes rather than actual evidence regarding the characteristics of the population).
Dubois strongly encourages IRBs to consult the research community rather than making an assumption that persons with severe mental disorders are “unable to provided informed consent, despite evidence that most individuals with depression or schizophrenia retain decision-making capacity.”
What are your thoughts on these varied approaches to understanding vulnerability?
Thank you Courtney.
I believe we have two groups: first are the"Special Populations" that were identified by Congress and may or may not be vulnerable and second are people who, due to some issue, have a diminished ability to make a voluntary or informed choice.
Dr. Kenneth Kipnis wrote an article for NBAC in 2000 titled "Vulnerability in Research Subjects: A Bioethical Taxonomy." He used 6 concepts of vulnerability: cognitive, juridic, deferential, medical, allocational, and infrastructural.
The conditions that make a person vulnerable are different for everyone and thinking about the underlying principles – and asking about them during review – is critical.
I completely agree with you! I will take a look at that article too! It is imperative that we ask the question "are there appropriate protections in place?" Protections meaning not only those additional support structures (i.e. counseling services, etc.) but the protections to subjects surrounding the research process as a whole (from recruitment to the start of participation to the finish and thereafter).