by Andrea Johnson, JD, CIP, regulatory specialist in the Research Integrity Office at Oregon Health and Science University
Respect for persons is one of the three tenets of human research subject protections advanced by The Belmont Report. It includes two moral requirements:
- Autonomy of individuals must be acknowledged; and
- Persons with diminished autonomy must be protected.
The Belmont Report states, “To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others.”
When most of us (including me) visualize the ideal informed consent process for a research study, it ends with the potential subject making a decision to participate or not based wholly on his or her individual assessment of an unbiased and comprehensive collection of facts about the research. Wednesday’s sessions, however, challenged this notion with additional considerations surrounding the concept of autonomy.
Jennifer Bell, MA, presented a poster during Panel III titled, “‘No Man is an Island’: Cancer Patients’ Experience of Autonomy Related to Their Decision-Making Process about Clinical Trial Participation.” The title says it all. There is more to a potential subject’s decision than his or her own personal interests. Bell described this broader view of autonomy as “relational autonomy.” It is a combination of personal, social, and situational factors. For example, someone may wish to participate in a study, but knows that it would require a family member to drive him or her to study visits. The desire to avoid inconveniencing a family member may prevent the person from participating. Is that family member obstructing the potential subject’s actions? Are such external factors a source of coercion or undue influence? Does this mean that autonomy is an illusion? No, I don’t think autonomy is an illusion.
I do think, though, that our highly individualistic society sometimes fails to recognize the importance of the social and situational factors that influence personal actions. These factors are not necessarily a hindrance to our autonomy; rather, they are contributors to our perspective and sculptors of our values. In some sense, they make each of us the person that we are.
These ideas made me think back to the keynote address given by James R. Gavin III, MD, PhD. In his discussion of the barriers to racial and ethnic minorities’ participation in research studies, he identified several ways in which cultural and community misconceptions can deter individuals from becoming subjects. Again, we see external factors playing a role in a person’s decision. When external factors include wrong or missing information, however, there is most certainly a negative effect on autonomy.
Based on these perspectives, I see broadening our concept of autonomy as a way to facilitate greater respect for persons rather than less. Becoming aware of the external factors that influence a potential subject’s decision to participate in research can help us identify and work to correct social misconceptions. Where such external factors are not misconceptions, we can show respect for potential subjects by allowing and encouraging them to seek input from other sources before making their decisions.