Posted on July 3, 2017 at 8:00 AM
Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research. This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991. Since then, there have been no major changes to the regulations – until now. After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017. The July 2017 issue of the American Journal of Bioethics addresses these changes. In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.
by Eric Wat MA, Nancy Shore PhD, Sarena D Seifer MD, CCPH, Lola Sablan-Santos, Alice Park MPH, Mei-Ling Isaacs MPH, Ahahui Malama I Ka Lokahi, Kelly Edwards PhD, Elaine Drew PhD, John Cooks, Paige Castro-Reyes BS BA, CCPH
We concur with Friesen and colleagues’ (2017) assertion that the Belmont Report requires, at a minimum, a “tune-up” to better reflect the unique ethical values and demands of community-engaged research (CEnR). The current Belmont principles and Common Rule inadequately consider issues of community harm and have too narrow of a conceptualization of social justice. Presented here are select revisions that include broadening and in some instances re-defining the meaning of the three guiding ethical principles. The information we share here was pulled directly from our full report, Research Ethics Reconsidered in the Context of Community-Engaged Research (2016).
Similar to the information cited in Friesen and colleagues’ paper, our partnership advocated for the broadening of Respect to Respect for Persons and Communities. Specific to community harm considerations, our partnership argued that Respect also requires that we consider how membership in a community may expose individuals to additional risks. Risks can arise when individuals are targeted for research due to an actual or perceived membership in a given community, or when the research process or outcomes stigmatize the community and/or when it conflicts with the shared values or beliefs of the involved community. These risks to the individual potentially can impact individuals regardless of their participation in the research. Researchers should identify possible stigmatizing risks in consultation with members of the involved community and discuss them as part of the informed consent process.
In addition to risks to individuals based upon actual or perceived membership in a community, Respect also demands that we consider risks to the involved community. Community-engaged research emphasizes equitable partnerships that recognize the community’s expertise and time, and the importance of the research process and outcomes respecting the community’s social and cultural context. Researchers must also consider how research can create conflict and tension within the community and must take measures to reduce this possibility. For example, research findings can result in stigmatizing or further marginalizing a community, or increase divisiveness among its members. Lastly, in regards to demonstrating Respect, determinations of “vulnerability” should be done in consultation with members from that community.
In regards to Beneficence, we argue that this principle must be viewed through the lens of potential benefits and harms for individuals and communities. Furthermore, involved communities must have the right to determine what constitutes benefits and risks, and what represents a justifiable risk/benefit ratio. How this determination occurs will vary across communities. In some instances, the process will entail researchers listening to and carefully considering the experiences and knowledge of the elders, leaders or other community members. For example, the community may want to identify up front (before any research begins) how a particular study’s findings may translate into actions to benefit the community, such as through community capacity building and policy changes that address a community-identified concern or priority.
With Justice, our partnership urged that this principle include both distributive and responsive justice considerations, inclusive of redistribution, recognition and responsibility. We also noted that equal access and opportunity to participate in research does not create a just outcome alone; issues of equity must be considered. To better highlight the extent of the abusiveness of the U.S. Public Health Service study of untreated syphilis in Tuskegee, and the federal government’s sanctioning of it, we argue that the Belmont Report must include appropriate name and timeframe (1932-1972). Currently the Belmont Report refers to it as Tuskegee syphilis study, which fails to highlight the responsibility and role of the U.S. Public Health Service.
Additionally, our team proposed three core researcher capacities to be outlined in the Belmont Report’s preamble, especially for researchers wanting to engage or include communities. These three capacities, defined below, are: Humility, Relational Integrity, and Accountability.
Humility: Researchers recognize the limitations of their own experience and perspectives, and respect the diverse ways of knowing and considerable strengths that exist within communities. Humility requires a willingness to learn from others different from yourself, not assuming you already know what’s best, and being open to a range of ways to proceed in research.
Relational Integrity: Researchers recognize and respect how trustworthy relationships take time and resources. These relationships occur over time, and often extend beyond the scope of a particular study. Power imbalances must be considered and made transparent, including what is at stake for each party.
Accountability: Researchers are accountable to the regulations and rules guiding research, as well as to any relational agreements established among study partners (e.g., partnership principles, memoranda of understanding). Individual researchers need to be accountable for institutional integrity and be ready to advocate for change when institutional processes risk disrupting trustworthy relationships.