During the latter years of my career, I had the privilege to chair a research review committee (Institutional Review Board or IRB) at Prisma Health-Upstate in Greenville SC. For four years, I helped review and approve research projects. These projects are integral to advancing health care and at the same time assuring quality and protections for research subjects. The dedicated folks on our committee were deeply committed to making sure that everything was done correctly and that no shortcuts were taken. In addition, we reviewed ongoing studies to guarantee that the proper standards were maintained even after approval. We had a “North Star” – the Belmont Report.1
The Belmont Report, published in 1979, was prepared in response to serious concerns about research that had been not only unethical but overtly harmful. Research on individuals with intellectual disability, prison detainees, prisoners of war and even healthy individuals with a treatable condition (the Untreated Syphilis Study at Tuskegee2) was at times shockingly inhumane. A commission was created “to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles.”1
The Belmont Report has become the standard by which potential and current research studies are judged, by which decisions regarding studies are accepted, by which decisions regarding studies are funded and by which decisions regarding studies are scrutinized. Now, one might ask, why am I discussing the principles put forth in the Belmont Report now. I contend that these principles identified as the basic tenets of human research are the same ones that should be used in our civil society and that we have lost track of these in our polarized society. I review them here to remind us of our responsibilities to each other, not just those under our research microscope.
Basic ethical principles from The Belmont Report (largely quoted directly from the primary source but abbreviated for clarity) –
- Respect for Persons– This respect incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. Respect for persons divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. An autonomous person is an individual capable of deliberation about personal goals. 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. To show lack of respect for an autonomous agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so. However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual’s life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.
- Beneficence– Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being, i.e., beneficence. This term is often understood to cover acts of kindness or charity, but research demands that beneficence be understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research and to a civil society. Members of the larger society are obliged to recognize the long-term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.
- Justice– The question of justice implies a sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit. Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940’s, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.
I am struck by the applicability of the three basic ethical principles of research to our social lives. Respect for others, beneficence and justice should be the guiding fundamentals for each of us. Hate and fear should be relegated to the dustbin.3 Empathy should lead the way.4 These ethical principles are “woke” and thankfully so.5,6
One could easily substitute the word “immigrant” for “research subject” when applying the principles of the Belmont Report. Respect for persons, beneficence and justice are demanded for immigrants. They are not persons to be discarded in an ethical society. A purposeful exclusion of those principles speaks to the erosion of our civil society and the unraveling of our moral fabric, not a situation I recognize in the country of my birth.
The Belmont Report can be applied beyond the research arena. In my opinion, respect for persons, beneficence and justice are required for all interactions. Anything less does not exhibit the selflessness and care for each other that our civil engagement demands.
- https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
- https://www.cdc.gov/tuskegee/about/index.html
- https://mychildrenschildren.com/hate-and-fear-enemies-of-children/
- https://mychildrenschildren.com/em-within-pathos-suffering-empathy-revisited-2025/
- https://mychildrenschildren.com/amazing-grace/
- https://mychildrenschildren.com/woke-is-good-not-evil/