Does ‘The Belmont Report’ provide guidance for patient stipends?

“Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.”



This post looks at ‘The Belmont Report’ to understand whether it provides guidance related to ethical considerations for patient stipend payments. Although The Belmont report is over 40 years old and could be out of date for today’s standards, it provided important guidance for ethical issues of its day. The commission puts forth three ‘basic ethical principles’ for conducting human research. We’ll examine “Justice” as it pertains the most to patient stipends, and the idea of “what is fair”.

‘The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research’ (National Commission 1979)

Justice Section 1:

“Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the 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. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. 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.”

Commentary: Payments to trial participants are common, acceptable, and the IRB has final say regarding how much and for what purpose payments may be used. The Belmont Report made sure to protect the vulnerable, who at many points in history were being taken advantage of and in some cases participating in research without their consent. Today, things are different. Participating in clinical research provides opportunities for those with serious and rare conditions to get early access to potential life changing medicines. However, this participation comes with heavy burdens for patients and their caregivers including time spent away from work, family, and friends, costs associated with travel, and stress from planning and managing each visit. When we think about today’s clinical trial landscape and the constant calls for more diversity in trials, it begs the question, if everything is equal, and stipends are set on the lower end of the spectrum, is the burden of trial participation higher for those with limited resources?

Justice Section 2:

“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.”

Commentary: According to Food and Drug Administration data, in 2020 75% of trial participants were white, 11% were Hispanic, 8% were Black, and 6% were Asian. This data would seem to suggest that the demographic of participants has shifted, away from the vulnerable (and now the skeptical) and is now dominated by white Americans. This diversity issue is exacerbated by the fact that trials have gotten extremely complex, and often require repeat visits every few weeks for years on end. So what is creating this diversity issue in clinical trials? Could it simply be that the burdens for those choosing not to participate outweigh the benefits? Stipends therefore may need to cover this gap, the FDA states that stipends should consider “their time, inconvenience, discomfort, or some other consideration.” Inconvenience and other considerations are variable components and may vary between patients even if they’re participating in the same trial. Could the clinical trial industry implement variable stipend amounts so long as the formula is transparent?


Ethical standards in clinical trials have changed over the years and for the better. However, today’s clinical trial landscape requires a more diverse patient population, and struggles with recruitment as a whole. If this were business (it is), one could assume the “market” is telling research that “it’s not worth it”. One way to make it worth it would be to pay stipends that are fair, and more specifically, outweigh the burdens of trial participation in earnest. It may also be time to implement a variable stipend formula that considers each patient individually.