In the annals of research ethics within the United States, the importance of the Belmont Report
(http://ohsr.od.nih.gov/guidelines/belmont.html) cannot be overstated. It was an outgrowth of the National Research Act of 1974, which came about because of a series of events that had occurred in the 30 years leading up to the implementation of the Act. While the initial impetus came from the discovery of the Nazi atrocities in World War II, the fact was that even in the US there were research ethics violations, including the Willowbrook hepatitis study (involving retarded children), the Jewish Chronic Disease Hospital study (involving chronically ill but demented patients), the Tuskegee syphilis study (involving elderly Black sharecroppers), the thalidomide crisis, and other events. The Belmont Committee was charged with developing a framework for the ethical conduct of research, protecting those people who would be willing to participate as research subjects. Three principles emerged from the conference: (1) Respect for persons; (2) Beneficence; and (3) Justice.
Respect for Persons: two issues arise with regard to respect to persons. One is that individuals are to be treated as autonomous agents, and those with diminished autonomy would require additional protection. This makes sense in that some of the most egregious violations that had occurred involved vulnerable populations- the poor, children, the elderly. Thus, the issue here is autonomy, or the right of people to self-determination. Embedded in this precept is the concept of informed consent. That is, no one should consent to being a research participant with being informed as to the risks and benefits of that involvement. For ac competent person, this requires disclosure of information and then an ability to make a decision to participate free from any force or coercion. In the case of someone with diminished competency or who is not competent (such as children, who are not legally competent), a surrogate (such as a parent) must make that decision.
Beneficence: This means more than simply to do no harm; it means that efforts must be taken to reduce the risks for participation while doing what you can to enhance the benefits, if any are there. Today, the leading ethical framework for bioethics- principlism- has broken the harm aspect out from the benefit aspect, so that one might talk about beneficence and nonmaleficence, to do good and to do no harm, but they are obviously different sides of the same coin. One of the issues that arises in clinical research is known as the therapeutic misconception, which occurs when patients confuse the goals of research (generalizable knowledge) with the goals of clinical practice (doing all you can to help the patient). Researchers are constrained by research protocols which they must follow, meaning that they cannot do all they can for a specific patient, something most patients initially do not grasp.
Justice: This relates to more than simply how we disburse health care resources. In the context of research, it also addresses the need that everyone share equally in risk if everyone will end up sharing in the benefit. Thus, we should not always look to local impoverished populations as research subjects because we know they are easily available and likely to find a small enticement more desirable than a wealthier potential research base. Our research should not systematically select specific classes or types of individuals because they have a compromised position in society.
The Belmont Report was an influential development in research ethics, and one that is very much a part of today’s research environment. Anyone considering conducting research should familiarize themselves with its precepts.
