Human Subject Protections

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Many kinds of research depend on the participation of volunteers. The kinds of study procedures that these volunteers experience are reviewed by Institutional Review Boards (IRBs). IRBs are federally mandated and consist of community members, faculty, staff and experts. They are charged with reviewing human subject studies to make sure that volunteers are treated with respect and fairness, that risks are minimized to the greatest extent possible and that there is benefit to the study being done (to the individual and/or society).

The Belmont Principles
The triad of respect for persons, beneficence and justice are known as the Belmont principles and guide IRB decision-making regarding the approval and conduct of research studies involving human participants. The Belmont principles were developed in 1979 in response to Nazi war crimes and other abuses of humans in the name of research. These principles set the stage for the development of federal regulations that mandated IRBs and the conduct of research with human volunteers.

The principle of respect for persons means respecting an individual's autonomy (his/her right to make decisions for him/herself). This means that individuals should participate in research voluntarily and be given enough information to make an informed decision about whether or not to participate. The principle of respect for persons is also embodied in the informed consent process. Three elements crucial to the informed consent process are information, comprehension, and voluntariness. While there is no standard for the amount of information to be provided to potential volunteers, the IRB is charged with making sure that these principles are met. For full comprehension and voluntariness, the way in which information is provided to the volunteer can be as important as the information itself.

The principle of beneficence requires that the investigator not only protect individuals from harm, but make efforts to secure their well-being. 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. Risks to participants may be balanced against the benefits to participants directly, or to society as a whole.

The principle of justice means that the benefits and burdens of the research are fairly distributed. 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. In this country, in the 1940's, the Public Health Service syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. It is a violation of the principle of justice to select a class of participants (e.g., welfare patients, an ethnic minority, institutionalized persons) simply because of easy availability rather than for reasons directly related to the problem being studied.

Ensuring the protection of human subjects
The Belmont principles in action are reflected in the applications researchers submit to the human protections program and in the careful and detailed review and discussion of the study by IRB members and staff. The researcher is asked to paint a picture of the research s/he plans to conduct so that lay people and professionals alike can understand what will be happening. Required elements in recruitment materials and informed consent help to assure that participants are adequately informed of the study they are thinking about taking part in. When researchers conduct studies as approved by the IRB, they, too, are putting the Belmont principles into action with each and every participant approached to enroll in studies.

The Code of Federal Regulations (CFRs), along with state laws and institutional policies, guide the work of IRBs and investigators in ensuring the safe conduct of human research. These laws and policies apply to biomedical, biobehavioral and behavioral/social science investigations and address areas such as recruitment, informed consent process, documentation, confidentiality, and compensation in research studies. Human research protections programs abide by these regulations, laws and policies while advancing effective and efficient research.

Vulnerable populations, such as prisoners, children, pregnant women and fetuses, and persons unable to provide consent, are given special protections by law. Research studies involving these populations receive additional scrutiny and added safeguards may be recommended or required of the investigator by the IRB.

Responsibility for human research protections is a team effort. Human research protection programs, Institutional Review Boards, researchers, and participants all have a stake in the proper conduct of scientific investigations.

Josy Lyons, R.N., M.Ed. Office for Research Protections The Pennsylvania State University

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