To discern the key components of what is considered in a review by the Committee on the Use of Human Research Subjects (aka "Committee" or "IRB"), it is essential to understand the ethical issues of research involving human subjects. The principles of autonomy, beneficence, and justice, set forth in the Belmont Report are basic to these ethical issues and merit your consideration.

Autonomy
Autonomy means that each person should be given the respect, time, and opportunity necessary to make his or her own decisions. Prospective participants must be given the information they will need to decide whether to enter research or not participate. There should not be pressure to participate.

The principle of autonomy requires that protection be given to potentially vulnerable populations such as children, the elderly, the mentally ill, prisoners, or others in status type differential relationships (e.g. student/teacher). Individuals in these groups may be incapable of understanding information that would enable them to make an informed decision about research participation. They are considered potentially vulnerable. Consequently, careful consideration of their situation and needs is required and extra care must be taken to protect them.

Beneficence
Beneficence obligates the researcher to secure the well-being of all research participants. It is your responsibility to protect participants from harm, as well as ensure that they experience the possible benefits of involvement. Balancing risks and benefits is an important consideration. The key, according to the 1979 Belmont Report on the protection of human subjects, is to "maximize possible benefits and minimize possible harms."

Justice
The ethical considerations of risks versus benefits raise the question of justice. Who should bear the risk of research, who is equal and who is not, and who should receive its benefits? The concept of justice may be questioned when we attempt to decide who will be given an opportunity to participate and who (and for what reason) will be excluded. Are some classes of persons being selected simply because of their availability, their compromised position, or their manipulability while others are not? Keep the following tips in mind when selecting prospective participants:

• Participants should not be selected due to class, socioeconomic status, or race unless justified by the research objectives.
• Women have been underrepresented in certain research studies because of the risks associated with child-bearing. Now researchers must justify why women may not included in a research population. Failure to provide scientifically sound arguments for the exclusion of one gender could be grounds for denial.
• An existing counselor-client or physician-patient relationship requires consideration of the potential for power-based coercion when expanding that relationship to include investigator-subject. Provisions, or adjustments, might need to be made to attempt to equalize the roles.
• Teacher-student relationships always carry a perception of inequalities in roles. The informed consent process should reflect the precautions taken to balance the relationship and guard against even the perception of coercion.