Ethical Research Guidelines and Procedures
Regulations established by the Department of Health and Human Services require that all human subjects research, whether federally funded or not, be conducted in an ethical manner which protects the rights and welfare of its research subjects. The Code of Federal Regulations (Title 45, Part 46) and the Belmont Report specify three basic ethical principles which must guide all human subjects research: respect for persons, beneficence and justice.
Respect for persons incorporates two basic ethical beliefs:
- individuals are autonomous actors capable of deciding whether or not to participate in a research study; the wishes of persons choosing not to participate must be respected, and
- individuals with diminished autonomy are entitled to protection from research which may exploit or harm them.
Respect for persons is manifested in the practice of informed consent. That is, researchers must treat prospective research subjects as truly autonomous agents by fully informing each individual in advance about the purpose of the study, who is conducting and/or sponsoring the study, the nature of the subject's participation, the potential benefits of the study, the potential risks to the subject, the fact that all participation is voluntary and alternatives to participation. Informed consent must provide each prospective research subject with sufficient information to decide whether or not to participate.
Beneficence is based on the general rule of "helping without harming". Ethical research should provide benefits to the general public and/or the research subject. However, federal regulations recognize that some research may inherently involve risks to research subjects. In such cases, regulations require the researcher to maximize the possible benefits while minimizing the possible risks.
Beneficence is manifested in the practice of estimating the risk-benefit ratio associated with each particular research program. In general, the researcher must be able to demonstrate that the benefits (which have been maximized) clearly outweigh the risks (which have been minimized). The IRB must, in turn, objectively review the risk-benefit ratio of each proposal. Generally speaking, IRB approval will be given to proposals which demonstrate a high ratio of benefits to risks. In some cases, however, the IRB may determine that it is justifiable to seek certain substantial benefits despite potentially high risks, or conversely, determine that certain possible risks may be so high as to forego any potential benefits.
Justice is based on the principle that the burdens of research should not be borne exclusively by the disadvantaged, poor, or powerless, nor should the benefits of research be enjoyed exclusively by the advantaged affluent, or powerful. Rather, the benefits and burdens should be shared equitably among all groups.
Justice is achieved in human research through the equitable selection of subjects. The guidelines for equity state that:
- the burdens of research should not be placed unduly on persons or groups who are unlikely to be among the beneficiaries of research findings; and
- both the researcher and the IRB must carefully scrutinize selection criteria in order to ensure that individuals, groups, or classes of people are selected as subjects because of reasons directly related to the problem under investigation rather than because they are gullible, powerless, or easily available and dependent on the researcher for rewards (including grades) or payments.
The principles of respect, beneficence and justice, and the associated practices of informed consent, risk-benefit analysis and equitable selection of subjects, acknowledge and promote the rights and dignity of human beings. Federal regulations and university policy require that the ethical principles of research must be observed and complied with by the researcher. It is the obligation of the IRB to scrutinize each proposal to assure that these principles and practices are upheld.
Further discussion of these ethical principles may be found in the Belmont Report, copies of which are available through the Office of the Dean of Faculty.