obtaining the potential participant’s informed consent to enroll in a study. The committee believes that there is a need to improve and standardize the approach to the informed consent process, which underpins the relationship between researcher and participant. Because many groups are currently reviewing various aspects of informed consent and because its complexity requires far more scrutiny than this committee can undertake, the topic is addressed only briefly in this report, as a central element of protection that should be conducted properly and scrutinized by the protection program. An appropriate informed consent process is an exchange between the researcher and the potential participant that is structured appropriately for the research design, the protocol risks, and the participant community in which the study is carried out.

Finally, the roles and responsibilities of research participants are addressed, as well as the need to include the participant perspective within the protection program and to provide basic educational material to potential participants on the general nature of research and the protection program itself.


The federal regulations do not speak specifically to the knowledge and expertise of the investigator, although they do require that the “IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.”1 In addition, the necessary qualifications and professional obligations of clinical investigators are defined within the Guideline for Good Clinical Practice developed by the International Conference on Harmonisation (1996, Section 4). The committee suggests that there are common responsibilities incumbent to any investigator who engages participants in research studies, regardless of the scientific discipline or methodology (see Box 4.1).

Regardless of the expertise of the investigator, a poorly designed human research protocol is unethical. If the data cannot be validated or replicated, research participants have been exposed to risk or have volunteered their time for no useful purpose. Thus, research that requires enrolling participants should be conducted only by properly trained individuals.

The question posed by the research protocol should be of sufficient scientific importance to justify the use of human participants and valuable


45 CFR 46.107(a), 21 CFR 56.107(a).

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