Section 6: Recruitment and Selection of Subjects

Distributive justice, the third principle of The Belmont Report, requires the fair selection of participants and the equitable distribution of the risks and benefits of research.

The systematic selection of participants because of their availability, their compromised status, or because of social, racial, sexual, economic or cultural biases institutionalized in society, may result in an uneven distribution of the benefits and the burdens of research. For example, students, patients, clients, or employees are compromised to the extent that their grades, access to health care and other services, or their jobs are dependent on those interviewing or those investigators recruiting them for research. The research application should clearly articulate how recruitment activities will avoid even the appearance of coercion when selecting participants who are in a dependent relationship to the investigators or their agents.

To insure that certain populations are not recruited solely because of their availability, for example, prisoners or patients in mental health institutions, the National Commission for the Protection of Human Subjects recommends a hierarchy of preference in the selection of subjects for research: adults before children, competent individuals before incompetent individuals, and non-institutionalized persons before institutionalized persons.

Further, the National Institutes of Health has issued guidelines to ensure that the risks and benefits of participation in research extend to women and minorities. These guidelines indicate that researchers should recruit and include minorities and women in study populations so that the research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study.

There are special ethical requirements for the recruitment of children. Children are in a dependent relationship to adults and can be easily manipulated in a school or clinical setting; for this reason they are entitled to extra protections as a "vulnerable subject population" as determined in federal regulations. Investigators should take every precaution to insure that a child's decision to participate in research is both voluntary and free from coercion. Refusal to participate should not be met with a negative response or any form of punishment. In an educational setting, school officials or teachers do not have the authority to give consent for the participation of children, unless the research qualifies for exemption or exclusion from the human subjects regulations. Only a parent or legal guardian may allow a child, with the child's assent, to participate in a research study that is not exempt or excluded from the human subjects regulations.

With all populations, the process of recruitment begins at the first point of contact with a potential human participant prior to the initiation of the procedures for obtaining informed consent. In many ways, recruitment is the introduction to the consent process, and may take the form of a flyer, a newspaper advertisement, or a verbal exchange between a member of the study team and the potential participant. Recruitment techniques must respect the rights of all individuals to decide whether or not they will participate voluntarily. They should not feel coerced; nor should they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. A person in authority, for example, a teacher recruiting students, should take special precautions to ensure that a decision to participate is not based on subtle pressures such as grades or a fear of loss in benefits such as counseling services. All flyers, posters, advertisements, letters, postings on the internet or any other recruitment materials should be attached to the research protocol for examination by the IRB and must be approved prior to their use.