Recruiting Volunteers

UT Southwestern IRB reviews and approves all methods and materials that investigators propose to use to recruit subjects according to 21 CFR 56.109(a) and 21 CFR 56.107(a) and 56.111. In addition, IRB reviews and approves procedures for recruitment, including special cases such as enrollment of vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

Recruitment is considered the first step in on the consent/assent process; therefore, IRB also reviews recruitment procedure to determine that it is not coercive and that it accurately describes the likely risks and benefits of study participation, and that study population is selected equitably according to 45 CFR 46.111.