IRB Guidelines - Establishing/Utilizing Subject Recruitment Databases

Researchers and the IRB share the responsibility for establishing a recruitment environment that adequately protects the rights and welfare of the prospective participants. [Belmont Report; 45 CFR §46.111(a)(3).] This ethical and regulatory guidance require consideration of the appropriate procedures for the initial identification, contact, and recruitment of potential subjects. The recruitment process should demonstrate adequate respect for the dignity and autonomy while honoring and preserving any confidential information necessary to identify and contact potential subjects while minimizing undue influence.

Generally, subject contact information acquired in a study would be destroyed at the end of the study. University of Massachusetts Amherst (UMass) researchers wishing to maintain subject information for the purpose of future recruitment must submit such a request to the IRB. Such information would be intentionally maintained for use as a prospective tool to recruit volunteers in order to conduct research. Databases must be maintained by one responsible qualified UMass researcher and in most cases subjects will fill out a consent form agreeing to the inclusion of their information into such a system.

NOTE – a collection of names, contact information and date of birth only is not considered a subject recruitment database. This information may be maintained with the subject's permission. If however, personal information is to be maintained with the name, UMass researchers must seek approval to maintain a subject recruitment database.

Establishing a Recruitment Database (More)