Overview of Participant Recruitment Regulations
In human participant research, the Institutional Review Board (IRB) is required to review and approve research activities covered by the IRB regulations [21 CFR 56.109(a)]. This is to ensure that the rights and welfare of human participants are being protected. Recruiting for a research study is one of the research activities that has a direct bearing on potential participants thus the IRB is required to review all recruitment methods and materials that will be used to directly recruit participants. This includes all print, video and audio materials.
Indirect advertisement does not need to be reviewed by the IRB. This includes communications that are meant to be seen or heard by research professionals such as “Dear Doctor” letters, news stories about a research study, or listing a research study on an internet directory like clinicaltrials.gov.
Cold-calling of potential research subjects is prohibited. "Cold-calling" is when investigators or research staff, unknown to the potential research subject, contact a potential participant based on their prior knowledge of private information.
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