Recruitment Methods

In their effort to recruit participants for a clinical trial, research team members can reach potential patients directly by means of posters, mailing, talks, and the media.  In many studies, in particular cancer prevention and screening trials, they can, and should, reach out to physicians and medical professionals in the community for patient referral.

Enrollment of a patient is only the first step toward the successful completion of a study.  The research team needs to pay special attention to retaining study patients.

It is crucial that the research team bear in mind the implication of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rules.  According to these Rules, research recruitment is neither a marketing nor a healthcare operations activity.  Under the Rule, a covered entity is permitted to disclose protected health information to the individual who is the subject of the information, regardless of the purpose of the disclosure.  Therefore, covered healthcare providers and patients may continue to discuss the option of enrolling in a clinical trial without patient authorization, and without an IRB or Privacy Board waiver of patient authorization.  However, where a covered entity wants to disclose an individual's information to a third party for purposes of recruitment in a research study, the covered entity first must obtain either authorization from that individual or a waiver of authorization as permitted at Sec. 164.512(i) of the Privacy Rule.  See http://privacyruleandresearch.nih.gov for useful information researchers need to know.  HIPAA is also discussed in Section 1, Module 2 "How are Participants Protected?"

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