“You Don't Know Me, But …”: Access to Patient Data and Subject Recruitment in Human Subjects Research

Name / volume / issue

53056

Page number

31-38

Primary author

Toby Schonfeld, Joseph S. Brown, N. Jean Amoura & Bruce Gordon

Tag(s): Journal article

Abstract

Recruiting subjects to participate in a research study is the first step in the consent process, and therefore falls within the purview of the institutional review board (IRB) (Huntington and Robinson 2007; Neff 2008). It is a common practice to screen patients’ medical information to ensure that recruitment efforts are targeted to the appropriate individuals, a practice permitted under the Heath Insurance and Portability and Accountability Act (HIPAA) preparatory research provision (U.S. Department of Health and Human Services 2003). However, this practice raises some privacy concerns. There is a clear tension here, between the needs of investigators to recruit subjects sufficient to the conduct of scientifically valid research (Ness 2007; Sataloff 2008; Wolf 2006) and the rights of patients to have their information protected.

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