title: The research subject advocate at minority Clinical Research Centers: an added resource for protection of human subjects.
abstract: In early 2001, the National Institutes of Health (NIH) created the research subject advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human participants in clinical research studies. We describe the RSA position in the context of clinical research, with a particular emphasis on the role of the RSA in two of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although we cannot yet provide substantive evidence of positive outcomes, this article illuminates the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. On the basis of initial results, we conclude that the RSA is an effective mechanism for achieving the NIH goal of maintaining the utmost scrutiny of protocols involving human subjects.
authors.affiliation: John A Burns School of Medicine, University of Hawai'i at Manoa, USA. davide@kapiolani.org
authors.forename: David
authors.initials: D
authors.lastname: Easa
authors.forename: Keith
authors.initials: K
authors.lastname: Norris
authors.forename: Zoë
authors.initials: Z
authors.lastname: Hammatt
authors.forename: Kari
authors.initials: K
authors.lastname: Kim
authors.forename: Esther
authors.initials: E
authors.lastname: Hernandez
authors.forename: Kambrie
authors.initials: K
authors.lastname: Kato
authors.forename: Venkataraman
authors.initials: V
authors.lastname: Balaraman
authors.forename: Tammy
authors.initials: T
authors.lastname: Ho
authors.forename: Samuel
authors.initials: S
authors.lastname: Shomaker
mesh_terms: D035843:Biomedical Research; D006805:Human Experimentation; D006801:Humans; D008913:Minority Groups; D009316:National Institutes of Health (U.S.); D010344:Patient Advocacy; D014481:United States