Research subject advocate: a new protector of research participants.

In 2001, the National Center for Research Resources (NCRR) directed the 78 General Clinical Research Centers (GCRC) to develop a Research Subject Advocate (RSA) position. The RSA would report directly to the Principal Investigator (PI) of each GCRC and assure compliance of studies conducted on the GCRC with federal regulations and policies. Seven RSAs agreed to be interviewed about their new role. Website documents, electronic correspondence, and presentations at the first annual national meeting of RSAs were scrutinized using discursive analysis to shed light on this new organizational form and its potential for increased protection of human research participants. The RSA role actualizes the ethical principles of respect for persons, justice, and beneficence that are the foundation of the protection of research participants. The results also reveal the regulatory, institutional, collegial, and personal resources and barriers that assist the RSA in the successful implementation of the RSA role. In addition, issues important to the RSAs are described.