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OIG - Recruiting Human SubjectsDepartment of Health and Human Services
OFFICE OF INSPECTOR GENERAL
Recruiting Human Subjects Sample Guidelines for Practice
JUNE GIBBS BROWN Inspector General
OFFICE OF INSPECTOR GENERALThe mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to protect the integrity of the Department of Health and Human Services programs as well as the health and welfare of beneficiaries served by them. This statutory mission is carried out through a nationwide program of audits, investigations, inspections, sanctions, and fraud alerts. The Inspector General informs the Secretary of program and management problems and recommends legislative, regulatory, and operational approaches to correct them.
Office of Evaluation and Inspections
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of Inspector General. It conducts short-term management and program evaluations (called inspections) that focus on issues of concern to the Department, the Congress, and the public. The inspection reports provide findings and recommendations on the efficiency, vulnerability, and effectiveness of departmental programs.
PURPOSETo identify institutional review board and professional medical association human-subject recruitment guidelines that exceed guidelines set forth by the Department of Health and Human Services.
BACKGROUNDIn our companion report, Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (OEI-01-97-00195), we indicated that the Department of Health and Human Services (HHS) guidelines do not address the recruitment practices that IRBs and others involved in clinical research find most troubling. In this report, we present other sources of guidance for IRBs and investigators, from such entities as professional medical associations and IRBs. We also include Canadian guidelines on recruitment practices to illustrate how these practices have been addressed by another nation’s research community.
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