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OIG - Recruiting Human Subjects

Department of Health and Human Services

OFFICE OF INSPECTOR GENERAL

Recruiting Human Subjects Sample Guidelines for Practice

JUNE GIBBS BROWN Inspector General

JUNE 2000

OEI-01-97-00196

OFFICE OF INSPECTOR GENERAL

The 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.

OEI's Boston regional office prepared this report under the direction of Mark R. Yessian, Ph.D., Regional Inspector General. Principal OEI staff included:

REGION

Nancy L. London, Lead Analyst

Laura C. McBride, Lead Analyst

HEADQUARTERS

Elise Stein, Program Specialist

To obtain copies of this report, please call the Boston Regional Office at (617) 565-1050.

Reports are also available on the World Wide Web at our home page address: http://www.dhhs.gov/progorg/oei

EXECUTIVE SUMMARY

PURPOSE

To 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.

BACKGROUND

In 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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