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ACADEMIA AND CLINIC

The Rise of Litigation in Human Subjects Research

Michelle M. Mello, JD, PhD, MPhil; David M. Studdert, LLB, ScD, MPH; and Troyen A. Brennan, MD, JD, MPH

1 July 2003 | Volume 139 Issue 1 | Pages 40-45

Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.

Author and Article Information

From Harvard School of Public Health and Brigham & Women's Hospital, Boston, Massachusetts.

Acknowledgments: The authors thank Joseph Anesi, JD, for research assistance.

Grant Support: By general institutional funds.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Michelle M. Mello, JD, PhD, MPhil, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115.

Current Author Addresses: Drs. Mello and Studdert: Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115.

Dr. Brennan: Brigham & Women's Hospital, 75 Francis Street, Executive Offices, PBB4, Boston, MA 02115.

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