Abstract
Those charged with assuring research accountability have little guidance as to how to best structure and manage data safety monitoring boards (DSMBs). One major concern is increased litigation surrounding human subject research which has led research institutions and those asked to serve on DSMBs to seek legal counsel regarding their risk of liability for DSMB activities. A major challenge is assessing the risk of potential liability. Yet, potential liability for DSMBs and their members has not been adequately addressed in the literature. The purpose of this article is to provide a legal and accountability analysis to begin to fill this gap.
This article undertakes an analysis and exploration of the potential liability that exists for DSMBs and their members under negligence theory and discusses the means by which DSMBs and their members may avoid litigation or defend themselves in the face of a lawsuit. Research accountability implications of imposing liability, or not, on DSMBs are also considered. It is suggested that legislation be contemplated requiring sponsors to indemnify DSMBs and their members in the face of litigation.
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ACKNOWLEDGMENT
Grant Support: This work was supported by a grant from the Greenwall Foundation for the project entitled, “Ethics and Data Monitoring Committees.”
Notes
CFR 50.24(a)(7)(iv).
CFR 21 Section 312.3(b)
FDA Guidance on Clinical Trial Data Monitoring Committees (DSMBs). Tuesday, November 27, 2001, p. 26.
Friter v. Iolab Corp. 414 Pa. Super. 622, 607 A.2d 1111 (1992).
Gregg v. Kane. 1997 WL 570909 (E.D. Pa. 1997).
Grimes v. Kennedy Krieger Institute, Inc. 366 Md. 29, 782 A.2d 807 (2001).
Heinrich v. Sweet. 308 F.3d 48 (1st Cir. 2002.)
Johnson v. Kosmos Portland Cement Co., 64 F.2d 193 (6th Cir. 1933).
Kus v. Sherman Hosp. 644 N.E.2d 1214, 1220–21 ) Ill. App. Ct.( 1995); Friter v. Iolab Corp., 607 A.2d 1111, 1113 (Pa. Super. Ct. 1992); Weiss v. Solomon, 1989 RJQ 731 (Can.); Bryant v. HC Health Servs. of No. Tenn., 15 S.W.3d 804, 810–11 (Tenn. 2000).
Restatement of Torts 2d Section 496B.
Taylor, C. W., Googasian, G. A., Falk, A. S. (2006). Chapter 9. Defenses and Immunities I. Defenses Generally C. Comparative Negligence § 9:296. General rule--Comparative negligence doing more than replacing contributory negligence. Michigan Practice Guide: Torts Database updated October.
Taylor, C. W., Googasian, G. A., Falk, A. S. (2006). Chapter 9. Defenses and Immunities II. Miscellaneous Immunities from Liability (Nongovernmental Tortfeasors) A. Miscellaneous Immunities from Liability (Nongovernmental Tortfeasors) § 9:591. Michigan Practice Guide: Torts Database updated October.
21 CFR 312.32(c) 2004.
U.S. Food and Drug Administration (FDA). Guidance for clinical trial sponsors. Establishment and operation of clinical trial data monitoring committees. Section 2.1-2.3. March 2006.
Wallmuth v. Rapides Parish School Board. 813 So. 2d 341 (La. 2002).
West Virginia Central RR Co. v. Fuller. 96 Md. 652, 666, 54 A. 669 671 (1903).
Whitlock v. Duke. 637 F. Supp.1463 (MDNC 1986).