 |
|
Legal Issues in Scientific Research
Paul E. Kalb, MD,JD;
Kristin Graham Koehler, JD
JAMA. 2002;287:85-91.
In recent years, regulatory and law enforcement authorities responsible for combating fraud and abuse have focused greater attention on the scientific research process, in particular, the process of seeking reimbursement for research costs, the process of performing clinical research, and the potential improper remuneration of researchers or research subjects. This article describes how the federal False Claims Act, which allows the government to recover treble damages plus substantial penalties from persons who knowingly submit false claims or make false statements to the government, has been used to achieve a number of multimillion-dollar settlements with research institutions. The article also discusses instances of temporary suspension of research activities at a number of prominent institutions and the investigation of illegal "inducements" or "kickbacks" provided by manufacturers to researchers and by research institutions to patients.
Author Affiliations: Sidley Austin Brown and Wood, Washington, DC.
RELATED ARTICLES
Medical Innovation and Institutional Interdependence: Rethinking University-Industry Connections
Annetine C. Gelijns and Samuel O. Thier
JAMA. 2002;287(1):72-77.
ABSTRACT
| FULL TEXT
Managing Conflicts of Interest in the Conduct of Clinical Trials
Karine Morin, Herbert Rakatansky, Frank A. Riddick, Jr, Leonard J. Morse, John M. O'Bannon III, Michael S. Goldrich, Priscilla Ray, Matthew Weiss, Robert M. Sade, and Monique A. Spillman
JAMA. 2002;287(1):78-84.
ABSTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
The Clinician as Investigator: Participating in Clinical Trials in the Practice Setting
Lader et al.
Circulation 2004;109:2672-2679.
ABSTRACT
| FULL TEXT
Due Process in Investigations of Research Misconduct
Mello and Brennan
NEJM 2003;349:1280-1286.
FULL TEXT
The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives
Lemmens and Miller
J Law Med Ethics 2003;31:398-418.
|
