Literature DB >> 11754713

Legal issues in scientific research.

Paul E Kalb1, Kristin Graham Koehler.   

Abstract

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.

Entities:  

Keywords:  Biomedical and Behavioral Research; Legal Approach

Mesh:

Year:  2002        PMID: 11754713     DOI: 10.1001/jama.287.1.85

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


  2 in total

1.  Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency.

Authors:  Rafael Dal-Ré; David Moher; Christian Gluud; Shaun Treweek; Jacques Demotes-Mainard; Xavier Carné
Journal:  PLoS Med       Date:  2011-12-27       Impact factor: 11.069

2.  Regulating the market in human research participants.

Authors:  Trudo Lemmens; Paul B Miller
Journal:  PLoS Med       Date:  2006-08       Impact factor: 11.069

  2 in total

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