Fraud, conflict of interest, and other enforcement issues in clinical research.
Fraud in scientific research is a widespread problem. It can involve falsifying data or documents, or knowingly failing to comply with regulations protecting research participants. Fraud can be committed by individuals, institutions, or corporations; in the context of research, fraud often is motivated by considerations beyond financial gain. Institutional review boards (IRBs) are designed to ensure that researchers comply with human research subject protections, including conflict-of-interest controls, but IRBs may fail to do so if investigators avoid existing IRB processes or if IRB members do not take responsibility for addressting actual or potential conflicts of interest.
Sheehan
James G
JG
US Attorney's Office, US Department of Justice, Philadelphia, PA 19106, USA. jim.sheehan@usdoj.gov
D000046:Academic Medical Centers / Q000941:ethics* / Q000331:legislation & jurisprudence; D035843:Biomedical Research / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence*; D016265:Conflict of Interest / Q000331:legislation & jurisprudence*; D017277:Drug Approval; D028744:Ethics Committees, Research / Q000941:ethics*; D005607:Fraud / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D019982:Organizational Case Studies; D015871:Scientific Misconduct; D014481:United States; D014486:United States Food and Drug Administration