Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan
Associate US Attorney, US Attorney’s Office, US Department of Justice, Philadelphia, PA
Correspondence: James G. Sheehan, Associate US Attorney, US Attorney’s Office, 615 Chestnut Street, Suite 1250, Philadelphia, PA 19106; email@example.com
Mr. Sheehan reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article apart from his salary from the US Department of Justice.
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.