Research compliance: entering Phase II

Brenda J. Russell, JD

From Baylor Research Institute, Dallas, Texas.

Corresponding author: Brenda J. Russell, JD, Baylor Research Institute, 3434 Live Oak, Dallas, Texas 75204 (e-mail: brendar@baylorhealth.edu).

Conducting human subject research is a scary scenario for investigators, institutional review boards (IRBs), and institutions in light of increasing scrutiny from government entities. The scrutiny is due, in part, to recent media coverage of patients who were harmed while participating in research. Oversight of research activities has increased drastically; for those failing to comply with the vast and complex network of legal and regulatory requirements, the consequences are severe. In the past few years, the federal Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) have suspended the authority to conduct research at a growing number of well-known institutions (Table). In addition, noncompliance has resulted in the withdrawal of funding from investigators and, in at least one case, fines and a prison sentence (1).

The current environment has motivated organizations involved in human research to create and implement research compliance programs to reduce risks. Both institutions and investigators may benefit from these compliance efforts. An effective research compliance program is one that identifies legal and regulatory problems, corrects deficiencies, and assists in preventing future problems. For a research compliance program to be effective, certain basic elements must be in place, including established standards of conduct in research, training, disciplinary procedures, auditing, monitoring, and corrective action. With an effective compliance program, the risks for both human subjects and research personnel are greatly reduced. (BUMC Proceedings 2001;14:349-351)

Subheadings:

Identifying the risks: Lack of oversight, Lack of training, Conflict of interest, Fund expenditures, Billing for research items * Keys to successful compliance