Broader federal oversight is needed to ensure that all people who take part in research studies, regardless of whether they are publicly or privately funded, have the same necessary protections for their health and well-being, says Responsible Research: A Systems Approach to Protecting Research Participants.

The Department of Health and Human Services commissioned the IOM to develop the report following the death of 18-year-old Jesse Gelsinger during a 1999 clinical study at the University of Pennsylvania. This case, along with incidents at other research centers, highlighted growing problems, such as conflicts of interest, inadequate safety monitoring and oversight, and insufficient communication with participants.

A series of recommendations in the report focus on solutions to the problems, including

• improving ethics review of protocols,
• access to information by research participants and those reponsible for review and monitoring of protocols,
• the informed consent process,
• safety monitoring, and
• compensation for those harmed as a result of their participation in research.

The report also calls for development of a standard of quality improvement in human research participant protection programs, including the need for an independent body to provide ongoing advice to policy makers on the needs of the national protection system.