Restoring the public's faith in the safety of human research will require significant changes in the current system of laws, regulations and institutions that protect human research participants, according to a new Institute of Medicine (IOM) report.
"Responsible Research: A Systems Approach to Protecting Research Participants," is the final report of the IOM's Committee on Assessing the System for Protecting Human Research Participants. The Department of Health and Human Services requested the report in the wake of a series of research accidents in the late 1990s, including the widely publicized death of gene therapy research participant Jesse Gelsinger in 1999.
After examining the individuals, organizations and activities that make up what it calls Human Research Participant Protection Programs (HRPPPs), the committee concluded that significant changes are needed in order to restore public confidence in HRPPPs and ensure the safety of research participants.
The report recommends that:
All human research, even research that is funded privately, be conducted under the oversight of an HRPPP.
Researchers, administrators, staff members and anyone else involved in making decisions about research receive training in research ethics.
Research participants and community representatives be an integral part of the review process.
Informed consent forms be clear and easy to understand.
Participants injured by research be compensated for the costs of treatment and rehabilitation.
The federal government fund studies to determine the actual number of research participants in the United States--current estimates range from 2 to 20 million--and the number and frequency of adverse events that those participants experience. Such information is not currently available and is needed to assist in shaping human research participant protection policies.
Institutional Review Boards (IRBs), which are currently responsible for assessing the scientific merit, financial conflicts of interest and ethics of each study that comes under their review, be refocused on ethical concerns and supplemented by separate mechanisms for assessing scientific merit and conflicts of interest.
The implications of the report for psychological research, which ranges from clinical trials of new medications to pen-and-paper surveys of healthy college students, are unclear. According to committee chair Daniel Federman, MD, of Harvard Medical School, "risk stratification"--determining the relative risk of different kinds of research and tailoring oversight accordingly--will be critical to implementing the report's recommendations effectively.