By Kim Coghill
WASHINGTON ¿ The National Bioethics Advisory Commission is recommending that President George Bush establish an independent federal office to oversee research involving humans.
The recommendations follow a year of study by the NBAC, created in 1995 by then-President Bill Clinton to provide advice and to consult with the National Science and Technology Council, the president and other federal agencies. The NBAC¿s charter expires in October, and Bush has not said whether he will extend it, said Eric Meslin, executive director of the Bethesda, Md.-based commission.
Meslin said the recommendations will be forwarded to the White House within the next few weeks as part of NBAC¿s upcoming report, ¿Ethical and Policy Issues in Research Involving Human Participants.¿ The report was requested by the Clinton White House two years ago and likely will be available later this summer.
Among other issues, the report addresses the Common Rule, a set of research regulations that has been adopted and codified by 17 federal agencies involved in conducting or supporting research with human participants. The Common Rule applies only to researchers and institutions receiving federal funds, and research reviewed by the FDA.
Meslin said while the commission did not suggest abolishing the Common Rule, the 18-member NBAC agrees that a uniform set of regulatory standards needs to be approved and followed by everyone from sponsors to institutional review boards to investigators.
¿The system that we hope would be implemented as a result of our regulations would place greater accountability and responsibility on all parts of the research enterprise,¿ Meslin told BioWorld Today. ¿So while you cannot expect that a system that has hundreds of thousands of participants in it at any one time will be fool-proof, we would hope that our recommendations would go a long way to reducing the risk of harm to people while ensuring that the public has got the kind of confidence it needs to support research.¿
Many of the issues included in the recommendations are already in place and being followed by some organizations, Meslin said. However, current rules do not apply to much of research that is being conducted around the country today.
¿For example, the issue of genetics research is an area that the current regulations were not designed to address directly,¿ Meslin said. ¿The current regulations were not constructed with the genome project in mind and I think that¿s one of the ways a unified set of regulations that can attend to various types of research would be an improvement.¿
Aside from establishing the National Office for Human Research Oversight to monitor research and establish a single set of regulations, the commission suggests informed consent to include an explanation of the risks involved in participation in clinical trials.