Sir

The National Bioethics Advisory Commission (NBAC), of which one of us (H.T.S.) was chair, issued its last report, Ethical and Policy Issues in Research Involving Human Participants (http://bioethics.georgetown.edu/nbac; M.S. was project director) in August 2001. We had been asked by the Office of Science and Technology Policy under the Clinton administration to examine the supervision system for protection of human participants in research, in the light of concern about possible fundamental flaws in the system — as discussed in your Opinion article “Time to cut regulations that protect only regulators” (Nature 414, 379; 2001). Our report contains 30 recommendations for a wide range of essential changes at the national and local level.

Our main conclusion is that a single, independent office is needed to oversee a unified, comprehensive federal policy embodied in a single set of regulations and guidance that would apply to all types of research involving human participants, and including policy development and regulatory reform. This would improve protection, reduce unnecessary bureaucratic requirements, and enhance the supervision system's credibility by conveying a common set of ethical requirements that must be applied to all such research. Further, proper protection would be provided for children, prisoners and others in vulnerable circumstances. Merely adding more rules would not improve protection, and would lead to more paperwork.

None of the recent initiatives by the Department of Health and Human Services (DHHS), or its Office for Human Research Protections (OHRP), addresses the most fundamental flaws in the current system. For example, OHRP cannot force federal departments outside DHHS to use the new federal-wide assurance developed by OHRP because it does not have the authority. DHHS initiatives to improve reporting of adverse events cannot eliminate regulatory inconsistencies between DHHS and Food and Drug Administration (FDA) requirements, because — even though DHHS could require the FDA to revise its regulations — DHHS cannot unilaterally change that part of its regulations.

Most troubling is the ethically indefensible situation that some human participants are protected by federal law and others are not. Only 17 federal departments or agencies (not including the FDA) have identical regulations, known as the common rule, requiring that the rights and welfare of research participants be protected. Some federal agencies sponsor human research but have not adopted the common rule, for example the Department of Labor, the Nuclear Regulatory Commission and the National Endowment for the Humanities. Although some institutions carrying out privately sponsored research do voluntarily protect research participants, there is an unknown amount of research in colleges and universities, fertility clinics, weight-loss clinics, work sites and businesses in which people are involved without their knowledge or informed consent, and without independent review.

Currently, no federal office has the authority to make government-wide rules to protect research participants, even for publicly sponsored research. Although the common rule was a reasonable way to create a uniform federal system of protection, it has not been modified since 1991, despite efforts. President Clinton, for example, directed federal agencies under the common rule to include protection when classified research is conducted. Despite three years of effort led by the Office for Protection from Research Risks (OPRR: the office that became OHRP), a presidential memorandum, and a challenge in the US District Court, the rule was not modified.

Some federal departments have modified their own set of common-rule regulations by issuing additional regulations or guidance. The Department of Veterans Affairs, for example, issued regulations for the treatment of research-related injuries in its medical centres. While laudatory to strengthen protection, this type of action can promote inconsistency and certainly undermines the unification the common rule was supposed to establish.

A supervision system can be successful only to the extent that those involved in human research recognize their ethical obligations to protect participants. Merely complying with regulations does not fulfil this duty. What is needed is a culture of concern and respect. Federal government and professional organizations must promote educational training in human research protection, certification for individuals and accreditation for institutions. NBAC recommends that everyone directly involved in human research know his or her ethical responsibilities and demonstrate his or her competence to conduct research ethically.

No supervision system can guarantee that research will be conducted without risks to participants. Nor can such a system prevent the recent tragedies at several well-known institutions. But a comprehensive, flexible system based on ethical principles and focused on ethically substantive requirements, rather than on obsessive documentation requirements, can ensure that tragedies are rare and the rights and welfare of participants are respected and protected. Until Congress and the executive branch of government acknowledge and address the three basic flaws of the system discussed here, the current supervision system will fail to adequately protect participants and will continue to frustrate institutions, investigators and Institutional Review Boards. Now is the time for change.