Republished by the LSU Medical Reseach Law Project

Good morning Mr. Chairman and members of the Subcommittee. I am Eric M. Meslin, Ph.D., Executive Director of the National Bioethics Advisory Commission (NBAC). I am pleased to appear before you this morning to describe the recommendations NBAC recently made in its recent report on Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity. The report is available on the Commission's website (www.bioethics.gov), and the Executive Summary was published in the Federal Register on February 19, 1999. The report was completed and published in late December 1998, and forwarded to the President on January 8, 1999-as required by our Executive Order. Since I have made copies of this report available to the subcommittees as part of my written testimony, with your permission I will briefly summarize NBAC's recommendations.

Mr. Chairman, as you are aware, there have been previous efforts to extend additional regulatory protections for research involving individuals with mental disorders, but these efforts have not been fully successful. In the late 1970s the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission), studied the need for special protections for research subjects with mental disorders in a report on Research Involving Those Institutionalized as Mentally Infirm. The Department of Health Education and Welfare proposed regulations in 1979, but these were never adopted.

NBAC decided to study this topic as part of its overall mission to advise both the National Science and Technology Council, and other government entities on appropriate policies, guidelines, and other instruments addressing the bioethical issues arising from research on human biology and behavior. NBAC examined this topic because of the special needs of these human subjects-including the need for more research-but also because of the weaknesses in federal regulations that have persisted for the past two decades. Several highly publicized incidents involving research subjects in this vulnerable population were also brought to the NBAC's attention.

During its 18-month study, NBAC heard testimony at 13 separate meetings from members of the public, scientists, former research subjects, their families, and others; obtained nearly 120 public comments during a 45-day comment period on a draft report; reviewed commissioned papers from leading experts in law, medicine, psychiatry, and ethics; and reviewed a small sampling of research protocols in this field.

NBAC found that important progress has been made by the nation's scientists on the cause and treatment of mental disorders, with more opportunities likely to emerge; that the scope of research is expanding; and that the research environment has become far more complex, involving both a larger societal investment and a greater role for the private sector.

NBAC concluded, however, that in addition to the existing Federal Policy for the Protection of Human Subjects, "research involving subjects with mental disorders that may affect decisionmaking capacity should be governed by specific further regulations."

As Dr. Harold Shapiro stated in his letter to the President transmitting the report, "While current U.S. regulations note the need to ensure ethical treatment of human research subjects with mental disorders, they provide no specific guidance for IRBs and investigators regarding vulnerable subjects…We believe that this state of affairs is not satisfactory, and that additional federal protections are necessary."

NBAC made 21 recommendations. Many of the Commission's recommendations are non-controversial, and should enjoy broad support. For example: research should not target people with mental disorders when research can be done with other subjects (Recommendation 3); researchers should describe the risks in studies to IRBs so that IRBs can make an informed risk/benefit assessment, a determination that is especially important when the studies involve placebo controls, symptom provocation, or rapid medication withdrawal (Recommendation 4); a subject's objection to participation should be heeded even if he or she is confused or is incompetent (Recommendation 7); and that IRBs should ensure that researchers establish and maintain ongoing communication with the subjects family and friends (Recommendation 17).

Some of the other recommendations will likely be seen by researchers as too restrictive of research, and by those concerned with the rights of subjects as too permissive. For example, NBAC's recommendation that where research involves greater than minimal risk, IRBs should often require researchers to obtain an independent assessment of the subject's capacity to consent (Recommendation 8) may be considered too great an imposition on researchers and institutions, while some advocates for patients' rights might have hoped to see this recommendation go further, requiring that all research subjects, regardless of the level of risk in a study, be assessed for their capacity. Some will no doubt consider NBAC's recommendations that subjects who are capable of consenting can, under certain conditions, give a "prospective authorization" to their future involvement in research (Recommendation 13) an important method for permitting competent persons to express their wishes for participation in studies in the future when they are no longer able to express their wishes, others may find that this recommendation permits people to be enrolled in research without their express informed consent.

NBAC was persuaded that for research involving greater than minimal risk but that does not hold out the prospect of any medical benefit, subjects could be involved only under the most stringent conditions. In particular, NBAC recommended that the Secretary of Health and Human Services convene a Special Standing Panel to review these protocols at the national level (Recommendation 2). This Standing Panel would include members representing the diverse interests of potential subjects, the research community and the public. This Panel would provide a national, and publicly accountable review mechanism for research. It would be charged with developing guidelines that could be used by local IRBs. NBAC recommended that all federal agencies subject to the Common Rule use this panel, and that a study of its effectiveness be completed within five years.

The NBAC report identified, where possible, those who should be responsible for implementing the recommendations. While NBAC did not single out the Veteran's Administration in its recommendations, NBAC intended for all agencies subject to the "the Common Rule," including the VA, and others responsible for human subjects protection to consider the Commission's recommendations.

NBAC proposed a number of recommendations for regulatory reform, but it did not take a position on whether these reforms would best be accomplished through changes in the Common Rule, or through the adoption of a new Subpart in the Code of Federal Regulations. More importantly, the commission made clear its belief that some of these changes could be implemented voluntarily at the local level, italicizing the following statement in the report: Regardless of which regulatory route is selected, NBAC encourages researchers and institutions to voluntarily adopt the spirit and substance of these recommendations.

Like all agencies subject to the Common Rule, the VA has recently received a copy of NBAC's report. It is my understanding that all federal agencies responsible for conducting research involving human subjects will be reviewing the report and providing comments to the National Science and Technology Council by the end of May. NBAC is pleased that the agencies are reviewing its report and recommendations stands ready to offer any advice or assistance.

The recommendations provide both a set of requirements that NBAC believes must be satisfied in all research protocols involving persons with mental disorders, and several additional or optional protections that may be considered, as appropriate, in particular circumstances. Taken together, these recommendations would both enhance existing protections and facilitate broad public support for continued research on mental disorders.

Mr. Chairman, the subject of this hearing comes at an important time in the history of human subjects protections in this country. The opportunity exists to identify and correct deficiencies in the present system, but also to plan for how best to build the system as we move into the next century. In NBAC's view, the enhanced protections recommended in its report will promote broad-based support for further research by engendering greater public trust and confidence that subjects' rights and interests are fully respected.

I would be pleased to discuss any of the report's recommendations in more detail, and of course, NBAC would be pleased to work with you and your subcommittee as you continue to address these important issues.

Thank you Mr. Chairman.

 General  Subcommittees  Meetings  Publications  Other Links  Search  Home