The President
The White House
Washington DC 20500

Dear Mr. President:

On behalf of the National Bioethics Advisory Commission (NBAC), I am pleased to transmit our third report to you: Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. This report addresses a topic that follows from the priorities established in Executive Order 12975-to consider the rights and welfare of human research subjects and the management and use of genetic information.

In this report, NBAC addresses an issue at the confluence of two important developments. The first development is the remarkably enhanced ability of biomedical researchers to study human biological materials, such as biopsy specimens obtained for diagnostic purposes, organs and tissues removed during surgery, and biological materials collected in research projects; to increase knowledge about human diseases; and to develop better means to prevent, diagnose, and treat these diseases. NBAC has estimated that there are more than 282 million such specimens in the nation's laboratories, tissue repositories, and health care institutions. The ability to use these materials in research in striking new ways will provide even more effective tools for improving health. Yet, the very power of these new research tools raises a number of important ethical issues.

The second development is the increasing concern that the use of genetic and other medical information found in these materials might infringe upon an individual's privacy, and if misused could result in discrimination-issues that you addressed in your remarks in the East Room on July 17, 1997. Because medical research using these specimens can reveal clinical and sometimes personal information about individuals, scientists must ensure that those who participate in research by providing these materials are adequately protected from unwarranted harms resulting from the inadvertent release of such information.

NBAC focused its deliberations on the following questions: How well does the existing Federal Policy for the Protection of Human Subjects (the Common Rule, codified at 45 CFR Part 46) meet the objective of protecting human subjects from harm in research involving human biological materials? Specifically, does it provide clear direction to research sponsors, investigators, IRBs, and others regarding the conduct of research using these materials in an ethical manner?

While the overall structure of the federal regulations is generally satisfactory for addressing this area of research, NBAC concluded that the Common Rule was not entirely responsive to these questions. In some cases, present regulatory language provides ambiguous guidance for research using human biological materials. For example, researchers are often unclear whether research on human tissue makes the people from whom it came "human subjects," and IRBs struggle to determine whether research on these samples poses more than a "minimal risk" to these people. Beyond these ambiguities, certain parts of current regulations are inadequate to ensure the ethical use of human biological materials in research and require some modification.

NBAC concluded that not only is it critical that human biological materials continue to be available to the biomedical research community, but, increasingly, it is essential for investigators to collect human biological materials from individuals who are also willing to share important ongoing clinical information about themselves. Policies and guidelines governing human subjects research should permit investigators-under certain circumstances and with the informed, voluntary consent of sample sources-to have access to identifying information sufficient to enable them to gather necessary data regarding the subjects. Provided that adequate protections exist (which usually, but not always, include informed consent), such information gathering could include ongoing collection of medical record data and even requests for individuals to undergo tests to provide additional research information. In some cases, it even will be acceptable for investigators to convey information about research results to the persons whose samples have been studied. Where identifying information exists, however, a well-developed system of protections must be implemented to ensure that risks are minimized and that the interests of sample sources are protected.

In this report, NBAC makes 23 recommendations to address the following concerns: addressing perceived difficulties in the interpretation of federal regulations and in the language of position statements of some professional organizations; ensuring that research involving human biological materials will continue to benefit from appropriate oversight and IRB review, the additional burdens of which are kept to a minimum; providing investigators and IRBs with clear guidance regarding the use of human biological materials in research, particularly with regard to informed consent; providing a coherent public policy for research in this area that will endure for many years and be responsive to new developments in science; and providing the public (including potential research subjects) with increased confidence in research. In particular, this report provides interpretations of several important concepts and terms in the Common Rule and recommends ways both to strengthen and to clarify the regulations and to make their implementation more consistent.

These recommendations benefited tremendously from the input of and consultation with scientists, research administrators, and the public. This report is a testament to the knowledge of and interest in these issues by patients, the research community, and professional organizations; their input helped inform the Commission's thinking and the report as a whole.

On behalf of the Commission, we appreciate the opportunity to transmit this report to you.

                                                               Sincerely,
                                                               
                                                               Harold T. Shapiro
                                                               Chair