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purpose of providing advice and recommendations, subject to the approval of the National

Science and Technology Council."

The Order also indicates that NBAC will terminate on October 3, 1997 unless extended

prior to that date.

The Assistant to the President for Science and Technology issued the Charter for NBAC

in July, 1996. In describing the functions of s the following:

"As a first priority, the Commission will direct its attention to consideration of:

A.

Protection of the rights and welfare of human research subjects; and

B.

Issues in the management and use of genetic information including but not limited
to human gene patenting."

Also in July, 1996, the President appointed the members of NBAC. The Chairman is Harold T.

Shapiro, Ph.D., President of Princeton University.

Initial Activities of NBAC

NBAC held its first meeting on October 4, 1996. Following a series of background presentations -- including remarks by the Assistant to the President for Science and Technology, other Executive Branch staff, a legislative assistant to former Senator Hatfield and the minority staff director of the Senate Committee on Governmental Affairs

and a general discussion of the President's charge to NBAC, Chairman Shapiro elected to create two subcommittees. The Human Subjects Subcommittee, chaired by James Childress, Ph.D. of the University of Virginia, has responsibility for examining the current system of protections for human research subjects -with emphasis on determining whether research sponsors and performers are adhering to the socalled "Common Rule" (i.e., a set of essentially identical regulations issued simultaneously by 16

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agencies of the Federal Government on July 18, 1991) and whether the rule itself is adequate to assess the ethical issues associated with current and future research endeavors. The Genetics

Subcommittee, chaired by Thomas H. Murray, Ph.D., of Case Western Reserve University, has responsibility for examining the management and use of genetic information -- with emphasis on the bioethical issues associated with the use of human tissue samples in genetics research.

Each of the two subcommittees has held a series of meetings toward fulfillment of their respective tasks. They have identified information needs, discussed alternative strategies for meeting them, and set priorities for follow-up efforts by individual commissioners and/or NBAC staff. For example, as both subcommittees identify leading experts from relevant disciplines from whom they wish to receive oral and/or written testimony, NBAC staff make the requisite contractual and logistic arrangements. In addition, with respect to assessment of the Common Rule, a DHHS staff group -- with guidance from the Human Subjects Subcommittee -- is gathering pertinent information from the participating agencies so that the subcommittee and, ultimately the full NBAC, will have a strong data base and set of analyses to facilitate its assessment as to how well the system for protection of human research subjects is working.

As I will describe in more detail in a few minutes, President Clinton's request for a study of the legal and ethical issues associated with cloning technology added a substantial task to NBAC's agenda -- one that demands and is receiving intensive effort from all the Commissioners. This unforeseen development caused both subcommittees to reformulate their work plans for this year with a view to making them less labor- and time-intensive than they otherwise would have been. Nevertheless, both subcommittees are intent upon providing important substantive contributions in their respective areas in a sufficiently timely manner so

that, by October, 1997, the full NBAC can report findings and recommendations regarding

human-subjects protection and genetic testing over and beyond whatever findings and

recommendations it provides within the next few weeks with respect to cloning.

NBAC Study of Issues associated with Cloning Technology

NBAC's operating priorities for this year changed abruptly in the wake of press announcements on February 23, 1997 that scientists in Scotland had cloned a lamb from a single cell from the mammary tissue of a six-year-old ewe. The scientists' research report appeared in that week's edition of the scientific journal Nature. On February 24, President Clinton sent a letter to NBAC Chairman Shapiro requesting that "the National Bioethics Advisory Commission undertake a thorough review of the legal and ethical issues associated with the use of this (cloning) technology and report back to me within ninety days with recommendations on possible federal actions to prevent its abuse". Further, on March 4, President Clinton issued to the Heads of Executive Departments and Agencies a memorandum entitled "Prohibition on Federal Funding for Cloning of Human Beings". In that memorandum, he mentioned his assignment to NBAC -- noting that cloning technology offers the potential for “enormous scientific breakthroughs that could offer benefits in such areas as medicine and agriculture" while raising "profound ethical issues, particularly with respect to its possible use to clone humans".

Since February 25, NBAC has devoted an extraordinary effort toward fulfilling President Clinton's request. The Commissioners quickly developed a preliminary framework for the issues they wished to address and organized themselves into several informal working groups so that they initially could pursue various subsets of these issues in parallel. They then identified within each issue area the specific topics for which they desired additional information; and they

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provided guidance to NBAC staff regarding leading experts in relevant scientific or professional disciplines who might be sources of -- or at least links to sources of -- such information.

Using this guidance, NBAC staff contracted for a series of special analyses on a variety of topics including the state of the science related to cloning, the current array of state- and locallevel statutes that might affect cloning and/or cloning-related research, and the historical experience with moratoria associated with other areas where rapid scientific advances raised major ethical issues -- i.e, fetal research, gene therapy, and recombinant DNA research. Further, NBAC staff invited experts in science, religion, ethics, and other relevant subject-matter areas to address the Commission directly and participate in in-depth discussion of critical issues. Moreover, NBAC staff made special efforts to accommodate within each meeting agenda those members of the public who requested an opportunity to address the Commission.

To date, the full NBAC has held three meetings largely or wholly devoted to the cloning assignment: March 13-14, April 13, and May 2. Between meetings, the informal subgroups have pursued their respective assignments through special meetings, conference calls, or EMAIL exchanges; and the NBAC staff has maintained regular, often daily, contact with Chairman Shapiro and the other Commissioners in anticipation of their needs for assistance or in response to specific requests. The Commissioners are optimistic that they can produce a thorough, wellreasoned report to President Clinton on or about the end of this month.

Management and Administrative Support for NBAC

The NBAC charter assigns to the Department of Health and Human Services the responsibility for providing management and administrative support services for NBAC.

Secretary Shalala initially delegated this responsibility to the Director, National Institutes of

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Health, who redelegated it to the Director, Office for Protection from Research Risks (OPRR).

The Director, OPRR, established the NBAC office, recruited the initial complement of staff, and

participated with them and Chairman Shapiro in planning and implementation of the initial NBAC activities.

During the fall of 1996, the Director, NIH expressed concern that the organizational placement of the NBAC office could create the appearance of conflict of interest. That is, because NBAC inevitably will focus on many issues that fall within the purview of the OPRR, any NBAC assessments that relate to OPRR's activities -- whether favorable or otherwise -might lack credibility in the eyes of some observers. After weighing these concerns, Secretary Shalala, on November 1, 1996, reassigned responsibility for NBAC management and administrative support to the Assistant Secretary for Health (ASH) -- who, in turn, requested that I provide day-to-day oversight of the NBAC staff in my capacity as his Science Advisor. Subsequently, I also assumed the role of Acting Executive Director, pending recruitment of an appropriately qualified individual to fill this position on a regular basis; and I arranged for a DHHS staff member thoroughly experienced in working with advisory commissions to serve as Acting Deputy Executive Director.

The Department recently published the vacancy announcement for the position of NBAC Executive Director. The position is classified within the Senior Executive Service and, depending upon the qualifications of the individual selected, offers an annual salary in the range of $104,000 to $120,000 and possibly higher if the individual selected is a physician. We expect

significant competition for this vacancy and look forward to receipt of applications by the deadline-- June 4, 1997.