By Rick Weiss
Washington Post Staff Writer
Wednesday, October 30, 2002; Page A01

The Bush administration has revamped the charter of the federal advisory committee that addresses the safety of research volunteers, stating for the first time that embryos in experiments are "human subjects" whose welfare should be considered along with that of fetuses, children and adults.

The addition of human embryos to the committee's charge -- completed at the beginning of October but not yet posted on the federal Web site that lists such committees -- marks the laatest effort by the administration to bring the unborn under the umbrella of federal health protections. In September the administration enacted a new policy that extends certain health benefits to fetuses.

The new move does not mandate that embryos used in research be given the same protections as fetuses, children or adults. The committee can only offer recommendations to the Department of Health and Human Services, which would then have to initiate rulemaking or encourage legislation if it wanted to put new protections in place.

But the wording marks a political victory for those in favor of increased protections for the unborn, experts inside and outside the government said. And depending on whom the administration selects to sit on the committee, it could be the start of a process that could result in greater restrictions on embryo research at some fertility clinics, universities and research labs, experts said.

Embryos are the balls of cells that constitute the earliest stages of human development. Fetuses, representing a later stage of development, already have a limited amount of protection under federal research rules, but scientists' attention has increasingly turned to embryos to improve understanding of birth defects and infertility and as a source of embryonic stem cells, which researchers hope to turn into therapies for a variety of degenerative diseases.

Opponents of embryo research hailed the change in wording.

"It's very welcome that HHS is recognizing the need for sound norms on human experimentation across the entire spectrum of life," said Richard M. Doerflinger of the U.S. Conference of Catholic Bishops.

Others noted that just because the committee now has embryos in its purview does not mean the group will ever act on that authority.

Several others, however, called the move an inappropriate political and religious intrusion into a scientific advisory committee that had been charged with improving research protections after several scandals in which patients were harmed in experiments.

Created during the Clinton administration as the National Human Research Protections Advisory Committee, it was allowed to expire in September after HHS officials said they wanted to broaden the committee's charge.

It was reincarnated by the new administration without fanfare Oct. 1 as the Secretary's Advisory Committee on Human Research Protections.

"I'm very concerned that this addition [of the word "embryos"] will serve to seriously politicize the reconstituted committee," said Robert R. Rich, executive associate dean of research at Emory University School of Medicine in Atlanta, who had been a member of the old committee. "Embryos are not included as human research subjects, according to [current federal regulations]. It will be impossible to gain consensus around this issue if appointees to the new committee represent both sides of this very contentious issue, since it is governed by emotions and beliefs and is really not amenable to rational or scientific discourse."

The new charter, a copy of which was obtained by The Washington Post, says "the committee will provide advice relating to the responsible conduct of research involving human subjects with particular emphasis on . . . pregnant women, embryos, and fetuses" and other "populations" of human research subjects.

Arthur J. Lawrence, HHS's deputy assistant secretary for health operations and assistant surgeon general, said he and others who together crafted the charter felt the wording was needed because of the growing inclusion of women in clinical trials. "There's no way you can ignore that some of those women may be pregnant," he said, so it was important to address the possibility that the research might harm the developing fetus.

He said the word "embryos" was included along with "fetuses," because some people use the two words interchangeably.

But experts said the impact of the change was far greater than that, extending the committee's charge beyond pregnant women to include embryos under study in laboratory dishes.

HHS has not named the new committee's members yet. But members of the old committee were previously told by an administration official that the department hopes to include Mildred Jefferson, a medical doctor who helped found the National Right to Life Committee and who three times served as that organization's president.

Marcy Wilder, a former deputy general counsel of HHS and now a partner in the Washington law firm Hogan & Hartson, described the changes as worrisome. "This could be the next step in according embryos new legal rights and the status of the person under the law," Wilder said. "We're seeing the politicization of what should be a scientific advisory committee."

Karen H. Rothenberg, dean of the University of Maryland School of Law and an expert on research ethics, echoed those concerns, saying the introduction of controversy could undermine the volunteerism that makes clinical trials work.

"We can't achieve the promise of clinical research without sustaining and maintaining society's trust," Rothenberg said. "Do we really want to avert our attention once again to embryos and politics and lose the opportunity to finally reach consensus on how to improve the research enterprise?"

Federal funding of embryo-harming research is banned by Congress, but that restriction expires annually unless renewed, and it does not go so far as to define embryos as human subjects.

Stricter rules could force embryo researchers to obtain approval from review boards that currently have the option of ignoring such studies as having more to do with cells than with human beings, experts said. Under one scenario, for example, a medical experiment might be precluded if the research did not promise a direct benefit to the embryo itself.

That could wreak havoc at some fertility clinics. "We do not think that an entity that is designed to protect human subjects of research is the appropriate place to deal with the regulation of reproductive tissues, be they sperm, eggs or embryos," said Sean Tipton, a spokesman for the American Society for Reproductive Medicine.

Others, however, said they were relieved to see the new wording.

"We applaud the administration for explicitly recognizing in the charter that the term 'human subjects' includes all living members of the species Homo sapiens at every stage of their development, and that all deserve protection from unethical experimentation," said Douglas Johnson, legislative director of the National Right to Life Committee.

© 2002 The Washington Post Company

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CHARTER

SECRETARY'S ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS

(Formerly Known as the National Human Research Protections Advisory Committee)

PURPOSE

The Department of Health and Human Services (HHS), Secretary's Advisory Committee on Human Research Protections, or Committee, formerly known as the National Research Protections Advisory Committee, will provide expert advice and recommendations to the Secretary of HHS and the Assistant Secretary for Health (ASH) on issues and topics pertaining to or associated with the protection of human research subjects.

AUTHORITY

42 U.S.C. 217a, section 222 of the Public Health Service (PHS) Act, as amended. The committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

FUNCTION

The Committee shall advise on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. Specifically, the committee will provide advice relating to the responsible conduct of research involving human subjects with particular emphasis on:

- special populations, such as neonates and children, prisoners, and the decisionally impaired;
- pregnant women, embryos, and fetuses;
- individuals and populations in international studies;
- populations in which there are individually identifiable samples, data, or information;
- investigator conflicts of interest.

In addition, the committee shall be responsible for reviewing selected ongoing work and planned activities of the Office of Human Research Protections (OHRP) and other offices/agencies within HHS responsible for human subjects protection. These evaluations may include but are not limited to a review of assurance systems, the application of minimal research risk standards, the granting of waivers, education programs sponsored by OHRP, and the ongoing monitoring and oversight of institutional review boards (IRBs) and the institutions that sponsor research.

STRUCTURE
The committee shall consist of eleven (11) members, including the Chair. The Secretary, or designee, shall select members and the Chair. Members will be selected from among individuals possessing demonstrated experience and expertise in any of the several disciplines and fields pertinent to human subjects protection and/or clinical research. In addition, the Committee shall have non-voting ex officio members representing the Agency for Healthcare Research and quality (AHRQ); Centers for Disease Control and Prevention, (CDC); the Food and Drug Administration (FDA); and the National Institutes of Health (NIH); and such ex officio members as the Secretary deems necessary to effectively carry out the Committee's function. The Director, OHRP, shall serve as the Executive Secretary of the Committee.

Members shall be appointed to serve for overlapping terms of up to four years, subject to the renewal of the Committee charter. Any member appointed to fill a vacancy for an un-expired term shall be appointed only for the remainder of that term. Members may serve after the expiration of their term until their successors have taken office. Individuals who have served as members may not be considered for re-appointment to the committee for a period of one year after the expiration of their term, including any extensions.

In carrying out its function, the Committee may establish subcommittees composed of members of the parent committee and seek advice from nonmember special consultants. The Department Committee Management Officer shall be notified upon establishment of each subcommittee and shall be given information regarding its name, membership, function, and estimated frequency of meetings.

MEETINGS
Meetings shall be held not less than two times a year at the call of the Chair, with the advance approval of the Designated Federal Official who shall also approve each agenda. A Government official shall be present at all meetings. A quorum for the conduct of business by the full committee shall consist of a majority of appointed members. Subcommittees shall meet according to the subcommittee plan, consider issues in accordance with the charge of the full Committee, and shall make reports to full Committee for consideration as appropriate.

Meetings shall be open to the public except as determined otherwise by the Secretary or other official to whom the authority has been delegated. Notice of all meetings shall be given to the public.

Meetings shall be conducted and records of the proceedings kept, as required by applicable laws and Department regulations and policies.

COMPENSATION
Members shall be paid at the rate of $150 per day, plus per diem and travel expenses, as authorized by Section 5703, Title 5, U.S.C., for persons in the government service employed intermittently. Members who are officers or employees of the United States shall not receive compensation for their services on the Committee.

ANNUAL COST ESTIMATE
Estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support is $150,637. Estimate of annual person-years of staff support is 2.0 at an estimated annual cost of $187,815.

REPORTS
In the event that a portion of a meeting is closed to the public, a report shall be prepared which shall contain, at a minimum, a list of members and their business addresses, the Committee's function, dates and places of meetings, and a summary of the Committee activities and recommendations made during the fiscal year. A copy of the report shall be provided to the Department Committee Management Officer.

TERMINATION DATE
Unless renewed by appropriate action prior it its expiration, the charter for the Secretary's Advisory Committee on Human Research Protections will expire two years from the date this charter is filed.

Approved:

_______________________ ____________________
Date Secretary

Research-AAMC