section. The Registry shall be under the general supervision of the Secretary, and under the direction of a board of directors that shall include representatives of marrow donor centers, marrow transplant centers, persons with expertise in the social science, and the general public.

(b) FUNCTIONS.-The Registry shall—

(1) establish a system for finding marrow donors suitably matched to unrelated recipients for bone marrow transplantation;

(2) establish a system for patient advocacy, separate from mechanisms for donor advocacy, that directly assists patients, their families, and their physicians in the search for an unrelated marrow donor;

(3) increase the representation of individuals from racial and ethnic minority groups in the pool of potential donors for the Registry in order to enable an individual in a minority group, to the extent practicable, to have a comparable chance of finding a suitable unrelated donor as would an individual not in a minority group;

(4) provide information to physicians, other health care professionals, and the public regarding bone marrow transplantation;

(5) recruit potential bone marrow donors;

(6) collect, analyze, and publish data concerning bone marrow donation and transplantation; and

(7) support studies and demonstration projects for the purpose of increasing the number of individuals, especially minorities, who are willing to be marrow donors.

(c) CRITERIA, STANDARDS, AND PROCEDURES.-Not later than 180 days after the date of enactment of this part, the Secretary shall establish and enforce, for entities participating in the program, including the Registry, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers

(1) quality standards and standards for tissue typing, obtaining the informed consent of donors, and providing patient advocacy;

(2) donor selection criteria, based on established medical criteria, to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases such as the viruses that cause hepatitis and the etiologic agent for Acquired Immune Deficiency Syndrome;

(3) procedures to ensure the proper collection and transportation of the marrow;

(4) standards that require the provision of information to patients, their families, and their physicians at the start of the search process concerning

(A) the resources available through the Registry;

(B) all other marrow donor registries meeting the standards described in this paragraph; and

(C) in the case of the Registry

(i) the comparative costs of all charges by marrow transplant centers incurred by patients prior to transplantation; and

(ii) the success rates of individual marrow transplant centers;

(5) standards that

(A) require the establishment of a system of strict confidentiality of records relating to the identity, address, HLA type, and managing marrow donor center for marrow donors and potential marrow donors; and

(B) prescribe the purposes for which the records described in subparagraph (A) may be disclosed, and the circumstances and extent of the disclosure; and

(6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure the establishment of a method for integrating donor files, searches, and general procedures of the center or registry with the Registry.

(d) COMMENT PROCEDURES.-The Secretary shall establish and provide information to the public on procedures, which may include establishment of a policy advisory committee, under which the Secretary shall receive and consider comments from interested persons relating to the manner in which the Registry is carrying out the duties of the Registry under subsection (b) and complying with the criteria, standards, and procedures described in subsection (c).

(e) CONSULTATION.-The Secretary shall consult with the board of directors of the Registry and the bone marrow donor program of the Department of the Navy in developing policies affecting the Registry.

(f) APPLICATION.-To be eligible to enter into a contract under this section, an entity shall submit to the Secretary and obtain approval of an application at such time, in such manner, and containing such information as the Secretary shall by regulation prescribe. (g) ELIGIBILITY.-Entities eligible to receive a contract under this section shall include private nonprofit entities.

(h) RECORDS.

(1) RECORDKEEPING.-Each recipient of a contract or subcontract under subsection (a) shall keep such records as the Secretary shall prescribe, including records that fully disclose the amount and disposition by the recipient of the proceeds of the contract, the total cost of the undertaking in connection with which the contract was made, and the amount of the portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(2) EXAMINATION OF RECORDS.-The Secretary and the Comptroller General of the United States shall have access to any books, documents, papers, and records of the recipient of a contract or subcontract entered into under this section that are pertinent to the contract, for the purpose of conducting audits and examinations.

(i) PENALTIES FOR DISCLOSURE.-Any person who discloses the content of any record referred to in subsection (c)(5)(A) without the

prior written consent of the donor or potential donor with respect to whom the record is maintained, or in violation of the standards described in subsection (c)(5)(B), shall be imprisoned for not more than 2 years or fined in accordance with title 18, United States Code, or both.

(j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $15,000,000 for fiscal year 1991 and such sums as may be necessary for each of fiscal years 1992 and 1993.

SEC. 379A. [2741] STUDY BY THE GENERAL ACCOUNTING OFFICE.

(a) IN GENERAL.-The Comptroller General of the United States shall conduct a study that evaluates

(1) the costs and benefits of the search process for an unrelated bone marrow donor among different marrow donor registries;

(2) the extent to which marrow donor registries protect donor confidentiality;

(3) the relationship between the Registry, individual marow donor centers, and other marrow donor registries;

(4) the effectiveness and appropriateness of policies and procedures of marrow donor centers, marrow transplant centers, and marrow donor registries, including

(A) the process of donor recruitment, including the policy of asking each donor whether the donor would want to donate more than one time;

(B) the maintenance and updating of donor files; and (C) the policy of initially typing donors for A/B antigens only instead of initially typing for both A/B and D/R antigens;

(5) the ability of the marrow donor registries to incorporate changes in medical research and clinical practice; and

(6) the costs associated with tissue typing.

(b) REPORT.-Not later than 1 year after the date of enactment of this part, the Comptroller General shall complete the study required under subsection (a) and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the findings made by the study and recommendations for legislative reform.

1

SEC. 378. [274g] AUTHORIZATION OF APPROPRIATIONS.

For the purpose of carrying out this part, there are authorized to be appropriated $8,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.

1 So in original. Section 206(a) of Public Law 101-616 added new sections 377 and 378 to the end of part H. Section 101(a)2) of the Public Law amended title III by "inserting after section 377" a new part I. The probable intent of the Congress was to insert part I after section 378, and therefore that section 378 provide an authorization of appropriations for part H. (Note that, as a conforming amendment to section 206(a) of the Public Law, section 206(b) struck section 371(c), which provided an authorization of appropriations for grants under section 371(a)).

34-807 0-91-7

PART J-BIOMEDICAL ETHICS

SEC. 381. [275] (a) There is established in the legislative branch of the Government the Biomedical Ethics Board (hereinafter referred to as the "Board").

(b)(1) The Board shall consist of twelve members as follows:

(A) Six Members of the Senate appointed as follows: Three members appointed by the Majority Leader of the Senate from the majority party and three members appointed by the Minority Leader from the minority party.

(B) Six Members of the House of Representatives appointed by the Speaker of the House of Representatives, three from the majority party and three from the minority party.

(2) The term of office of a member of the Board shall expire when the member leaves the office of Senator or Representative, as the case may be, or upon the expiration of eight years after the date of the member's appointment to the Board, whichever occurs first.

(3) Vacancies in the membership of the Board shall not affect the power of the remaining members to execute the functions of the Board and shall be filled in the same manner as in the case of the original appointment.

(4) The Board shall select a chairman and a vice chairman from among its members at the beginning of each Congress. The vice chairman shall act as chairman in the absence of the chairman or in the event of the incapacity of the chairman. The chairmanship and vice chairmanship shall alternate between the Senate and the House of Representatives with each Congress. The chairman during each even-numbered Congress shall be selected by the Members of the House of Representatives on the Board from among their number. The vice chairman during each Congress shall be chosen in the same manner from that House of Congress other than the House of Congress of which the chairman is a Member. (5) The Board shall meet once every three months unless such meeting is dispensed with by the chairman, and may meet at any time upon the request of four or more members of the Board or upon the call of the chairman.

(c)(1) The Board shall study and report to the Congress on a continuing basis on the ethical issues arising from the delivery of health care and biomedical and behavioral research, including the protection of human subjects of such research and developments in genetic engineering (including activities in recombinant DNA technology) which have implications for human genetic engineering.

(2)(A) Except as provided in subparagraph (B), an annual report shall be transmitted to the Congress identifying the issues which were the subject of the study conducted under paragraph (1) and identifying areas, programs, and practices of medicine and biomedical and behavioral research which have significant ethical implications and which would be appropriate subjects for study.

(B) A report on research and developments in genetic engineering (including activities in recombinant DNA technology) which have implications for human genetic engineering shall be transmitted to the Congress not later than eighteen months after the appointment of the Committee under subsection (d).

(d)(1) To conduct the studies and make the reports required by subsection (c), the Board shall appoint a Biomedical Ethics Advisory Committee (hereinafter referred to as the "Committee"). The Committee shall consist of fourteen members as follows:

(A) Four of the members shall be appointed by the Board from individuals who are distinguished in biomedical or behavioral research.

(B) Three of the members shall be appointed by the Board from individuals who are distinguished in the practice of medicine or otherwise distinguished in the provision of health care. (C) Five of the members shall be appointed by the Board from individuals who are distinguished in one or more of the fields of ethics, theology, law, the natural sciences (other than the biomedical or behavioral sciences), the social sciences, the humanities, health administration, government, and public affairs.

(D) Two of the members shall be appointed by the Board from individuals who are representatives of citizens with an interest in biomedical ethics but who possess no specific expertise.

(2)(A) The Committee, by majority vote, shall elect from its members a chairman and a vice chairman and appoint an executive director who shall serve for such time and under such conditions as the Committee may prescribe. In the absence of the chairman, or in the event of the incapacity of the chairman, the vice chairman shall act as chairman.

(B) The term of office of each member of the Committee shall be four years, except that any such member appointed to fill a vacancy occurring prior to the expiration of the term for which such member's predecessor was appointed shall be appointed for the remainder of such term. Terms of the members shall be staggered so as to establish a rotating membership.

(C) The members of the Committee shall receive no pay for their services as members of the Committee, but shall be allowed necessary travel expenses (or, in the alternative, mileage for use of privately owned vehicles and a per diem in lieu of subsistence at not to exceed the rate prescribed in sections 5702 and 5704 of title 5, United States Code) and other necessary expenses incurred by them in the performance of duties as a member of the Committee, without regard to the provisions of subchapter 11 of chapter 57 and section 5731 of title 5, United States Code, and regulations promulgated thereunder.

(D) The executive director of the Committee, with the approval of the Committee, may employ such staff and consultants as necessary to prepare studies and reports for the Committee.

(3)A) The Committee may, for the purpose of carrying out its functions, hold such public hearings, sit and act at such times and places, and take such testimony, as the Committee considers appropriate.

(B) Upon request of the Committee, the head of any Federal agency is authorized to detail, on a reimbursable basis, any of the

1 Probably should be "subchapter I".