niversit M souri um I O1 0-103860653 CONGRESS BIOHEDICAL ETHICS: HUMAN EXPERIHENTATION ISSUE BRIEF NUMBER IB74095 AUTHOR: Zegel, Vikki A. Science Policy Research Division THE LIBRARY OF CONGRESS CONGRESSIONAL RESEARCH SERVICE uhaoa ISSUES SYSTEM DATE OBIGINATED Q74g§;1g DATE UPDATED Q2g2;4§Q FOR AEDITIOHAL INFORMATION CALL 237-5700 0222 CRS- 1 1374095 OPDATE-02/22/80 .7 "$L7§_P. £2.13! .I..1.'.D.!! Rapid advances and life-saving discoveries made in the field of biomedical research over the past few decades have been paralleled by an increasing emphasis on the use of humans as experimental subjects in biomedical and behavioral research. Revelations of past abuses involving human experimentation have led to increased public and Federal concern over the need for definitive regulations and guidelines to protect human subjects of ‘biomedical and behavioral research. §..é§..fS..B.QQ.f!.I2..A..I!.12.P.9Ll£3.X_.;1!.1!A1.:X§l§ In 1947, the total expenditure from all sources for medical and health-related research in the United States was $87 million. By 1974, the national support for such R30 had grown to $4.4 billion, with the Federal Government supporting nearly two-thirds of the total amount. . The funding amount estimated for 1975 was $4.6 billion. Preliminary estimates for total 0.3. spending were $5.1 billion for 1976 and $5.6 billion for 1977. [These figures, of course, include medical and health-related RED expenditures.) A direct result of this increased level of biomedical research has been a growing demand for the use of human subjects in clinical investigations. ‘The major benefit of using human subjects in research is the direct relevance and applicability of the test data to clinical medicine. In 1970, over Jofi of ? 2 11,000 research grants awarded by the National Institutes of Health involved human subjects. In recent years, incidents such as the Tuskegee syphilis study, the Cincinnati whole body radiation study (DOD), and articles in the popular literature on human experimentation in prisons and mental institutions have brought the whole area of human experimentation into question. Of particular concern has been the extent to which individuals are becoming unwitting and/or uninformed participants in medical experiments. Several years ago the Department of Health, Education, and Welfare (HRH) established policy guidelines for the protection of human researchh subjects. Their guidelines required review and approval of any grant or contract for an HEw‘supported activity that involved human subjects. In Hay of 1974, the HEW policy was revised, with regulations providing more detailed requirements for review committees and procedures. In August 1974, HRH published its proposed regulations on the use of prisoners, children, fetuses, abortnses, and institutionalized mental patients. On June 28, 1974, Congress passed H.R. 7724, the National Research Act. This legislation, originally introduced in the House as a research training and fellowship bill, was amended by the Senate Labor and Public welfare Committee to include a separate title II concerning the protection of human subjects. In conference, the two Houses derived the final form of H.R. 7724, a form closely approximating the Senate version of the legislation. The Act \ ; signed into Public Law 93-348 on July 12, 1974. The Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, composed of eleven members appointed by the Secretary of HRH. The duties of the Commission were set cas— 2 1374095‘ uPblTE—o2/22/so forth by.the Act to identify the basic ethical principles and develop appropriate guidelines that should underlie the conduct of biomedical and behavioral research involving human subjects. In addition, the Commission was directed to investigate specific relevant issues, such as the use ff children, prisoners, and mental patients; the assessment of risk-benef_p criteria in biomedical research; the nature and definition of informed consent; the nature and extent of fetal research; and the use of psychosurgery in the United States. The Commission was given a 4-month deadline by Congress to investigate and make its recommendations on the fetal research issue. The remainder of the issues, along with any others that developed during the course of the Commission's deliberations, were to be reported on during its 2-year lifetime established by P.L. 93-348. The Commission's lifetime was extended until December 1977 by P.L. 9u—573. It was further extended until Nov. 1, 1978 by P.L. 95-203. All reports and“ recommendations have been completed by the Commission, which has now officially concluded its work. It is to be replaced by a Presidential commission with broadened focus and expanded duties, under a measure passed in the final days of the 95th Congress (Title III, P.L. 95-622--see LEGISLATION). The National Commission completed its work on the fetal research issue and made its recommendations to the Secretary of HEW on May 21, 1975. The Secretary published the Commission's report in the Aug. 8, 1975, issue of the Federal Register, and declared that “The moratorium on fetal research imposed on Aug. 27, 1974, is hereby lifted....“ A full report of the Commission's deliberations and recommendations, as submitted July 25, 1975, is available through the U.S. Govt. Print. 0ff., Supt. of Docs. (see REFERENCES). Proposed amendments concerning fetuses, pregnant women, and ;g_ giggg fertilization were published by the Secretary of HEW in the Jan. 13, 19’ Federal Register, Part II. These amendments have since been made part of the u.s. Code of Federal Regulations on the Protection of Human Subjects (45 CFB Part 46) by the NIH office of Protection from Research Risks, which adopted the proposed changes on Apr. 1, 1977. Additional protections pertaining to fetuses, pregnant women, and in vitro fertilization were published by the Department of HEW in the Jan. 11, 1978 Federal Register, Part III. The Commission has also submitted reports and recommendations on the prison research issue, the use of psychosurgery, the use of children as research subjects, the disclosure of research information, institutional review boards, ethical guidelines for the delivery of health services by the HEW, a staff report summarizing the policies and regulations of the various Federal departments and agencies regarding research involving human subjects, the "Belmont Report" on ethical principals and guidelines for the protection. of. human subjects of research, and a “special study“ on‘ the implications of advances in biomedical and behavioral research (see REFERENCES for full citations). The DHEW Ethics Advisory Board (EAB) a separate body created to advise the DREW Secretary on ethical issues raised by departmental biomedical and behavioral research activities, has conducted public hearings on the issue of Federal funding of experiments involving human ;n_g;§gg fertilization. .(The Board was authorized by departmental regulations codified at #5 CFR Part 46, Subpart B.) Departmental regulations concerning the protection of human subjects currently prohibit the support of research involving human in .vitro fertilization until the EAB has advised the BER Secretary as to the ethic acceptability of the particular research proposal. -In 1977, such a proposal was received by DHEH and was forwarded to the Board in 1978. Following the birth of a baby in England, (July 26, 1978) who was conceived by means of in vitro fertilization, the Board was directed to broaden its study of the CBS- 3 IB74095 UPDATE-02/22/80 individual research proposal to include the scientific, ethical, legal, and social aspects of human in vitro fertilization and embryo transfer in general. The EAB voted unanimously on Mar. 16, 1979, to end the ban on so-called "test-tube baby‘ research, but it did pg; make a recommenation one 5 y or the other on whether the Federal Government ghgglg fund such reearch. This is a separate ethical issue relating to the allocation of biomedical resources, and it was not felt to be within the authority or the expertise of the Board to make such a recommendation. The EAB's report was published in the June 18, 1979 Federal Register. Heanwhile, privately funded ‘test-tube baby“ clinics may open in the United States in the near future, regardless of decisions on Federal funding (see REFERENCES). Several bills concerning the specific issues of fetal research, prison research, psychosurgery and informed consent were introduced during the 94th and 95th Congresses. None of these bills received final action during those Congresses. Each of these issues, however, was reported on by the national Commission for the Protection of Human Subjects. Legislation was also introduced during the Quth and 95th Congresses to make the commission a Presidential Commission, with broadened focus and expanded duties. 5. 2579 (replacing S. 1893) of the 95th Congress, to create such a Presidential; Commission, was passed by the Senate on June 26, 1978, and referred to the“ House. on that same day, the Senate also passed 5. 2450, the Community Mental Health Centers and Biomedical Research Extension Amendments Act, incorporating a new title, which embodied many of the same provisions of S. 2579. A similar bill, H.R. 13662, was introduced in the House on July 31, 1978. On Oct. 1a, 1978, (the final day of the 95th Congress), the House and Senate adopted compromise language and agreed to Title III —- ‘The President's Commission for the Study of Ethical nProblems in Hedicine and 8 medical and Behavioral Research" -- of S. 2450. The bill became P.L. 9s-622 on Nov. 9, 1978. The new commission is authorized~ to be funded through FY 1982. L§§-§LA$£Q! P.L. 95-622 (Title III, S. 2450) Agreed to by the House and Senate on the last day of the 95th Congress, this title of the Community Hental Healthw Centers and Biomedical Research Extension Amendments Act establishes the “President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research." The Senate had added a similar title to S. 2450 on June 26, 1978, by the adoption of the Kennedy unprinted amendment No. 1344 during the floor debate on the bill. Compromise language was adopted by the House ad Senate on Oct. 1u,v1978, as Title III, establishing the President's Commission, with funding authority granted through FY82. The measure was signed into public law on Nov. 9, 1978. To prohibit psychosurgery in federally connected health care facilities. Introduced Jan. 15, 1979 and referred to the mcommittee on Interstate and Foreign commerce. §§é3I!§§ U.S. Congress. House. Committee on Interstate and Foreign Commerce. subcommittee on Public Health and Environment. National Health CRS- 4 IB74095 UPDATE-02/22/80 Research Fellowship and Traineeship Act of 1973. Hearings, 93d Congress, 1st session. Washington, 0.S. Govt. Print. Off., 1973. 340 p. "H.R. 5640 and H.R. 5948, bills to amend the Public Health Service Act to establish a national program of health research fellowships and traineeships to assure the continued excellence of biomedical research in the United states." Hearings held Har. 20-23, 1973. "Serial no. 93-13“ Biomedical Research Ethics and the Protection of Human Research Subjects. Hearings, 93d Congress, 1st session, on H.R. 10003, Protection of Human subjects Act, and related bills. Sept. 27-28, 1973. Washington, 0.5. Govt. Print. off., 1974. 292 p. “Serial no. 93-79" Developments in cell biology and genetics. Hearings, 95th Congress, 2d session on the "The area of science most properly termed ‘cell biology,’ ‘cloning’ being one aspect of the general area." may 31, 1978. Washington, 0.5. Govt. Print. off., 1978. 90p. "Serial no. 95-105“ ---- In-vitro fertilization. Oversight hearings, 95th Congress, 2d session. Aug. 0, 1978.. [Hot yet published] -—--- President's Commission on bioethics. Hearings, 95th congress, 2d-session, on H.R. 13662.: Aug. 4, 1978: 68 p. 7 "Serial no. 95-147' 0.5. Congress.v House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice. Behavior Modification Programs--Federal Bureau of Prisons. Hearings, 93d Congress, 2d session. Feb. 27, 1974. Washington, 0.3. Govt. Print. Off., 1974: 73 p. "Serial no . 26 "' -—--- Prison inmates in medical research. Hearings, 94th Congress, 1st session, on H.R. 3603. Sept. 29 and Oct. 1, 1975. Washington, 0.3. Govt. Print. off., 1975: 612 p. "Serial no. 31." 0.5. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology. Science Policy Implications of DNA Recombinant Molecule Research. Hearings, 95th Congress, 1st session. Bar. 29-31; Apr. 27-28; May 3_5, 25-26; and Sept. 7-8, 1977. Washington, 0.5. Govt. Print. off., 1977: 1293 p. "Serial no. 24* 0.5. Congress. Senate. Committee on Government Operations. Subcomittee on Government Research. National Commission on Health Science and Society. Hearings, 90th Congress, 2d session, on S.J.Res. 105, a joint resolution for the establishment of the National Commission on Health Science and Society. Mar. 7, 8, 21, 22, 27, and 28; Apr. 2, 1968. Washington, 0.5. Govt. Print. Off., 1968. 532 p. \ U.S. Congress. Senate. Committee on Human Resources. Subcommittee on Health and Scientific Research. Biological testing involving human subjects by the Department of Defense. Hearings, 95th Congress, 1st session. mar. 8 and Hay 23, 1977. Washington, U.S. Govt. Print. Off., 1977. 297 p. --—- Human drug testing by the CIA, 1977. Hearings, 95th Congress, ‘1st session on S. 1893. Sept. 20 and 21, 1977. Washington, U.S. Govt. Print. Off., 1977. 219 p. Oversight of biomedical and behavioral research in the United States, 1977. Hearings, 95th Congress, 1st session. mar. 31 and Apr. 1, 1977. Washington, u.s. Govt. Print. Off., 1977. 3&0 p. U.S. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health. Basic issues in biomedical and behavioral research, 1976. Hearings, 94th Congress, 2d session, to examine public policy in the area of biomedical and behavioral research. June 16 and 17, 1976. Washington, U.S. Govt. Print. Off., 1976. 903 p. ---- Genetic engineering, 1975. Hearing, 94th Congress, 1st session, to examine the relationship of a free society and its scientific community. Apr. 22, 1975. Washington, U.S. Govt. Print. off., 1975. 35 p. Quality of Health Care--Human Experimentation, 1973. Hearings, 93d Congress, 1st session, on S. 97a, 5. 878, and S.J. Res. 71. Washington, 0.5. Govt. Print. Off., 1973. M v. (1659 p.) 1 Hearings held Feb. 21-23, Mar. 6-8, Apr. 30, June 28-29, and July 10, 1973. Part 1 concerns certain contraceptives in experimentation; Part 2, psychosurgery; Part 3, the use of convicts as subjects; and Part H, on S. 2071, S. 2072, and H.B. 7724. 0.3. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health. / Special Subcommittee on National Science Foundation. national Advisory Commission on Health Science and Society, 1971. Hearings, 92d Congress, 1st session, on S.J.Res._75, to provide for a study and evaluation of the ethical, social, and legal implications of advances in biomedical research and technology. Nov. 9, 1971. [Washington, U.S. Govt. Print. Off.) 1971. 267 p. yU.S. Congress. Senate. Committee on Labor and Public Welfare- subcommittee on Health. / Committee on Veterans‘ Affairs. Subcommittee on Health and Hospitals. Psychosurgery in Veterans Administration Hospitals. Joint hearings, 93d Congress, 1st session. June 18, 1973. Washington, U.S. Govt. Print. Off., 1973. 192 p. U.S. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health. / Committee on the Judiciary. Subcommittee on Administrative Practice and Procedure. Biomedical and behavorial research, 1975. Hearings, 94th Congress, 1st session, related to S. 2515. Washington, U.S. Govt. Print. Off., 1976. 1265 p. c3s— 5 11374095 UPDATE-02/22/80 cns— 6 1374095 mm».-o 2/22/ao Hearings held Sept. 10, 12, and Nov. 7, 1975. U.S. Congress. Senate. Select Committee on Intelligence. / Committee on Human Resources. Subcommittee on Health and Scientific Research. Human experimentation activities conducted by the CIA. Hearings, 95th Congress, 1st session. Aug. 3, Sept. 20-21, 1977. [Not yet printed] 5‘l3.P03l'§ 3ND_Q9F.§.11§§§lQ!A1-.20C‘l.!§!2§ Kennedy, Edward H. Introduction of S. 1893, to establish the President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Congressional record [daily ed.] v. 123, July 19, 1977: S12371-512377. -+--- Introduction of S. 2579, (introduced as a rework of S. 1893), to establish the President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and for other purposes. Congressional record [daily ed.] v. 124, Feb. 23, 1978: S2182-S2184. ---- Voteaand floor debate on S. 2579, to establish the President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (vote 68 yeas to 10 nays). Congressional record [daily ed.] v. 124, June 26, 1978: 59689-59707; 59812-59814. See also S9718—s9720 gg: Kennedy unprinted amendment Ho. 1344 to S. 2450 (Community Mental Health Centers Extension and Biomedical Research Extension Act of 1978), adding a new Title IV embodying provisions of S. 2579. 4 Roth, Toby. No federal funds for in vitro fertilization. Congressional Record [daily ed.] v. 125, June 26, 1979: E3228- Rudd, Eldon. Congress should prohibit use of tax dollars for test tube baby research. Congressional record [daily ed.] v. 125, Mar. 14, 1979: E1112—E1114. Schweiker, Richard S. Protection of human subjects. (Statement on S. 2579). Feb. 24, 1978: Congressional record [daily ed.] v. 124, 52331 0.5. Congress. Conference Committee (House Interstate and Foreign Commerce Committee and Senate Labor and Public welfare Committee). National Research Act; conference report to accompany H.R. 7724. Washington, 0.5. Govt. Print. Off., 1974. 24 p. (93d Congress, 2d session. House. Report no. 93-1148) Congress. House. Committee on Interstate and Foreign Commerce. National Biomedical Research Fellowship, Traineeship, and Training Act of 1973; report to accompany H.R. 7724. Washington, U.S. Govt. Print. Off., 1973. 29 p. (93d Congress, 1st session. House. Report no. 93-224) R 0.5. Congress. Senate. Committee on Human Resources. President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Act of 1978. Report to accompany CRS- 7 1374095 UPDATE-0 2/22/80 S. 2579. Washington, U.S. Govt. Print. Off., 1978. 50 p. (95th Congress, 2d session. Senate. Report no. 95-852) ----- Subcommittee on Health and Scientific Research. Biomedical research and the public. Edited transcript of a conference on the relationship between biomedical research and the public, held at Airlie House, Airlie, Va., Apr. 1-3, 1976; sponsored by the Hastings Institute of Society, Ethics, and the Life Sciences, and by the Case western Reserve University Hedical School. Washington, Hay 1977. 154 p. At head of title: 95th Congress, 1st session. Committee print. 0.5. Congress. Senate. Committee on Labor and Public Welfare. National Research Service Award Act; report to accompany H.R. 7724. Washington, U.S. Govt. Print. Off., 1973. 96 p. (93d Congress, 1st session. Senate. Report no. 93-381) ---- President's Commission for the Protection of Human Subjects of Biomedical and Behavorial Research Act of 1976; report to accompany S. 2515. Washington, U.S. Govt. Print. Off., 1976. 25 p. (94th Congress, 2d session. Senate. Report no. 94-885) U.S. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health. Federal Regulation of Human Experimentation, 1975. Prepared by the Congressional Research Service. Iiashington, 0-3. Govt. Print. Off., 1975. 256 p. At head of title: 94th Congress, 1st session. Committee print.‘ Q§.§°N0LQGY 0F=§!§!!1'§ 06/18/79 -- DHBH Ethics Advisory Board's report published in Federal Register (35033-35058). 03/16/79 -03/17/79 - DHEH Ethics Advisory Board voted unanimously to end the Federal moratorium on funding in-vitro fertilization research; (but did pg; make any recommendation as to whether the Federal Government shgulg fund such research). 02/02/79 - 02/03/79 --DHEW Ethics Advisory Board discussed draft report and possible recommendations regarding human in-vitro fertilization experimentation. P.L. 95-622 (S. 2450, 95th Congress) signed; Title III established "The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research." 11/09/78 10/14/78‘ House and Senate adopted compromise language and enacted Title III of S. 2450 to establish a 6 Presidential commission on bioethics. national Commission report and recommendations on ethical guidelines for the delivery of health Aservices by the HE? (see REFERENCES). 09/30/78 09/15/78 09/01/78 01/26/78 07/21/78 02/10/78 02/03/78 02/02/78 01/16/78 01/13/78 01/11/78 01/05/78 11/23/77 09/05/77 06/16/77 06/15/77 cns- 8 1374095 UPDATE-oz/zz/80 National Commission issued the Belmont Report on ethical principals and guidelines for the protection of human subjects of research. -O9/16/78 —- DREW Ethics Advisory Board held a public meeting on in-vitro fertilization. National Commission report and recommendations on institutional review boards (see REFERENCES). Birth of Louise Brown in England; first baby born after conception by means of in vitro fertilization. DHEH proposed regulations gg: children (see REFERENCES). research involving National Commission Staff Report summarizing policies of other Federal agencies with'regard to the protection of human subjects was issued (see REFERENCES). First public meeting of the BER Ethics Advisory Board. National commission report and recommendations on .research involving those institutionalized as mentally infirm issued (see REFERENCES). AAAS, AAU, and NASDLGC sponsored a seminar on the policy aspects of research involving human subjects, EF100, 0.5. Capitol. ‘HEW Secretary published in the Federal Register the National Commission's report and recommendations regarding research involving children (see REFERENCES). HEW published in the Federal Register additional protections; pertaining to fetuses, pregnant women, and in vitro fertilization (see REFERENCES). 9 HEW proposed regulations on research involving prisoners, issued in the Federal Register (see REFERENCES). P.L. 95-203 (Saccharin Study and Labeling Act) was signed, thereby enacting the amendment to extend the National Commission until Nov. 1, 1978. The National Commission for the Protection of Human Subjects submitted to Congress its report and recommendations on research involving children (see REFERENCES). Bioethics Workshop for Congress held by the Congressional Research Service. (see REFERENCES) ERDA gave final ruling on the protection of human subjects in research activities supported by the agency. Amends Nov. 30, 1976, action (Federal Register, June 15, 1977: 30492-3). 05/23/77 04/08/77 04/01/77 03/14/77 01/1a/77 01/13/77 10/21/76 1Q/01/76 09/10/6 06/13/76 04/22/76% 08/00/75 CRS- 9 IB7u095 UPDATE-Oz/22/80 The Secretary of HEW published in the Federal Register for public comment the report and recommendations of the National Commission for the Protection of Human Subjects, on use of psychosurgery in practice and reearch. The National Commission for the Protection of Human Subjects submitted to Congress its report and recommendations on disclosure of research information (as required by Title III of P.L. 94-278). The NIH Office of Protection from Research Risks adopted the proposed amendments concerning fetuses, pregnant women, and in vitro fertilization and incorporated them into the Code of Federal Regulations pertaining to Protection of Human Subjects. (#5 CFR Part 46). The National Commission for the Protection of Human Subjects submitted to Congress its report and recommendations concerning the use of psychosurgery (see REFERENCES). The Secretary of HE? published in the Federal Register the report and recommendations of the National commission for the Protection of Human Subjects on research involving prisoners. The Secretary of HEW published in the Federal Register the Commission's proposed amendments concerning fetuses, pregnant women, and in vitro fertilization.h inedical Services Amendments of 1976“ A provision of the Act extended National Commission for one S. 2548, “Emergency became P.L. 94-573. the lifetime of the year (Dec. 1977). The National Commission for the Protection of Human Subjects: submitted to Congress its report and recommendations concerning research involving prisoners (see REFERENCES). The National Commission for the Protection of Human . Subjects unanimously recommended the continued use of psychosurgery with suggested requirements for HEW-supported research in this area. The National Commission for the Protection of Human Subjects Subjects approved their report and recommendations on biomedical and behavioral research involving prisoners. (see also 10/O1/7b entry). P.L. 94-278 enacted.~ Title III directs the National Commission to report on the implications of disclosure of research information (see 04/08/77 entry). The August 1975 issue of gggiaggigg carried the text of a fetaI*research code, as proposed by the American Academy of Pediatrics (AAP) Task Force on Pediatric Research. The code proposes that determinations of viability must be made by the physician attending labor, not an investigator. The 08/08/75 07/25/75 05/21/75 CRS—1O IB7nO95 UPDATE-02/22/80 Task Force concluded that a beating heart alone was not sufficient evidence of viability, and that at least one additional necessary condition would be that the fetal lungs could be inflated. The Secretary of HEW published the Commission's report in the Federal Register, declaring “The moratorium on fetal research imposed Aug. 27, 197a, is hereby lifted..." The Commission's report and recommendations on fetal research were submitted to the HEW Secretary, (pursuant to section 202-b of P.L. 93-3H8). The National Commission for the Protection of Human Subjects approved its final report providing recommendations concerning fetal research. The Commission endorsed an end to the Federal moratorium on fetal research, but detailed specific rules and procedures to regulate this area of clinical investigation. 05/15¢75-O5/16/75 —- New York Academy of Science and Institute of Society, 05/13/75 03/13/75 12/05/74 10/00/74 08/23/70 07/19/74 07/12/74 ’05/30/74 Ethics, and the Life Sciences held a Conference on Ethical and Scientific Issues Posed by Human Uses of molecular Genetics. E The National Science Foundation renewed its Advisory Committee on Ethical and Human Value Implications of Science and Technology as necessary and in the public interest. ” 45 CFR Part #6 re: protection of human subjects adopted as final regulations, with technical amendments (see REFERENCES). First meeting of the Commission for the Protection of Human Subjects was held; Dr. Ryan was elected chairman. Members of the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (under the authority of P.L. 93-348) were appointed: Dr. K.J. Ryan, Dr. Robert E. Cooxe, Dr. J.V. Brady, Dr. E. Stellar, Dr. D.H. Seldin, Dr. Albert Jonsen, David Louisell (deceased, 1977), Dorothy Height, Dr. Karen Lehacgz, Robert H. Turtle, and Pat King. HEW published proposed regulations concerning fetuses,0 abortuses, pregnant women, prisoners, and the institutionalized mentally disabled. Senate Health Subcommittee held hearing on fetal research. H.R. 7724, National Research Act, was enacted into law ”‘ (P.L. 93-3u8); Title II of the Act established the Rational Commission for the Protection of Human Subjects of Biomedical and Behavior Research. HEW announced its policy regulations for the protection of human subjects involved in HEW-supported~x. cas-11 ‘ 1374095 upDATE—oz/22/80 research activities.. 04/00/74 --Pive physicians in Boston, uass., were indicted in cases involving fetal research. 08/16/73 -- P.L. 93-96, National Science Foundation Appropriations, was enacted, containing the provision that no funds may be used to conduct or support fetal research. 07/00/73 - nichigan court ruled that experimental brain surgery to alter behavior is prohibited on persons confined against their will in institutions. On/28/73 -- Final report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel was released. 10/26/72 -- P.L. 92-570, military Procurement Authorization Act, was 7 enacted, containing an amendment prohibiting Defense funds for research involving uninformed or nonvoluntary humans as experimental subjects. 04/15/71 ‘* HEW announced its policy governing research using human subjects. These guidelines were based on earlier Public Health Service policy, but contained more specific requirements for informed consent. 05/01/69 --Public Health Service Guidelines: Protection of the Individual as a Research Subject was released. 01/00/67 -- Experiments were disclosed on mentally retarded children at Willowbrook State Hospital (H.Y.) involving the injection of a live hepatitis virus. 06/00/64 —— Declaration of Helsinki was issued, asserting the importance of individual rights in human experimentation and setting forth specific implementing guidelines; endorsed by major medical organizations in the United States. 10/10/62 -— Kefauver-Harris amended the Food, Drug, and Cosmetic Act requiring subject's consent for participation in experiments involving new drugs. A-_;I£Q!AL-§§§§B§!§§_§QQ§Q§§ Annas, George J., et al. Informed consent to human experimentation: The subject's dilemma. xcambridge, Hass: Ballinger, 1977. 333 p. Barber, Bernard et al. Research on human subjects. »Problens of social control in medical experimentation. new York: Russel sage foundation, 1973. 263 p. Bloomberg, Seth Allan, and Leslie T. Wilkins. Ethics of research involving human subjects in criminal justice. Crime and delinquency, Oct. 1977: 435-444. Bogomolny, Robert L. Human experimentation. Symposium on Human CBS-12 IB74095 UPDATE-Oz/22/80 Experimentation, 1975. Dallas: SHU Press, 1976. 148 p. Branson, Boy. Prison research: National Commission says "no, unless..." The Hastings center report, v. 7, no. 1, Feb. 1977: 15-21. British birth "poses many problems to society" (interview with Dr. John L. Harlow). U.S. News 6 World Report, Aug. 7, 1978: p. 24. Clothier, C.H. Consent to medical experiment. The Lancet, Mar. 19, 1977: 642-643. Cohn, Victor. Test-tube baby study debated by HEW panel. Washington post, Feb. 3, 1979: A.7 (See also Washington post, Feb. 4, 1979: A5.) -5-—-Ethics board gives backing to test-tube baby research. Washington post, mar. 17, 1979: A1, 11. ----- Ethical aspects of experimentation with human subjects. Daedalus, Journal of the American Academy of Arts and Sciences. Spring 1969. 603 p. Frankel, Mark S. The Public Health Service guidelines governing>~% research involving human subjects: an analysis of the ‘Z? policy-making process. Program of Policy Studies in Science and Technology. The George Washington University, Washington)“; D.C. February 1972. 64 p. ‘v Hatfield, Frank. Prison research: the view from inside. The Hastings center report, v. 7, no. 1, Feb. 1977: 11~12. "PL: Freund, Paul A. (ea.) Experimentation with human subjects. New York: George Braziller, 1969. 470 p. *7‘ mm 1,e£ Fried, Charles. Medical experimentation: personal integrity and social policy. New York: American Elsevier publishing co.;‘““’ iD.C., Po ' 2”‘. , . Grabel, Wendy. Pleas for test-tube babies useless in U.S. Medical tribune, Sept. 6, 1978: 1, 18-19. Gray, Bradford H. Institutional review boards as an instrument “I4 of assessment: research involving human subjects in the 0.5. Science, technolo9Yo and human values, fall 1978: 34+4B%3 ----— The functions of human subjects review committees. ~¢fifiV American Journal of Psychiatry, Aug. 1977: 907-910. “ ”“ --—-- Human subjects in medical experimentation. A sociologicalV3f”" study of the conduct civil and regulation of clinical research. New York: John Wiley and Sons, 1975. 298 p. Hershey, Nathan and Robert D. Miller. Human experimentation anu7 the law. Germantown, Hd., Aspen Systems Corporation, 1976. 165 p. "F“” Horrock, Nicholas H. C.I.A. data show 14-year project on controlling CBS-13 IB74095 UPDATE-02/22/80 human behavior. New York times, July 21, 1977:. A1, 34. Human experinentation——the ethical questions persist. The Hastings Center report, v. 3, no. 3, June 1973. 16 p. In vitro fertilization: a cautious move ahead. Bioscience, Nov. 1978: 685-688. Katz, Jay. Experimentation with human beings. 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