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Federal Regulations for Fetal Research: A Case for Reform

Published online by Cambridge University Press:  28 April 2021

John C. Fletcher  and
Kenneth J. Ryan
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Extract

In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research considered many aspects of fetal research. The Commission received some detailed ethical, legal, and scientific analyses, invited public testimony, and recommended guidelines for biomedical research involving the human fetus. One of the authors of the present article (KJR) chaired the Commission. Many of its recommendations became federal regulations on fetal research issued in 1975.

These regulations explicitly govern only research “conducted by the Department of Health and Human Services (DHHS) or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship.” However, as Baron pointed out in his legal review, they effectively cover all federally funded institutions, regardless of the source of the funds the institution may be using for fetal research.

Type
Article
Information
Law, Medicine and Healthcare , Volume 15 , Issue 3 , Fall 1987 , pp. 126 - 138
Copyright
Copyright © American Society of Law, Medicine and Ethics 1987

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References

The material in this article is taken from a chapter written by the authors for Fetal Diagnosis and Therapy: Science, Ethics, and the Law, ed. Evans, MI, Fletcher, JC, Dixler, AO, Schulman, JD, to be published by Lippincott Harper in 1987.Google Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and recommendations, research on the fetus, Washington, D.C.: U.S. Government Printing Office, 1975, DHEW Publication No. (OS) 76–127 (hereafter cited as “Report”), pp. 61–88.Google Scholar
Title 45, Code of Federal Regulations, Part 46—Protection of Human Subjects, Subpart B—Additional Protections Pertaining to Research Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization (revised as of March 8, 1983). Available from Office of Protection from Research Risks, Building 31, Room 4B-09, NIH, Bethesda, MD 20892.Google Scholar
Baron, CH, Legislative regulation of fetal experimentation, in Milunsky, A, Annas, G, eds., Genetics and the law III, New York: Plenum Press, 1985: 431–35.Google Scholar
45 CFR 46.103 (b) (1).Google Scholar
Goodlin, RD, Cutaneous respiration in a fetal incubator, American Journal of Obstetrics & Gynecology 1963, 86: 571–79.Google Scholar
Adam, PAJ, et al., Cerebral oxidation of glucose and DBOH-Butyrate by the isolated perfused fetal head, Pediatric Research 1973, 7: 309 (abstract).Google Scholar
Roe v. Wade, 410 U.S. 113, 159 (1973); Doe v. Bolton, 310 U.S. 113, 179 (1973).Google Scholar
Ramsey, P, The ethics of fetal research, New Haven: Yale University Press, 1975: 1–20; Maynard-Moody, S, Fetal research dispute, in Nelkin, D, ed., Controversy: Politics of technical decisions, Beverly Hills, Cal.: Sage Publications, 1979: 197-211; Hellegers, AE, Fetal research, in Reich, WT, ed., Encyclopedia of bioethics, New York: Free Press, 1978: 489-93; also, Levine, RJ, Ethics and regulation of clinical research, Baltimore: Urban & Schwarzenberg, 1981: 197-206.Google Scholar
Copsey, D, Gold, M, NIH ethics policy near on fetal research, OB-GYN News, April 15, 1973, at A1. Cases of objectionable fetal research were collected in a broad, objective review by Mahoney MJ, The nature and extent of research involving living human fetuses, in Appendix, Research on the human fetus, Washington, D.C.: U.S. Government Printing Office, 1976, DHEW Publication No. (OS) 76–128 (hereafter cited as “Appendix”), pp. 1–1 to 1-48.Google Scholar
Cohn, V, NIH vows not to fund fetus work, Washington Post, April 13, 1973, at A1.Google Scholar
Department of Health and Social Security, Report of the Advisory Group: The use of fetuses and fetal material for research, London: Her Majesty's Stationery Office, 1972; known as the Peel Commission Report.Google Scholar
National Institutes of Health, Protection of human subjects: Policies and procedures, Federal Register, Nov. 16, 1973, 38: 31738–49.Google Scholar
Collected in Appendix, supra note 9.Google Scholar
Gaylin, W, Lappe, M, Fetal politics: The debate on experimenting with the unborn, Atlantic Monthly, May 1975, at 66–71; Fletcher, JF, Fetal research: An ethical appraisal, Appendix, supra note 9, at 3–1 to 3–14.Google Scholar
Jonsen, A, Ethical aspects of human fetal tissue transplantation, talk given at Case-Western Reserve School of Medicine, Cleveland, Ohio, December 4, 1986.Google Scholar
Ramsey, supra note 8; also, Moral issues in fetal research, Appendix, supra note 9, at 6–1 to 6–14. Louisell DW, Fetal research: Response to the recommendations, Hastings Center Report, Oct. 1975, 5: 9–11.Google Scholar
McCormick, RA, Experimentation on the fetus: Policy proposals, Appendix, supra note 9, at 5–1 to 5–11; Walters, L, Ethical and public policy issues in fetal research, Appendix at 8–1 to 8–18; McCormick, RA, Walters, W, A good beginning, Hastings Center Report, Oct. 1975, 5: 13–14.Google Scholar
McCormick, RA, Proxy consent in the experimentation situation, Perspectives in Biology and Medicine 1974, 18: 2–20.Google ScholarPubMed
McCormick, RA, How brave a new world?, Washington, D.C.: Georgetown University Press, 1981: 76.Google Scholar
Walters, L, Appendix, supra note 9, at 8–8.Google Scholar
Id.: 8–10.Google Scholar
Report, supra note 1, at 67.Google Scholar
45 CFR 46.207 (a) (1).Google Scholar
45 CFR 46.210.Google Scholar
45 CFR 46.102 (g).Google Scholar
Ethics Advisory Board of the U.S. Department of Health, Education, and Welfare, Report and conclusions: DHEW support of research involving in vitro fertilization and embryo transfer, May 4, 1979; also, Federal Register 1979, 44: 35.Google Scholar
Steinfels, M, At the EAB, same members, new ethical problems, Hastings Center Report, October 1979, 5: 2.Google Scholar
Fletcher, JC, Schulman, JD, Fetal research: The state of the question, Hastings Center Report, April 1985, 15: 6–12.Google ScholarPubMed
Anshan Department of Obstetrics and Gynecology, Fetal sex prediction by sex chromatin of chorionic villi cells during early pregnancy, Clinical Medical Journal 1975, 1: 117–126.Google Scholar
Kazy, Z, Rozovsky, IS, Bakharev, V, Chorion biopsy in early pregnancy, Prenatal Diagnosis 1982, 2: 39–45.Google Scholar
Ward, RHT, et al., Method of sampling chorionic villi in first trimester of pregnancy under guidance of real time ultrasound, British Medical Journal 1983, 286: 1542.Google ScholarPubMed
Simoni, G, et al., Diagnostic application of first trimester trophoblast sampling in 100 pregnancies, Human Genetics 1984, 66: 252–59.Google ScholarPubMed
Fletcher, JC, Ethical aspects of a controlled clinical trial of chorion biopsy approach to prenatal diagnosis, in Berg, K, ed., Medical genetics: Past, present and future, New York: Liss, 1985, at 213–48.Google Scholar
Cowart, V, NIH considers large-scale study to evaluate chorionic villi sampling, Journal of the American Medical Association 1984, 252: 11–15.Google ScholarPubMed
Jackson, L, CVS newsletter, Dec. 1, 1986, at 1.Google Scholar
Schulman, JD, ed., Fetal therapy, Clinical Obstetrics & Gynecology 1986, 29: 481–614.Google Scholar
Evans, MI, et al., Pharmacologic suppression of the fetal adrenal gland in utero: Attempted prevention of abnormal external genital masculinization in suspected congenital adrenal hyperplasia, Journal of the American Medical Association 1985, 253: 1014–20.Google ScholarPubMed
Redmond, DE, et al., Fetal neuronal grafts in monkeys given methylphenyltetrahydopyridine, Lancet 1986, i: 1124–27.Google Scholar
Fishman, DS, Neural transplantation: Scientific gains and clinical perspectives, Neurology 1986, 36: 389–92.Google ScholarPubMed
Brundin, T, et al., Behavioural effect of human fetal dopamine neurons grafted in a rat model of Parkinson's disease, Experimental Brain Research 1986, 65: 235–40.Google Scholar
O'Reilly, RJ, et al., Fetal liver transplantation in man and animals, in Gale, RG, ed., Recent advances in bone marrow transplantation, New York: Liss, 1983: 799–830.Google Scholar
Fletcher, JC, Robertson, JA, Harrison, M, Primates and fetuses as sources of organs: Medical, ethical, and legal issues, Fetal Therapy 1986, 1: 150–64.Google Scholar
Uniform Anatomical Gift Act, Table of jurisdictions wherein act has been adopted, 8A Uniform Laws Annotated 1983, 8A:15–16.Google Scholar
45 CFR 46.209 (b) (2).Google Scholar
Ethics Committee of the American Fertility Society, Ethical consideration of the new reproductive technologies, Fertility and Sterility 1986, 46 (Supp 1): 74.Google Scholar
West, JD, et al., Sexing the human pre-embryo by DNA-DNA in-situ hybridisation, Lancet 1987, i: 1345–47.Google Scholar
Penketh, R, McLaren, A, Prospects for prenatal diagnosis during pre-implantation human development, in Rodeck, C, ed., Balliere's International Obstetrics & Gynecology, WD Saunders & Co., in press.Google Scholar
Ethics Advisory Board, supra note 26.Google Scholar
Id.: 108.Google Scholar
Ciba Foundation, Human embryo research: Yes or no?, London: Tavistock Publications, 1986.Google Scholar
Legislative History, Public Law 99–158, Health Research Extension Act of 1985, pp. 718–19.Google Scholar
Id.: 718.Google Scholar
Id.: 719.Google Scholar
McCormick, RA, Brave new world, supra note 19, at 79.Google Scholar
Report, supra note 1, at 5.Google Scholar
Id.: 62.Google Scholar
Council on Science and Society, Report of a Working Party, Human procreation, Oxford: Oxford University Press, 1984: 3.Google Scholar
Dunstan, GR, The moral status of the human embryo: A tradition recalled, Journal of Medical Ethics 1984, 1: 38–44.Google Scholar
Sumner, LW, Abortion and moral theology, Princeton: Princeton University Press, 1981.Google Scholar
Callahan, D, Abortion: Law, choice and morality, New York: Macmillan, 1970: 377.Google Scholar
Grobstein, C, From chance to purpose, Reading, Mass.: Addison-Wesley, 1981: 102.Google Scholar
Bok, S, Fetal research and the value of life, Appendix, supra note 9, at 2–1 to 2–18.Google Scholar
Toulmin, S, Fetal experimentation: Moral issues and institutional controls, Appendix, supra note 9, at 10–1 to 10–26.Google Scholar
Id.: 10–8.Google Scholar
Id.: 10–15.Google Scholar
Dunstan, , supra note 58, at 43.Google Scholar
Ethics Advisory Board, supra note 26, at 108.Google Scholar
Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilization and Embryology, London: Her Majesty's Stationery Office, 1984: 84.Google Scholar
Victoria, Committee to Consider the Social, Ethical, and Legal Issues Arising from In Vitro Fertilization, Report on the disposition of embryos produced by in vitro fertilization, Melbourne: F.D. Atkinson Government Printer, August 1984, p. 60.Google Scholar
Ethics Committee, American College of Obstetrics and Gynecology, Ethical issues in in vitro fertilization and embryo placement, July 1986.Google Scholar
45 CFR 46.406.Google Scholar
McCormick, Brave new world, supra note 19, at 66.Google Scholar
Report, supra note 1, at 66.Google Scholar
Commission, Research involving children: Report and recommendations, DHEW Publication No. (OS) 77–0004, 1977; specific reference to the earliest definition of minimal risk is in Federal Register 1975, 40: 33529.Google Scholar
45 CFR 46.303 (d).Google Scholar
Harlap, S, Shiono, PH, Ramcharan, S, A life table of spontaneous abortions and the effects of age, parity, and other variables, in Porter, IH, Hook, EB, eds., Human embryonic and fetal death, New York: Academic Press, 1980: 148.Google Scholar
One hopeful sign of renewed commitment to study, debate, and recommendations on these necessarily related policies is the creation of the congressional Biomedical Ethics Board and its Biomedical Ethics Advisory Committee, established by the Health Research Extension Act of 1985. One of the Board's mandates is to “conduct a study of the nature, advisability, and biomedical and ethical implications of exercising any waiver of the risk standard published in section 46.102 (g) … or any successor to such regulations.”Google Scholar