Federal Regulations for Fetal Research: A Case for Reform

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.

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.

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.

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.

45 CFR 46.103 (b) (1).

Goodlin RD , Cutaneous respiration in a fetal incubator, American Journal of Obstetrics & Gynecology 1963, 86: 571–79.

Adam PAJ , Cerebral oxidation of glucose and DBOH-Butyrate by the isolated perfused fetal head, Pediatric Research 1973, 7: 309 (abstract).

Roe v. Wade, 410 U.S. 113, 159 (1973); Doe v. Bolton, 310 U.S. 113, 179 (1973).

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.

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.

Cohn V , NIH vows not to fund fetus work, Washington Post, April 13, 1973, at A1.

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.

National Institutes of Health, Protection of human subjects: Policies and procedures, Federal Register, Nov. 16, 1973, 38: 31738–49.

Collected in Appendix, supra note 9.

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.

Jonsen A , Ethical aspects of human fetal tissue transplantation, talk given at Case-Western Reserve School of Medicine, Cleveland, Ohio, December 4, 1986.

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.

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.

McCormick RA , Proxy consent in the experimentation situation, Perspectives in Biology and Medicine 1974, 18: 2–20.

McCormick RA , How brave a new world?, Washington, D.C.: Georgetown University Press, 1981: 76.

Walters L , Appendix, supra note 9, at 8–8.

Id.: 8–10.

Report, supra note 1, at 67.

45 CFR 46.207 (a) (1).

45 CFR 46.210.

45 CFR 46.102 (g).

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.

Steinfels M , At the EAB, same members, new ethical problems, Hastings Center Report, October 1979, 5: 2.

Fletcher JC Schulman JD , Fetal research: The state of the question, Hastings Center Report, April 1985, 15: 6–12.

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.

Kazy Z Rozovsky IS Bakharev V , Chorion biopsy in early pregnancy, Prenatal Diagnosis 1982, 2: 39–45.

Ward RHT , Method of sampling chorionic villi in first trimester of pregnancy under guidance of real time ultrasound, British Medical Journal 1983, 286: 1542.

Simoni G , Diagnostic application of first trimester trophoblast sampling in 100 pregnancies, Human Genetics 1984, 66: 252–59.

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.

Cowart V , NIH considers large-scale study to evaluate chorionic villi sampling, Journal of the American Medical Association 1984, 252: 11–15.

Jackson L , CVS newsletter, Dec. 1, 1986, at 1.

Schulman JD , ed., Fetal therapy, Clinical Obstetrics & Gynecology 1986, 29: 481–614.

Evans MI , 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.

Redmond DE , Fetal neuronal grafts in monkeys given methylphenyltetrahydopyridine, Lancet 1986, i: 1124–27.

Fishman DS , Neural transplantation: Scientific gains and clinical perspectives, Neurology 1986, 36: 389–92.

Brundin T , Behavioural effect of human fetal dopamine neurons grafted in a rat model of Parkinson's disease, Experimental Brain Research 1986, 65: 235–40.

O'Reilly RJ , Fetal liver transplantation in man and animals, in Gale RG , ed., Recent advances in bone marrow transplantation, New York: Liss, 1983: 799–830.

Fletcher JC Robertson JA Harrison M , Primates and fetuses as sources of organs: Medical, ethical, and legal issues, Fetal Therapy 1986, 1: 150–64.

Uniform Anatomical Gift Act, Table of jurisdictions wherein act has been adopted, 8A Uniform Laws Annotated 1983, 8A:15–16.

45 CFR 46.209 (b) (2).

Ethics Committee of the American Fertility Society, Ethical consideration of the new reproductive technologies, Fertility and Sterility 1986, 46 (Supp 1): 74.

West JD , Sexing the human pre-embryo by DNADNA in-situ hybridisation, Lancet 1987, i: 1345–47.

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.

Ethics Advisory Board, supra note 26.

Id.: 108.

Ciba Foundation, Human embryo research: Yes or no?, London: Tavistock Publications, 1986.

Legislative History, Public Law 99–158, Health Research Extension Act of 1985, pp. 718–19.

Id.: 718.

Id.: 719.

McCormick RA , Brave new world, supra note 19, at 79.

Report, supra note 1, at 5.

Id.: 62.

Council on Science and Society, Report of a Working Party, Human procreation, Oxford: Oxford University Press, 1984: 3.

Dunstan GR , The moral status of the human embryo: A tradition recalled, Journal of Medical Ethics 1984, 1: 38–44.

Sumner LW , Abortion and moral theology, Princeton: Princeton University Press, 1981.

Callahan D , Abortion: Law, choice and morality, New York: Macmillan, 1970: 377.

Grobstein C , From chance to purpose, Reading, Mass.: Addison-Wesley, 1981: 102.

Bok S , Fetal research and the value of life, Appendix, supra note 9, at 2–1 to 2–18.

Toulmin S , Fetal experimentation: Moral issues and institutional controls, Appendix, supra note 9, at 10–1 to 10–26.

Id.: 10–8.

Id.: 10–15.

Dunstan , supra note 58, at 43.

Ethics Advisory Board, supra note 26, at 108.

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.

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.

Ethics Committee, American College of Obstetrics and Gynecology, Ethical issues in in vitro fertilization and embryo placement, July 1986.

45 CFR 46.406.

McCormick, Brave new world, supra note 19, at 66.

Report, supra note 1, at 66.

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.

45 CFR 46.303 (d).

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.

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.”