Ethical consideration of maternal participation in clinical research

Current Opinion in Obstetrics and Gynecology

Volumn 11, Issue 6, 1999, Pages 549-551

  Chervenak, Frank A ^a,c   McCullough, Laurence B ^b  

^a Department of Obstetrics Gynecology   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; FETUS; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; PATIENT RIGHT; PREGNANCY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT;

BIOMEDICAL AND BEHAVIORAL RESEARCH; GENETICS AND REPRODUCTION;

ETHICS, MEDICAL; FEMALE; FETUS; HUMAN EXPERIMENTATION; HUMANS; MATERNAL WELFARE; MOTHERS; PATIENT ADVOCACY; PERSONNEL SELECTION; PREGNANCY;

EID: 0033451744     PISSN: 1040872X     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001703-199912000-00002     Document Type: Review

References (10)

1. 1 Harman CR (editor). Invasive fetal testing and treatment. Boston: Blackwell Scientific Publications; 1995.
2. 2 Kahn JP, Mastroiani AC, Sugarman J (editors). Beyond consent: seeking justice in research. New York: Oxford University Press; 1998. This volume of 10 chapters explores the shift from an ethics of human subjects research based almost exclusively on informed consent to an ethics of human subjects research based on justice. A justice-based approach retains the ethics of informed consent, but adds to it an equal concern to secure access of all patients and patient populations to the benefits of research. The new approach explored in this book marks a conceptual shift from protection of vulnerable individuals, which often denies them access to the benefits of research, to access to research. Chapters address research with the vulnerable sick, children, women, racial and ethnic minorities, convenient and captive populations, justice in international research, theories of justice in the context of research, and implementing justice in a changing research environment. Research involving pregnant women and fetuses is discussed in several of these chapters, providing a rich and insightful perspective on the ethics of maternal involvement in clinical research.
3. 3 Brody BA. The ethics of biomedical research: an international perspective. New York: Oxford University Press; 1998.
4. 4 Department of Health and Human Services. Regulations for the protection of human subjects. 45 CFR 46:207.
5. 5 Kass N. Gender in research. In: Beyond consent: seeking justice in research. Kahn JP, Mastroiani AC, Sugarman J (editors). New York: Oxford University Press; 1998: pp. 67-87.
6. 6 Brody BA. Research on the vulnerable sick. In: Beyond consent: seeking justice in research. Kahn JP, Mastroiani AC, Sugarman J (editors). New York: Oxford University Press; 1998: pp. 32-46. This is the first comprehensive, international account of the ethics of fetal research. This volume contains well documented and clinically applicable accounts of the development of the ethics of human subjects research in the USA and other developed countries. There are detailed discussions of ethical issues concerning research that involves pregnant women and fetuses, in one chapter devoted entirely to these topics, and elsewhere in the volume. The author's accounts of these and other topics take into consideration not only the American literature and US regulations, but also the literature and regulations of other countries such as the UK, France, Germany, and Canada, and transnational entities such as the Council for International Organizations of Medical Sciences, the World Medical Association, and the Council of Europe. The author underscores the remarkable convergence among the ethical perspectives and resolutions that have developed in different countries. An especially valuable aspect of this volume is its extensive appendix of international documents pertaining to the ethics and regulation of human subjects research, many of which pertain to research on pregnant women and fetuses.
7. 7 American College of Obstetricians and Gynecologists, Committee on Ethics. Ethical considerations in research involving pregnant women. ACOG Committee Opinion 213. Washington DC: American College of Obstetricians and Gynecologists; 1998. The American College of Obstetricians and Gynecologists Committee Opinion is 'designed to provide reasonable guidelines for research that involves pregnant women.' This statement provides succinct and clinically applicable accounts of the ethics of human subjects research, informed consent, involvement of primary care givers in the informed consent process (as an aid to the pregnant woman's right both to consent and to refuse to enrol in clinical investigation and trials), and research related to fetal diagnosis and therapy. The statement also offers recommendations for research involving pregnant women. These recommendations emphasize scientific excellence in research methods and designs, avoidance of conflict of interest on the part of investigators, avoiding potentially coercive financial inducements, the primacy of the health care needs of the pregnant woman, informed consent, evaluation of impact of research interventions on the fetus, and protecting the fetus from more than minimal risk.
8. 8 American Academy of Pediatrics, Committee on Bioethics. Fetal therapy: ethical considerations. Pediatrics 1999; 103:1061-1063. The American Academy of Pediatrics statement provides guidelines for the physician's role in assisting the pregnant woman and her involved family members to make decisions about participation in clinical research on fetal interventions. The statement notes that the ethics of this topic are defined in large measure by a conflict between the interests of the fetus and the pregnant woman's interest in her own health and life. The consent process for such research should involve a team approach, with clear policies governing communication with the pregnant woman and others whom she wishes to involve in the consent process, diagnostic and therapeutic interventions, and quality improvement. The risks to both the fetus and the pregnant woman should be carefully evaluated by the interdisciplinary team and presented to the woman in an unbiased fashion in the informed consent process. This process should educate the woman about the full range of possible outcomes between cure and death. The consent process should also make it clear that the investigational intervention is of unproved efficacy. Neither the pregnant woman, her husband, nor other family members should be pressured in any way to participate or made to believe that she has an obligation to participate for fetal benefit, the advancement of science, or any other reason.
9. 9 McCullough LB, Chervenak FA. Ethics in obstetrics and gynecology. New York: Oxford University Press; 1994.
10. 10 Chervenak FA, McCullough LB. The limits of viability. J Perinat Med 1997; 25:418-420.