Preventive ethics for including women of childbearing potential in clinical trials

American Journal of Obstetrics and Gynecology

Volumn 194, Issue 5, 2006, Pages 1221-1227

  McCullough, Laurence B ^a   Coverdale, John H ^b   Chervenak, Frank A ^c  

^a Center for Medical Ethics and Health Policy   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Clinical investigators; Clinical trials; Institutional review boards; Preventive ethics; Women of childbearing potential

Indexed keywords

ARTICLE; CLINICAL RESEARCH; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; METHODOLOGY; MORALITY; PATIENT COUNSELING; PATIENT REFERRAL; PREGNANCY; PREVENTIVE MEDICINE; PRIORITY JOURNAL; RESEARCH ETHICS; STATISTICAL SIGNIFICANCE;

ADOLESCENT; ADULT; CLINICAL TRIALS; ETHICS, RESEARCH; FEMALE; HUMANS; INFORMED CONSENT; PATIENT SELECTION; PREGNANCY; PREVENTIVE MEDICINE; RESEARCH; RESEARCH DESIGN; SOCIAL RESPONSIBILITY;

EID: 33646081771     PISSN: 00029378     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajog.2005.10.818     Document Type: Article

References (30)

1. US Food and Drug Administration. Guideline for the study and evaluation of gender differences in clinical evaluation of drugs. Federal Register (July 22, 1993) 58FR39406
2. Merkatz R.B., and White S. Historical background of changes in FDA policy on the study and evaluation of drugs in women. Acad Med 69 (1994) 703-707
3. Brody B.A. The ethics of biomedical research: an international perspective (1998), Oxford University Press, New York
4. US National Institutes of Health. NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research-October, 2001. Available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Accessed April 29, 2005.
5. Merton V. The exclusion of pregnant, pregnable, and once-pregnable people (a.k.a. women) from biomedical research. Am J Law Med 19 (1993) 369-451
6. Mastroianni A.C., Faden R., and Federman D. Women and health research: ethical and legal issues of including women in clinical studies. Volume 1 (1994), National Academy Press, Washington, DC
7. Mastroianni A.C., Faden R., and Federman D. Women and health research: ethical and legal issues of including women in clinical studies. Volume 2 (1994), National Academy Press, Washington, DC
8. Eckenwiler L.A. Attention to difference and women's consent to research. IRB 20 (1998) 7-11
9. Anderson J.R., Schonfeld T.L., Kelso T.K., and Prentice E.D. Women in early phase trials: an IRB's deliberations. IRB 25 (2003) 7-11
10. Frank E., Novick D.M., and Kupfer D.J. Beyond the question of placebo controls: ethical issues in psychopharmacological drug studies. Psychopharmacology (Berl) 171 (2003) 19-26
11. American College of Obstetricians and Gynecologists. Research involving women. Ethics in Obstetrics and Gynecology (2004), American College of Obstetricians and Gynecologists, Washington, DC p. 86-92
12. VandenBosch T., Ward B., and Mattison D. A reappraisal of female adolescent participation in drug clinical trials. IRB 21 (1999) 1-5
13. Schonfeld T., and Gordon B.G. Contraception in research: a policy suggestion. IRB 2 (2005) 15-20
14. 45 FCFR 46. Department of Health and Human Services, Regulations for the Protection of Human Subjects. 1991. Revised November 13, 2001, effective December 13, 2001. Available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.204. Accessed April 21, 2005.
15. McCullough L.B., Coverdale J.H., and Chervenak F.A. A comprehensive ethical framework for responsibly designing and conducting pharmacologic research involving pregnant women. Am J Obstet Gynecol 193 (2005) 901-907
16. Chervenak F.A., and McCullough L.B. Clinical guides to preventing ethical conflicts between pregnant women and their physicians. Am J Obstet Gynecol 162 (1990) 303-307
17. Forrow L., Arnold R.M., and Parker L.S. Preventive ethics: expanding the horizons of clinical ethics. J Clin Ethics 4 (1993) 287-294
18. US Food and Drug Administration. Labeling and prescription drug advertising: content and format for labeling for human prescription drugs. Federal Register 44 (1979) 434-467
19. Beauchamp T.L., and Childress J.C. Principles of biomedical ethics. 5th ed. (2001), Oxford University Press, New York
20. McCullough L.B., and Chervenak F.A. Ethics in obstetrics and gynecology (1994), Oxford University Press, New York
21. Institute of Medicine. Committee on the ethical and legal issues relating to the inclusion of women in clinical studies: executive summary. In: Mastroianni A.C., Faden R., and Federman D. (Eds). Women and health research: ethical and legal issues of including women in clinical studies Volume I (1994), National Academy Press, Washington, DC 1-25
22. Rivera R., Yacobson I., and Grimes D. The mechanism and action of hormonal contraceptives and intrauterine contraceptive devices. Am J Obstset Gynecol 181 (1999) 1263-1269
23. Committee on Bioethics, American Academy of Pediatrics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics 95 (1995) 314-317
24. Chervenak F.A., and McCullough L.B. The fetus as a patient: an essential concept for the ethics of perinatal medicine. Am J Perinatalol 20 (2003) 399-404
25. Institute of Medicine. Committee on the ethical and legal issues relating to the inclusion of women in clinical studies: legal considerations. In: Mastroianni A.C., Faden R., and Federman D. (Eds). Women and health research: ethical and legal issues of including women in clinical studies Volume I (1994), National Academy Press, Washington, DC 128-174
26. Halbreich U., and Carson S.W. Drug studies in women of childbearing age: ethical and methodological considerations. J Clin Pharmacol 9 (1989) 328-333
27. Nolan M.T., Pressman E.K., Starklauf B.L., and Gregory R.E. Consent documents, reproductive issues, and the inclusion of women in clinical trials. Acad Med 74 (1999) 275-281
28. Pole M., Einarson A., Pairaudeau N., Einarson T., and Koren G. Drug labeling and risk perceptions of teratogenicity: a survey of pregnant Canadian women and their health professionals. J Clin Pharmacol 40 (2000) 573-577
29. Koren G., Bologa M., Long D., Feldman Y., and Shear N.H. Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. Am J Obstet Gynecol 160 (1989) 1190-1194
30. Chervenak F.A., and McCullough L.B. The threat of the new managed practice of medicine to patients' autonomy. J Clin Ethics 6 (1995) 320-323