Research Ethics in Obstetrics and Gynecology
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Published:
Sep 30, 2018
Keywords:
pregnancy research ethics informed consent fetus
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Abstract
Women should be presumed eligible to participate in obstetrics and gynecology studies. The potential for pregnancy should not automatically exclude a woman from participating in a study although the use of contraception may be required to participate. A significant concern in moving forward with enrolling pregnant women in research is that an intervention could cause harm to the fetus, and especially that the intervention or medication under study could cause a birth defect or other harms. Researchers and research ethics committees must ensure that potential research participants are adequately informed about the risks to breastfeeding women and their infants, and about the risks to pregnant women (including future fertility), their pregnancies and their fetuses. When evidence concerning risks is unknown or conflicting, this must be disclosed to the pregnant or breastfeeding woman as part of the informed consent process.
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How to Cite
(1)
Panichkul, S. Research Ethics in Obstetrics and Gynecology. Thai J Obstet Gynaecol 2018, 26, 142-148.
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Special Article
References
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26. Lyerly AD, Mitchell LM, Armstrong EM, Harris LH, Kukla R, Kuppermann M, et al. Risk and the pregnant body. Hastings Cent Rep 2009;39:34–42.
27. Neill KM. Research subject advocate: a new protector of research participants. Account Res 2003;10:159–74.
28. Silber TJ. Human gene therapy, consent, and the realities of clinical research: is it time for a research subject advocate? Hum Gene Ther 2008;19:11–4.
29. National Human Research Protections Advisory Committee. Comment letter to HHS on 45 CFR 46 Subpart B—September 2001. Washington, DC: NHRPAC; 2001. Available at: https://www.hhs.gov/ohrp/archive/nhrpac/documents/oct01c.pdfc/documents/oct01c.pdf. Retrieved April 28, 2018.
2. National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research – amended, October 2001. Bethesda (MD): NIH; 2001. Available at: https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. Retrieved April 28, 2018.
3. NIH Revitalization Act of 1993, Pub. L. No. 103-43 (1993).
4. National Institutes of Health. Monitoring adherence to the NIH policy on the inclusion of women and minorities as subjects in clinical research. Comprehensive report: tracking of clinical research as reported in fiscal year 2011 and fiscal year 2012. Bethesda (MD): NIH; 2013. Available at: https://orwh.od.nih.gov/research/inclusion/pdf/Inclusion-ComprehensiveReport-FY-2011-2012.pdf. Retrieved April 28, 2018.
5. Beauchamp TL, Childress JF. Principles of biomedical ethics. 7th ed. New York (NY): Oxford University Press; 2013.
6. Chen MS Jr, Lara PN, Dang JH, Paterniti DA, Kelly K. Twenty years' post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials. Cancer 2014;120 (suppl 7):1091–6.
7. Dickerson DL, Leeman RF, Mazure CM, O’Malley SS. The inclusion of women and minorities in smoking cessation clinical trials: a systematic review. Am J Addict 2009;18:21–8.
8. Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Womens Health (Larchmt) 2011;20:315–20.
9. Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues 2013;23:39–45.
10. National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants. Bethesda (MD): NBAC; 2001. Available at: https://bioethicsarchive.georgetown.edu/nbac/human/overvol1.pdf. Retrieved April 28, 2015.
11. Anderson JR, Schonfeld TL, Kelso TK, Prentice ED. Women in early phase trials: an IRB’s deliberations. IRB 2003;25(4):7–11.
12. Kim JH, Scialli AR. Thalidomide: the tragedy of birth defects and the effective treatment of disease [published erratum appears in Toxicol Sci 2012;125:613]. Toxicol Sci 2011;122:1–6.
13. Teo SK, Harden JL, Burke AB, Noormohamed FH, Youle M, Johnson MA, et al. Thalidomide is distributed into human semen after oral dosing. Drug Metab Dispos 2001;29:1355–7.
14. Geiger CJ, Fahrenbach DM, Healey FJ. Bendectin in the treatment of nausea and vomiting in pregnancy. Obstet Gynecol 1959;14:688–90.
15. Mitchell AA, Rosenberg L, Shapiro S, Slone D. Birth defects related to bendectin use in pregnancy. I. Oral clefts and cardiac defects. JAMA 1981;245:2311–4.
16. Zierler S, Rothman KJ. Congenital heart disease in relation to maternal use of bendectin and other drugs in early pregnancy. N Engl J Med 1985;313:347–52.
17. Holmes LB. Teratogen update: bendectin. Teratology 1983;27:277–81.
18. McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology 1994;50:27–37.
19. Gee RE, Wood SF, Schubert KG. Women’s health, pregnancy, and the U.S. Food and Drug Administration. Obstet Gynecol 2014;123:161–5.
20. Daw JR, Mintzes B, Law MR, Hanley GE, Morgan SG. Prescription drug use in pregnancy: a retrospective, population-based study in British Columbia, Canada (2001-2006). Clin Ther 2012;34:239–49.
21. National Institutes of Health. NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. Bethesda (MD): NIH; 1998. Available at: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Retrieved April 28, 2018.
22. Shaddy RE, Denne SC. Clinical report - guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs and Committee on Pediatric Research. Pediatrics 2010;125:850–60.
23. Lyerly AD, Namey EE, Gray B, Swamy G, Faden RR. Women’s views about participating in research while pregnant. IRB 2012;34:1–8.
24. Maternal-fetal intervention and fetal care centers. Committee Opinion No. 501. American College of Obstetricians and Gynecologists. Obstet Gynecol 2011;118:405–10.
25. Informed consent. ACOG Committee Opinion No. 439. American College of Obstetricians and Gynecologists. Obstet Gynecol 2009;114:401–8.
26. Lyerly AD, Mitchell LM, Armstrong EM, Harris LH, Kukla R, Kuppermann M, et al. Risk and the pregnant body. Hastings Cent Rep 2009;39:34–42.
27. Neill KM. Research subject advocate: a new protector of research participants. Account Res 2003;10:159–74.
28. Silber TJ. Human gene therapy, consent, and the realities of clinical research: is it time for a research subject advocate? Hum Gene Ther 2008;19:11–4.
29. National Human Research Protections Advisory Committee. Comment letter to HHS on 45 CFR 46 Subpart B—September 2001. Washington, DC: NHRPAC; 2001. Available at: https://www.hhs.gov/ohrp/archive/nhrpac/documents/oct01c.pdfc/documents/oct01c.pdf. Retrieved April 28, 2018.