Minimal Risk in Research Involving Pregnant Women and Fetuses

Journal of Law, Medicine and Ethics

Volumn 39, Issue 3, 2011, Pages 529-538

  Strong, Carson ^a  

^a UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ETHICS; FEMALE; FETAL RESEARCH; HUMAN; HUMAN EXPERIMENT; PEER REVIEW; PRACTICE GUIDELINE; PREGNANCY; PREGNANT WOMAN; RISK ASSESSMENT; UNITED STATES;

FEMALE; FETAL RESEARCH; GUIDELINE ADHERENCE; HUMAN EXPERIMENTATION; HUMANS; PEER REVIEW, RESEARCH; PREGNANCY; PREGNANT WOMEN; RISK ASSESSMENT; UNITED STATES;

EID: 80051997913     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2011.00619.x     Document Type: Article

References (55)

1. 45 C.F.R. § 46.102(i) (2005).
2. 45 C.F.R. § 46.110(b)(1) (2005).
3. 45 C.F.R. § 46.116(d) (2005).
4. 45 C.F.R. § 46.117(c)(2) (2005).
5. 45 C.F.R. § 46.204(b) (2005).
6. 45 C.F.R. § 46.204(d) (2005).
7. Department of Health and Human Services, Office for Human Research Protections, "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure, "November 9, 1998, available at (last visited May 18, 2011).
8. C. Coutelle and C. Rodeck, "On the Scientific and Ethical Issues of Fetal Somatic Gene Therapy, "Gene Therapy 9, no. 11 (2002): 670-673.
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11. B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children, "Hastings Center Report 23, no. 2 (1993): 13-19. For a commentary that agrees with the position and argument of Freedman et al., see C. Weijer, "The Ethical Analysis of Risk, "Journal of Law, Medicine & Ethics 28, no. 4 (2000): 344-361; see also P. B. Miller and C. Weijer, "Moral Solutions in Assessing Research Risk, "IRB 22, no. 5 (2000): 6-10.
12. National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, August 2001, at 83, available at (last visited May 25, 2011). For an earlier statement of an argument based on justice, see L. Kopelman, "Estimating Risk in Human Research, "Clinical Research 29, no. 1 (1981): 1-8.
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18. See Kopelman, supra note 12, at 2.
19. See Freedman Fuks, and Weijer, supra note 11; Department of Health and Human Services, supra note 13.
20. See Kopelman, supra note 12, at 4.
21. See Kopelman, supra note 16, at 364.
22. See Institute of Medicine, supra note 14, at 123.
23. See National Bioethics Advisory Commission, supra note 12, at 83.
24. See Department of Health and Human Services, supra note 13, at 1.
25. See Institute of Medicine, supra note 14, at 122; Department of Health and Human Services, supra note 15. For an example of an age-indexed approach, see D. Wendler, "Minimal Risk in Pediatric Research as a Function of Age, "Archives of Pediatric and Adolescent Medicine 163, no. 2 (2009): 115-118.
26. See id. (Department of Health and Human Services).
27. See Freedman Fuks, and Weijer, supra note 11.
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29. The studies include: J. Janofsky and B. Starfield, "Assessment of Risk in Research on Children, "Journal of Pediatrics 98, no. 5 (1981): 842-846; S. Shah, A. Whittle, B. Wilfond, G. Gensler, and D. Wendler, "How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?"JAMA 291, no. 4 (2004): 476-482.
30. See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra note 10, at xx-xxi.
31. See Department of Health and Human Services, supra note 18.
32. See Institute of Medicine, supra note 14, at 126.
33. See Department of Health and Human Services, supra note 18.
34. See National Bioethics Advisory Commission, supra note 12, at 80-85.
35. See Kopelman, supra note 16, at 375.
36. Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 2002, at 49, available at (last visited May 25, 2011).
37. See Kopelman, supra note 12, at 4.
38. See Kopelman, supra note 16, at 361.
39. D. B. Resnik, "Eliminating the Daily Life Risks Standard from the Definition of Minimal Risk, "Journal of Medical Ethics 31, no. 1 (2005): 35-38.
40. See Freedman, Fuks, and Weijer, supra note 11, at 16.
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42. See Kopelman, supra note 16, at 361.
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45. See Wendler (2005), supra note 49, at 40.
46. American College of Obstetricians and Gynecologists, Routine Tests in Pregnancy, available at (last visited May 18, 2011).
47. American Institute of Ultrasound in Medicine, Prudent Use and Clinical Safety, available at (last visited January 1, 2011); American College of Obstetricians and Gynecologists, Committee on Ethics, "Nonmedical Use of Obstetric Ultrasonography, "Obstetrics and Gynecology 104, no. 2 (2004): 423-424.
48. J. L. Simpson and S. Elias, Genetics in Obstetrics and Gynecology, 3rd ed. (Philadelphia: Elsevier, 2003) at 101-102.
49. T. C. Michels and A. Y. Tiu, "Second Trimester Pregnancy Loss, "American Family Physician 76, no. 9 (2007): 1341-1346.
50. P. R. Wyatt, T. Owolabi, C. Meier, and T Huang, "Age-Specific Risk of Fetal Loss Observed in a Second Trimester Serum Screening Population, "American Journal of Obstetrics and Gynecology 192, no. 1 (2005): 240-246, at 241. This study might underestimate the post-first-trimester mortality rate because it involved pregnancies at 15 weeks gestational age onward.
51. L. Dugoff, H. S. Cuckle, and J. C. Hobbins et al., "Prediction of Patient-Specific Risk for Fetal Loss Using Maternal Characteristics and First- and Second-Trimester Maternal Serum Down Syndrome Markers, "American Journal of Obstetrics and Gynecology 199, no. 3 (2008): 290e1-290e6, at 290e3-290e4. This study reports early and late fetal loss rates that, when combined, yield the percentage stated in the text.
52. F. G. Cunningham, J. C. Hauth, and K. J. Leveno et al., Williams Obstetrics, 22nd ed. (New York: McGraw-Hill, 2005): Chap. 27, "Abnormalities of the Placenta, Umbilical Cord, and Membranes, "at 619-630. "Nuchal cord" refers to the umbilical cord being wrapped around the fetal neck. This can cause cord compression and associated decrease in oxygenation leading to fetal brain injury or death.
53. J. F. Clapp, W. Stepanchak, K. Hashimoto, H. Ehrenberg, and B. Lopez, "The Natural History of Antenatal Nuchal Cords, "American Journal of Obstetrics and Gynecology 189, no. 2 (2003): 488-493.
54. D. J. Burton and R. A. Filly, "Sonographic Diagnosis of the Amniotic Band Syndrome, "American Journal of Roentgenology 156, no. 3 (1991): 555-558, at 555. Amniotic band syndrome is believed to be caused when disruption of the amniotic membrane leads to fetal parts entering the space between the amniotic and chorionic membranes and becoming entangled with fibrous septa, disrupting normal development.
55. M. J. K. Osterman, J. A. Martin, and F. Menacker, "Expanded Health Data from the New Birth Certificate, 2006, "National Vital Statistics Reports 58, no. 5 (2009): 1-24, at 4.