How should risks and benefits be balanced in research involving pregnant women and fetuses?

IRB Ethics and Human Research

Volumn 33, Issue 6, 2011, Pages 1-5

  Strong, Carson ^a  

^a UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BENEFICENCE; ETHICS; FEMALE; FETUS; HUMAN; HUMAN EXPERIMENT; MOTHER FETUS RELATIONSHIP; PERSONHOOD; PREGNANCY; PREGNANT WOMAN; RISK ASSESSMENT;

BENEFICENCE; FEMALE; FETUS; HUMAN EXPERIMENTATION; HUMANS; MATERNAL-FETAL RELATIONS; PERSONHOOD; PREGNANCY; PREGNANT WOMEN; RISK ASSESSMENT;

EID: 82955214914     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. U. S. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46.204 (c).
2. 45 CFR 46.111 (a).
3. 45 CFR 46.204.
4. 45 CFR 46.102 (i). For a discussion of how to interpret minimal risk in the context of research involving pregnant women and fetuses
5. see Strong C, Minimal risk in research involving pregnant women and fetuses. Journal of Law, Medicine and Ethics 2011, in press.
6. 45 CFR 46.405.
7. Department of Health and Human Services, Office for Human Research Protections. How do subparts B, C, and D of the HHS human research regulations at 45 CFR part 46 relate to subpart A? http://answers.hhs.gov/ohrp/questions/ 7190.
8. Chervenak FA, McCullough LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. American Journal of Bioethics 2011;11(5):39-49.
9. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Research on the Fetus: Report and Recommendations. DHEW Publication No. (OS) 76-127. Bethesda, MD: Department of Health and Human Services, 1974. P-73
10. 45 CFR 46.406 (c).
11. Deprest JA, Devlieger R, Srisupundit K, et al. Fetal surgery is a clinical reality. Seminars in Fetal and Neonatal Medicine 2010;15:58-67.
12. Martison D, Zajicek A. Gaps in knowledge in treating pregnant women. Gender Medicine 2006;3(3):169-182. (Pubitemid 44615984)
13. Waddington SN, Kramer MG, Hernandez-Alcoceba R, et al. In utero gene therapy: Current challenges and perspectives. Molecular Therapy 2005;11:661-676. (Pubitemid 40575612)