Complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials

Journal of Women's Health

Volumn 13, Issue 6, 2004, Pages 743-749

  Uhl, Kathleen ^a   Miller, Margaret Ann ^a   Kennedy, Dianne L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CLINICAL RESEARCH; DRUG APPROVAL; DRUG EFFICACY; DRUG INFORMATION; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMED CONSENT; LAW; MATERNAL WELFARE; MEDICAL DECISION MAKING; MEDICOLEGAL ASPECT; METHODOLOGY; PATIENT SELECTION; PREGNANCY; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; PUERPERIUM; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; RISK BENEFIT ANALYSIS;

CLINICAL TRIALS; CONGRESSES; DRUG EVALUATION; ETHICS, RESEARCH; FEMALE; HUMANS; POSTPARTUM PERIOD; PREGNANCY; PREGNANT WOMEN; RESEARCH SUBJECTS; UNITED STATES;

EID: 4644292725     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2004.13.743     Document Type: Review

References (6)

1. Goodrum LA, Hankins GDV, Jermain D, Chanaud CM. Conference report: Complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials. J Wom Health 2003;12:857.
2. Department of Health and Human Services: Protection of human subjects. 45 CFR 46. Federal Register online at ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
3. Macklin R. Reversing the presumption: The IOM report on women in health research. J Am Med Wom Assoc 1994;49:113, 121.
4. De Vigan C, De Walle HEK, Cordier S, et al. Therapeutic drug use during pregnancy: A comparison in four European countries. J Clin Epidemiol 1999;52:977.
5. Lacroix I, Damase-Michel C, Lapeyre-Mestre M, et al. Prescription of drugs during pregnancy in France. Lancet 2000:356;1735.
6. Clinical pharmacology during pregnancy: Addressing clinical needs through science. December 4-5, 2000. www.fda.gov/cder/present/clinpharm2000/default.htm