Contraceptive requirements for clinical research

Obstetrics and Gynecology

Volumn 95, Issue 6, 2000, Pages 861-866

  Cain, Joanna ^a,b   Lowell, Jane ^a,b   Thorndyke, Luanne ^a,b   Localio, A Russell ^a,b  

^a PENN STATE COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTRACEPTION; EPIDEMIOLOGY; FEMALE; HUMAN; WOMEN'S HEALTH;

CLINICAL PROTOCOLS; CLINICAL TRIALS; CONTRACEPTION; FEMALE; HUMANS; SELECTION BIAS; WOMEN'S HEALTH;

EID: 0034204372     PISSN: 00297844     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0029-7844(00)00824-3     Document Type: Article

References (18)

1. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. 59 Federal Register 14508. Washington, DC: March 28, 1994.
2. National Institutes of Health Revitalization Act of 1993. United States Public Law. 103rd Congress, first session, p. 107, statute 122. Washington, DC: Government Printing Office, 1993.
3. Merkatz RB, Temple R, Sobel S, Feiden K, Kesler DA. Women in clinical trials of new drugs - A change in Food and Drug Administration policy. N Engl J Med 1993;329:292-6.
4. Office of Research on Women's Health. Recruitment and retention of women in clinical studies. NIH publication no. 95-3756. Washington, DC: National Institutes of Health, 1995.
5. Clayton EW. Liability exposure when offspring are injured because of their parent's participation in clinical trials. In: Mastroianni AC, Faden R, Federman D, eds. Women and health research: Ethical and legal issues of including women in clinical studies. Vol. 2. Washington, DC: National Academy Press, 1994:103-10.
6. Clayton EW. Legal considerations. In: Mastroianni AC, Faden R, Federman D, eds. Women and health research: Ethical and legal issues of including women in clinical studies. Vol. 2. Washington, DC: National Academy Press, 1994:128-70.
7. International Union versus Johnson Controls. 1991:n159 111 Supreme Court 1196.
8. Annas GJ. Fetal protection and employment discrimination - The Johnson Controls case. N Engl J Med 1991;325:740-3.
9. Coyle M. Fetal protection ruling buoys rights groups. National Law J 1991;5:22.
10. Herz SE. Don't test, do sell: Legal implications of inclusion and exclusion of women in clinical disease trials. Epilepsia 1997;38:42-9.
11. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Department of Health Education and Welfare Publication no. (OS) 78-0013, (OS) 78-0014. Washington, DC, 1979.
12. Swann JR, Reinstein PF. Annual adverse drug experience report 1993. Washington, DC: Food and Drug Administration, 1993.
13. Schmucker DL, O'Mahony MS, Vesell ES. Women in clinical drug trials: An update. Clin Pharmacokinet 1994;27:411-7.
14. Edgar H, Rothman DJ. New rules for new drugs: The challenge of AIDS to the regulatory process. Milbank Q 1990;68:111-41.
15. Physician's desk reference. 52nd ed. Montvale, NJ: Medical Economics Company, 1998.
16. Nolan MT, Pressman EK, Starklauf BL, Gregory RE. Consent documents, reproductive issues, and the inclusion of women in clinical trials. Acad Med 1999;74:275-81.
17. McCullough LB, Cervenak FA. Ethics in obstetrics and gynecology. Oxford, England: Oxford University Press, 1994:176-8.
18. Tri-Council Policy Statement: Ethical conduct for research involving humans: August 1998, Ottawa, Canada: Medical Research Council of Canada, Natural Science and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, 1998.