Ethical dilemma of mandated contraception in pharmaceutical research at catholic medical institutions.
The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance.
Creighton University School of Medicine, USA.
Murray Joseph
MJ
Casey
Richard
R
O'Brien
Marc
M
Rendell
Todd
T
Salzman
D002410:Catholicism; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D003270:Contraceptive Agents / Q000008:administration & dosage*; D015507:Drugs, Investigational / Q000009:adverse effects*; D026689:Ethical Analysis; D032984:Ethics, Research; D005260:Female; D016519:Hospitals, Religious / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D011247:Pregnancy; D011258:Pregnancy Tests; D035842:Research Subjects / Q000600:supply & distribution; D012577:Schools, Medical / Q000941:ethics; D012746:Sexual Abstinence; D013723:Teratogens; D014481:United States; D014486:United States Food and Drug Administration
D003270:Contraceptive Agents; D015507:Drugs, Investigational; D013723:Teratogens