“NO ONE ASKED THE BABY” – AN ETHICAL ISSUE IN PLACEBO-CONTROLLED TRIALS IN PREGNANT SMOKERS
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Keywords
Ethics, placebo-controlled trial, consent, nicotine
Abstract
This case report involving a placebo-controlled nicotine patch trial illustrates the difficult issue of conducting placebo studies in pregnancy, when one of the two patients involved cannot be asked to consent.
References
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2. Fuchs FD, Klag MJ, Whelton PK. The classics: a tribute to the fiftieth anniversary of the randomized clinical trial. J Clin Epidemiol 2000;53:335-42.
3. Shapiro AK, Shapiro E. The placebo: is it much ado about nothing? In: Anne Harrington, editor. The placebo effect. Cambridge: Harvard University Press; 1997. p. 12-36.
4. Windsor R, Boyd N, Orleans T. A meta- evaluation of smoking cessation intervention research among pregnant women: Improving the science and art, Health Educ Res. 1998; 13(3), 419-438.
5. Fisher S, Greenberg RP. How sound is the double- blind design for evaluating psychotropic drugs? J Nerv Ment Dis 1993; 181:345-50.
6. Koren G: Ethics of drug research in pregnancy, infancy and childhood. In: G. Koren, editor. Textbook of Ethics in Pediatric Research, Malabar, Fla; Krieger; 1993. p. 171-81.
2. Fuchs FD, Klag MJ, Whelton PK. The classics: a tribute to the fiftieth anniversary of the randomized clinical trial. J Clin Epidemiol 2000;53:335-42.
3. Shapiro AK, Shapiro E. The placebo: is it much ado about nothing? In: Anne Harrington, editor. The placebo effect. Cambridge: Harvard University Press; 1997. p. 12-36.
4. Windsor R, Boyd N, Orleans T. A meta- evaluation of smoking cessation intervention research among pregnant women: Improving the science and art, Health Educ Res. 1998; 13(3), 419-438.
5. Fisher S, Greenberg RP. How sound is the double- blind design for evaluating psychotropic drugs? J Nerv Ment Dis 1993; 181:345-50.
6. Koren G: Ethics of drug research in pregnancy, infancy and childhood. In: G. Koren, editor. Textbook of Ethics in Pediatric Research, Malabar, Fla; Krieger; 1993. p. 171-81.
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Published
Dec 8, 2018
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How to Cite
Selby, P. S., Kapur, B. M., Hackman, R., & Koren, G. (2018). “NO ONE ASKED THE BABY” – AN ETHICAL ISSUE IN PLACEBO-CONTROLLED TRIALS IN PREGNANT SMOKERS. Journal of Population Therapeutics and Clinical Pharmacology, 12(2). Retrieved from https://jptcp.com/index.php/jptcp/article/view/93
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