Miller, FG; Brody, H. Makes Placebo-Controlled Trial Unethical?” American Journal of Bioethics “What 2.2 (2002): 3-9. 9 September 2013. Temple, R; Ellenberg, SS. Trials and Active-Control Trials in the Evaluation of New “Placebo-Controlled Treatments. Part 1: Ethical and Scientific Issues.” Annals of Internal Medicine 133.6 (2000): 455-463. 9 September 2013. World Medical Association (WMA). of Helsinki.” WMA. 9 September 2013. “Declaration Element 2: ←Essential → Standard of Care London, AJ. Ambiguity and the Exigency: Clarifying of Care’ Arguments in International “The ‘Standard Research.” Journal of Medicine and Philosophy 25.4 (2000): 379–397. 9 September 2013. Wendler, D; Emanuel, EJ; and Lie, RK. Standard of Care Debate: Can Research in Developing “The Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?” American Journal of Public Health 94.6 (2004): 923-928. 9 September 2013. Gu, S. Ethics of Placebo-Controlled Studies on Perinatal HIV Transmission and Its Treatment in the “The Developing World.” Penn Bioethics Journal 2.2 (2006): 21-24. 9 September 2013. Element 2: ←Essential → Essential Element 3: Choice of Study Design Examples Statements indicating that the ethical impact of the chosen study design has been considered: The ethics section should not repeat what is discussed in other sections of the protocol. The details of the design and the scientific rationale for the choice of each of the design elements should have been well explained elsewhere. However, because of the central importance of scientific validity as the basis for ethical soundness, it may be useful to introduce the ethical section with a statement summarizing and recognizing that the authors believe it is scientifically valid. The following examples in an ethical section acknowledge what should be completely supported in the rest of the protocol. study has been carefully designed to collect the data needed to reach its objective while “The enrolling the lowest possible number of subjects.”
Miller, FG; Brody, H. “What Makes Placebo-Controlled Trial Unethical?” American Journal of Bioethics 2.2 (2002): 3-9. 9 September 2013. Temple, R; Ellenberg, SS. “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues.” Annals of Internal Medicine 133.6 (2000): 455-463. 9 September 2013. World Medical Association (WMA). “Declaration of Helsinki.” WMA. 9 September 2013. ←Essential Element 2: → Standard of Care London, AJ. “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research.” Journal of Medicine and Philosophy 25.4 (2000): 379–397. 9 September 2013. Wendler, D; Emanuel, EJ; and Lie, RK. “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?” American Journal of Public Health 94.6 (2004): 923-928. 9 September 2013. Gu, S. “The Ethics of Placebo-Controlled Studies on Perinatal HIV Transmission and Its Treatment in the Developing World.” Penn Bioethics Journal 2.2 (2006): 21-24. 9 September 2013. ←Essential Element 2: → Essential Element 3: Choice of Study Design Examples Statements indicating that the ethical impact of the chosen study design has been considered: The ethics section should not repeat what is discussed in other sections of the protocol. The details of the design and the scientific rationale for the choice of each of the design elements should have been well explained elsewhere. However, because of the central importance of scientific validity as the basis for ethical soundness, it may be useful to introduce the ethical section with a statement summarizing and recognizing that the authors believe it is scientifically valid. The following examples in an ethical section acknowledge what should be completely supported in the rest of the protocol. “The study has been carefully designed to collect the data needed to reach its objective while enrolling the lowest possible number of subjects.”
toolkit_essentialelementsofethics_108_pg_11-24-14_revised_clean1.docx