Leber, P. The use of placebo control groups in the assessment of psychiatric drugs: an historical perspective. Biol Psychiatry
2000; 47: 699–706.
Miller, FG. Placebo-controlled trials in psychiatric research: an ethical perspective. Biol Psychiatry
2000; 47: 707–16.
Millum, J, Grady, C. The ethics of placebo-controlled trials: methodological justifications. Contemp Clin Trials
2013; 36: 510–4.
O'Connor, AB. Building comparative efficacy and tolerability into the FDA approval process. JAMA
2010; 303: 979–80.
Barbui, C, Bighelli, I. A new approach to psychiatric drug approval in Europe. PLoS Med
2013; 10: e1001530.
Kaufman, KR. Comparative bioethics in bipolar and epilepsy research. Seizure
2002; 11: 51–6.
Temple, R, Ellenberg, SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med
2000; 133: 455–63.
Ellenberg, SS, Temple, R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med
2000; 133: 464–70.
Fleischhacker, WW, Czobor, P, Hummer, M, Kemmler, G, Kohnen, R, Volavka, J. Placebo or active control trials of antipsychotic drugs?
Arch Gen Psychiatry
2003; 60: 458–64.
Sudore, RL, Landefeld, CS, Williams, BA, Barnes, DE, Lindquist, K, Schillinger, D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med
2006; 21: 867–73.
Hein, IM, Troost, PW, Lindeboom, R, Benninga, MA, Zwaan, CM, van Goudoever, JB, et al. Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research. JAMA Pediatr
2014; 168: 1147–53.
Anderson, KK, Mukherjee, SD. The need for additional safeguards in the informed consent process in schizophrenia research. J Med Ethics
2007; 33: 647–50.
McDermott, BE. Coercion in research: are prisoners the only vulnerable population?
J Am Acad Psychiatry Law
2013; 41: 8–13.
Fisher, JA. Expanding the frame of “voluntariness” in informed consent: structural coercion and the power of social and economic context. Kennedy Inst Ethics J
2013; 23: 355–79.
Schonfeld, T. The perils of protection: vulnerability and women in clinical research. Theor Med Bioeth
2013; 34: 189–206.
Frew, PM, Saint-Victor, DS, Isaacs, MB, Kim, S, Swamy, GK, Sheffield, JS, et al. Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices. Clin Infect Dis
2014; 59 (suppl 7): S400–7.
Chen, SC, McCullumsmith, C, Kim, SY. Disclosing the potential impact of placebo controls in antidepressant trials. BJPsych Open
2015; 1: 1–5. .
Falagas, ME, Korbila, IP, Giannopoulou, KP, Kondilis, BK, Peppas, G. Informed consents: how much and what do patients understand?
Am J Surg
2009; 198: 420–35.
Tam, NT, Huy, NT, Thoa, LT, Long, NP, Trang, NT, Hirayama, KH, et al. Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ
2015; 93: 186–98.
Appelbaum, PS, Roth, LH, Lidz, CW, Benson, P, Winslade, W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep
1987; 17: 20–4.
Appelbaum, PS, Anatchkova, M, Albert, K, Dunn, LB, Lidz, CW. Therapeutic misconception in research subjects: development and validation of a measure. Clin Trials
2012; 9: 748–61.
Lidz, CW, Albert, K, Appelbaum, P, Dunn, LB, Overton, E, Pivovarova, E. Why is therapeutic misconception so prevalent?
Camb Q Healthc Ethics
2015; 24: 231–41.
Flory, J, Emanuel, E. Interventions to improve research participants' understanding in informed consent for research. JAMA
2004; 292: 1593–601.
Nishimura, A, Carey, J, Erwin, PJ, Tilburt, JC, Murad, MH, McCormick, JB. Improving understanding in the research consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics
2013; 14: 28.
Hernández, A, Baños, JE, Llop, C, Farré, M. The definition of placebo in the informed consent forms of clinical trials. PLoS One
2014; 9: e113654.
Arnold, MH, Finniss, DG, Kerridge, I. Medicine's inconvenient truth: the placebo and nocebo effect. Intern Med J
2014; 44: 398–405.
Rutherford, BR, Wall, MM, Glass, A, Stewart, JW. The role of patient expectancy in placebo and nocebo effects in antidepressant trials. J Clin Psychiatry
2014; 75: 1040–6.
Tait, AR, Voepel-Lewis, T, Malviya, S, Philipson, SJ. Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding. Arch Pediatr Adolesc Med
2005; 159: 347–52.
de Vries, MC, Houtlosser, M, Wit, JM, Engberts, DP, Bresters, D, Kaspers, GJ, et al. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences. BMC Med Ethics
2011; 12: 18.