Evaluating the quality of informed consent for clinical research

Clinical Center

Investigators

Linked publications & trials

Abstract

The project primarily uses surveys and interviews of both lay public and patient-subject samples. A series of online experimental surveys with lay public attempt to delineate the impact of linguistic factors (pragmatics of language) on the way informed consent quality is measured. The results are then applied to patient samples either in interviews or online. The project also employs phone interviews with persons entering or are considering entering clinical trials. In addition to these empirical methods, the project employs normative analysis to evaluate the ethical requirements of informed consent for special types of research studies. In the past year, we have published the following articles: Kim SYH, Wilson R, De Vries R, Kim HM, Holloway RG, Kieburtz K. It is not guaranteed that you will benefit: True but misleading? Clinical Trials 2015;12(4), 424-429. doi: 10.1177/1740774515585120 Kim SYH, Wilson R, De Vries R, Ryan K, Holloway RG, Kieburtz K. Are Amyotrophic Lateral Sclerosis Patients at Risk of a Therapeutic Misconception? Journal of Medical Ethics. doi: 10.1136/medethics-2015-103319. Chen S, McCullumsmith C, Kim SYH. Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials. British Journal of Psychiatry Open. Jun 2015, 1 (1) 1-5; DOI: 10.1192/bjpo.bp.115.000109 Kim SYH, Wilson R, De Vries R, Ryan K, Holloway RG, Kieburtz K. Are Amyotrophic Lateral Sclerosis Patients at Risk of a Therapeutic Misconception? Journal of Medical Ethics. doi: 10.1136/medethics-2015-103319.