Abstract

During the past year, we completed analysis of a survey of the US general public. As described in previous year, the survey used an experimental design to assess whether a post-randomization consent procedure for two types of pragmatic trials of different stakes was ethically and personally acceptable. It also tested whether the language used to describe the trials affected the subjects' responses, comparing traditional randomized control trial language versus language that avoided that language. Miller DG, Kim SYH, Li X, Dickert NW, Flory J, Runge CP, Relton C. Ethical Acceptability of Post-Randomization Consent in Pragmatic Clinical Trials: A National Survey of the US General Public. JAMA Network Open. 2018;1(8):e186149. Doi:10.1001/jamanetworkopen.2018.6149. Work continues on normative analyses of research risk analyses for standard of care trials and a review of ethical issues in comparative effectiveness pragmatic trials.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIACL010538-05
Application #
9997615
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
5
Fiscal Year
2019
Total Cost
Indirect Cost

  Institution

Name
Clinical Center
Department
Type
DUNS #
City
State
Country
Zip Code

  Publications

Kalkman, Shona; Kim, Scott Y H; van Thiel, Ghislaine J M W et al. (2017) Ethics of Informed Consent for Pragmatic Trials with New Interventions. Value Health 20:902-908
Kim, Scott Y H; Miller, Franklin G (2016) Waivers and Alterations to Consent in Pragmatic Clinical Trials: Respecting the Principle of Respect for Persons. IRB 38:1-5
Dickert, Neal W; Brown, Jeremy; Cairns, Charles B et al. (2016) Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients. Ann Emerg Med 67:538-45
Karlawish, Jason; Kim, Scott Y H (2016) Acute stroke trials without informed consent: Toward an evidence-based ethical practice. Neurology 86:1472-3
Kim, Scott Y (2016) Clinical Trials Without Consent? Perspect Biol Med 59:132-46
Kim, Scott Y H; Miller, Franklin G (2016) Response to Magnus and Wilfond. Clin Trials 13:244-5
Kim, Scott Y H; Miller, Franklin G (2015) Ethical complexities in standard of care randomized trials: A case study of morning versus nighttime dosing of blood pressure drugs. Clin Trials 12:557-63
Nayak, Rahul K; Wendler, David; Miller, Franklin G et al. (2015) Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey. Ann Intern Med 163:356-64
Kim, Scott Y H; Miller, Franklin G (2015) Varieties of standard-of-care treatment randomized trials: ethical implications. JAMA 313:895-6
Kim, Scott Y H; Miller, Franklin G (2014) Informed consent for pragmatic trials--the integrated consent model. N Engl J Med 370:769-72