Abstract

During the past year, we completed two empirical projects. The first project was led by Neal Dickert of Emory University. We surveyed the US general public regarding the acceptability of various types of informed consent procedures for pragmatic trials in the acute care setting. Dickert NW, Wendler D, Devireddy CM, Goldkind S, Ko Yi-An, Speight CD, Kim SYH. Consent Preferences for Pragmatic Trials in Acute Illness. J Am College Cardiology. 2018: 71(9); 1051-1053.Dickert NW, Wendler D, Devireddy CM, Goldkind S, Ko Yi-An, Speight CD, Kim SYH. Understanding Preferences Regarding Consent for Pragmatic Trials in Acute Care. Accepted for publication. The second project was a survey of the US general public, using an experimental survey 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. A manuscript is in preparation.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIACL010538-04
Application #
9770226
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2018
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