Abstract

During the past year, we published three papers in this project. All were normative analyses papers, focusing on the risk-benefit analysis of pragmatic comparative effectiveness RCTs and on the continuing discussions of ethically acceptable modifications of informed consent for such trials. Chen S, Kim SYH. A Framework for Analysis of Research Risks and Benefits to Participants in Standard of Care Pragmatic Clinical Trials. Clinical Trials. 2016 doi: 10.1177/1740774516656945. Kim SYH. Clinical Trials Without Consent? Perspectives in Biology and Medicine. 2016; 59 (1), 132-146. DOI: 10.1353/pbm.2016.0023 Kim SYH, Miller FG. Ethical Complexities in Standard of Care Randomized Trials: A Case Study of Morning Versus Nighttime Dosing of Blood Pressure Drugs. Clinical Trials. 12(6), 557-563. doi: 10.1177/1740774515607213.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIACL010538-02
Application #
9339117
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2016
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