The project will employ both normative and empirical approaches. Empirical studies include online surveys of the lay public to ascertain their views on informed consent and assess their perception of risk. Normative studies apply norms of research ethics to analyze various comparative effectiveness trials and proposed informed consent practices or research analyses. In the past fiscal year, 2 normative analytic papers and 1 empirical paper was published in NEJM, JAMA, and Annals of Internal Medicine.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIACL010538-01
Application #
9154100
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
Zip Code
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