Informed consent, comparative effectiveness, and learning health care

New England Journal of Medicine

Volumn 370, Issue 8, 2014, Pages 766-768

  Faden, Ruth R ^a   Beauchamp, Tom L ^b   Kass, Nancy E ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; DECISION MAKING; HEALTH CARE SYSTEM; HOSPITALIZATION; HUMAN; INFORMED CONSENT; MEDICAL ERROR; MORALITY; PRIORITY JOURNAL; SHORT SURVEY; SOCIAL PARTICIPATION; TOTAL QUALITY MANAGEMENT; WELFARE;

EID: 84894120088     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMhle1313674     Document Type: Article

References (5)

1. Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent Rep 2013;43:S4-S15.
2. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning healthcare system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 2013;Spec No:S16-S27.
3. Faden R, Kass N, Whicher D, Stewart W, Tunis S. Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data. Med Care 2013;51:Suppl 3: S53-S57.
4. Truog RD, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials? N Engl J Med 1999;340:804-7.
5. Morris MC, Nelson RM. Randomized, controlled trials as minimal risk: an ethical analysis. Crit Care Med 2007;35:940-4. (Pubitemid 46407814)