The concept of risk in comparative-effectiveness research

New England Journal of Medicine

Volumn 371, Issue 22, 2014, Pages 2129-2130

  Lantos, John D ^a   Spertus, John A ^a  

^a UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; DECISION MAKING; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PROTOCOL COMPLIANCE; RESEARCH ETHICS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY; CLINICAL TRIAL (TOPIC); GOVERNMENT REGULATION; HEALTH CARE QUALITY; LEGISLATION AND JURISPRUDENCE; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RISK; UNITED STATES;

CLINICAL TRIALS AS TOPIC; COMPARATIVE EFFECTIVENESS RESEARCH; ETHICS COMMITTEES, RESEARCH; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INFORMED CONSENT; RISK; STANDARD OF CARE; UNITED STATES;

EID: 84915819140     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMhle1413301     Document Type: Article

References (4)

1. Department of Health and Human Services. Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. Fed Regist 2014;79(206):63629-34 (http://www.gpo.gov/fdsys/pkg/FR-2014-10-24/pdf/2014-25318.pdf).
2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. April 18, 1979 (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html).
3. Code of Federal Regulations. Title 45, part 46: protection of human subjects (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html).
4. Code of Federal Regulations. 45 CFR 46, Section 46.111(2).