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Informed Consent for Comparative Effectiveness Research Should Include Risks of Standard Care.
- Source :
-
Journal of Law, Medicine & Ethics . Fall2017, Vol. 45 Issue 3, p352-364. 13p. - Publication Year :
- 2017
-
Abstract
- The article discusses the author's claim that the informed consent that is needed for comparative effectiveness research (CER) should include disclosures about the risks associated with standard care interventions, and it mentions risks of research and oversight by the U.S. Office for Human Research Protections (OHRP). Regulations to protect human subjects are examined, along with the medical research ethics, the Nuremberg Code, and American common law protections for individuals.
- Subjects :
- *INFORMED consent (Medical law)
*COMPARATIVE studies
*RISK
*MEDICAL research ethics
*HUMAN research subjects -- Legal status, laws, etc.
*COMMON law
*MEDICAL experimentation on humans -- Law & legislation
*CONFERENCES & conventions
*ACTIVE oxygen in the body
*PREMATURE infants
*RESEARCH ethics
*RESPIRATORY therapy
*DISCLOSURE
*RESEARCH
*RANDOMIZED controlled trials
*HUMAN research subjects
*SAFETY
UNITED States. Office of Human Research Protections
Subjects
Details
- Language :
- English
- ISSN :
- 10731105
- Volume :
- 45
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- Journal of Law, Medicine & Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 125778984
- Full Text :
- https://doi.org/10.1177/1073110517737535