Research ethics committee: Difference between revisions

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'''{{PAGENAME}}s''' are "hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects"<ref>{{MeSH}}</ref>
'''{{PAGENAME}}s''' are "hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects"<ref>{{MeSH}}</ref>




==Background==
==Background==
* [http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Belmont Report] addresses:
 
===Department of Health & Human Services Inspector General (1998)===
===Belmont Report===
The [http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Belmont Report] (1979) addresses:
Boundaries Between Practice and Research
Boundaries Between Practice and Research
*Basic Ethical Principles
*Basic Ethical Principles
Line 13: Line 17:
**Assessment of Risk and Benefits
**Assessment of Risk and Benefits
**Selection of Subjects
**Selection of Subjects
===45 CFR 46 (1974)===
[http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html 45 CFR 46] is the "Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research"
===National Research Act (1974)===
* Established the "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" ("The National Commission")
* Required Institutional Review Boards (IRBs) at institutions receiving Public Health Service support for human subjects research.
===The Nuremberg Code (1947)===
Established 10 points
===Beecher article (1966)===
Text.<ref name="pmid5327352">{{cite journal| author=Beecher HK| title=Ethics and clinical research. | journal=N Engl J Med | year= 1966 | volume= 274 | issue= 24 | pages= 1354-60 | pmid=5327352 | doi=10.1056/NEJM196606162742405 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=5327352  }} </ref>


==References==
==References==
<references/>
<references/>

Latest revision as of 19:48, 9 September 2020

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Research ethics committees are "hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects"[1]


Background

Department of Health & Human Services Inspector General (1998)

Belmont Report

The Belmont Report (1979) addresses: Boundaries Between Practice and Research

  • Basic Ethical Principles
    • Respect for Persons
    • Beneficence
    • Justice
  • Applications
    • Informed Consent
    • Assessment of Risk and Benefits
    • Selection of Subjects

45 CFR 46 (1974)

45 CFR 46 is the "Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research"

National Research Act (1974)

  • Established the "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" ("The National Commission")
  • Required Institutional Review Boards (IRBs) at institutions receiving Public Health Service support for human subjects research.

The Nuremberg Code (1947)

Established 10 points

Beecher article (1966)

Text.[2]

References