Appendix C:
Ethical Standards and IRB Requirements
·
Complete
information about ethical standards and IRB requirements can be found at both
the National Academies of Science IRB home page and the U.S. Department of
Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP)
website (ohrp.osophs.dhhs.gov).
That website also has links to sites with additional information.
·
The Federal
Policy for the Protection of Human Subjects (45 CFR 46) is available at
ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
·
Food and Drug
Administration Requirements for Human Research, including Requirements for
Exemption from Informed Consent for Emergency Research (21 CFR 50) is available
here:
www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html.
The Belmont Report, which was an important basis for the development of ethical
research standards in the U.S., can be found at
ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm.
A tutorial on ethical requirements for research that was designed for
employees of the NIH but available to
anyone is available here:
ohsr.od.nih.gov.
· The National Association of EMS Physicians website contains information on ethical challenges in emergency medical services at www.naemsp.org.
· Suggested Reading: Mahon NE, Yarcheski A: Ethical concerns in research with adolescents. J Ped Nurs 1988; 3(5):341-344.
