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 Servicesí (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.