KatzJ.The Nuremberg Code and the Nuremberg Trial: a reappraisal.JAMA1996; 276: 1662–6.
2.
RickhamP.P.Human experimentation: code of ethics of the World Medical Association. Declaration of Helsinki.BMJ1964; 5402: 177–80.
3.
Final report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel.US Public Health Service; 1973.
4.
WhiteR.M.Unraveling the Tuskegee Study of Untreated Syphilis.Arch Intern Med2000; 160: 585–607.
5.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Department of Health. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research.Washington (DC): Office of the Secretary; 1979. OPRR Publication no. 887–806.
6.
Advisory Committee on Human Radiation Experiments.Research ethics and the medical profession.JAMA1996; 276: 403–9.
7.
BirosM.H., LewisR.J., OlsonC.M.Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.JAMA1995; 273: 1283–7.
8.
PassamaniE.R., WeisfeldtM.L.31st Bethesda Conference. Emergency cardiac care: task force 3: special aspects of research conduct in the emergency setting: waiver of informed consent.J Am Coll Cardiol2000; 15: 862–80.
9.
Office of the Secretary, Department of Health and Human Services, Food and Drug Administration.Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research: final rule.Fed Reg1996; 61: 51498–51533.
10.
Office of Human Research Protections. Available at: www.ohrp.osophs.dhhs.gov (accessed Jan 7, 2004).
11.
US Department of Health and Human Services.HHS-Office for Civil Rights-HIPAA. Available at: http://www.hhs.gov/ocr/hipaa (accessed Jan 9, 2004).
12.
US Department of Health and Human Services.Fact sheet: administrative simplification under HIPAA: national standards for transactions, security and privacy. March 3, 2003. Available at: www.hhs.gov/news/press/hipaa.html
13.
BirosM.H., RungeJ.W., LewisR.J., DohertyC.Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances.Acad Emerg Med1998; 5: 359–68.
14.
BirosM.H., FishS.S., LewisR.J.Implementing the Food and Drug administration's Final Rule for waiver of informed consent in certain emergency research circumstances.Acad Emerg Med1999; 6: 1272–82.
15.
LewisR.J., BerryD.A., CryerH.IIIMonitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: The Diaspirin Cross-Linked Hemoglobin Traumatic Hemorrhagic Shock Efficacy Trial.Ann Emerg Med2001; 38: 397–404.
16.
CliftonG.L., KundsonP., McDonaldM.Waiver of informed consent in studies of acute brain injury.J Neurotrauma2002; 19: 1121–6.
17.
MurrelleL., McCarthyC.R.What's so important about conducting research involving third parties?J Contin Educ Health Prof2001; 21: 198–202.
18.
SmithlineH.A., GerstleM.L.Waiver of informed consent: a survey of emergency medicine patients.Am J Emerg Med1998; 16: 90–1.
19.
BurstenB.Voluntariness of waiver of Fifth Amendment rights.Bull Am Acad Psychiatry Law1979; 7: 352–62.
20.
EtchellsE.Informed consent in surgical trials.World J Surg1999; 23: 1215–9.
21.
PlautE.A.The ethics of informed consent: an overview.Psychiatr J Univ Ottawa1989; 14: 435–8.
22.
AdamsJ.G., WegenerJ.Asking without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research.Ann Emerg Med1999; 33218–23.
23.
SprungC.L., WinickB.J.Informed consent in theory and practice: legal and medical perspectives on the informed consent doctrine and a proposed re-conceptualization.Crit Care Med1989: 17: 1346.
24.
DixE.S., EspositoD., SpinosaF.Implementation of community consultation for waiver of informed consent in emergency research: one Institutional Review Board's experience.J Invest Med2004; 52: 113–6.
25.
ShahA.N., SugarmanJ.Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community.Ann Emerg Med2003; 41: 72–8.
26.
MaloneyD.M.Proposal on waiver of informed consent poses major issues for research ethics.Hum Res Rep1997; 12: 1–3.