Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: From experimental design to institutional review board approval
COMMUNITY CARE;
EMERGENCY CARE;
EXPERIMENTAL DESIGN;
HEALTH CARE PERSONNEL;
HUMAN;
INFORMED CONSENT;
MEDICAL ETHICS;
MEDICAL RESEARCH;
MEDICAL SOCIETY;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
REVIEW;
CRITICAL ILLNESS;
EMERGENCY TREATMENT;
ETHICS COMMITTEES, RESEARCH;
ETHICS, CLINICAL;
FEDERAL GOVERNMENT;
GOVERNMENT REGULATION;
HUMANS;
INFORMED CONSENT;
RISK ASSESSMENT;
STATE GOVERNMENT;
THERAPEUTIC HUMAN EXPERIMENTATION;
UNITED STATES;
Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10. Washington, DC: US Government Printing Office; 1949: 181-182.
World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. 2004. http://www.wma.net/e/ policy. Accessed February 8, 2005.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: US Government Printing Office
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: US Government Printing Office; 1978. DHEW Publ (OS) 78-0012.
Waiver of informed consent requirements in certain emergency research
National Institutes of Health; Department of Health and Human Services
National Institutes of Health; Department of Health and Human Services. Waiver of informed consent requirements in certain emergency research. Fed Regist. 1996;61:51531-51533.
Exception from informed consent for studies conducted in emergency settings: Regulatory language and excerpts from preamble
Accessed February 11, 2005
Exception from informed consent for studies conducted in emergency settings: regulatory language and excerpts from preamble. US FDA Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update. http://www.fda.gov/oc/ohrt/irbs/except.html. Accessed February 11, 2005.
Initial experience using the Food and Drug administration guidelines for emergency research without consent
Kremers MS, Whisnant DR, Lowder LS, Gregg L. Initial experience using the Food and Drug administration guidelines for emergency research without consent. Ann Emerg Med. 1999;33:224-229.
Conducting research using the emergency exception from informed consent: The Public Access Defibrillation (PAD) Trial experience
Mosesso VN Jr, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. Resuscitation. 2004;61:29-36.
Implementing the Food and Drug Administration's Final Rule for waiver of informed consent in certain emergency research circumstances
Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration's Final Rule for waiver of informed consent in certain emergency research circumstances. Acad Emerg Med. 1999;6:1272-1282.