David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library||
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Jessica Berg & Nicole Deming (2011). New Rules for Research with Human Participants? Hastings Center Report 41 (6):10-11.
Malcolm G. Booth (2007). Informed Consent in Emergency Research: A Contradiction in Terms. Science and Engineering Ethics 13 (3):351-359.
Piotr S. Iwanowski (2007). Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective. Science and Engineering Ethics 13 (3):333-336.
Kathleen R. Diviak, Susan J. Curry, Sherry L. Emery & Robin J. Mermelstein (2004). Human Participants Challenges in Youth Tobacco Cessation Research: Researchers' Perspectives. Ethics and Behavior 14 (4):321 – 334.
Joanna Różyńska & Marek Czarkowski (2007). Emergency Research Without Consent Under Polish Law. Science and Engineering Ethics 13 (3):337-350.
Joan E. Sieber (2004). Introduction to the Special Issue: Using Our Best Judgment in Conducting Human Research. Ethics and Behavior 14 (4):297 – 304.
Andrew D. McRae, Stacy Ackroyd-Stolarz & Charles Weijer, Risk in Emergency Research Using a Waiver of/Exception From Consent: Implications of a Structured Approach for Institutional Review Board Review.
Andrew D. McRae & Charles Weijer, Lessons From Everyday Lives: A Moral Justification for Acute Care Research.
Celia B. Fisher, Susan Z. Kornetsky & Ernest D. Prentice (2007). Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations. American Journal of Bioethics 7 (3):5 – 10.
Dennis John Mazur (2007). Evaluating the Science and Ethics of Research on Humans: A Guide for Irb Members. Johns Hopkins University Press.
Stephanie R. Solomon (2013). Protecting and Respecting the Vulnerable: Existing Regulations or Further Protections? Theoretical Medicine and Bioethics 34 (1):17-28.
Trisha B. Phillips (2011). A Living Wage for Research Subjects. Journal of Law, Medicine and Ethics 39 (2):243-253.
F. William Dommel & Duane Alexander (1997). The Convention on Human Rights and Biomedicine of the Council of Europe. Kennedy Institute of Ethics Journal 7 (3):259-276.
Added to index2010-09-08
Total downloads9 ( #163,302 of 1,099,774 )
Recent downloads (6 months)2 ( #189,552 of 1,099,774 )
How can I increase my downloads?