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Related Concept Videos

Ethical Dilemmas II01:30

Ethical Dilemmas II

Resolving an ethical dilemma in healthcare involves a systematic approach that considers every aspect of the issue, respecting both the patient's needs and values and the healthcare professional's ethical obligations. Here are potential steps to resolve an ethical dilemma:
Ethical Dilemmas I01:17

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Ethics and Bioethics01:22

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Ethics is a philosophical study of moral actions. Ethics attempts to determine what is valuable for individuals and society. It examines the rational justification of moral judgments and analyzes what is morally just, fair, and right. Bioethics is a sub-discipline of applied ethics that analyzes the philosophical, social, and legal issues in life sciences and medicine. Ethical theories serve as a foundation for decision-making and represent the viewpoints from which people seek direction. They...
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Working with Human Tissues for Translational Cancer Research
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Published on: November 26, 2015

Ethics committee experience with emergency exception from informed consent protocols.

Nicole M Deiorio1, Katie B McClure, Maria Nelson

  • 1Oregon Health and Science University (USA).

Journal of Empirical Research on Human Research Ethics : JERHRE
|April 24, 2009
PubMed
Summary

U.S. regulations permit emergency research without consent under specific conditions. Most Institutional Review Boards (IRBs) have reviewed such studies and believe the rule protects subjects, though views on consultation differ from public opinion.

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Area of Science:

  • Medical Ethics
  • Clinical Research Oversight
  • Regulatory Science

Background:

  • U.S. federal regulations enacted in 1996 allow for emergency research without informed consent.
  • These regulations apply when no satisfactory treatment exists, consent cannot be obtained in time, and community consultation occurs.
  • The impact and experiences of Institutional Review Boards (IRBs) with these regulations have not been previously documented.

Purpose of the Study:

  • To quantify the number of emergency research protocols reviewed by IRBs.
  • To assess IRB chairpersons' attitudes and preparedness regarding the emergency research rule.
  • To understand the rule's practical impact on IRB operations and human subject protection.

Main Methods:

  • A survey was distributed to IRB chairpersons at 126 U.S. medical schools.
  • Sixty-nine surveys were returned, representing a 55% response rate.
  • Respondents were queried about their awareness, review experience, and opinions on the emergency research regulations.

Main Results:

  • Of 52 respondents aware of the rule, 48% had reviewed at least one emergency research study.
  • Forty percent of those who reviewed such studies had rejected at least one protocol.
  • Seventy-eight percent of respondents believed the rule protects human subjects, and 88% felt prepared to implement it.
  • IRB views on public notification and consultation methods differed from public opinion.

Conclusions:

  • IRBs have practical experience with emergency research regulations, including protocol rejections.
  • The majority of surveyed IRBs perceive the rule as protective of human subjects and feel equipped for its implementation.
  • Discrepancies exist between IRB and public perspectives on community engagement strategies for emergency research.