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Related Concept Videos

Ethical Issues01:27

Ethical Issues

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Nurses are essential in patient care, upholding the ethical principles of their profession and effectively navigating ethical dilemmas. Neglecting ethical issues can lead to inadequate patient care, compromised therapeutic relationships, and moral distress among healthcare workers.
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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:
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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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Ethics in Research01:56

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Ethics review in compassionate use.

Jan Borysowski1, Hans-Jörg Ehni2, Andrzej Górski3,4

  • 1Department of Clinical Immunology, Medical University of Warsaw, Nowogrodzka Str. 59, 02-006, Warsaw, Poland. jborysowski@interia.pl.

BMC Medicine
|July 25, 2017
PubMed
Summary

Compassionate use, the application of unapproved drugs, requires mandatory review by research ethics committees due to inherent research aspects and patient safety concerns.

Keywords:
Clinical trialCompassionate useExpanded accessInformed consentInstitutional review boardResearch ethics committee

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Area of Science:

  • Medical Ethics
  • Drug Regulation
  • Patient Safety

Background:

  • Compassionate use allows access to unapproved drugs outside clinical trials.
  • Regulations vary globally, with some countries requiring research ethics committee (institutional review board) approval and others not.
  • Key countries with differing regulations include the US, Canada, European nations, Australia, Brazil, Japan, and China.

Purpose of the Study:

  • To examine the role of research ethics committees in reviewing compassionate use cases.
  • To analyze critical aspects of compassionate use, including patient risks, informed consent, physician qualifications, and selection criteria.

Main Methods:

  • Literature review and analysis of existing compassionate use regulations and ethical considerations.
  • Comparative analysis of arguments for and against mandatory ethical review.

Main Results:

  • Arguments favoring mandatory ethical review for compassionate use significantly outweigh counterarguments.
  • Compassionate use often contains research elements, involves drugs with unproven safety and efficacy, and presents challenges in informed consent.

Conclusions:

  • Mandatory approval by a research ethics committee is essential for compassionate use.
  • Despite being considered treatment, compassionate use differs from standard care and necessitates ethical oversight due to research aspects and unproven drug status.