Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards

Although critically ill patients represent a vulnerable group of individuals, guidelines in research ethics assert that ethically acceptable research may proceed with such vulnerable subjects if additional safeguards are in place to minimize the risk of harm and exploitation. Such safeguards include...

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Bibliographic Details
Published inAnnals of intensive care Vol. 1; no. 1; p. 8
Main Author Silverman, Henry
Format Journal Article
LanguageEnglish
Published Paris Springer Paris 13.04.2011
Springer Nature B.V
BioMed Central Ltd
Springer
Subjects
Anesthesiology
Critical Care Medicine
Emergency Medicine
Intensive
Intensive care
Medicine
Medicine & Public Health
Review
Proxy Consent
Minor Increment
Direct Benefit
Informed Consent Process
Therapeutic Misconception
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Summary:Although critically ill patients represent a vulnerable group of individuals, guidelines in research ethics assert that ethically acceptable research may proceed with such vulnerable subjects if additional safeguards are in place to minimize the risk of harm and exploitation. Such safeguards include the proper obtainment of informed consent that avoids the presence of the therapeutic misconception and the assessment of decisional capacity in critically ill patients recruited for research. Also discussed in this review are additional safeguards for such vulnerable subjects, as well as the issues involved with proxy consent. Heightened awareness to principles of ethics and provision of additional safeguards to enhance protections of vulnerable subjects would help to maintain the public trust in the research endeavor.
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ISSN:2110-5820
2110-5820
DOI:10.1186/2110-5820-1-8