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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| Published in | Annals of intensive care Vol. 1; no. 1; p. 8 |
|---|---|
| Main Author | |
| Format | Journal Article |
| Language | English |
| Published |
Paris
Springer Paris
13.04.2011
Springer Nature B.V BioMed Central Ltd Springer |
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| Online Access | Get full text |
| ISSN | 2110-5820 2110-5820 |
| DOI | 10.1186/2110-5820-1-8 |
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| Abstract | 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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| AbstractList | 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. 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. 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. |
| ArticleNumber | 8 |
| Author | Silverman, Henry |
| AuthorAffiliation | 1 University of Maryland School of Medicine, 110 South Paca Street; 2nd floor, Baltimore, Maryland, USA 21201, USA |
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| Author_xml | – sequence: 1 givenname: Henry surname: Silverman fullname: Silverman, Henry email: hsilverm@medicine.umaryland.edu organization: University of Maryland School of Medicine |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/21906335$$D View this record in MEDLINE/PubMed |
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| Copyright | Silverman; licensee Springer. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Société de réanimation de langue française (SRLF) and Springer-Verlag France 2011 Copyright ©2011 Silverman; licensee Springer. 2011 Silverman; licensee Springer. |
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| Keywords | Proxy Consent Minor Increment Direct Benefit Informed Consent Process Therapeutic Misconception |
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| PublicationTitle | Annals of intensive care |
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| Title | Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards |
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