protecting vulnerable research subjects in critical care trials enhancing the informed consent process and recommendations for safeguards保护脆弱的研究对象在重症监护试验提高知情同意过程和对保障措施的建议.pdfVIP

Silverman Annals of Intensive Care 2011, 1:8 /content/1/1/8 REVIEW Open Access Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards Henry Silverman 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. Introduction welfare” of “mentally disabled persons” [7]. Similar lack Critical care research presents special ethical challenges of guidance as well as ambiguity has been raised with largely due to the potential for exploitation stemming the European Union Directive [8,9]. In the absence of from the vulnerability of the critically ill patients who the specification of at least the essential safeguards, the are solicited for enrollment. Vulnerability refers to the protection of vulnerable subjects relies too heavily on inability to protect oneself and can be due to intrinsic the views of diverse IRBs, le