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Biomedical subjects

Henry J Silverman

Publications and source records attributed to Henry J Silverman.

11 recordsLinked to original sources
PubMed2006

Ethics and research in critical care.

BACKGROUND: The past few years have witnessed several controversies regarding the ethics of conducting research involving critically ill patients, and such research is ethically challenging. DISCUSSION: Research ethics is a changing field, one that is influenced by empirical data, contemporary events, and new ideas regarding aspects of clinical trial design and protection of human subjects. We describe recent thoughts regarding several aspects of research ethics in the critical care context. CONCLUSION: The ability of the research community to conduct research ethically and to maintain public trust would benefit from heightened awareness to the principles and requirements that govern such research.

Critical Care↗
PubMed2005

Recommendations for informed consent forms for critical care clinical trials.

BACKGROUND: Many subjects enrolled in research studies have a limited understanding of the research to which they consented. OBJECTIVE: To develop recommendations to enhance comprehensiveness and understanding of informed consent forms used in critical care clinical trials. DESIGN: Consensus process. RECOMMENDATIONS: We provide recommendations regarding the U.S. federally required basic and additional elements of informed consent as applied to critical care clinical trials. We also identify issues that investigators need to address, if relevant, in the informed consent forms of critical care clinical trials. These include the description, in understandable language, of complex and detailed experimental protocols that are the focus of the clinical trial, disclosure of death as a risk factor if mortality is an outcome variable, and the identification of who can legally serve as the prospective subject's surrogate. We also offer suggestions to enhance subjects' understanding of informed consent forms. CONCLUSIONS: The literature on informed consent forms suggest that shorter informed consent forms written at a lower reading level, when read carefully, might provide better subject understanding. Prospective evaluation is needed to determine whether our recommendations enhance the informed consent process.

Clinical Trials as Topic↗
PubMed2004

The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis.

OBJECTIVE: We perform an ethical analysis of European Union Directive 2001/20/EC on the simplification and harmonization of guidelines regarding good clinical practice in the conduct of clinical trials involving drugs. BACKGROUND: The Directive provides guidance on protecting incapacitated subjects who participate in drug clinical trials. Such guidance promotes society's obligations of beneficence because the participation of incapacitated subjects in research is crucial in advancing the understanding and treatment of serious diseases. The Directive requires proxy consent for incapacitated subjects which adheres to the principle of respect for persons. The Directive also recommends additional safeguards to further protect subjects against exploitation and harm. These include respect for the assent and dissent of incapacitated subjects and the "necessity" and "subject-condition" requirements. RESULTS: While these essential protection mechanisms are commendable, the Directive fails to endorse other safeguards that have been recommended by other research ethics guidelines, especially for riskier research. The Directive's silence regarding research in the emergency setting frustrates the principle of beneficence because the lack of guidance might prove to be a barrier for the conduct of such potentially beneficial research. CONCLUSIONS: We conclude that the European Directive fails in many respects to promote several important ethical principles in research involving incapacitated subjects.

Critical Care↗
PubMed2004

Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

BACKGROUND: Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. OBJECTIVE: To develop a framework for analyzing control group selection for critical care trials. METHOD: Ethical analysis. RESULTS: A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. CONCLUSION: Weighing and balancing the competing ethical objectives of trial design should be done for each trial.

Control Groups↗
PubMed2004

The acute respiratory distress syndrome network controversy: lessons and legacy.

PURPOSE OF REVIEW: Several of the Acute Respiratory Disease Syndrome Network clinical trials embrace a clinical trial design that evaluates contrasting strategies, one or both of which represents only a segment of standard practices. Such a trial design has engendered ethical controversy regarding the value of such trials and their ability to protect human subjects. During the past year, commentators have continued to reflect on the significance of such trials. RECENT FINDINGS: Several authors have reflected on the ethical significance of the standard of care in clinical trial design and have offered a framework for determining control group selection in critical care trials. Other authors have written on methodologic issues and approaches to determine whether control groups are reflective of standard practices. Surveys have been performed to determine the impact and hence the relevancy of the Acute Respiratory Disease Syndrome Network tidal volume trial on clinical practice. SUMMARY: The controversy related to and the impact of the Acute Respiratory Disease Syndrome Network clinical trial design on clinical practice offer an opportunity to explore the trade-offs between explanatory and pragmatic types of clinical trials. Such discussions will lead to a clearer understanding of the value of both types of clinical trials and the optimal ethical conduct of such trials.

Clinical Trials as Topic↗