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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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The institutional review board and beyond: future challenges to the ethics of human experimentation.

Over the past two decades, institutional review boards (IRBs) have transformed the conduct of clinical research, in the process protecting human subjects and setting an admirable standard for monitoring the ethics of science. Nevertheless, the very proliferation of these committees, in addition to changing the character and sponsorship of new research, suggests that a ¿one size fits all¿ approach to the governance of human experimentation may have outlived its usefulness. It may be time to remove the ¿I¿ from the IRB and create a system with greater national oversight. Whether such a change can be accomplished within the current political climate is debatable. But the need for such a shift is becoming increasingly apparent.

Advisory Committees↗

Surrogate decision-making and ethics committees: the new role of the New York State nurse.

"When Others Must Choose: Deciding for Patients Without Capacity" is health care legislation proposed for New York state. Its intent is to remedy the absence of legal authority for families or other surrogates to make treatment decisions for their incapacitated loved ones who have neither completed an advance directive nor designated a health care agent. This paper provides a summary of this legislation and highlights nursing implications and the role of the nurse as a member of institutional ethics committees.

Adolescent↗

Remodelling IRBs.

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Committee Membership↗

Should trustees be members of medical staff committees? Its' debatable.

Trustee membership on medical staff committees is not an appropriate way of ensuring liasion between the medical staff and the governing board. All assurances concerning quality of care should come to the governing board from the organized medical staff, to whom such accountability is and should be delegated.

Governing Board↗

Improving protection for research subjects in France: analysis of regional ethics committees.

OBJECTIVE: The aim of this study was to analyze the functioning of the French committees for the protection of people in biomedical research (CCPPRB). DESIGN: An independent evaluator visited all of the committees and analyzed their functioning by assessing the annual activity reports, filling data grids and observing the committees in session. RESULTS: We observed that the representation of a range of professions, which is required by law, was not always respected. This was partly because the administrative authority had accumulated delays in nominating members. Another explanation could be the absence of remuneration for the work and attendance of the members. There was considerable inter-committee variation concerning the way documents were distributed to the members during sessions and the extent of investigator and promoter involvement. Finally, large differences in the number of dossiers handled between committees led us to investigate the fairness of dossier distribution, as the number of dossiers dealt with has consequences, particularly for the finality of the opinions of the committees. CONCLUSIONS: This evaluation of the committees playing a crucial role in protecting participants in research trials provides new information that could be helpful for improving the way in which these committees function in the context of the European Directive.

Clinical Protocols↗