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David B. Resnik - One of the best experts on this subject based on the ideXlab platform.
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Standards of Evidence for Institutional Review Board Decision-Making.
Accountability in research, 2020Co-Authors: David B. ResnikAbstract:A standard of evidence is a rule or norm pertaining to the type or amount of evidence that is required to prove or support a conclusion. Standards of evidence play an important role in Institutional Review Board (IRB) decision-making, but they are not mentioned in the federal research regulations. In this article, I examine IRB standards of evidence from a normative, epistemological perspective and argue that IRBs should rely on empirical evidence for making decisions, but that other sources of evidence, such as intuition, emotion, and rational reflection, can also play an important role in decision-making, because IRB decisions involve an ethical component which is not reducible to science. I also argue that an IRB should approve a study only if it has clear and convincing evidence that the study meets all the approval criteria and other relevant, ethical considerations; and that for studies which expose healthy volunteers to significant risks, an IRB should require that evidence be more than clear and convincing as a condition for approval. Additional empirical research is needed on how IRBs use evidence to make decisions and how standards of evidence influence IRB decision-making at the individual and group level.
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How U.S. research institutions are responding to the single Institutional Review Board mandate.
Accountability in research, 2018Co-Authors: David B. Resnik, Elise Smith, Min ShiAbstract:ABSTRACTOne of the most significant changes to the Common Rule is the requirement that institutions use a single Institutional Review Board (IRB) for cooperative research in the United States, unle...
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how u s research institutions are responding to the single Institutional Review Board mandate
Accountability in Research, 2018Co-Authors: David B. Resnik, Elise Smith, Min ShiAbstract:One of the most significant changes to the Common Rule is the requirement that institutions use a single Institutional Review Board (IRB) for cooperative research in the United States, unless more ...
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Some reflections on evaluating Institutional Review Board effectiveness.
Contemporary clinical trials, 2015Co-Authors: David B. ResnikAbstract:Most commentators agree that it is important to conduct empirical research on the effectiveness of Institutional Review Board (IRB) Review and oversight but the studies that have been published so far do not directly address this question because they do not attempt to measure the impact of the IRB on the welfare or rights of human subjects. Additional studies on IRB composition, staffing, Review times, consistency, and so forth will not yield that evidence that is needed to measure IRB effectiveness if they do not also collect data on the welfare and rights of human research subjects. Researchers should consider developing studies, such as randomized, controlled trials, or prospective, cohort designs, which directly measure IRB effectiveness. Such studies could yield information that will be invaluable in improving IRB Review and oversight and protecting human research subjects.
William J Tremaine - One of the best experts on this subject based on the ideXlab platform.
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the role of the Institutional Review Board in the oversight of the ethical aspects of human studies research
Nutrition in Clinical Practice, 2013Co-Authors: Gary C Cseko, William J TremaineAbstract:Institutional Review Boards are charged with overseeing that human studies research is conducted in accordance with federal and state regulations and with their own policies and procedures, with the goal of minimizing risks to participants and maximizing the quality of the research data. Nutrition research often involves vulnerable populations, including children and the cognitively impaired, for whom there are specific regulations. Ethical issues are common in nutrition research, and both the investigative team and the Institutional Review Board should seek input regarding ethical issues that arise.
Kevin T. Mcvary - One of the best experts on this subject based on the ideXlab platform.
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Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Randomized, Controlled Surgical Trial
The Journal of urology, 2009Co-Authors: Brian T. Helfand, Anne K. Mongiu, Claus G. Roehrborn, Robert F. Donnell, Reginald C. Bruskewitz, Steven A. Kaplan, John W. Kusek, Laura P. Coombs, Kevin T. McvaryAbstract:Purpose: The primary responsibility of Institutional Review Boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of Institutional Review Boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various Institutional Review Boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol.Materials and Methods: We obtained the Institutional Review Board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an Institutional Review Board at ...
Jonathan Sevransky - One of the best experts on this subject based on the ideXlab platform.
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Navigating the Institutional Review Board approval process in a multicenter observational critical care study.
Critical care medicine, 2014Co-Authors: Carmen Polito, Sushma K. Cribbs, Greg S. Martin, Terence O'keeffe, Daniel L. Herr, Todd W. Rice, Jonathan SevranskyAbstract:OBJECTIVE To characterize variation in the Institutional Review Board application process of a multicenter, observational critical care study. DESIGN, SETTING, AND SUBJECTS Survey analysis of 36 investigators who applied for participation in the United States Critical Illness and Injury Trials Group: Critical Illness and Outcomes Study, an observational study of 69 adult ICUs. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Analysis of investigator-specific characteristics, Institutional Review Board process, application and approval dates, and level of difficulty in obtaining approval. Surveys were analyzed from 36 sites (95%) that applied for Institutional Review Board approval. Level of Review ranged from full Board, expedited, to exempt. Seventy-five percent of applications were submitted by an experienced investigator while 25% were submitted by a less experienced investigator. Median time to Institutional Review Board approval was 30 days (interquartile range, 14-54) and ranged from 5 days to 5.5 months. Time to approval was 29 days (interquartile range, 17-48) for applications submitted by an experienced investigator compared with 97 days (interquartile range, 25-159) for those submitted by a less experienced investigator (p = 0.08). Subjective level of difficulty was significantly higher for less experienced investigators (4 of 10; interquartile range, 2-8) vs experienced investigators (2 of 10; interquartile range, 1-3) (p = 0.04). Four sites cited Institutional Review Board concern regarding waiver of consent as a major barrier to approval and were required to perform revisions or participate in Board meetings regarding this concern. CONCLUSIONS In a multicenter, observational critical care study, significant variation was observed between sites in all aspects of the Institutional Review Board evaluation and approval process. The level of difficulty was significantly higher for less experienced investigators with a trend toward longer time to Institutional Review Board approval. Variation in Institutional Review Board interpretation of waiver of informed consent regulations was cited as a major barrier to approval.
William L. Gannon - One of the best experts on this subject based on the ideXlab platform.
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Victor Frankenstein’s Institutional Review Board Proposal, 1790
Science and Engineering Ethics, 2015Co-Authors: Gary Harrison, William L. GannonAbstract:To show how the case of Mary Shelley’s Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board (IRB) protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative anatomy, medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries’ scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from “dead” tissues. In Mary Shelley’s Frankenstein , Victor failed to consider his creature’s autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself.
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Victor Frankenstein's Institutional Review Board Proposal, 1790
Science and engineering ethics, 2014Co-Authors: Gary Harrison, William L. GannonAbstract:To show how the case of Mary Shelley’s Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board (IRB) protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative anatomy, medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries’ scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from “dead” tissues. In Mary Shelley’s Frankenstein, Victor failed to consider his creature’s autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself.