The Experts below are selected from a list of 195798 Experts worldwide ranked by ideXlab platform
Mildred K Cho - One of the best experts on this subject based on the ideXlab platform.
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the emergence of clinical Research Ethics consultation insights from a national collaborative
American Journal of Bioethics, 2018Co-Authors: Kathryn M Porter, Mildred K Cho, Marion Danis, Holly A Taylor, Benjamin S WilfondAbstract:The increasing complexity of human subjects Research and its oversight has prompted Researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research Ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 Research Ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other Research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts with...
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building a central repository for Research Ethics consultation data a proposal for a standard data collection tool
Clinical and Translational Science, 2015Co-Authors: Mildred K Cho, Holly A Taylo, Jennife Mccormick, Nicholas R Anderso, David Arnard, Mary Oyle, Alexander Morga Capro, Elizabeth Dorfma, Kathry Havard, Carso ReideAbstract:Clinical Research Ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of Research Ethics consultation information to serve as a foundation for quality improvement, education, and Research efforts. This approach includes categorizing and documenting descriptive information about the requestor, Research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical Research Ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of Research.
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Research Ethics consultation ethical and professional practice challenges and recommendations
Academic Medicine, 2015Co-Authors: Richard R Sharp, Mildred K Cho, David Magnus, Marion Danis, Holly A Taylor, Margaret A Brinich, Mary M Boyle, Marilyn E Coors, Molly Havard, Benjamin S WilfondAbstract:The complexity of biomedical Research has increased considerably in the last decade, as has the pace of translational Research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal Research Ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical Research. Key functions of a REC service include assisting with Research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic Research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
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biomedical scientists perceptions of ethical and social implications is there a role for Research Ethics consultation
PLOS ONE, 2009Co-Authors: Angie Boyce, Jennifer B Mccormick, Mildred K ChoAbstract:Background Research Ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical Research. A number of these programs are modelled after clinical Ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science Researchers' perceived need for and utility of Research Ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with Researchers from Stanford University and a mailed survey in December 2006 to 7 Research universities in the U.S. Findings A total of 16 Researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of Researchers surveyed (51%) reported that they would find a Research Ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects Research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects Research (20% vs 10%; chi2 p<0.001). Conclusion Our findings indicate that biomedical Researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical Researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.
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strangers at the benchside Research Ethics consultation
American Journal of Bioethics, 2008Co-Authors: Mildred K Cho, Sara L Tobin, Henry T Greely, Jennifer B Mccormick, Angie Boyce, David MagnusAbstract:Institutional Ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical Researchers. We discuss several models of Ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As Research Ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of Research Ethics consultation, based on our initial experiences in a pilot program.
Benjamin S Wilfond - One of the best experts on this subject based on the ideXlab platform.
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the emergence of clinical Research Ethics consultation insights from a national collaborative
American Journal of Bioethics, 2018Co-Authors: Kathryn M Porter, Mildred K Cho, Marion Danis, Holly A Taylor, Benjamin S WilfondAbstract:The increasing complexity of human subjects Research and its oversight has prompted Researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research Ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 Research Ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other Research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts with...
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Research Ethics consultation ethical and professional practice challenges and recommendations
Academic Medicine, 2015Co-Authors: Richard R Sharp, Mildred K Cho, David Magnus, Marion Danis, Holly A Taylor, Margaret A Brinich, Mary M Boyle, Marilyn E Coors, Molly Havard, Benjamin S WilfondAbstract:The complexity of biomedical Research has increased considerably in the last decade, as has the pace of translational Research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal Research Ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical Research. Key functions of a REC service include assisting with Research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic Research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
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the establishment of Research Ethics consultation services recs an emerging Research resource
Clinical and Translational Science, 2013Co-Authors: Jennifer B Mccormick, Holly A Taylor, Benjamin S Wilfond, Richard R Sharp, Abigale L Ottenberg, Carson ReiderAbstract:Emphasis on translational Research to facilitate progression from the laboratory into the community also creates a dynamic in which Ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with Research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational Research pathway.
Christine Grady - One of the best experts on this subject based on the ideXlab platform.
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beyond open communication a call for partnership between clinical Ethics and Research Ethics committees
American Journal of Bioethics, 2018Co-Authors: Hae Lin Cho, David Miller, Christine GradyAbstract:In proposing strategies to improve access to and quality of Research Ethics consultation (REC) services, Porter and colleagues (2018) call for “open communication” between REC and clinical Ethics c...
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introduction the fogarty international Research Ethics education and curriculum development program in historical context
Journal of Empirical Research on Human Research Ethics, 2013Co-Authors: Joseph Millum, Christine Grady, Gerald T Keusch, Barbara SinaAbstract:In response to the increasing need for Research Ethics expertise in low- and middle-income countries (LMICs), the NIH’s Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international Research Ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of Research Ethics in LMICs, and the lessons learned over 12 years of international Research Ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of Research Ethics as applied to LMIC Research, the underpinning and evolution of the Fogarty bioEthics program, and summarize key conclusions from the other papers in the collection.
Jennifer B Mccormick - One of the best experts on this subject based on the ideXlab platform.
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the establishment of Research Ethics consultation services recs an emerging Research resource
Clinical and Translational Science, 2013Co-Authors: Jennifer B Mccormick, Holly A Taylor, Benjamin S Wilfond, Richard R Sharp, Abigale L Ottenberg, Carson ReiderAbstract:Emphasis on translational Research to facilitate progression from the laboratory into the community also creates a dynamic in which Ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with Research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational Research pathway.
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biomedical scientists perceptions of ethical and social implications is there a role for Research Ethics consultation
PLOS ONE, 2009Co-Authors: Angie Boyce, Jennifer B Mccormick, Mildred K ChoAbstract:Background Research Ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical Research. A number of these programs are modelled after clinical Ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science Researchers' perceived need for and utility of Research Ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with Researchers from Stanford University and a mailed survey in December 2006 to 7 Research universities in the U.S. Findings A total of 16 Researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of Researchers surveyed (51%) reported that they would find a Research Ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects Research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects Research (20% vs 10%; chi2 p<0.001). Conclusion Our findings indicate that biomedical Researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical Researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.
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strangers at the benchside Research Ethics consultation
American Journal of Bioethics, 2008Co-Authors: Mildred K Cho, Sara L Tobin, Henry T Greely, Jennifer B Mccormick, Angie Boyce, David MagnusAbstract:Institutional Ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical Researchers. We discuss several models of Ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As Research Ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of Research Ethics consultation, based on our initial experiences in a pilot program.
Angie Boyce - One of the best experts on this subject based on the ideXlab platform.
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biomedical scientists perceptions of ethical and social implications is there a role for Research Ethics consultation
PLOS ONE, 2009Co-Authors: Angie Boyce, Jennifer B Mccormick, Mildred K ChoAbstract:Background Research Ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical Research. A number of these programs are modelled after clinical Ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science Researchers' perceived need for and utility of Research Ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with Researchers from Stanford University and a mailed survey in December 2006 to 7 Research universities in the U.S. Findings A total of 16 Researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of Researchers surveyed (51%) reported that they would find a Research Ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects Research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects Research (20% vs 10%; chi2 p<0.001). Conclusion Our findings indicate that biomedical Researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical Researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.
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strangers at the benchside Research Ethics consultation
American Journal of Bioethics, 2008Co-Authors: Mildred K Cho, Sara L Tobin, Henry T Greely, Jennifer B Mccormick, Angie Boyce, David MagnusAbstract:Institutional Ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical Researchers. We discuss several models of Ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As Research Ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of Research Ethics consultation, based on our initial experiences in a pilot program.
