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Item Confronting the ethics of pandemic influenza planning: communiqué from the 2008 Summit of the States(Indiana University Center for Bioethics, 2008-07)Recognizing the vital role that public health departments play in planning for an outbreak of pandemic influenza, this “Summit of the States” was convened on July 14-15, 2008, on the campus of Indiana University-Purdue University Indianapolis (IUPUI) by the Association of State and Territorial Health Officials, the Indiana State Department of Health and the Indiana University Center for Bioethics. Invitations were extended to all 50 states, 6 territories and the District of Columbia. More than 150 delegates from 35 jurisdictions accepted, making this one of the largest gatherings of senior leadership from state and territorial public health departments ever convened to discuss the ethical issues in pandemic influenza planning.Item Data points on the growth of international human subjects research(http://bioethics.iu.edu/, 2011-02-23) Odell, Jere D.This fact sheet provides a referenced list of data points demonstrating the growth of internationalization in clinical research. In 2008, 78% of all subjects in U.S. funded clinical trials were enrolled in non-U.S. sites.Item Diverse Perspectives: Considerations About Embryonic Stem Cell Research(2006-09-01T18:18:29Z) Indiana University Center for Bioethics, Stem Cell Study GroupSince the initial isolation of human embryonic stem cells in 1998 (Thomson et al. 1998), important developments in research have offered the promise of valuable therapeutic breakthroughs while continuing to raise significant social, ethical, legal and policy challenges. Among the interests of the Indiana University Center for Bioethics (IUCB) is a desire to engage issues of this kind, and in so doing, to provide a resource to the IU community, to Indiana, and to the entire country. The topic of stem cell research was, therefore, an appropriate one for discussion at the Center. In January 2002, the IUCB created a Stem Cell Study Group (SCSG). Our primary goal was to provide a forum for informed public discussion of the issues by making use of the considerable local scientific, legal and ethical expertise. In other words, we wanted primarily to educate ourselves about these issues. Our secondary goal was to identify and describe those points on which agreement could be achieved, as well as those issues on which agreement proved difficult if not impossible. This paper summarizes our efforts to meet both of these goals.Item Final Summary Report: Review of Merck-Regenstrief Partnership(Indiana University Center for Bioethics, 2014) Meslin, Eric M.; Gaffney, Margaret M.; Quaid, Kimberly A.; Schwartz, Peter H.; Pitt, Avril Rua; Rager, Joshua B.Item Health Related Philanthropy: The Donation of the Body (And Parts Thereof)(2006-09-05T14:59:22Z) Indiana University Center for Bioethics, Health Related Philanthropy Study GroupThe academic study of philanthropy has focused on private action for the public good, and on the area of various determinants of giving. Yet one very obvious act of giving in the health field has been largely neglected in philanthropic studies; the literal donation of self: blood, tissue, DNA, organs and bodies. There is a long tradition in bioethics research involving the ethical, legal and policy issues associated with donation, including factors involving the donation of bodies and their parts whether for transplantation, treatment, research, or education. This report describes the main outcomes of the Study Group, specifically the results of a national telephone survey conducted on our behalf by the IUPUI Public Opinion Lab; and the publications, scholarly presentations, and related outreach efforts in the media and elsewhere.Item International Research Ethics: A Needs Assessment of Research Ethics Capacity Final Report and Responses(2006-09-11T13:32:14Z) Meslin, Eric M.; Sidle, JE; Wools-Kaloustian, K; Were, E; Salmon, K; Chuani, CInternational collaborative research often raises challenging ethical issues for researchers, review committees and institutions. To date, much of the commentary and discussion surrounding these issues have focused on difficulties in interpreting guidelines, regulations, and policies and on the lack of harmonization. Efforts at regulatory reform and guideline development is one method of contributing to research ethics capacity building, but these are “top-down” approaches involving governments, regulatory agencies, and the challenge of achieving consensus. A complementary strategy is to work from the “ground up”: fashioning collaborative agreements between institutions, ethics review committees, and researchers. Working from the “ground up,” we conducted a needs assessment with participants from the Indiana University School of Medicine and the Moi University Faculty of Health Science in order to determine how best to implement a Memorandum of Understanding (MOU) developed between the two institutions. The MOU was designed to address the working relationship between the two universities with respect to their joint research activities and was the product of a Workshop convened in Eldoret, Kenya in February 2003. This work is a direct result of the MOU which explicitly states that “It is expected and intended that among the actions arising from this MOU will be the development of policies, Standard Operating Procedures and other resources that will address specific issues not mentioned here.” The interviews and focus groups provided a wealth of information about current knowledge, policies, procedures, and systems in place at MU and IU, respectively. They also provided a rich source of ideas for enhancing research ethics capacity.Item Pandemic flu preparedness: ethical issues and recommendations to the Indiana State Department of Health(2009-06-29T16:36:53Z) Meslin, Eric M.; Alyea, Jennifer M.; Helft, Paul R.Four Recommendations are proposed: 1. the State must identify all healthcare workers who are deemed to be critically necessary during the pandemic; 2. the State and healthcare organizations should adopt a “high expectations, no punishment” approach to absenteeism; 3. the State should set and communicate expectations that healthcare institutions have adequate medical supplies and that these institutions ensure these supplies be made available to all personnel expected to interact with patients; and 4. the State should encourage healthcare institutions to establish clear policies for determining sanctions for noncompliance with expected responsibilities that are both fair and responsive to exceptional circumstances.Item Pandemic influenza preparedness: ethical issues and recommendations to the Indiana State Department of Health(Indiana University Center for Bioethics, 2008-08) Meslin, Eric M.; Alyea, Jennifer M.; Helft, Paul R.In August of 2007, the Indiana University Center for Bioethics (IUCB) presented to the Indiana State Department of Health (ISDH) a set of technical advisory documents (TADs) addressing ethical issues that may arise in the event of an influenza pandemic. The topics of altered standards of care, triage, vaccine allocation, and healthcare workforce management all were addressed in these documents, each with its own annotated bibliography. Additionally, IUCB provided to ISDH an ethical framework entitled Points to Consider, which consisted of a set of seven ethical points that the Center believed the State should take into consideration when developing policies and procedures related to pandemic influenza response. Since that time, ethicists, researchers, and policymakers have continued to contribute to the literature and develop policies addressing ethical pandemic influenza planning. As a result, ISDH again contracted with IUCB to update the previous documents with the most current thinking on the respective topics.Item Points to consider in ethically constructing patient-controlled electronic health records(2012-08-31) Meslin, Eric M.; Alpert, Sheri A.; Carroll, Aaron E.; Odell, Jere D.; Schwartz, Peter H.Patient advocates and leaders in informatics have long proposed that patients should have greater ability to control the information in their electronic health record (EHR), including how it can be accessed by their health care providers. The value of such “granular” control, as it has been termed, has been supported prominently in an influential report by the President’s Council of Advisors on Science and Technology (PCAST). Recently, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) funded several projects to study key components of EHR systems, including exploring ways to allow granular control. This “Points to Consider” document provides an overview of the benefits, risks and challenges of granular control of EHRs; a review of the key ethical principles, values, and Fair Information Practices that ought to guide development of an EHR that accommodates granular control, and seven detailed Points to Consider to guide decision making.Item Posthumous assisted reproduction(IU Center for Bioethics, 2011-11-11) McBride, Kalli D.