IU Center for Bioethics Reports
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Published reports generated through Center activities and research.
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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 Posthumous assisted reproduction(IU Center for Bioethics, 2011-11-11) McBride, Kalli D.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 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 Public Attitudes Regarding Genetic Research: Summary of Methods and Findings(2009-10-09T21:31:24Z) Survey Research Center at IUPUI; Wolf, James G.The Indiana University School of Medicine Center for Bioethics Program in Predictive Health Ethics Research commissioned the Survey Research Center at IUPUI to conduct a random-digit-dial telephone survey of Indiana residents in an effort to determine the following: the public’s perception of its own understanding of medical and genetic research, public confidence in medical and genetic research, the likelihood of participation if asked, and the sense of public control of genetic research. The following report details the main findings from this research.Item Relevant academic literature, applicable federal regulations for the protection of human subjects on emergency research involving artificial/substitute blood products (including PolyHeme)(Indiana University Center for Bioethics, 2006-03-27) Brown, BrandonFederal oversight of research involving human subjects is found in two regulatory regimes within the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). 21 CFR 50, 56 - the Office of Human Research Protections (OHRP), and 45 CFR 46. Generally, any research that is testing a drug, device, or other product that will be submitted for FDA approval must follow their regulations (21 CFR 50/56), while research that is supported by federal funds (e.g., an NIH grant) must also comply at a minimum with 45 CFR 46 Subpart A (the federal policy for the protection of human subjects, also known as the Common Rule), and with Subparts B,C,D as appropriate. While most of the FDA and OHRP regulations are similar (or substantially overlap), there are a number of areas in which they differ. Further, all institutions supported by federal funds must negotiate a Federalwide Assurance with OHRP that provides for all research within an institution to be subject to the Common Rule, regardless of whether the research is federally funded.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 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 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 Report from the PredictER Expert Panel Meeting, November 2, 2007(2008-10-27T16:44:59Z) Barrett, Patrick R.; Meslin, Eric M.; Schwartz, Peter H.; Girod, Jennifer; Odell, Jere D.; Quaid, Kimberly; Wolf, James G.On November 2, 2007, the Indiana University Center for Bioethics convened an expert panel on predictive health research (PHR) as part of the Center’s Program in Predictive Health Ethics Research (http://www.bioethics.iu.edu/predicter.asp) which is supported by a grant from the Richard M. Fairbanks Foundation. The goal of this meeting was to identify the major obstacles and opportunities for engaging the community in PHR. PredictER intends to use the results of this meeting as a first step toward more fully engaging the Indianapolis community in discussions about PHR.