To Be or Not to Be – A Research Subject

Most people do not know there are different kinds of medical studies; some are conducted on people who already have a disease or medical condition, and others are performed on healthy volunteers who want to help science find answers. No matter what sort of research you are invited to participate in, or whether you are a patient when you are asked, it’s entirely up to you whether or not to do it. This decision is important and may have many implications for your health and well-being, as well as those of other patients now and in the future. Making a good decision – the right one for you – requires you to become educated about topics you may not have thought about before, some of which may be quite complicated. This chapter explains the key issues to help you make a good decision

How Bioethics Principles Can Aid Design of Electronic Health Records to Accommodate Patient Granular Control

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest

Biobanks and Electronic Health Records: Ethical and Policy Challenges in the Genomic Age

In this paper we discuss the ethical and policy challenges presented by the construction and use of biobanks and electronic health records systems, with a particular focus on how these resources implicate certain types of security concerns for patients, families, health care providers and institutions. These two technology platforms are selected for special emphasis in this paper for two reasons. First and foremost, there is a close connection between them. Indeed, of the many accepted definitions, this one from the German National Bioethics Commission provides a sense of this close connection and the great power and reflects the great power these two separate platforms provide to probe more deeply the connection between genotype and phenotype: "...[B]iobanks are defined as collections of samples of human bodily substances (e.g., cells, tissues, blood or DNA as the physical medium of genetic information) that are or can be associated with personal data and information on their donors." Second, these two topics implicate both clinical ethics issues (those arising at the bedside for health care providers and patients), and human research ethics issues (issues arising for scientists, research subjects, ethics review bodies and regulatory authorities). Both of these sub-specialty areas confront similar and complementary ethical issues; for example, issues arising from the nature and adequacy of informed consent, the sufficiency of systems to protect personal privacy and confidentiality, or the need to balance concerns relating to data security and the need to know. A growing research base supports calls for more attention to these issues, and yet current professional ethics frameworks and policy consultation methods are poorly organized and ill-equipped to anticipate and fully address ethical issues in health information technology generally, or to provide adequate ethical assessment of the tools that elicit these issues. Our strategy is to orient readers to the history and context of these issues, to frame several key challenges for researchers and policy makers, and then to close with several recommendations for next steps.Richard M. Fairbanks Foundation, Indianapolis; Grant #UL1RR025761-01, NCRR/NIH: Indiana Clinical and Translational Sciences Institut

Leadership of the Consortium for Health Policy, Law and Bioethics

poster abstractThe Consortium for Health Policy, Law, and Bioethics completed another successful year of educational programs, public outreach, and collaborative research. Educational highlights include (1) offering for the second time, an innovative graduate course co-taught by the three Consortium-directors (Wright, Kinney, Meslin) that is open to students in law, public health, philosophy; (2) The addition of a new “concentration in international research ethics” (offered in the Philosophy Department that is now eligible for joint-degree status with the JD; and (3) approval of a new JD/MSW. Research highlights include (1) twenty publications (2) several grants awarded to Consortium co-directors; $4,958,909.75 and (3) the establishment of year-long a multidisciplinary study group focusing on ethical, legal, social, and policy issues involving comparative effectiveness research. Outreach highlights include nine presentations to community groups, professional associations, and academic institutions

To research (or not) that is the question: ethical issues in research when medical care is disrupted by political action: a case study from Eldoret, Kenya

While considerable attention has been focused on understanding the myriad of ethical analysis in international research in low and middle income countries, new issues always arise that have not been anticipated in guidelines or studied extensively. The disruption of medical care arising as a direct result of political actions, including strikes, postelection violence and related activities, is one such issue that leaves physician-researchers struggling to manage often conflicting professional responsibilities. This paper discusses the ethical conflicts that arise for physician-researchers, particularly when disruption threatens the completion of a study or completion is possible but at the expense of not addressing unmet medical needs of patients. We review three pragmatic strategies and the ethical issues arising from each: not starting research, stopping research that has already started, and continuing research already initiated. We argue that during episodes of medical care disruption, research that has been started can be continued only if the ethical standards imposed at the beginning of the study can continue to be met; however, studies that have been approved but not yet started should not begin until the disruption has ended and ethical standards can again be assured

What Makes International Research Ethical (Or Unethical)?

First lecture in a series: International Research Ethics. February 3, 2006.Co-hosted by the IUPUI Office of International Affairs and the Indiana University Center for Bioethic

Pandemic flu preparedness: ethical issues and recommendations to the Indiana State Department of Health

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.The Indiana State Department of Healt

Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: a case study in international research collaboration

Multinational collaborators in health research face particular ethical challenges when conducting studies involving vulnerable populations such as children. We use an example from our first attempt to implement pediatric assent in the context of a longstanding research and clinical partnership between Kenyan and American medical schools to highlight the ethical and procedural issues related to pediatric assent that must be considered for multinational, pediatric studies. We consider relevant domestic, professional, and international guidelines for assent in pediatric research subjects, and we discuss the particular ethical challenges related to pediatric assent in the Kenyan context. Finally, we propose a way forward for approaching pediatric assent within our collaborative research program in Kenya that may apply to other multinational research partnerships.Fogarty International Center at the National Institutes of Health [R25TW006070]; USAID-AMPATH Partnership, United States Agency for International Developmen

Health-Related Philanthropy: Toward Understanding the Relationship Between the Donation of the Body (and Its Parts) and Traditional Forms of Philanthropic Giving

The academic study of philanthropy has focused on the public good from private action and includes the study of the public good of improving health and studies of the various determinants of giving. Yet one very obvious act of giving in the health field has been largely neglected in philanthropic studies: the donation of the body, such as blood and tissue donation, organ donation, and the donation of one’s body for medical research or education. In August 2003, a research team at the Indiana University Center for Bioethics conducted a study of these two aspects of philanthropy as part of a project titled Health Related Philanthropy: The Donation of the Body (and Parts Thereof). This article describes the project and summarizes the results of a national survey conducted as part of that project