Developing a Living Donor Ethics Framework

This chapter advances an ethical framework for living donor transplantation. Given the analogies between living donor transplantation and human subjects research, the three principles enumerated in the National Commission’s Belmont Report are adopted as the starting point: respect for persons, beneficence, and justice. Two additional principles are also adopted: the principle of vulnerability and the principle that special relationships create special obligations. Whereas the Belmont Report discussed vulnerable groups, vulnerability is more aptly understood as an assortment of vulnerabilities that may apply to different people in different circumstances at different times of their lives. Eight distinct but overlapping vulnerabilities are described: capacitational, juridic, deferential, social, medical, situational, allocational, and infrastructural. The living donor advocate team (LDAT) stands in special relationship with the potential living donor and supports living organ donation provided that the living donor successfully addresses the challenges to autonomy and voluntariness that these vulnerabilities pose.

Using IRB Protocols to Teach Ethical Principles for Research and Everyday Life

Undergraduate research as a high-impact practice demonstrates many positive benefits for students, but little research has delved into the impact of ethical training for research, in particular submitting Institutional Review Board (IRB) protocols to determine if the study meets ethical standards for the treatment of human subjects. This study explored if students in two experimental and one nonexperimental research methods class benefited from increased knowledge of research ethics and how to apply them in daily-life situations if they participated in various aspects of IRB protocol procedures either as part of a class-based research project or by completing an IRB protocol activity for developing a hypothetical program to help families. Some students in all three classes had previously engaged in a 4-hr online extended training [the Collaborative Institutional Training Initiative (CITI) Program] in research ethics focused on the Belmont Report principles of beneficence, respect, and justice, but not in IRB protocols. Students were given a pre- and posttest to assess knowledge in both research and daily-life settings for applying the Belmont Report research ethics principles. Results indicate students gained greater knowledge of research ethics when they completed IRB protocol training during a class-based undergraduate research or program-design project, even if they had already completed some extended case-based training in the CITI Program. Results are discussed in terms of the value of using modified IRB protocol approaches as a high-impact practice to teach ethics in research and daily life to students.

Some Questions of Ethics in RCTs

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

Ethical Considerations in Clinical Biochemistry and Laboratory Medicine: A Discussion Based on ‘The Belmont Report’

With technical sophistication and innovation in the field of medical science, a considerable proportion of medical diagnosis now rely on laboratory analyses, which emphasises the crucial role of laboratory physicians in patient care. Sustaining high ethical standards remains crucial in both clinical biochemistry and laboratory medicine, and several ethical dilemmas are faced by laboratory physicians in day-to-day practice. In a low-resource country like Bangladesh, formal ethics education or ethical framework in laboratory practice is still absent; ethics has not received that much attention it this field. This paper has considered ethical issues encountered during the daily routine work of laboratory physicians and specially focused on the ethical issues encountered during the pre-analytical, analytical and post-analytical phases of laboratory medicine practice and discuss those issues in light of ‘The Belmont Report’ (1978) perspective. It is not intended to be a comprehensive one, rather it aims to complement existing guidelines and documents that are available in some institutions and to offer a framework for addressing ethical issues encountered in the practice of clinical biochemistry and laboratory medicine in Bangladesh.

First do no harm: An exploration of researchers’ ethics of conduct in Big Data behavioral studies

Research ethics has traditionally been guided by well-established documents such as the Belmont Report and the Declaration of Helsinki. At the same time, the introduction of Big Data methods, that is having a great impact in behavioral research, is raising complex ethical issues that make protection of research participants an increasingly difficult challenge. By conducting 39 semi-structured interviews with academic scholars in both Switzerland and United States, our research aims at exploring the code of ethics and research practices of academic scholars involved in Big Data studies in the fields of psychology and sociology to understand if the principles set by the Belmont Report are still considered relevant in Big Data research. Our study shows how scholars generally find traditional principles to be a suitable guide to perform ethical data research but, at the same time, they recognized and elaborated on the challenges embedded in their practical application. In addition, due to the growing introduction of new actors in scholarly research, such as data holders and owners, it was also questioned whether responsibility to protect research participants should fall solely on investigators. In order to appropriately address ethics issues in Big Data research projects, education in ethics, exchange and dialogue between research teams and scholars from different disciplines should be enhanced. In addition, models of consultancy and shared responsibility between investigators, data owners and review boards should be implemented in order to ensure better protection of research participants.

Reconciling Lists of Principles in Bioethics

In celebration of the fortieth anniversary of the publication of Beauchamp and Childress’s Principles of Biomedical Ethics, a review is undertaken to compare the lists of principles in various bioethical theories to determine the extent to which the various lists can be reconciled. Included are the single principle theories of utilitarianism, libertarianism, Hippocratism, and the theories of Pellegrino, Engelhardt, The Belmont Report, Beauchamp and Childress, Ross, Veatch, and Gert. We find theories all offering lists of principles (or the equivalent) numbering from one to ten. Many of the differences can be reconciled, but some critical differences remain.