Introduction: Global Justice and Bioethics

This introduction begins with two simple case studies that reveal a background of socio-economic complexities that hinder development. The availability of healthcare and the issue of cross-border justice are the key points to be addressed in this study. The chapters consider philosophy, economics, and bioethics in order to provide a global perspective. Two theories come into play in this book—the ideal and non-ideal—which offer insight on why and how things are done

Canada’s new ethical guidelines for research with humans: A critique and comparison with the United States

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with particular attention to its similarities and differences to the US system and their shared challenges going forward with their changes

Introduction: Case Studies in the Ethics of Mental Health Research

This collection presents six case studies on the ethics of mental health research, written by scientific researchers and ethicists from around the world. We publish them here as a resource for teachers of research ethics and as a contribution to several ongoing ethical debates. Each consists of a description of a research study that was proposed or carried out and an in-depth analysis of the ethics of the study

Streamlining Ethical Review

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical review, and studies that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process

The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, the proposed declaration contains persistent flaws..

The Ethics of Transactions in an Unjust World

In this paper I examine the ethics of benefit-sharing agreements between victims and beneficiaries of injustice in the context of trans-national bodily giving, selling, and sharing. Some obligations are the same no matter who the parties to a transaction are. Prohibitions on threats, fraud and harm apply universally and their application to transactions in unjust contexts is not disputed. I identify three sources of obligations that are affected by unjust background conditions. First, power disparities may illegitimately influence transactions in unintentional ways. Second, better-off individuals have duties to ameliorate injustices. These are not specifically duties to those with whom they interact, though often it is easier and more effective to help those with whom one already interacts. Third, the power differentials created by injustice make exploitative transactions more likely. I summarize a transactional account of exploitation and argue that avoiding exploitation is usually easiest to achieve by ensuring that the more powerful party does not obtain an unfair share of the benefits from the transaction. The beneficiaries of a transaction do not have to be only those individuals directly involved in it. Indeed, in many cases it is thought that exploitation may be avoided by providing benefits to third parties. Working out when this is the case requires working out when a contribution or burden on another’s behalf can count towards the avoidance of exploitation. I argue that it counts as such in two main cases: when the people in question are already involved in relationships of reciprocation, and when the individual making the contribution identifies with the interests of the other people

Introduction: International Research Ethics Education

NIH's fogarty international Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly changing health research landscape. This collection of papers is the result

International Research Ethics Education

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting doctoral and postdoctoral training and career paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training