COVID-19 vaccine research success and emergency use authorizations have shown the life sciences’ potential for positive health impact. But they also underscore potentially divergent and conf...

It is well established that demographic representation in clinical research is important for understanding the safety and effectiveness of novel therapeutics and vaccines in diverse patient populations. In recent years, the National Institutes of Health and Food and Drug Administration have issued guidelines and recommendations for the inclusion of women, older adults, and racial and ethnic minorities in research. However, these guidelines fail to provide an adequate explanation of why racial and ethnic representation in clinical research is important. This article (...) aims to both provide the missing arguments for why adequate representation of racial and ethnic minorities in clinical research is essential and to articulate a number of recommendations for improving diversity going forward.Appropriate racial and ethnic representation and fair inclusion help (1) increase the generalisability of clinical trial results, (2) equitably distribute any benefits of clinical research and (3) enable trust in the research enterprise. (shrink)

Could an accreditation, certification, or rating mechanism help the pharmaceutical industry improve both its bioethical performance and its public reputation? Other industries have used such systems to assess, improve, distinguish, and demonstrate the quality of their services, processes, and products. These systems have also helped increase transparency, accountability, stakeholder confidence, and awareness of industry best practices. This article explains how market forces can be harnessed to recognize and promote better bioethical performance by pharmaceutical companies when there are good systems to (...) accredit, certify, or rate. It concludes with a review of relevant failures of credit-rating agencies — such as conflicts of interests and revolving-door practices — to illuminate some of the pitfalls of developing a bioethics accreditation, certification, or rating system for pharmaceutical companies. (shrink)

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...) protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (shrink)

Timothy Murphy argues in his article “In Defense of Irreligious Bioethics” (2012) that the role of religion in normative bioethics should be limited and that a viable means for limiting its role (o...

This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating. Other industries have used such systems to define best practices, set standards, and assess and signal the quality of services, processes, and products. These systems have also informed decisions in other industries about where to invest, what to buy, where to work, and when to regulate. Similarly, accreditation, certification, and rating programs can help (...) drug companies address stakeholder concerns in four areas: clinical trial design and management, dissemination of clinical trial results, marketing practices, and the accessibility of medicines. To illuminate processes — such as conflicts of interests and revolving-door policies — that can jeopardize the integrity of accreditation, certification, and ratings systems, the article concludes with a consideration of recent failures of credit-rating agencies and a review of the regulatory capture literature. (shrink)

In 1971, President Richard Nixon declared a “war against cancer,” stating that “the same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease.” Nixon signed the National Cancer Act, and shortly thereafter the first national registry listing all ongoing clinical trials for cancer therapies was published by the National Cancer Institute. The registry was proposed by Mary Lasker (“a patroness and advocate of clinical research”) to help doctors (...) find open trials in which to enroll their patients and to help researchers maintain a steady supply of research participants. The registry appeared to be a win for doctors, patients, researchers, and pharmaceutical companies alike. However, it ended up exposing corrupt practices and tensions between ethics, the corporate need for profits, and public health goals. How did this happen? (shrink)

Children and pregnant women are often excluded from clinical research. This has resulted in a paucity of evidence on how medicines work for fetuses, neonates, infants, and adolescents. It also raises bioethics, scientific, and public health concerns. For over half a century, doctors have prescribed medicines to children largely on the basis of how they work in adults, despite children’s varied physiologies and differences in how their bodies absorb and metabolize drugs. Regulations and legislation have led to an increase in (...) the number of pediatric studies and to better drug labeling. However, children at all stages of their lives often remain “therapeutic orphans” owing to insufficient evidence about how medicines work for them. (shrink)

After more than a dozen years of activity, some 161 indictments, 64 arrests, and 47 surrenders, the International Criminal Tribunal for the former Yugoslavia (ICTY) has accomplished a good deal in terms of its primary task of prosecution. Nonetheless, there is still much debate over the state of transitional justice in the Balkans and what has been accomplished. We cannot forget that the ICTY was created with broad political and social purposes in mind, specifically to contribute to the restoration and (...) maintenance of peace. Using a comparative framework, we develop benchmarks of transitional justice outcomes to examine these vague but important and ambitious goals. Although conventional wisdom says that the ICTY is used instrumentally by Balkan leaders who are fundamentally opposed to the court’s existence, we demonstrate that there is also evidence of broader political and social change throughout the region. Thus, we contend that Balkan countries have indeed moved beyond mere prosecution. (shrink)