Bioethics Collaborative

Abstract: There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people... [See Details]

Topic: Gene Therapies: Probing the Ethics (open to all) There is understandable excitement about the potential for cellular products and gene therapies to transform the therapeutic landscape for many medical conditions. Although a number of cell... [See Details]

In recent years, the use of artificial intelligence (AI) has steadily increased across many industries, including clinical research. The November 2022 release of OpenAI’s ChatGPT – a large language model that generates human-like output text in... [See Details]

Research ethics since the Belmont Report has rested on the assumption that there is an ethically important distinction between clinical research and clinical care. This distinction has provided the foundation for analyses of numerous bioethical concepts,... [See Details]

N-of-1 trials share a common feature: they are single-subject study designs with the goal of determining how an individual patient responds to treatment intervention(s). These trials can take several forms, spanning different purposes and study populations,... [See Details]

We live in a destabilizing world, where natural disasters, wars, pandemics, and other disruptive events are becoming more common. In clinical research, such disruption is detrimental to research participants and to the advances in scientific knowledge... [See Details]

In November 2017, the MRCT Center published the Post-Trial Responsibilities: Continued Access to Investigational Medicines Guidance Document and Toolkit. This framework outlined a case-based, principled, stakeholder approach to evaluate and guide the ethical responsibilities related to... [See Details]

The roles of sex, gender, and sexual orientation in clinical research are important but underexplored. Discussion at the Bioethics Collaborative focused on two types of ethical issues related to sex, gender, and sexual orientation in clinical... [See Details]

Governments, companies, academic research institutions, and the public are increasingly aware of the value of data, prompting a reevaluation of who “owns,” controls, and benefits from the use of an individual's data. Discussion at the Bioethics... [See Details]

Human challenge studies are a type of research study in which participants are intentionally exposed to a pathogen. These study designs have a long and complicated history, figuring in notorious cases of research abuse (Willowbrook, Guatemala... [See Details]

Institutional Review Boards (IRBs) are responsible for protecting research participants by reviewing the study at initial and periodic review and ensuring that risks are minimized and appropriately balanced with benefits, and that key features of research... [See Details]

Limited English proficiency (LEP) refers to a limited ability to read, speak, write, and/or understand English. The exclusion of individuals with LEP from research is a significant issue, and this exclusion raises issues of justice. Strategies... [See Details]

Despite the potential benefits of community engagement (CE), the rigor, quality, and impact of CE are difficult to assess, in part due to the lack of a standardized understanding of what is meant by CE. Relatedly,... [See Details]

Decentralized clinical trials (DCTs) are clinical trials that are executed in part or in whole through remote modalities, such as telemedicine, healthcare providers who travel to participants’ homes, smart phone applications, and mobile health wearables, inter... [See Details]

AI technologies may be used to facilitate certain aspects of clinical trials, or AI may be the intervention under investigation in a clinical trial or an observational study. Both applications raise questions about data privacy, the... [See Details]

Ethical questions relating to the work of patient advocates in clinical research have been given insufficient attention. What experience and training must a person have to participate in patient engagement in clinical research? What does it... [See Details]

The COVID-19 pandemic has raised novel ethical issues and intensified existing ones in clinical research. From the abundance of ethical issues, the MRCT Center identified 3 topics to initiate discussion at the June 1st Bioethics Collaborative:... [See Details]

Pragmatic clinical trials (PCTs) compare or assess interventions in real-world practice settings, hoping to deliver data on effectiveness and safety that more closely resembles clinical care than explanatory clinical trials that focus on demonstrating efficacy in... [See Details]

Adaptive and platform trials may promise greater efficiency and scientific sophistication, but they also raise ethical questions about the principles of informed consent, clinical equipoise, and justice, in addition to practical challenges. Attendees engaged and expanded... [See Details]

The widespread use of mobile smart devices and wearables has the potential to change how clinical research is conceptualized and conducted. Participants’ data may now be leveraged for a variety of health purposes, including the development... [See Details]

The use of social media in clinical research carries many potential benefits—for example, it enables the creation of valuable support and communication networks for research participants. However, it also carries potential risks, including the possibility that... [See Details]

The MRCT Center Return of Individual Results Work Group has formulated key principles and recommendations on the return of individual results to research participants from clinical trials in which the participants were enrolled (see above). A... [See Details]

This meeting of the MRCT Center Bioethics Collaborative will explore the ethical considerations underscoring the challenge of informed selection of clinical trials. We will examine the responsibilities of various stakeholders within the clinical trial ecosystem, and... [See Details]

Presently, there is no operational framework to guides investigators in designing, and IRBs in evaluating, recruitment methodologies and payment proposals to international research participants. This lack of guidance has been a cause for concern amongst regulators,... [See Details]

Efficacy and safety of medicines can vary depending on a number of intrinsic and extrinsic factors, such as an individual’s genetic background, ethnicity, lifestyle, and age. In appreciation of these differences and in the interest of... [See Details]

Clinical trials are closed prematurely for a variety of reasons, including for scientifically-driven reasons of efficacy, safety, and futility wherein there is no justification for continuing to enroll participants. The majority of clinical trials, however, terminate... [See Details]

The administration of an investigational product via Expanded Access is not meant to answer questions about the product’s safety and effectiveness; rather, it is intended to treat an individual patient with a serious or immediately life-threatening... [See Details]