Bioethics Collaborative
The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
The Bioethics Collaborative Planning Committee chooses discussion topics in advance. The MRCT Center then prepares a case statement of the topic to be discussed and circulates the case statement, relevant examples and readings prior to the meetings. At the end of each Bioethics Collaborative meeting, we consider whether the topic warrants further discussion or development as a publication or other deliverable. In order to promote open dialogue, the meetings are run by ‘Chatham House Rule,’ by which commentary will not be attributed to any individual nor to their institutional affiliation.
For any questions or interest in sponsoring the Bioethics Collaborative, contact us at mrct@bwh.harvard.edu.
Objectives
- Nurture collaboration regarding emerging bioethical issues
- Host productive, thoughtful, and enjoyable meetings
- Produce deliverables derived from Bioethics Collaborative meetings
Project leadership & Staff
- Mark Barnes, JD, LLM. Faculty Co-Director, MRCT Center
- Emina Berbic, MPH. Program Manager, MRCT Center
- Barbara E. Bierer, MD. Faculty Director, MRCT Center
- Luke Gelinas, PhD, MA. Senior Advisor, MRCT Center
- Sarah White, MPH. Executive Director, MRCT Center
- Sarah Evenson, MBE, Project Manager, MRCT Center
With appreciation to the following sponsors:
- Genentech, Inc
- Eli Lilly & Co.
- Johnson & Johnson
- Merck, known as MSD outside of U.S and Canada
- Pfizer, Inc.
- Sanofi
- Takeda Pharmaceuticals
Meetings
Meeting of the Bioethics Collaborative
Topic: TBD This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here. [See Details]
Meeting of the Bioethics Collaborative
Topic: TBD This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here. [See Details]
Therapeutic Misconception Revisited
Location: Hybrid Topic: Therapeutic Misconception Revisited Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed... [See Details]
Location: Virtual Topic: Medical Need or Market Opportunity: Setting Research Priorities Abstract: Since funding and other resources for clinical research are limited, decisions must be made about which research projects to pursue, which not to pursue,... [See Details]
Is It Time to Retire the Concept of Deidentification?
In the US, research with data only qualifies as human subjects research and triggers protections, such as ethics board review and informed consent, when those data are identifiable, defined as “information for which the identity of... [See Details]
Topic: Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research In 2022, the United States Supreme Court ruled, in Dobbs vs. Jackson Women’s Health Organization, against a federal right to abortion. The effects of this ruling continue... [See Details]
Topic: Reciprocity in Research: Does Justice Support Community Investment? Abstract: It is generally agreed that sponsors and other entities undertaking research in limited-resource settings incur certain duties of reciprocity. These obligations ensure that host communities are... [See Details]
Click here to view the Meeting Summary. 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... [See Details]
Gene Therapies: Probing the Ethics
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]
The chat is out of the bag: The future of AI in clinical research
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]
Trials and Tribulations of N of 1 Trials
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]
Emergency Preparedness in Clinical Research
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]
Post-Trial Responsibilities: Continued Access to Investigational Medicines and Devices
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]
Sex and Gender in Clinical Research
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]
Data Ownership, Reciprocity, and Research
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]
Ethical Complexities with Human Challenge Trials
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]
Navigating Interactions Between DMCs and IRBs
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]
Community Engagement
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
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]
Artificial Intelligence in Clinical Research
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]
Patient Advocacy and Engagement in Clinical Research
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 & Real-World Evidence
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]
Ethical Challenges in Adaptive and Platform Trials
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]
Impact of Mobile Devices & Wearable Technologies on the Design and Conduct of Clinical Research
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]
Impact of Social Media on Clinical Trial Integrity
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]
Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities
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]
Diversity in Clinical Research
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]
Early Termination of Clinical Trials
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]
Expanded Access to Investigational Medicines
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]