Focus Area: Current Project
Focus Area: Ethics, Conduct, and Oversight
The Bioethics Collaborative is an impartial forum to propose, share, and discuss ethical frameworks to address issues arising in the context of multi-national clinical trials. Meetings bring together individuals from academia, industry, patient groups, ethics committees, and government. The Bioethics Collaborative meets 3-4 times per year.
A 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. The meetings themselves follow modified “Chatham House Rule” by which commentary will not be attributed to any individual, not to their institutional affiliation. After the meetings, the MRCT Center generates a summary of the issues and discussion for participants. At each meeting, the attendees decide whether and how the summary will be adapted for broader distribution or publication.
The MRCT Center is grateful to the following sponsors of the MRCT Bioethics Collaborative:
- Genentech, Inc.
- Eli Lilly & Co.
- Johnson & Johnson
- Merck, known as MSD outside of U.S. and Canada
- Pfizer Inc.
- Takeda Pharmaceuticals International, Inc.
Impact: Discussion forum for pressing ethical issues in multi-regional clinical trials
- Nurture collaboration regarding emerging bioethical issues
- Host productive, thoughtful, and enjoyable meetings
- Produce deliverables derived from Bioethics Collaborative meetings
Please contact email@example.com if you are interested in sponsoring the Bioethics Collaborative.
- Toolkit: MRCT Center Expanded Access to Investigational Products: A practical Approach for Sponsors, Physicians, and Institutional Review Boards (Dec 2017)
- NEJM Publication: A Framework for Ethical Payment to Research Participants (Feb 2018)
See our Events page.
|Date and Topic||Topic Summary||Output/ Next Steps|
|June 2022: |
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 research. First, while sexual orientation and gender identity (SOGI) are social constructs, disease risk, manifestation, and/or response to treatment may vary by SOGI characteristics. It is important to understand that any variation in disease risk, manifestation, or response, if it exists, is likely related to other underlying differences (e.g., hormonal status). Nevertheless, collecting and analyzing data on sex, gender, and sexual orientation may point to differences that need to be understood biologically to provide safe and effective interventions across diverse populations. Second, research should be respectful and inclusive of individuals of diverse sexes, genders, and sexual orientations. The principles of respect for persons and justice must be considered in addition to that of biologic relevance.||Meeting Summary|
|April 2022: |
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 Collaborative focused on models of data ownership and stewardship in research. The meeting scope included data collected during clinical research and health data from the medical record that are used for research.||Meeting Summary|
|February 2022: 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 STI experiments) but also as important components in treatment advances for conditions that tend to disproportionately impact the world’s worst-off, such as dengue and malaria. The potential for human challenge studies to be leveraged ethically in relation to Sars-CoV-2 has been a matter of recent and significant debate in the bioethics community.||Meeting Summary|
|October 2021: 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 are adequately disclosed to participants. Data monitoring committees (DMCs) play a role in protecting participant safety, ensuring the integrity and credibility of a trial, identifying beneficial treatments early, and advising termination of a trial if a treatment is or is likely to be ineffective. Although IRBs and DMCs share the goal of protecting research participants, the extent to which IRB and DMC responsibilities overlap or diverge is not clear and is often difficult to navigate in practice. Further complicating the division of labor is the fact that IRBs and DMCs rarely communicate directly.||Meeting Summary|
|June 2021: Limited English Proficiency and Translation of Study Materials||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 to accommodate individuals with LEP in research must include consideration of the principles of autonomy and beneficence/non-maleficence; safeguards may be added to ensure that the consent and participation of individuals with LEP is informed and voluntary, and furthermore, that the safety and well-being of individuals with LEP can be maintained throughout their research participation. These ethical considerations must be weighed against the expense and delay of translation and interpreter services.||Meeting Summary|
|April 2021: 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, it can be challenging to define ‘community’ in the abstract, and any decision about how to specify the relevant community will be ethically and politically significant. Other ethical challenges are connected to practical issues, such as identifying individuals who can speak on behalf of a community and/or marginalized populations within a community; engaging individuals without taxing their time or services too much; and how to ensure that there is sufficient reciprocity to the interactions. Finally, it is often difficult for sponsors, sites, and investigators and their study teams to know whether they have achieved representativeness, that is, whether they have heard from an adequate range of perspectives in a community.||Meeting Summary|
|February 2021: 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 alia. Bioethics Collaborative attendees will discuss questions of justice and access, privacy, oversight for research participant safety, and the changing roles and responsibilities of various stakeholders in the research process, among other ethical challenges raised by DCTs.||Meeting Summary|
|November 2020: 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 risks of non-representative and/or biased data, and the appropriate oversight mechanisms for AI in clinical research.||Meeting Summary|
|October 2020: 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 mean for an advocate to be representative, and to what extent are advocates expected to represent the full range of perspectives of patients with the condition or that may be impacted by the proposed research? Are there conflicts of interest (financial and otherwise) that affect patient engagement in clinical research, and if so, how can they be managed?||Meeting Summary|
|June 2020: COVID-19 and Ethical Challenges for Clinical Research||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: 1) clinical equipoise and the standard-of-care for COVID-19 research, 2) clinical trial prioritization amidst a scarcity of resources, and 3) the role of the Institutional Review Board in COVID-19 research. Attendees guided discussion beyond these issues over the course of the Bioethics Collaborative.||Meeting Summary|
|February 2020: 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 a highly controlled setting. PCTs obscure the distinction between research and clinical care more than traditional randomized control trials (RCTs), which in turn raises novel ethical questions concerning informed consent, data privacy, incidental findings, and other issues.||Meeting Summary|
|October 2019: 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 upon these ethical issues and considered strategies for addressing the theoretical and practical challenges they raise for investigators, sponsors, IRBs, participants, and other stakeholders.||Meeting Summary|
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 of remote screening and diagnostic tools, early intervention programs, and the promotion of public health. While these developments can make research participation less burdensome, they also raise ethical and regulatory challenges around acceptable levels of privacy risk, necessary precautions for safeguarding participants’ confidentiality, and the optimal approach to risk mitigation. The promises and potential barriers to integrating mobile devices and wearable technologies in clinical trial workflows was the focus of the May 2, 2019, meeting of the MRCT Center Bioethics Collaborative.||Meeting Summary|
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 participants may share information online in ways that permit themselves, other participants, and/or the research team to be unblinded to key aspects of the research data. These potential risks, as well as the practical approaches by which they may be mitigated, were the topic of the January 22nd meeting of the Bioethics Collaborative.||May 2019: Publication in The American Journal of Bioethics: Social Media as an Ethical Tool for Retention in Clinical Trials|
|Apr. 2018 |
Return of Individual Results to Research Participants and Axes of Communication
|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 number of unanswered questions, however, related to return of individual results to research participants persist. For example, who should communicate urgent results and urgent incidental findings to individual research participants? The lead or site investigators? The referring health care provider? The study sponsors? This meeting explored the pragmatic considerations underlying the return of individual results to research participants and axes of communication.||Meeting Summary|
|Jan. 2018 |
Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities
|Realization of clinical trials’ potential benefits depends largely on successful recruitment of study participants, but significant obstacles to patient recruitment persist. Barriers to clinical trial recruitment are well-studied and include a number of patient-, protocol-, and clinician-related factors, such as perceived complexity of enrollment, lack of resources, and mistrust between patients and providers. The current landscape of clinical trial resources is fragmented, which prevents the informed selection of clinical trials in which to enroll.||Meeting Summary|
|Oct. 2017 |
Recruitment of and Fair Payment to International Research Participants
|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, trialists, advocacy groups, and research participants –especially when conducting clinical trials in low-and middle-income countries (LMICs).||February 2018: Publication in the NEJM: A Framework for Ethical Payment to Research Participants|
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 generating generalizable knowledge—the participant population enrolled in a clinical trial ought to be representative of the general population. Despite this normative ideal, underrepresentation of gender, sex, ethnic, and racial minorities in clinical trials persists.||October 2017: Establishment of new MRCT Center project: Representation of Diverse Populations in Clinical Trials|
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 early as a result of operational issues—such as inadequate recruitment, commercial product viability, insufficient funding or resources, or de-prioritization by an investigator, institution, or sponsor. The decision to terminate a trial raises complex ethical questions regarding the appropriate communication with and responsibilities owed to participants.||Meeting Summary|
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 disease or condition for which no satisfactory alternative therapy exists. In the absence of robust guidance for assessing requests for expanded access, physicians and sponsors are left without a critical understanding of the legal, ethical, and financial considerations that ought to influence expanded access determinations.||December 2017: Toolkit MRCT Center Expanded Access to Investigational Products: A practical Approach for Sponsors, Physicians, and Institutional Review Boards|
- Mark Barnes, JD, LLM. Faculty Co-Director, 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
- Walker Morrell, BSc, Project Manager, MRCT Center
Contact Information: firstname.lastname@example.org