Current Project Archives

Policy Engagement

Policy Engagement

The MRCT Center works to improve the integrity, safety, and rigor of global clinical research by shaping policies that foster ethical, responsible, and accessible research practices. Contributing to policy engagement and public dissemination by submitting public commentary on regulatory proposals, draft guidance, and policies ensures that evolving frameworks, guidelines, and rules reflect the needs of research participants, sponsors, investigators, and the broader scientific community. Our ongoing engagement demonstrates our dedication to strengthening research integrity through thoughtful feedback on evolving regulations, promoting participant protection and ethical considerations, and encouraging innovation and practical implementation. Our submissions address a wide range of critical topics, shaping policies and practices that impact sponsors, researchers, and participants in the U.S. and worldwide. These contributions help ensure that research remains rigorous, responsible, and accessible.

OBJECTIVES

Enhance research integrity by providing thoughtful comments on evolving federal regulations to ensure clinical research remains ethical, transparent, and responsible.
Promote participant protection by advocating for global policies and practices that prioritize the rights, safety, and inclusion of research participants.
Encourage ethical innovation by supporting regulatory frameworks that foster advancement while maintaining rigorous ethical and practical standards.
Foster stakeholder engagement by bridging the needs of sponsors, researchers, and participants, contributing to policy writing and regulatory discussions that shape effective, transparent, and patient-centered research.

KeY MILESTONES

Public comments submitted to federal and international agencies

project Leadership & sTAFF

Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Faculty Director, MRCT Center
Julia S. Etkin, MBE Candidate, Research Assistant II, MRCT Center

Project Resources

Research Ethics Committee Systems Optimization

Research Ethics Committee Systems Optimization

The MRCT Center collaborates with the World Health Organization (WHO), the African Vaccine Regulatory Forum (AVAREF), and other local organizations to build capacity for National Ethics Committees (NECs) across Africa and worldwide. Our work aims to strengthen the ability to apply ethical principles to the review of research, harmonize the clinical trial application review process, and build a robust, competent, and efficient system for the ethics review of clinical research in African countries. In support of that effort, we are co-creating common tools, templates, and other resources for use by ethics committees across Africa and beyond. We aim to develop and deliver curricula to strengthen and improve the clinical research process.

The online, on-demand training course on Ethics and Review of Interventional Clinical Research course is now freely available on the WHO Academy platform. Development for the second course in the series, Ethics and Review of Interventional Clinical Research II, is ongoing and anticipated to be available in the fall of 2025.

In 2025, the MRCT Center joined the Africa Clinical Trial Regulatory and Ethics System Optimization project as a Core Project Team Member. In this role, the MRCT Center will lead system assessments using the WHO Global Benchmarking Tool for Ethics Committees, provide training and capacity building for NECs/Institutional Review Boards (IRBs), define and implement an IRB reliance approach, and develop a national accreditation program under the NEC. Additionally, the MRCT Center will work collaboratively with the group to create a model fee structure for NECs to enable them to charge differentiated and meaningful fees, develop a financial sustainability plan, and support the development of robust ethics systems that integrate effectively with national regulatory authorities. This work is being carried out in collaboration with AVAREF and is supported by funding from the Gates Foundation.

OBJECTIVES

Help ensure that regional, national, and local ethics committees (ECs) are guided by established international and national ethics guidelines.
Help conduct assessments and provide targeted improvements to NECs using the WHO’s benchmarking tool for ECs.
Contribute to the development of individual development plans (IDPs) following WHO-based assessments, to understand needs and opportunities of NECs and the systems of ethical review.
Utilizing IDPs to identify common needs and challenges, develop sharable resources and support.

KeY MILESTONES

February 2025: Kick-off meeting with core team for the Africa Clinical Trial Regulatory and Ethics System Optimization project
October 2024: Released online course “Ethics and Review of Interventional Clinical Research”
February 2024: Meetings in Rwanda and Zimbabwe to strengthen and sustain the clinical trial ecosystem in Africa
January 2024: Meetings in Ethiopia for assessment of clinical trial system
May 2023: Presented MRCT Center’s capacity building effort at AVAREF meeting in Cameroon
December 2022: Clinical Trial Optimization visit in Kenya and Nigeria
March/April 2022: Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa- Part 2
September 2021: Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa – Part 1

project Leadership & sTAFF

Barbara E. Bierer, MD, Faculty Director, MRCT Center
Sarah White, MPH, Executive Director, MRCT Center
Willyanne DeCormier Plosky, DrPH, Program Director, MRCT Center
Hayat Ahmed, MSc, Program Manager, MRCT Center
Lauren Otterman, MBHL, Project Manager, MRCT Center

Project Resources

Environmental Sustainability in Clinical Trials

Environmental Sustainability in Clinical Trials

While clinical trials contribute only a small percentage of greenhouse gas (GHG) emissions within the healthcare sector (estimated to contribute 8-12% of overall healthcare related GHG emissions), each stakeholder is responsible for understanding one’s contributions, and all must play their part in mitigation efforts.

The MRCT Center is exploring the complex set of issues related to environmental sustainability in clinical trials.

A series of in-depth discussions with multiple parties identified critical areas and potential approaches, such as the development of standardized carbon footprint analyses for clinical trialsand the assessment of current emission reporting standards.

Building on these insights, we advocated for multi-stakeholder investment in environmentally sustainable practices across the clinical trial lifecycle, including practical and actionable steps each stakeholder in the clinical trial enterprise can take and makes the case for stakeholder consideration of action in the collective effort to achieve net zero emissions while maintaining the value and integrity of clinical trials. A key priority is ensuring that only informative and necessary trials that generate meaningful and actionable data are conducted. Additionally, we recognize that opportunities for improvement exist at every stage of the clinical research lifecycle.

Contact Information: mrct@bwh.harvard.edu

OBJECTIVES

Increase awareness of environmental sustainability in clinical trials through engagement with stakeholders, supporting existing initiatives, and positioning the MRCT Center as a collaborator and possible convener.
Amplify existing efforts to garner buy-in from all involved stakeholders.
Elucidate mitigation opportunities while addressing the complexities and trade-offs accompanying decision-making for clinical trials.

KeY MILESTONES

July 22, 2024: Lisa Koppelman (virtually) presented MRCT Center findings to date at a meeting of The Greener Trials Consortium (UK)
March 2024: Completed a thematic analysis of scoping calls
February 2024: Completed a series of 6 group scoping calls with 4-6 participants each and several additional individual scoping calls, representing the UK, Europe, the US, and South Africa; Stakeholders included academic researchers; clinical trialists; industry

project Leadership & sTAFF

Lisa Koppelman, MSW, LICSW, MPH, Program Director, MRCT Center
Trevor Baker, MS, Program Manager, MRCT Center
Barbara Bierer, MD, Faculty Director, MRCT Center

Project Resources

Artificial Intelligence (AI) and Ethical Research

Artificial Intelligence (AI) refers to machine-based systems that learn from data and “learn” to perform tasks such as making predictions. Using algorithms and models, AI systems can process vast amounts of information to make recommendations or decisions that influence real or virtual environments. AI can be narrowly focused on completing a specific task but can also be purposed more generally, aiming to replicate human intelligence across multiple domains.

In 2024, the MRCT Center established a project to explore the ethical considerations when using artificial intelligence (AI) in research. AI is rapidly being deployed across all aspects of research, including as the intervention itself and in the design, planning, and analysis stages. As with all research involving human participants, research with AI should be grounded in existing ethical principles and governing regulations to protect participants.

The MRCT Center, in collaboration with WCG Clinical, convened a task force to develop resources to address ethical and regulatory challenges during the IRB review of clinical research protocols involving AI. This collaborative project includes representatives from academia, industry, AI technologists, and IRB ethicists, members, and chairs to develop resources designed to assess research protocols and evaluate the risk-to-benefit ratio of AI deployed across various aspects of clinical trials, including informed consent considerations, patient safety, and data privacy and confidentiality.

The MRCT Center is also exploring the expanding uses of data and AI in support of clinical trials, particularly the increasing use of digital twins and synthetic data to create virtual simulations of patient outcomes and evaluate the technical, ethical, and practical considerations involved.

OBJECTIVES

Identify and analyze key ethical and regulatory considerations in clinical research involving AI.
Develop practical and actionable resources to strengthen the capacity of IRBs, ethicists, investigators, and sponsors to protect participants in research as AI is deployed in research.
Convene multidisciplinary discussions through task forces, panels, and webinars to address emerging ethical issues.
Explore and develop guidance on the responsible use of digital twins, synthetic data, and other AI-driven research innovations.

KeY MILESTONES

November 2024: Organized a panel session during the MRCT Center’s Annual Symposium on the Expanding the Uses of Data and AI in Support of Clinical Trials, beginning the Digital Twins and Synthetic Data workstream.
March 2024: Convened the first meeting of subject matter experts for the MRCT Center & WCG task force for the ethical review of research protocols involving AI.

project Leadership & sTAFF

Barbara Bierer, MD, Faculty Director, MRCT Center
Donna Snyder, MD, MBE, Executive Physician, WCG Clinical
Trevor Baker, MS, Program Manager, MRCT Center

Project Resources

Cell and Gene Therapies

Cell and Gene Therapies

There is justified excitement about the emergence and potential of cell and gene therapies (CGT): a number of CGTs have recently received market approval and hundreds more are in preclinical and/or clinical development. As a new therapeutic class, there is still much to learn about the benefits and risks of CGT, necessitating complex decision-making and long-term follow-up in many trials. Many CGTs also have complex manufacturing and/or supply chain challenges. For these reasons and because of the need for specialized clinical expertise, trial sites are often geographically limited. The CGT project aims first to ascertain and characterize the ethical, regulatory, and logistical issues that are arising in the specific context of CGT research and development. We will then work to address and mitigate these challenges through a collaborative, multi-stakeholder approach.

OBJECTIVES

Identify and characterize ethical, regulatory, and logistical challenges arising in the context of global research and development of cell and gene therapies.
Employ a multi-stakeholder approach to co-develop actionable and practical mechanisms for addressing these challenges to support efficient, safe, and respectful clinical development of CGT products.

KeY MILESTONES

December 2024: Carolyn Chapman spoke at the Institute for Advanced Clinical Trials for Children (I-ACT)’s webinar, “Science Applications and Ethics of Cell and Gene Therapy”
December 2024: “What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges” webinar, co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group
September 2024: Launch of the Long-Term Follow-Up Working Group and of the Strategic Advisory Committee
May 2024: Poster presentation at ASGCT meeting in Baltimore, Maryland
December 2023: MRCT Center Bioethics Collaborative, “Gene Therapies: Probing the Ethics”

project Leadership & sTAFF

Carolyn Riley Chapman, PhD MS, MRCT Center. Lead Investigator, Brigham and Women’s Hospital and Member of the Faculty, Harvard Medical School.
Barbara E. Bierer, MD, Faculty Director, MRCT Center.
Sarah White, MPH, Executive Director, MRCT Center.
Emina Berbic, Program Manager, MRCT Center

Project Resources

Oversight and Implementation of Decentralized Clinical Trials

The MRCT Center is collaborating with Medable and other organizations to address the oversight and conduct of decentralized and hybrid clinical trials (collectively, DCTs), with a focus on planning and monitoring the trial appropriately.

While almost every trial utilizes some elements of technology, DCTs are highly variable in terms of the elements of ‘decentralization’ deployed throughout the trial, from remote recruitment utilizing social media, electronic consent, remote visits through either virtual visits or local providers, and use of devices and software for data collection, among others. There is also significant variability in IRB understanding of DCTs and, therefore, often prolonged delay in approval.

Working with a multi-stakeholder task force, the first initiative of this project addresses the ethical review of DCTs, focusing on how DCTs differ from traditional clinical trials. Next, specific recommendations for the roles and responsibilities of PIs (including PI oversight) and sponsors will be addressed.

OBJECTIVES

Provide guidance and tools for IRBs, sponsors, investigators and their study teams regarding ethical review and approval of DCTs
Consider the specific responsibilities of principal investigators, sub-investigators, study staff, sponsors, and vendors in DCTs
Develop resources for use by stakeholders involved in DCTs

KeY MILESTONES

February 2024: Launch of “PI Oversight in DCTs” taskforce
June 2023: Release of the IRB/EC Considerations for DCT Review
June 2023: Launch webinar “Ethical review of Decentralized Clinical Trials: Tools, resources and best practices”
May 2023: Meeting held in Washington DC with Key stakeholders to discuss PI Oversight in DCTs
March 2023: A multi-stakeholder workgroup of ~30 people has completed a series of meetings, and the core team developed deliverables for ethical review of DCT trials
June 2022: Conclusion of task force meetings; key deliverable development begins
October 2021: Launch of DCT taskforce

project Leadership & sTAFF

Barbara Bierer, MD., Faculty Director, MRCT Center
Emina Berbic, MPH, Program Manager, MRCT Center
Pam Tenaerts, MD., Chief Scientific Officer, Medable, Inc.
Andre Chiriac, MD., Vice President of Medical, Medable, Inc.

Task Force Members

Luke Bates, Medable
Lora Black, Sanford Health
Dave Borasky, WCG
Christina Brennan, Northwell
John Campbell, Walgreens
Penny Carlson, Takeda
David Carruthers, Abbvie
Cathy Collins, Headlands Research
Karen Hartman, Mayo Clinic
Amanda Higley, Advarra
Patricia Hurley, ASCO
David Jensen, Duke Clinical Research Institute
Hassan Kadhim, Vertex Pharmaceuticals
Maimah Karmo, Tigerlily Foundation
Greg Licholai, ICON
Trevan Locke, Duke Margolis Center
Therica Miller, Mount Sinai
Amy Nos, Minnesota Cancer Clinical Trials Network
Julie Ozier, Advarra
Robert Romanchuk, Advarra
Gabriele Schwarz, BfArM – Germany
Denise Snyder, Duke University
Rebecca Stanbrook, Novartis
Theresa Strong, Novartis
Ramita Tandon, Walgreens
Colleen Tenan, Javara
Ramya Thota, Intermountain Health
Neil Weissman, Medstar

Project Resources

Health Literacy in Clinical Research

Health Literacy in Clinical Research Project-Specific Website

Principles of health literacy provide a basis from which to adopt and integrate health literacy practices into clinical research.

Project-Specific Website

Health Literacy in Clinical Research

Clear research communications that are understandable to patient and participant communities are critical to inclusive, representative research studies.

After completing work on return of research results that included a focus on health literacy, in 2018 the MRCT Center convened a workgroup of diverse representatives from across the research ecosystem to address the issue of limited health literacy in the clinical research context. Guided by the fundamental belief that communicators are responsible for sharing information in ways that are designed to promote understanding and empowerment, one of the workgroup’s goals was to develop clinical research-focused health literacy resources that support the integration of health literacy strategies across the clinical trial life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.

Click Here to access our interactive project-specific website >

Since then, we strive to develop MRCT Center deliverables with an eye towards promoting understanding, especially when the audience includes patients, participants, and caregivers. Our plain language, patient-centric Clinical Research Glossary which was piloted in 2020 continues to grow via a collaborative consensus-building workgroup and adopted as a CDISC global standard in April 2023.

Our newly expanded Clinical Research Glossary launched in April 2024 and includes over 110 new terms and their definitions, customized images for most of the terms, and additional information and resources to provide users with valuable background information. Looking ahead, each new term and its definition, will continue to go through the robust, consensus-based creation process as well as the CDISC public review process that invites external users to share their feedback. Further, the Clinical Research Glossary has improved search functionality, supportive accessibility features, and ample opportunities to share feedback on the site itself. The content is also easier to download for external users in a variety of formats.

Other Health Literacy in Clinical Research efforts include a suite of Data Literacy Infographics to be released in summer 2024, an ongoing virtual Health Literacy Training and Checklist for IRBs, and COVID-19 Research Flyers.

Objectives

Establish and support initiatives that increase the use of health literacy best practices when developing clinical research-related communications for patients, participants and their caregivers.
Develop and share resources with sponsors and funders, investigators and their study teams, and institutional review boards that maximize their efforts to integrate health literacy principles throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.
Promote the use of plain language in clinical research via a harmonized, patient co-developed Clinical Research Glossary that can be used across the research industry, and used by research professionals and potential participants to foster clear, bi-directional information exchange.

Key Milestones

September 2024: Released Version 2.0 of the Clinical Research Glossary
September 2024: Published “Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age” in Medical Writing
April 2024: Launched expanded Clinical Research Glossary
October 2023: Presented “Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials” webinar
June 2023: Published “Communicating complex numeric information in clinical research” in Frontiers.
April 2023: MRCT Center and CDISC announce collaboration solidifying the Clinical Research Glossary as a CDISC global standard
June 2022: Launched online Health Literacy Training for IRBs
March 2022: Launched Clinical Research Glossary Expansion activities
August 2021: Released health literacy resources for IRBs
June 2021: Launched Clinical Research Glossary
June 2020: Launched Plain Language Clinical Research Glossary Pilot workgroup
May 2020: Released COVID-19 research fliers that were developed and designed using health literacy best practices.
March 2020: Launched a small Taskforce to develop a training resource on Health Literacy Considerations for Institutional Review Boards
October 2019: Launched interactive Health Literacy in Clinical Research website
April 2018: Health Literacy in Clinical Research Workgroup launch

Project leadership & STAFF

For Health Literacy in Clinical Research project, please link here.

For Clinical Research Glossary, please link here.

Project Resources

Joint Task Force for Clinical Trial Competency

Joint Task Force for Clinical Trial Competency Project-Specific Website

Explore our project-specific website, that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.

Project-Specific Website

Joint Task Force for Clinical Trial Competency

The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators and clinical research professionals that has developed a framework that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.

The MRCT Center initially co-led an effort in 2013 to convene a group of diverse stakeholders to align and harmonize core competencies for clinical research professionals into a single, high-level set of standards that could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. Since the Harmonized Core Competency Framework was released in 2014, clinical trial researchers and training organizations have been able to rely on a single set of harmonized competencies for training and qualification purposes. Institutions around the world have utilized and applied the Framework to develop job descriptions, training modules, and other resources. The MRCT Center continues to lead the Joint Task Force for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally.

Click Here to Access our Interactive Project-Specific Website >

Objectives

Continuously assess and evolve the JTF Core Competency Framework for Clinical Research Professionals to meet the needs of clinical researchers globally
Develop additional resources to aid in the professional development of clinical researchers
Convene virtual biannual meetings of the JTF

key milestones

March 2025: Launch of “Co-Creating Clinical Research Competencies to Support Effective Patient Partner Engagement Activities” Workgroup
December 2024: Biannual Global Meeting (Executive Summary and conference slides are available)
August 2024: Published Portuguese translation of the Core Competency Framework
June 2024: Biannual Global Meeting (Executive Summary and conference slides are available)
April 2024: Published Arabic translation of the Core Competency Framework
November 2023: Biannual Global Meeting (Executive Summary and conference slides are available)
October 2023: Published Korean translation of the Core Competency Framework
August 2023: Published Chinese translation of the Core Competency Framework
May 2023: Biannual Global Meeting (Executive Summary and conference slides are available)
April 2023: Published the Italian translation and the Vietnamese translation of the Core Competency Framework
February 2023: Published the Bahasa Indonesia translation of the Core Competency Framework
January 2023: Published the Thai translation of the Core Competency Framework
November 2022: Second JTF Strategic Global Meeting (Executive Summary and conference slides are available)
June 2022: Published French translation of the Core Competency Framework
May 2022: Strategic Global Meeting (Executive Summary and conference slides available)
March 2022: Published Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training
June-November 2020: Conducted Self-Assessment Survey of Clinical Research Competency
February 2020: Launched Version 3.1 of Core Competency Framework, including changes from Clinical Project Management Workgroup
January 2020: Published the Japanese translation of the Core Competency Framework
February 2019: Launched new Joint Task Force for Clinical Trial Competency project website and launched workgroup for Clinical Project Management (CPM)
December 2018: Released summary of Leveling the Harmonized Core Competency Framework Version 3.0, including leveled competencies, at MRCT Center Annual Meeting
October 2018: Published the Spanish translation of the Core Competency Framework
October 2018: Published Leveling of Joint Task Force Core Competencies for Clinical Research Professionals
April 2018: Joint Task Force for Clinical Trial Competency was one of three finalists for the ACRP Innovation in Workforce Development Award
December 2017: Released Summary of Harmonized Core Competency Framework Version 2.0 at MRCT Center Annual Meeting
November 2016: Initiated 2 new workgroups in the wake of the workshop:
The Revisions Workgroup, constituted to update the Harmonized Core Competency Framework based on suggestions from implementers and stakeholders;
and The Levelling Workgroup, to define and stratify competencies at fundamental, skilled, and advanced levels.
October 2016: Convened Joint Task Force Core Competencies Workshop to discuss real world applications and potential future revisions of competency framework
June 2014: Disseminated Framework through simultaneous publication in 5 peer reviewed journals including Clinical Researcher, Journal of Clinical Research Best Practices, and CenterWatch White Papers
March 2013: Convened first meeting of stakeholder groups including industry, academia, clinical research organizations, clinical sites, and professional societies; the group was termed the Joint Task Force for Clinical Trial Competency

project leadership & Staff

Barbara E. Bierer, MD, Faculty Director, MRCT Center, Co-Chair, Joint Task Force for Clinical Trial Competency
Stephen Sonstein, PhD. Co-Chair, Joint Task Force for Clinical Trial Competency
Carmen Aldinger, PhD, MPH, PMP, Project Manager

Project Resources

Return of Individual Results

Return of Individual Research Results Project-Specific Website

The guidance, recommendations, and tools on this website can further enable researchers to return individual research results (IRR) to participants.

Project-Specific Website

Return of Individual Results

The practice of returning individual research results (IRR) has been identified consistently by research participants as desired and, often, expected. Returning individual research results can benefit individuals, communities, and the research enterprise by increasing trust and transparency in research, and by adding value to research participation.

The MRCT Center first convened a workgroup in 2015 to address the absence of standard guidelines and criteria related to returning IRR. SACHRP provided initial guidance for return of individual research results in 2016, and the MRCT Center released recommendations in guidance and toolkit documents in 2017.

Despite significant attention and effort, as well as consensus on the importance of returning individual research results, adoption of the practice continues to lag. To respond to this need, the MRCT Center convened a taskforce to further detail the challenges associated with returning IRR and create guidance to specifically address and move beyond those challenges. These updated resources were released in 2022, followed by a series of case studies to highlight scenarios where individual results and data were successfully returned to participants.

The MRCT Center invites the research community to consider how to start returning individual results and data back to participants, and to share their experiences of using the updated Guidance and Toolkit.

Click Here to Access Project-Specific Website >

Objectives

Identify both the opportunities and common barriers encountered throughout the process of returning individual research results
Provide guidance and resources to help organizations return individual research results in a respectful and compliant manner
Promote the value of organizations to prepare for and prioritize returning individual research results

Key Milestones

Summer 2023: Facilitated Digging Deeper Webinar Series with case study authors
April 2023: Release of Return of Individual Results Case Studies
March 2022: Launch of Return of Individual Results (IRR) website
January 2021: Initiated Return of Individual Results Project Update/Revision Taskforce
December 2017: Return of Individual Results to Participants Recommendations Document Version 1.2 and Return of Individual Results to Participants Toolkit Version 1.2 released and “Return of Individual Results to Participants: Principles” Nov 2017 version released; results from Task Force on Communication of Research Results survey were presented at MRCT Center Annual Meeting.
June 2017: “Return of Individual Results to Participants: Principles” Version 2.1 released
February 2017: “Return of Individual Results to Participants: Principles” released
January 2017: Genomics Sub-Group launched to expand on genetic/genomic sections of Individual Return of Results Guidance Document and Use-Case Sub-Group launched to develop simulations to test the workgroup output in real life situations
December 2016: Draft Recommendations Document, Toolkit and Principles presented at MRCT Center Annual Meeting
April 2016: Task Force on Communication of Research Results launched to (1) understand current practices in communication of research results to clinical trial participants and (2) develop recommendations to guide communication processes between clinical investigators, primary care physicians, and study participants
December 2015: Launched Return of Individual Results Working Group

Project leadership & Staff

Original project (2015-2017) was co-chaired by:

Barbara E. Bierer, MD. Faculty Director, MRCT Center
Debra Mathews, PhD, MA. Assistant Director for Science Programs, Johns Hopkins
David Pulford, PhD. Genetics Therapy Area Head, GSK
Sandra Prucka, MS. Clinical Innovations, Eli Lilly and Company
Carmen Aldinger, PhD. Project Manager, MRCT Center

Taskforce for the project update (2020-current):

Barbara E. Bierer, Faculty Director, MRCT Center
Sylvia Baedorf Kassis, Program Manager, MRCT Center
Linda Coleman, Director of Human Research Protection Program, Yale University
Anna Kang Liu, Director, Pre-Approval Access and Bioethics, Genentech
David Leventhal, Senior Director, Clinical Trial Experience, Pfizer
Megan McBride, Associate Director, Janssen Clinical Innovation
Nancy Levitan Poorvu, Patient Advocate
Sandra Prucka, Director of Genetic Counseling for Clinical Services, Asst. Professor of Clinical Medical and Molecular Genetics, Indiana University
Kate Robins, Patient Advocate
Jessica Scott, Head of R&D Patient Engagement, Takeda
Jamie Tyrone, Patient Advocate
Carol Weil, Program Director for Ethical and Regulatory Affairs, National Cancer Institute
Sarah White, Executive Director, MRCT Center
Sylvia Baedorf Kassis, Program Director, MRCT Center

Project Resources

Bioethics Collaborative

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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

December 8, 2025

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]

September 8, 2025

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]

June 4, 2025

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]

March 10, 2025

Medical Need or Market Opportunity: Setting Research Priorities

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]

December 12, 2024

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]

September 10, 2024

Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research

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]

June 18, 2024

Reciprocity in Research: Does Justice Support Community Investment?

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]

March 8, 2024

Advancing Inclusion: Integrating Pregnant and Lactating People in Research

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]

December 14, 2023

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]

October 10, 2023

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]

June 27, 2023

Blurring Boundaries: Revisiting the distinction between research and care

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]

April 13, 2023

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]

February 2, 2023

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]

October 13, 2022

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]

June 2, 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... [See Details]

April 5, 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... [See Details]

February 3, 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... [See Details]

October 5, 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... [See Details]

June 29, 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... [See Details]

April 29, 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,... [See Details]

February 25, 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... [See Details]

November 16, 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... [See Details]

October 1, 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... [See Details]

June 1, 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:... [See Details]

February 11, 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... [See Details]

October 17, 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... [See Details]

May 2, 2019

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]

January 22, 2019

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]

April 24, 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... [See Details]

January 23, 2018

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]

October 2, 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,... [See Details]

May 15, 2017

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]

January 31, 2017

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]

October 24, 2016

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]

Policy Engagement

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KeY MILESTONES

project Leadership & sTAFF

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Research Ethics Committee Systems Optimization

OBJECTIVES

KeY MILESTONES

project Leadership & sTAFF

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Training

Environmental Sustainability in Clinical Trials

OBJECTIVES

KeY MILESTONES

project Leadership & sTAFF

Project Resources

Artificial Intelligence (AI) and Ethical Research

OBJECTIVES

KeY MILESTONES

project Leadership & sTAFF

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Cell and Gene Therapies

OBJECTIVES

KeY MILESTONES

project Leadership & sTAFF

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Webinar

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Meeting Summary

Publication

Oversight and Implementation of Decentralized Clinical Trials

OBJECTIVES

KeY MILESTONES

project Leadership & sTAFF