Current Project Archives

Reproductive Health Considerations in Clinical Research

Reproductive Health Considerations in Clinical Research

The Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization introduced new challenges for the conduct of clinical trials involving people of reproductive potential, for the study of pregnancy-related conditions, and for participants in clinical research and research staff. The changing landscape of reproductive rights in the U.S. requires further consideration by clinical research stakeholders. Among other concerns, reproductive health intersects with clinical research with respect to the privacy of clinical trial participants.

The MRCT Center has started initial work to better understand whether and how reproductive privacy risks are addressed in study protocols, and particularly in informed consent documents. We are also exploring, through interviews with IRB chairs and research leaders across the country, existing approaches to reproductive health privacy protections and participant communication in single and multi-site trials.

Through this process, we are also working to identify recommendations for improved practices, which we plan to develop into a practical toolkit. The toolkit will include guidance documents on key privacy considerations, recommendations for notifying participants of privacy risks and communicating the importance of pregnancy reporting, best practices for addressing incidental pregnancies in research, and guidelines on medical record documentation. It will also explore the protections afforded by and the limits of Certificates of Confidentiality upon which the research community has relied.

OBJECTIVES

Evaluate current practices regarding reproductive privacy risks in clinical research informed consent forms and develop standardized guidance for addressing these concerns.
Develop resources to help research institutions mitigate participant privacy risks in the pregnancy testing and reporting processes, and to support research teams in communicating the risks to staff and participants.
Create standardized guidance for multi-site trial investigators to effectively manage the complexities of conducting research across jurisdictions.

KeY MILESTONES

January 2025: IRB protocol, “Pregnancy-Related Privacy Risks in Clinical Trials: Understanding Current Risks and Approaches,” approved
September 2024: Bioethics Collaborative, Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research

project Leadership & sTAFF

Barbara E. Bierer, MD, Faculty Director, MRCT Center
Willyanne DeCormier Plosky, Program Director, MRCT Center
Ava Glazier, Research Assistant, MRCT Center (former)
Blythe Chen, Research Assistant, MRCT Center

Project Resources

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

TRACE (Trial Regulatory and Clinical Ethics Optimization) is a dynamic initiative to strengthen and streamline clinical trial regulatory and ethics systems across Africa. Its mission is to remove barriers to clinical research by streamlining review processes, reducing duplication, and establishing clear, efficient timelines.

Despite growing interest in African clinical research, sponsors still encounter unclear submission pathways, manual or outdated systems, redundant reviews, and unpredictable timelines, all barriers TRACE aims to eliminate.

The MRCT Center, as a member of TRACE’s Core Project Team and lead of the Capacity Building & Accreditation and Funding Models sub-teams, is working alongside the African Vaccine Regulatory Forum (AVAREF) and Garnet Partners, with funding support from the Gates Foundation, to design and implement sustainable regulatory and ethics solutions.

In close collaboration with local stakeholders, TRACE co-develops tools, templates, and resources tailored to the needs of African ethics committees. It promotes inter-institutional coordination and cooperation.

By bringing together national ethics committees (NECs), institutional review boards (IRBs), regulatory agencies, and sponsors, TRACE fosters a transparent, efficient, and sustainable environment for clinical research oversight. The initiative’s goal is to position Africa as a leading hub for clinical research, with pilot efforts currently underway in Rwanda, Tanzania, Zimbabwe, and Nigeria.

As part of its role, the MRCT Center leads national system assessments using the WHO Global Benchmarking Tool for Ethics Committees, provides targeted training and capacity-building programs for NECs, and supports the implementation of IRB reliance strategies. It is also collaborating with stakeholders to design a model fee structure and contributing to long-term financial sustainability and regulatory alignment.

To further support training, the MRCT Center offers an online, on-demand training course on Ethics and Review of Interventional Clinical Research available free on the WHO Academy platform. A follow-up course, Ethics and Review of Interventional Clinical Research II, is currently in development and expected in fall 2025.

Ultimately, TRACE is committed to establishing a sustainable, efficient, and globally dependable landscape for clinical research across Africa by tackling persistent challenges such as manual workflows, redundant reviews, and inconsistent timelines.

OBJECTIVES

Ethics Systems Strengthening: Enhancing NEC and IRB capabilities, developing accreditation frameworks, and operationalizing a national accreditation program.
Capacity Building: Providing comprehensive training, curriculum development, and resource support to empower ethics committees and regulatory authorities.
Financial Sustainability: Creating equitable fee structures, implementing differentiated charging models, and constructing robust financial sustainability strategies for NECs.
Integration with National Authorities: Facilitating the alignment of ethics systems with national regulatory infrastructures.
Regulatory Optimization: Simplifying submission pathways and review procedures to reduce ambiguity and inefficiency.

KeY MILESTONES

August 2025: Financial Sustainability sub-team kickoff meeting
July–August 2025: Core team face-to-face meeting in Kigali to discuss project direction with participating countries
July 2025: Capacity Building sub-team kick-off meeting
June 2025: Visit Zimbabwe and Tanzania for gap and opportunity assessment
April–May 2025: Visit Nigeria and Rwanda to consult with NECs and regulatory bodies on gaps and opportunities
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 continues to explore the complex set of issues related to environmental
sustainability in clinical trials. In Europe and many other parts of the world, the focus on environmental sustainability is prominent with well-established efforts to study and reduce GHG. The U.S. interest and investment, strong in many individual states and companies, is variable.

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 trials and 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

June 2025: Held a Webinar to launch the Framework for Review of Clinical Research Involving Artificial Intelligence
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

June 2025: Held webinar: “Patient-Centered Long-Term Follow-Up for Gene Therapies”
June 2025: Carolyn Chapman spoke at the June 2025 Bridging the Gap webinar, “Ethical Issues in CGT Trials: Benefits, Risks, Long Term Follow-Up and Beyond,” sponsored by Azenta Life Sciences and the Emily Whitehead Foundation
May 2025: Published “Patient-centered long-term follow-up for gene therapies aligns with ethics and science” in Molecular Therapy
May 2025: Two poster presentations at ASGCT meeting in New Orleans, Louisiana
May 2025: Held webinar: “Innovative Approaches for Gene Therapy Long-Term Follow-Up”
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

The MRCT Center is guided by the fundamental belief that communicators are responsible for sharing information in ways that are designed to promote audience understanding and empowerment. Clear research communications that are understandable to patient and participant communities are critical to inclusive, representative research studies.

As such, the MRCT Center launched an effort in 2018 to develop clinical research-focused health literacy resources with a workgroup of diverse representatives from across the research ecosystem that would support the integration of health literacy strategies across the clinical development life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.

Click Here to access our interactive project-specific website >

All of us here at the MRCT Center strive to develop tools and resources that promote 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 process, and was adopted as a CDISC global standard in April 2023.

The most recent version of the Clinical Research Glossary includes 187 words and definitions, customized images, and additional details and resources that provide users with valuable background information. Thirty new terms and definitions will be released in September 2025.

Other Health Literacy in Clinical Research efforts include the 2025 release of a suite of Data Literacy Infographics, an ongoing virtual Health Literacy Training and Checklist for IRBs, and a newly initiated project to update the Health Literacy in Clinical Research website content.

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

April 2025: Released a suite of data literacy infographics and hosted a launch webinar with PHUSE
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

June 2025: Biannual Global Meeting (Executive Summary and conference slides are available)
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

Reproductive Health Considerations in Clinical Research

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project Leadership & sTAFF

Project Resources

Policy Engagement

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KeY MILESTONES

project Leadership & sTAFF

Project Resources

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Research Ethics Committee Systems Optimization

OBJECTIVES

KeY MILESTONES

project Leadership & sTAFF

Project Resources

Tools

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

Project Resources

Framework

Webinar

Cell and Gene Therapies

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KeY MILESTONES

project Leadership & sTAFF

Project Resources

Webinar

Publication