Ethics Review of Human Research Involving Artificial Intelligence (AI)

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 – in collaboration with WCG Clinical – convened a task force to address ethical and regulatory challenges in the IRB review of clinical research protocols involving AI. The task force includes representatives from academia, industry, AI technologists, and IRB ethicists, members, and chairs.

The task force will evaluate AI’s use in various aspects of clinical trials, including protocol design, consent considerations, patient safety, privacy and confidentiality, and participant recruitment. In addition, it will examine AI when it is being studied as an investigational product for use in medical care. The group’s mandate is to create guidelines and tools to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.

OBJECTIVES

  • Define and analyze the current critical ethical and regulatory challenges when reviewing clinical research involving AI.
  • Discuss and develop practical and actionable resources to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.
  • Identify new practical and actionable resources and tools needed by stakeholders.

KeY MILESTONES

  • March 2024: Convened first meeting of subject matter experts, including representation from academic medical centers and universities, industry, AI technologists, and IRB ethicists, members, and chairs.

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

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.

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

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.

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

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.

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

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]

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]

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]

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]

In the US, research with data only qualifies as human subjects research and triggers protections, such as ethics board review and informed consent, when those data are identifiable, defined as “information for which the identity of... [See Details]

Topic: Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research  In 2022, the United States Supreme Court ruled, in Dobbs vs. Jackson Women’s Health Organization, against a federal right to abortion. The effects of this ruling continue... [See Details]

Topic: Reciprocity in Research: Does Justice Support Community Investment? Abstract:  It is generally agreed that sponsors and other entities undertaking research in limited-resource settings incur certain duties of reciprocity. These obligations ensure that host communities are... [See Details]

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

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

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

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

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

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

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

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

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

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

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

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

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]

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

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

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

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

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

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

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

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

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

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

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

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

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


Advancing the Quality of Clinical Trial Enterprise

Advancing the Quality of Clinical Trial Enterprise

Evidence that substantial numbers of trials do not contribute meaningful information to the evidence base raises both ethical and scientific concerns. Participants assume the risks and burdens of a study, while mistakenly believing that they are contributing to medical progress. At the same time, these non-informative trials divert participants, researchers, and other resources from more valuable trials, potentially making it more difficult to reach enrollment targets.

Although others have identified the conduct of non-informative trials as a significant problem, there has been less progress in defining, studying, and attempting to reduce their frequency and thus improve the quality of the medical evidence base. This program focuses on efforts to improve the efficiency and quality of clinical trials, with the overall objective of optimizing the impact of each trial participant and informing key medical and policy decisions. In addition, we build on the established foundation of trial reporting to ClinicalTrials.gov with the aims of improving the timeliness and quality of reports, as well as increasing the use of data from ClinicalTrials.gov by the research enterprise.

Contact us: mrct@bwh.harvard.edu

Objectives

  • Develop “best practices” for the conduct of landscape analyses that enable researchers and other oversight entities to understand what is already known, and what is currently being investigated, about their research question
  • Analyze large samples of informed consent forms in order to establish better (and worse) practices, and to start to develop tools that might help researchers to write future consent forms
  • Increase use of data from ClinicalTrials.gov to inform research decisions

key Milestones

Project leadership & STAFF

  • Deborah Zarin, MD, Program Director, Advancing the Clinical Trial Enterprise, MRCT Center
  • Barbara E. Bierer, MD, Faculty Director, MRCT Center
  • Sarah White, MPH, Executive Director, MRCT Center

Project Resources

Training & Education

TRAINING MODULES
MRCT Center Virtual Training

View all MRCT Center virtual training modules here:

Training & Education

Global Capacity Building

The skills and experience of investigators and study staff, research ethics boards, and regulators vary widely across the globe. To meet the demands of the changing regulatory and ethics landscape, regulators, ethics committees, Investigators, and site staff need continuous learning and discussion of emerging issues in clinical research. Training and capacity building is one of the core strengths of the MRCT Center. Our objective is to develop and deliver curricula to inspire students and improve the clinical research process.

Long-standing history in capacity building

The MRCT Center has a long-standing history of developing ethics and regulatory skills in both high and low-middle income countries. The MRCT Center has been endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as a training associate and designated as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence. Over the past decade, our capacity building efforts have trained more than 5,000 participants from over 90 countries and spanned from data monitoring committees, pharmacovigilance and safety, clinical research professional competency, good clinical practice and MRCTs, to research ethics.

Approach to capacity building and training

Since 2020, the MRCT Center has leveraged technical capabilities to develop both virtual and sustainable online trainings.

  • Online, recorded training modules: available free of charge on an MRCT Center portal within the Mass General Brigham Office of Continuing Professional Development website. 
  • Virtual training: live, interactive training sessions delivered virtually, in collaboration with an in-country partner
  • In-person or in-country training: in-person / in-country dynamic trainings using a training model in which we partner with a local collaborator (e.g., academic leader, regulator, institution) to identify the appropriate topics that are of highest need and select the trainees for the course

OBJECTIVES

  • Improve regulatory capacity to provide a unified standard for conducting and oversight of clinical trials
  • Improve capacity of those planning and reviewing clinical trials to conduct effective multi-regional trials
  • Improve capacity of those planning, reviewing, and conducting clinical trials to ultimately lead to participant safety

project Leadership & sTAFF

  • Barbara Bierer, MD. Faculty Director, MRCT Center
  • Sarah White, MPH. Executive Director, MRCT Center
  • Carmen Aldinger, PhD, MPH, PMP. Senior Administrative and Training Manager, MRCT Center
  • Samjhana Bogati, BSN, RN. Program Manager
  • Lauren Otterman, MBE. Project Manager, MRCT Center

Training Sessions

Please click on the topics below to get information on the related training sessions

Causality Training

Safety assessments of an investigational product depends upon understanding of causality and the differentiation from correlation or association. Assignment of causality of adverse drug reactions during a clinical trial is predicated on an accurate causality assessment and determination of whether the injury or death is related to participation in the trial and a consequence of the investigational product. This training enables clinicians and ethics committee members to follow best practice procedures in determining causality for participant injuries or illnesses occurring in the course of a clinical trial.

DateTrainingTraining Type
NOV 2015Data Monitoring Committees, Pharmacovigilance and Vaccine Development

U. of Witwatersrand & U. of Cape TownGlobal Health Network
In-country Training
Johannesburg & Cape Town, South Africa
FEB 2015Best Practices for Determining Causality Assessment for Adverse Events Occurring During Clinical Trial Participation

Indian Society of Clinical Research
In-country Training
Delhi, India

Details
NOV 2014Causality Assessment Workshop for Clinical Trial Investigators

Biogen
In-country Training
Gurgeon, India

Details

Clinical Research Design and Conduct

The curriculum is designed to introduce the audience to the process of drug development and clinical research, including research and development, bioethics, good clinical practice, regulatory requirements, as well as post-market surveillance and real world evidence. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local regional context.

DateTrainingTraining Type
OCT 2022Pfizer Biotech Program: Training for public and private university lecturers

Pfizer Indonesia
Virtual training

Details
OCT 2021Pfizer Biotech Fellowship Program: Higher Height

Pfizer Indonesia
Virtual training

Details
MAY/JUN 2021B-Imtiyaz, a program to supplement university education for pharmaceutical and bioengineering majors through lectures given by international experts

Pfizer Algeria
Virtual training

Details

Data Monitoring Committee Training

Countries in which global clinical trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee these trials. Recognizing the need for greater engagement from emerging economies, the MRCT Center created a training program in 2012 aiming to engage motivated individuals to become DMC champions within their home country and to participate in DMCs for multi-regional clinical trials.

DateTrainingTraining Type
JUL 2022Data Safety Monitoring Committee (DSMC) training

National Institutes of Health at the University of the Philippines in Manila, Philippines
Virtual training
Manila, Philippines

Details
JAN 2015Data Safety Monitoring Board (DSMB) Training

HIV-NAT
In-country training
Bangkok, Thailand

Details
MAY 2014Data Safety Monitoring Board (DSMB) Pre-Conference DIA Workshop

DIA
In-country training
Shanghai, China
APR 2014Japan Data Safety Monitoring Board (DSMB) Training

JPMA
In-country training
Tokyo, Japan
JAN 2014Data Monitoring Committee / Data Safety Monitoring Committee (DMC/DSMB) training course

ISCR
In-country training
Bangalore, India
OCT 2013Data Safety Monitoring Board (DSMB) Workshop

Daegu Catholic University Medical Center
In-country training
Daegu, South Korea
MAY 2013“So you’ve said ‘yes’ Now What? Sitting on or Chairing a Data Safety Monitoring Board” and “Data Safety Monitoring Boards for Multi-Regional Clinical Trials”

Society of Clinical Trials
In-person training
Boston, US

Details

Diversity, Equity and Inclusion (DEI) in Clinical Research

The participant population enrolled in clinical trials ideally reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. The MRCT Center training is intended to aid attendees in improving their ability to enroll underrepresented participants in clinical research and develop mechanisms for ongoing sustainability of DEI in clinical research.

DateTrainingTraining Type
MAR/APR 2022Equity by Design, a virtual training course communicating an understanding of, and training on best practices for, diversity, equity, and inclusion (DEI) of underrepresented populations in clinical trials, focusing on cancer trials.

Center for Cancer Equity and Engagement at the Dana-Farber/Harvard Cancer Center (DFHCC)
Virtual training and online training

Details

GCP and MRCT

Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide wish to ensure that drugs, biologics and devices are developed by processes that uphold the highest ethical standards and scientific principles. The MRCT Center has been designated as an ICH Associate and as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence in the area of Multi-Regional Clinical Trials and Good Clinical Practice (GCP) and offers onsite, in-country and online training on this topic.

DateTrainingTraining Type
Since FEB 2020Interpretation and Application of ICH E6(R2)

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Online training

Details
FEB 2019ICH E6(R2) Good Clinical Practice and ICH E17 Multi-Regional Clinical Trials Training

Health Canada
In-country training
Ottawa, Canada

Details
APR 2018APEC Pilot Center of Excellence Training on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)

Asia-Pacific Economic Cooperation (APEC) Harmonization Center (AHC)
In-person training
Cambridge, USA

Details
OCT 2017ICH E6(R2) GCP Pilot Training

International Council for Harmonisation (ICH)
In-person training
Cambridge, USA

Details
SEPT 2016Multi-Regional Clinical Trials (MRCTs): Practice and Issues of Multi-Regional Clinical Trials’ Global Acceptance

Yale, Novartis, CFDA
In-person training
New Haven, USA
OCT 2015Regulatory and Scientific Workshop

Peking U.
In-country training
Beijing, China

Details

Health Literacy

Since 2018, the MRCT Center has focused on the importance of clear communication through the development of health literacy resources as part of the MRCT Center’s Health Literacy in Clinical Research Program. Online, virtual and in person capacity building activities that provide research professionals with practical guidance and tools to integrate health literacy best practices into their roles are available.

DateTrainingTraining Type
APR 2022Health Literacy for Human Research Protections Programs and Institutional Review Boards

Mass General Brigham Office of Continuing Professional Development
Online training

Details
FEB – APR 2021Applying Health Literacy Principles to Clinical Research Studies: A Three-part Health Literacy Training (Health Literacy 101, Health Literacy in Action, Health Literacy and Returning Research Results)

University of Utah
Virtual training

Details
OCT 2020Disseminating Research Results to Participants and the Public: Integrating Health Literacy Best Practices into Clinical Research Processes

Tufts Clinical and Translational Sciences Institute
Virtual training
APR 2019Plain Language for Health – Writing and Design Workshop for Health Research

Tufts Clinical and Translational Sciences Institute
Onsite training
Boston MA

Post-Trial Responsibilities

Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a participant’s time on the trial has completed. The MRCT Center has provided training to clarify terms and interpretations related to “post-trial responsibilities” and to suggest standards with regard to the practical application of those directives.

DateTrainingTraining Type
APR 2016Post-Trial Responsibilities to Research Participants

Sociedade Brasileira de Medicina Farmacêutica, Lilly
In-country training
Sao Paolo, Brazil

Research Ethics

“Research Ethics” refers to addressing ethical issues in the design of clinical trials and documenting their rationale in a section of the study protocol. The MRCT Center collaborates with partners to design the curriculum specific to the audience as well as the local/regional Ethics Committee context.
The MRCT Center offers an online course that guides the development of a dedicated “Ethics section” of the protocol and offers virtual training of ethics committees and those reviewing clinical research applications, with a focus on Africa.

DateTraining Training Type
OCT 2024Ethics and Review of Interventional Clinical Research
World Health Organization & MRCT Center
Online Training
Details
MAR-APR 2022Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa

World Health Organization &
African Vaccine Regulatory Forum (AVAREF)
Virtual Training

Details
SEPT 2021Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa

World Health Organization &
African Vaccine Regulatory Forum (AVAREF)
Virtual Training

Details
Since NOV 2014Essential Elements of Ethics

The Global Health Network
Online Training

Details

Impact of Privacy Laws on Clinical Research

Impact of Privacy Laws on Clinical Research

The MRCT Center remains at the forefront of analyzing and understanding the impact of the GDPR and other privacy laws that impact clinical research data and biospecimen sharing. The patchwork of privacy laws that apply to the processing of personal data and in some cases restrict the transfer of such data across national boundaries impedes the progress of science and public health and the use of personal data for secondary research.

The European Union’s General Data Protection Regulation (GDPR) took effect on May 25, 2018. The regulation governs the processing of personal data of individuals located in any member state of the European Economic Area (EEA) or personal data processed in the context of an entity’s establishment located in an EEA member state. Following “Brexit,” the United Kingdom has enacted national legislation, commonly referred to as the UK GDPR, that is substantially similar to GDPR.  Under both GDPR and UK GDPR, personal data are defined broadly as “any information relating to an identified or identifiable natural person (“data subject”); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural, or social identity of that natural person. The GDPR had an immediate impact on clinical research generally and multi-regional clinical trials specifically.

In addition to the GDPR, recent years have seen a growing number of sector-specific and omnibus state privacy laws in the U.S., such as the CCPA/CPRA and recently-passed data privacy legislation in Colorado, Utah and Virginia, as well as Florida’s Protecting DNA Privacy Act.  Also of note, China enacted an omnibus data privacy law known as the Personal Information Protection Law (“PIPL”), which took effect in 2021, Brazil’s General Data Protection Law (“LGPD”) became subject to enforcement in 2021, and India’s Digital Personal Data Protection Act (“DPDP Act”) was enacted in 2023. The MRCT Center continues to monitor the development of these laws and suggests strategies to help the research community comply with such laws, including through advocacy with relevant public authorities and industry stakeholders.

Contact Information: mrct@bwh.harvard.edu

objectives

  • Identify, explain, and discuss key problems that the GDPR and other privacy laws have introduced for the for the domestic and global research community on clinical research, biobanking, and data banking, as well as big data research.
  • Highlight the major challenges and ambiguities that privacy laws present for regulators, industry, academia, IRBs/research ethics committees, and researchers.
  • Engage with the European Commission and EDPB to explore potential solutions.
  • Share preferred operational practices in each of these areas.
  • Identify where further guidance or explanations (e.g., FAQs) would be helpful.

key milestones

  • November 2024: MRCT Center submitted public comments to the U.S. Department of Justice’s proposed rule “Provisions pertaining to preventing access to U.S. sensitive personal data and government-related data by countries of concern or covered persons”
  • October 2024: MRCT Center Research, Development, & Regulatory Roundtable discussed limitations on sharing data with China and other countries of concern
  • December 2023: MRCT Center Research, Development, & Regulatory Roundtable discussed developments over the past year, including adoption of the EU-US Data Privacy Framework
  • During 2023: Convened experts in the field to assess the ongoing and evolving impact of privacy laws on clinical research and data sharing
  • December 2022: MRCT Center Research, Development, & Regulatory Roundtable hosted a one-day conference on GDPR and privacy laws in other geographies (China, India, Japan, and South Africa). Dr. Francis Collins, Senior Advisor to the President (Acting) and Former Director of the National Institutes of Health, delivered the keynote address. The five sessions included panelists from academia, pharmaceutical companies, and regulatory bodies.
  • February 2022: MRCT Center submitted public comments to the National Institutes of Health (NIH) “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy”
  • October 2021: Co-authored “Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data,” Journal of Law and the Biosciences
  • September 2021: MRCT Center comments on European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers
  • April 2021: MRCT Center comments in response to European Data Protection Board questions on research and GDPR.
  • October 2020:  Co-authored an article in Science Magazine entitled “How to Fix the GDPR’s Frustration of Global Biomedical Research.”  The article received significant attention and has been provided as a briefing material to members of the Biden administration seeking to understand international data sharing issues.
  • May 2020: David Peloquin participated in a webinar organized by ISC that was a follow-up to the November 2019 Brussels conference and discussed the MRCT Center’s comments submitted to the European Commission in April 2020.
  • April 2020: MRCT Center submitted comments to the European Commission outlining the challenges that GDPR has created for the research community along with potential solutions in response to the European Commission’s call for comments on GDPR.
  • March 2020: Co-authored an article in the European Journal of Human Genetics entitled “Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data” discussing the challenges of GDPR for secondary research and biobanking activities.
  • November 2019: MRCT Center and Ropes & Gray LLP co-organized ISC Seminar on Challenges for Health Research arising from GDPR in Brussels, Belgium.
  • May 2019: Mark Barnes attended a meeting with the Irish Data Protection Commission to discuss the challenges the GDPR poses to the research community.
  • February 2019: Mark Barnes and colleagues at Ropes & Gray co-authored an article discussing the challenges in the EDPB’s February 2019 opinion on the intersection of the GDPR and the EU Clinical Trials Regulation.
  • January 2019: MRCT Center sent a letter to the EDPB commenting on the EDPB’s November 2018 draft guidance on the territorial scope of the GDPR.
  • July 30, 2018: Application of the GDPR to Research: Legal, Practical and Strategic Implications: The MRCT Center convened over 110 representatives from academia, industry, and government. The conference explored the impact of the EU GDPR on human subjects’ research, biobanking and data banking, and big data research. A letter summarizing the findings was sent to the European Commission Directorate-General for Research and Innovation with a copy to EMA, NIH, and others.

PRoject leadership & Staff

  • Mark Barnes, JD, LLM, Faculty Co-Director, MRCT Center
  • Barbara E. Bierer, MD, Faculty Director, MRCT Center
  • David Peloquin, JD, Ropes & Gray LLP

Project Resources