Resources

• Webinar

Returning Individual Research Results and Data: Digging Deeper Webinar Series

• Public Comments

Response to E6(R3) Guideline for Good Clinical Practice; International Council for Harmonization; Draft for Guideline for Industry

• Publication

Defining “recklessness” in research misconduct proceedings

• Publication

Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection–Inclusion Dilemma

• Publication

The Unresolved Challenge of Triage

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Chinese)

• Webinar

Returning of Individual Research Results and Data: Digging Deeper into IRB/HRPP Responsibilities

• Publication

Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement

• Publication

Enhancing diversity of clinical trial populations in multiple sclerosis

• MRCT Sponsor Resource
• Public Comments

Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders

• Public Comments

Response to the proposed revision of the EU general pharmaceuticals legislation

• Publication

Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomized, factorial, mixed-methods trial

• Webinar

Returning Individual Research Results and Data: Digging Deeper into Pfizer’s Patient Data Return Solution

• Publication

Terms and conditions apply: an ethical analysis of mobile health user agreements in research

• Public Comments

Response Letter to NIH Request for Information (RFI) on the Updated Policy Guidance for Subaward/Consortium Written Agreements

• Public Comments

Response to Institute for Clinical and Economic Review (ICER) re: Proposed Changes to the 2023 Value Assessment Framework

• Tools

What is Clinical Research? ARABIC

• Tools

Assent to Consent – ARABIC

• Tools

What Happens at the End of a Research Study? – ARABIC

• Tools

What is Assent? – ARABIC

• Webinar

Ethical Considerations for Decentralized Clinical Trials: Tools, Resources and Best Practices

• Publication

Communicating complex numeric information in clinical research

• Framework
• Guidance
• Principles
• Tools

IRB/EC Considerations for DCT Review

• Publication

Bringing data monitoring committee charters into the sunlight

• Publication

Guest Blog: New Tools to Support Inclusion of People with Disabilities in Clinical Research 

• Publication

Returning Individual Research Results from Digital Phenotyping in Psychiatry

• Webinar

Accessibility by Design (AbD) Toolkit Release

• Proceedings

Strategic Global Meeting of The Joint Task Force For Clinical Trial Competency May 2023

• Webinar

Returning Individual Research Results And Data To Participants: Experience From The Field

• Publication

Data sharing in the context of community-engaged research partnerships

• Publication

Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

• Publication

How To Limit Uninformative Trials: Results From A Delphi Working Group

• Meeting Summary
• MRCT Sponsor Resource

Trials and Tribulation of N-of-1 Trials

• Webinar

A Global Standard For Plain Language In Clinical Research: MRCT Center And CDISC Collaboration

• Publication

Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials

• Publication

Use Plain Language to Increase Understanding

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Italian)

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Vietnamese)

• Video

How to Submit Comments on Glossary Definitions via JIRA

• Publication

Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed

• Publication

Data visualization explorer: A tool for participant representation

• Case Study

IRR: Responsibly Returning Secondary Findings

• Case Study

IRR: Returning Routine Lab Results to Participants During a Clinical Trial

• Case Study

IRR: Supporting Participant Decision-Making in Genetic Testing Studies

• Case Study

IRR: Implementing a Robust, Scalable Participant Data Return Solution

• Case Study

IRR: Returning Non-validated Test Results

• Video

Time to Listen: Hearing from Young People in Clinical Research – PART 2

• Video
• Webinar

Advancing International Pediatric Clinical Research: Promoting Global Clinical Research in Children: Informing the Future

• Tools

Including Young People in Research

• Video

Including Young People in Clinical Research Toolkit Companion

• Principles

Guiding Principles for Protecting Children in and through Pediatric Clinical Research

• MRCT Sponsor Resource
• Public Comments

Investigational New Drug Application Annual Reporting; A Proposed Rule

• Meeting Summary

Emergency Preparedness in Clinical Research

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Bahasa Indonesia)

• Publication

Establishing a Global Regulatory Floor for Children’s Decisions about Participation in Clinical Research

• Publication

Ensuring the Scientific Value and Feasibility of Clinical Trials

• Public Comments

Ethical Considerations for Clinical Investigations of Medical Products involving Children: Guidance for Industry, Sponsors, and IRBs

• Annual Report

2022 MRCT Center Annual Report

• Publication

Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies

• MRCT Sponsor Resource
• Presentation

MRCT Center 2022 Annual Meeting Slides

• Proceedings

MRCT Center 2022 Annual Meeting Proceedings

• Publication

Protecting the Vulnerable and Including the Under-Represented

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1 (Thai)

• Webinar

Advancing International Pediatric Clinical Research: Facilitating Pediatric Medicines Development

• Video

Prioritizing Young People’s Voices in Clinical Research Part 3

• Publication

Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.

• Proceedings

Strategic Global Meeting of The Joint Task Force For Clinical Trial Competency Nov. 2022

• Publication

Ethical Challenges in Clinical Research During the COVID-19 Pandemic

• Public Comments

Comments related to 2005 PHS Policies on Research Misconduct

• Publication

Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinate multinational study

• Publication

Supported decision-making can advance clinical research participation for people with disabilities

• Meeting Summary
• MRCT Sponsor Resource

Post-Trial Responsibilities: Continued Access to Investigational Medicines and Devices

• Publication

Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification

• Public Comments

Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Institutional Review Board Oversight Points to Consider for IRB Reviewers to assess DEI factors at Initial and Continuing Review

• Publication

Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19

• Publication

Externalist, Process-Based Approach to Supported Decision-Making

• Webinar

FDA Office of Minority Health and Health Equity Webinar Introducing MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Supplemental Toolkit

• Public Comments

Draft of New Drugs, Medical Devices and Cosmetics Bill

• Publication

The proportion of randomized controlled trials that inform clinical practice

• Publication

Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials?

• Publication

Integrate Health Literacy Training into Your IRB’s Onboarding and Professional Development Activities

• Flyer
• Tools

What is Assent?

• Flyer
• Tools

Sharing Your Information (Data) In Research

• Flyer
• Tools

What is Clinical Research?

• Flyer
• Tools

What Happens at the End of a Research Study?

• Tools

Assent to Consent

• Flyer
• Tools

Sensitive Information In Research

• Flyer
• Tools

What Is a Focus Group & Why Should I Join One?

• Presentation

Equitable Practices for Children’s Vision Research

• Publication

Implementing expanded COVID-19 testing in Massachusetts community health centers

• Video
• Webinar

Launch Of Equity By Design (EBD) In Clinical Research: The EBD Metrics Framework

• Webinar

Advancing International Pediatric Clinical Research: Assent and Consent in the Field: Culture, Context, and Respect

• Video

Prioritizing Young People’s Voices in Clinical Research Part 2

• Webinar

Supporting IRB Efforts To Advance Diversity And Inclusion In Clinical Research Tools And Resources

• Framework

Leveled Core Competency Framework for the Clinical Research Profession Version 3.1(French)

• Tools

Developing and Implementing a Self-Monitoring Toolkit For a Coordinated Multinational Randomized Acupuncture Trial

• Presentation

Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research

• Presentation

Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity

• Webinar

Launch of Online Health Literacy Training For IRB Members and Staff

• Publication

Approach For Reporting Master Protocol Study Designs on ClinicalTrials.gov: Qualitative Analysis

• Framework

Return of Individual Research Results: Returning Actionable Results

• Tools

Return of Individual Research Results Resources: IRR Information Sheet for Participants Template

• Meeting Summary

Sex and Gender in Clinical Research

• Meeting Summary

Limited English Proficiency and Translation of Study Materials

• Framework

Return of Individual Research Results: How to Return Different Data Types

• Training

IRB Health Literacy in Clinical Research

• Tools

Return of Individual Research Results Resources: Informed Consent Sample Language

• Framework

Return Of Individual Research Results: Roadmap For Research Sponsors

• Framework

Return of Individual Research Results Topics: Informed Consent

• Tools

Return of Individual Research Results Resources: Resources for Participants

• Framework

Return Of Individual Research Results Topics: Informed Consent

• Tools

Diversity, Inclusion, and Equity in Clinical Research: IRB Resources

• Tools

Diversity, Inclusion, and Equity in Clinical Research: IRB Health Literacy Training

• Framework

Return of Individual Research Results: Returning Urgent Results

• Framework

Return of Individual Research Results: How to Get Started

• Framework

Return Of Individual Research Results Topics: Regulations

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Resources for IRBS/HRPPS to Provide to Investigators/research Teams

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Approaches to Support IRB members

• Framework

Return of Individual Research Results How to Return IRR: Determining What to Return

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Diversity & Inclusion Overlay: NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template

• Framework

Return of Individual Research Results Topics: Funders

• Tools

Diversity, Inclusion, and Equity in Clinical Research: HRPP and IRB Statement of Commitment to Inclusion

• Framework

Return of Individual Research Results How to Return IRR: IRR Roadmap by Role

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Diversity & Inclusion Overlay: TransCelerate’s Common Protocol Template

• Framework

Return of Individual Research Results Topics: Study Integrity

• Tools

Diversity, Inclusion, and Equity in Clinical Research: IRB Statement of Commitment to Inclusion

• Framework

Return of Individual Research Results: Why to Get Started?

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Incorporating DEI into Clinical Research Protocol Templates

• Framework

Equity by Design in Clinical Research: The EbD Metrics Framework

• Publication

Strategies to Optimize Inclusion of Women in Multi-National Clinical Trials

• Tools

Diversity, Inclusion, and Equity in Clinical Research: IRB Membership Self-Assessment Template (Self-Evaluation Survey)

• Framework

Return of Individual Research Results: Roadmap for Study Staff & Investigators

• Framework

Return of Individual Research Results Topics: Liability

• Framework

Return of Individual Research Results: Roadmap for Patients & Participants

• Tools

Diversity, Inclusion, and Equity in Clinical Research: An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants

• Framework

Return of Individual Research Results: Returning Results With No Known Implications

• Framework

Return of Individual Research Results: Roadmap for IRBS & HRPPS

• Tools

Return of Individual Research Results Resources: IRB Approval Checklist for Returning IRR

• Tools

Diversity, Inclusion, and Equity in Clinical Research: An IRB Resource for Participants: Costs and Payments

• Framework

Return of Individual Research Results: Returning Personally Valuable Results

• Tools

Return of Individual Research Results Resources: Healthcare Provider Contact Form Template

• Tools

Diversity, Inclusion, and Equity in Clinical Research: Procedural & Logistical Checklist

• Public Comments

Diversity Plans to Improve Enrollment of Participants From Underrepresented Populations

• Presentation

Big Ideas and Ethics in the Big Easy

• Presentation
• Proceedings

Strategic Global Meeting of the Joint Task Force for Clinical Trial Competency May 2022

• Publication

When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research

• Meeting Summary

Data Ownership, Reciprocity, and Research

• Training

Equity by Design in Clinical Research: A Six-Part Course

• Publication

IRBs and the Protection-Inclusion Dilemma: Finding a Balance