Resources

• Podcast

Podcast Episode 2: Trials Beyond Borders

• Tools

Exit Survey Inclusive of the LGBTQIA+ Perspective

• Tools

Participant Questionnaire from the LGBTQIA+ Perspective

• Tools

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

• Tools

Site Feasibility Decision Tree from the LGBTQIA+ Perspective

• Principles

Principles of Post-Trial Responsibility: Continued Access to an Investigational Product

• Framework

Framework: Post-trial, Continued Access Responsibilities to Investigational Medicines

• Publication

Engaging children and adolescents in the design and conduct of paediatric research

• Publication

Towards A National Action Plan To Improve Representation In Clinical Trials

• Training

ICH E8(R1) Introductory Overview Video

• Webinar

Health Literacy Month Webinar Series

• Training

Ethics and Review of Interventional Clinical Research

• Webinar

Designing PowerPoint Presentations to Support Health Literacy and Accessibility

• Training

Accessibility 101 Training Series

• Publication

Declaration of Helsinki – Revisions for the 21st century

• Webinar

Creating and Sharing Plain Language Summaries: One Team’s Experience

• Webinar

Designing Impactful Informed Consent Processes that Empower Participants

• Public Comments

Public Comments submitted: “Remarks for Rep. Robin Kelly’s Roundtable to Diversity Clinical Trials”

• Public Comments

Public Comments submitted: “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies FDA-2021-D-0789”

• Tools

Model Diversity Action Plan (DAP)

• Tools

Global Representation Roadmap

• Publication

Creating educational materials about clinical research data for patients and the public

• Public Comments

Public Comments submitted: “Evolving the Network of the National Library of Medicine NOT-LM-24-001”

• Podcast

Podcast Episode 1: Trials Beyond Borders

• Public Comments

Public Comments submitted: “Request for Information on the National Institutes of Health Draft Public Access Policy”

• Publication

The PubPeer conundrum: Administrative challenges in research misconduct proceedings

• Public Comments

Public Comments submitted: “Strategies for Maximizing Public Engagement in NIH Supported Clinical Research”

• Publication

Pediatric drug development issues during public health emergencies

• Publication

E-Book: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies

• Publication

The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research

• Public Comments

Public Comments submitted: “NIH-OSP Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning”

• Public Comments

Public Comments submitted: “Federal Evidence Agenda on Disability Equity”

• Publication

Editorial: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies

• Webinar

Accessibility 101: How to Write Alt-Text and Map Participant Journeys

• Public Comments

Comments Submitted: Cancer Clinical Trial Eligibility Criteria: Performance Status

• Public Comments

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications”

• Public Comments

Public Comments submitted: “Declaration of Helsinki Public Comment Period Two”

• Public Comments

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values”

• Publication

Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials

• Publication

The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No, by Carl Elliott. New York: W.W. Norton & Company, 2024

• Publication

Proposed Increases in Government Authority Over Research Misconduct Proceedings

• Public Comments

Public Comments submitted: “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products”

• Meeting Summary

Reciprocity in Research: Does the Principle of Justice Support Community Investment

• Public Comments

Public Comments submitted: “FDA-NIH Terminology for Clinical Research”

• Webinar

Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design

• Tools

Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist

• Tools

Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist

• Presentation
• Proceedings

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency June 2024

• Webinar

Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

• Publication

A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19

• Publication

First, do no harm: a global perspective on diversity and inclusion in clinical trials

• Framework

Toward a National Action Plan for Achieving Diversity in Clinical Trials

• Public Comments

Public Comments submitted: “Draft Guidance, Key Information and Facilitating Understanding in Informed Consent”

• Public Comments

Comments Submitted: Draft Guidance, Key Information and Facilitating Understanding in Informed Consent; FDA-2022-D-2997

• Public Comments

Comments Submitted: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (FDA-2016-D-3561)

• Public Comments

Public Comments submitted: “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”

• Public Comments

Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials

• Tools

LGBTQIA+ Inclusion – Inclusive Language Checklist

• Case Study

LGBTQIA+ Inclusion – Inclusive Imagery

• Framework

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

• Framework

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

• Webinar

The Clinical Research Glossary: New Words, New Opportunities

• Public Comments

Public Comments submitted: VolREthics initiative – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials

• Public Comments

Master Protocols for Drug and Biological Product Development

• Meeting Summary

Advancing Inclusion: Integrating Pregnant and Lactating People in Research

• Meeting Summary

Advancing Inclusion: Integrating Pregnant and Lactating People in Research

• Webinar

REACH: Advancing DEI in Human Participant Research

• Publication

Ethical Considerations in Decentralized Clinical Trials

• Other

Essential Elements of Ethics – Statistics 2023

• Meeting Summary

2023 Annual Meeting Proceedings

• Public Comments

Comment on the NPRM regarding regulations to title II of the Americans with Disabilities Act: Accessibility of Medical Diagnostic Equipment of State and Local Government Entities

• Meeting Summary

Gene Therapies: Probing the Ethics

• Public Comments

Public Comments on Declaration of Helsinki: Phase 1

• Project-Specific Website

Promoting Global Clinical Research in Children: An Overview

• Publication

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency 

• Public Comments

Comments on the Public Health Service Policies on Research Misconduct Notice of Proposed Rulemaking

• Publication

Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

• Presentation
• Proceedings

Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency November 2023

• Public Comments

Comment on the NPRM Request of the Office for Civil Rights (OCR) re: Discrimination on the Basis of Disability in Health and Human Services Programs or Activities

• Public Comments

Comment on the American Community Survey SOGI Test

• Webinar

Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials

• Framework

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

• Meeting Summary

The chat is out of the bag: The future of AI in clinical research

• Publication

Deprioritization of Ongoing Clinical Trials

• Other

Essential Elements of Ethics – Statistics to 2022

• Public Comments

Comments and Suggestions on Updating the NIH Mission Statement

• Video

Pediatric Video Series

• Webinar

Returning Individual Research Results and Data: Digging Deeper Webinar Series

• Webinar

Returning Individual Research Results and Data: Digging Deeper into Genetic Results and Secondary Findings

• 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

• Public Comments

Response to the proposed revision of the EU general pharmaceuticals legislation

• Public Comments

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

• 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

• Flyer

What is Assent? – ARABIC

• Flyer

What is Clinical Research? ARABIC

• Flyer

Assent to Consent – ARABIC

• Flyer

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

• Webinar

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

• Publication

Communicating complex numeric information in clinical research

• Meeting Summary

Blurring Boundaries: Revisiting the Distinction Between Research and Care

• Framework
• Guidance
• Principles
• Tools

IRB/EC Considerations for DCT Review

• Publication

Losartan in hospitalized patients with COVID-19 in North America

• Publication

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

• Publication

Bringing data monitoring committee charters into the sunlight

• Meeting Summary

The Evolving Role of PI in the Oversight of Decentralized Clinical Trials

• Flyer
• Publication

DEI in Clinical Research: Tools & Resources for Incorporating DEI in IRB/HRPP Processes (AAHRPP poster)

• Publication

Returning Individual Research Results from Digital Phenotyping in Psychiatry

• Tools

Accessibility by Design (AbD) Toolkit

• Webinar

Accessibility by Design (AbD) Toolkit Release

• Webinar

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

• Presentation
• Proceedings

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

• 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

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

• Framework

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

• Publication

Use Plain Language to Increase Understanding

• 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: Returning Non-validated Test Results

• 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

• Video
• Webinar

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

• Video

Including Young People in Clinical Research Toolkit Companion

• Tools

Including Young People in Research

• Video

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

• Principles

Guiding Principles for Protecting Children in and through Pediatric Clinical Research

• 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