Public Comments
Submitted on: January 4, 2024
Comments provided to: The Office of Research Integrity
Language: English
Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency November 2023
Proceedings and Presentations
Proceedings from: Joint Task Force for Clinical Trial Competency Biannual Global Meeting on November 14, 2023
Held at: Virtual Meeting
Conference Slides
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 Comment
Submitted on: November 11, 2023
Comments provided to: Office of Civil Rights, U.S. Dept. of Health and Human Services
The MRCT Center submitted a response to the Notice for Proposed Rulemaking (NPRM) request of the Office for Civil Rights (OCR) for comments on the draft, “Discrimination on the Basis of Disability in Health and Human Service Programs or Activities. The MRCT Center applauds OCR’s considerations of the rights of people with disabilities and OCR’s effort to clarify and strengthen Section 504 of the Rehabilitation Act of 1973. The MRCT endorsed several key areas in the proposed rule Center presented some suggestions for further clarification.
Comment on the American Community Survey SOGI Test
Public Comment
Submitted on: November 10, 2023
Comments provided to: U.S. Census Bureau
The MRCT Center commented on the Census Bureau’s proposed American Community Survey Sexual Orientation and Gender Identity Test (the ‘Test’) as part of its ongoing American Community Survey Methods Panel Tests. The MRCT Center thanked the Bureau for its commitment to bringing Sexual Orientation and Gender Identity (SOGI) data collection to the foreground. In our response, we asked specific questions about the design of the ‘Test’ and the reliability and privacy of proxy reporting by one household member about the sexual orientation and gender identity of other household members.
Accessibility by Design (AbD) Toolkit
Toolkit
Date: May 4th, 2023
Description: The Accessibility by Design (AbD) in Clinical Research Toolkit is a comprehensive resource intended to be used by sponsors, institutions, investigators, ethics committees/IRBs, participants, and patient advocacy groups to support greater inclusion of people with disabilities in clinical research. It was developed by the MRCT Center in collaboration with people with disabilities, family caregivers, allies, disability rights advocates, and stakeholders working in clinical research, and aligns with the MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document and the Equity by Design in Clinical Research Metrics Framework.
Toolkit
Related Resources:
Accessibility by Design (AbD) Toolkit
Integrating Supported Decision-Making into the Clinical Research Process (Publication)
MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit
Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)
Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials
Webinar
Presented on: October 23, 2023
Learn how these panelists incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand. Collecting feedback enhances engagement, empowers patients, improves communication, and addresses information gaps, paving the way for enriched participant experiences and improved health outcomes.
Additional Resources
MRCT Center Health Literacy Website
Health Literacy Resources for IRBs
Health Literacy Best Practices
Accessibility by Design Toolkit
MRCT Plain-Language Clinical Research Glossary
Including Young People in Clinical Research Toolkit
Webinar Panelist Bio Book
Essential Elements of Ethics – Statistics to 2022
The Evolving Role of PI in the Oversight of Decentralized Clinical Trials
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Returning Individual Research Results and Data: Digging Deeper into Genetic Results and Secondary Findings
Webinar
Presented on: September 21, 2023
Presented at: Virtual
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar in May. Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.
This webinar was the third of the three webinars in the Digging Deeper series. Megan Frone of the National Cancer Institute discussed a case about returning genetic/genomic results and secondary findings.
Related Resources
ACMG/AMP Recommendations for Return of Secondary Findings
NASEM Returning Individual Research Results to Participants
Case Study: Responsibly Returning Secondary Findings
May 2, 2023 webinar: Returning Individual Research Results and Data to Participants
July 27, 2023 webinar: Digging Deeper into Pfizer’s Patient Data Return Solution
August 17, 2023: Digging Deeper into IRB/HRPP Responsibilities
Return of Individual Results website
Defining “recklessness” in research misconduct proceedings
Publication
Published on: September 5, 2023
Published in: Accountability in Research
Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application, and proposing a framework and factors to consider in recklessness determinations.
