Framework
Developed on: July 2023
Developed by: Joint Task Force for Clinical Trial Competency, MRCT Center, Xunyuan, School of Public Health: Capital Medical University, Beijing Tiatan Hospital: Capital Medical University.
Focus Area: Clinical Trials & Research
Covid-19 Clinical Research Flyers: I am a Healthy Adult: Should I Join a COVID-19 Research Study? URDU
Flyer / Tools
Developed on: February 2022
Developed by: MRCT Center Health Literacy Workgroup
Thank you to Dr. Farah Asif and colleagues at the Shaukat Khanum Memorial Cancer Hospital And Research Centre, Lahore, Pakistan for helping us translate, adapt text, and provide these flyers in Urdu.
Related Resources
Covid-19 Clinical Research Flyers: I am Sick with COVID-19: Should I Join a COVID-19 Research Study? URDU
Flyer / Tools
Developed on: February 2022
Developed by: MRCT Center Health Literacy Workgroup
Thank you to Dr. Farah Asif and colleagues at the Shaukat Khanum Memorial Cancer Hospital And Research Centre, Lahore, Pakistan for helping us translate, adapt text, and provide these flyers in Urdu.
Related Resources
Covid-19 Clinical Research Flyers: I am a Child with COVID-19: Should I Join a COVID-19 Research Study? URDU
Flyer / Tools
Developed on: February 2022
Developed by: MRCT Center Health Literacy Workgroup
Thank you to Dr. Farah Asif and colleagues at the Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan for helping us translate, adapt text, and provide these flyers in Urdu.
Related Resources
Covid-19 Clinical Research Flyers: I am a Healthy Child: Should I Join a COVID-19 Research Study? URDU
Flyer / Tools
Developed on: February 2022
Developed by: MRCT Center Health Literacy Workgroup
Thank you to Dr. Farah Asif and colleagues at the Shaukat Khanum Memorial Cancer Hospital And Research Centre, Lahore, Pakistan for helping us translate, adapt text, and provide these flyers in Urdu.
Related Resources
Covid-19 Clinical Research Flyers: I am Healthy: Should I Join a COVID-19 Research Study? URDU
Flyer / Tools
Developed on: February 2022
Developed by: MRCT Center Health Literacy Workgroup
Thank you to Dr. Farah Asif and colleagues at the Shaukat Khanum Memorial Cancer Hospital And Research Centre, Lahore, Pakistan for helping us translate, adapt text, and provide these flyers in Urdu.
Related Resources
Returning of Individual Research Results and Data: Digging Deeper into IRB/HRPP Responsibilities
Webinar
Presented on: August 17, 2023
Presented at: Virtual
Related Resources
Case Study: IRB/HRPP Responsibilities
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
Return of Individual Results website
Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement
Publication
Published on: August 11, 2023
Published in: Med (Cell Press)
Description: Laura Meloney, Hayat Ahmed, and Barbara Bierer coordinated a modified Delphi process to establish consensus on recommendations for IRBs/ethics committees and institutions to promote diversity and inclusion in interventional clinical research. In this paper, they discuss the 25 consolidated recommendations across four themes.
Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders
Public Comments
Presented on: July 31, 2023
Details: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870). The MRCT Center applauds the FDA for providing this timely and informative guidance, and our comments are intended to further clarify and expand the Agency’s recommendations. Read more here.
Terms and conditions apply: an ethical analysis of mobile health user agreements in research
Publication
Published on: July 14, 2023
Published in: Journal of Law and the Biosciences
Description: Luke Gelinas, MRCT Center Senior Advisor, Walker Morrell, former MRCT Center Project Manager, and Barbara Bierer published an ethical analysis of terms of service and other agreements used in mobile health technologies in clinical research. Risks, mitigating strategies, and recommendations for disclosure (with points to consider) were discussed to help ensure the privacy interests and rights of participants.
