Public Comments
Comments provided on: April 29, 2020
Comments provided to: European Commission
Comments to the European Commission on the Challenges that GDPR Raises for Research
Language: English
Equity by Design in Clinical Research: A Six-Part Course
Training Material
Released on: May 2022
Developed by: MRCT Center in collaboration with Dana-Farber/Harvard Cancer Center
Biannual Global Meeting of The Joint Task Force For Clinical Trial Competency May 2023
Proceedings and Presentations
Proceedings from: Joint Task Force for Clinical Trial Competency Biannual Global Meeting on May 2, 2023
Held at: Virtual Meeting
Conference Slides
Guest Blog: New Tools to Support Inclusion of People with Disabilities in Clinical Research
Publication
Published on: May 25, 2023
Published in: Amp&rsand, the PRIM&R blog
Description: Dr. Willyanne DeCormier Plosky and Barbara Bierer published “New Tools to Support Inclusion of People with Disabilities in Clinical Research,” based on the recently released Accessibility by Design (AbD) Toolkit.
Returning Individual Research Results from Digital Phenotyping in Psychiatry
Publication
Published on: May 8, 2023
Published in: American Journal of Bioethics
Description: Dr. Barbara Bierer, Francis Shen, and others published a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research, with specific reference to psychiatry.
Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations
Publication
Published on: April 26, 2023
Published in: International Journal of Clinical Trials
Description: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” describing the experience of conducting a multinational acupuncture study during the pandemic.
IRB Health Literacy in Clinical Research
Training Material
Released on: June 2022
Developed by: MRCT Center Health Literacy Team
Bringing data monitoring committee charters into the sunlight
Publication
Published on: May 25, 2023
Published in: National Center for Biotechnology Information, NIH
Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.
DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.
Trials and Tribulation of N-of-1 Trials
Ethical Considerations for Decentralized Clinical Trials: Tools, Resources and Best Practices
Webinar
Presented on: June 20, 2023
Presented at: Virtual
Description: The MRCT Center and Medable convened a multi-stakeholder group to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs) and presented a joint webinar titled “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices” on June 20, 2023.
During the webinar, Dr. Barbara Bierer (MRCT Center) and Dr. Pam Tenaerts and Leanne Madre (Medable) presented guidance and tools organized around 12 key elements. These elements are grouped into three domains: People, Remote Data Collection, and Data Oversight. The aim is to provide IRBs, ethics committees (ECs), and sponsors with the necessary framework, tools, and recommendations for conducting ethical reviews. Robert Ramanchuk provided insights into the real-world, practical implications of the recommendations.