Quality & Transparency Archives

Comments to the European Commission on the Challenges that GDPR Raises for Research

Public Comments

Comments provided on: April 29, 2020

Comments provided to: European Commission

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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.

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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.

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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.

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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.

Link to PubMed article