News Type: Public Comments

The MRCT Center submitted public comments to the National Institutes of Health (NIH) “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy,” published in the Federal Register on November 30, 2021. 

The MRCT Center appreciates the NIH’s efforts to update its policy on Genomic Data Sharing (GDS) to maintain currency with evolving technology and understanding and commented on multiple issues, including de-identification and evolving concept of “identifiability,” data linkage, data management and sharing principles for NIH-supported resources, harmonization of GDS and NIH Policy for Data Management and Sharing (DMS) plans, and the types of research covered by the GDS policy. In addition, the MRCT Center proposed that the NIH consider several additional issues in its revision including withdrawal of consent, third party risks, harmonization with other federal and international agencies, the increased likelihood of re-identification with future technology advances, sanctions for misuse of data, public education, and the effectiveness and impact of the GDS policy. Read comments

MRCT Center Program Director Dr. Deborah Zarin authored invited commentary in JAMA Internal Medicine with Dr. Robert Califf: “Trial Reporting and the Clinical Trials Enterprise.” Discussing how trial reporting has evolved and why academic medical centers must double down on efforts to ensure complete and accurate reporting.

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MRCT Program Director, Deborah A. Zarin commented on the National Institute of Health’s release of its final policy for managing and sharing publicly funded scientific data in STAT’s Pharmalot.

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Harvard University’s Multi-Regional Clinical Trials Center (MRCT) submitted the following comments on FDA’s proposal, 78 Fed. Reg. 33421 (June 4, 2013), to make de-identified and masked clinical and preclinical data, from marketing applications submitted to FDA, available to external experts and others, as part of the Agency’s transparency initiative.

FDA proposes to make available to the public pooled data that have been sufficiently de-identified and masked (as to the drugs involved in the trial) in order to protect confidential commercial information, for analysis by the broader community.