Resource Type: Public Comments

Public Comments submitted to TEHDAS2 regarding Health Data Access Bodies for public consultation

Public Comment

Comments provided on: June 28, 2026

Comments provided to: TEHDAS2, coordinated by the Finnish Innovation Fund SITRA

Description: The MRCT Center submitted responses to several TEHDAS2 draft guidelines to Health Data Access Bodies offered for public consultation, including one on international and third country access and transfer of electronic health data; on linkage of health data sets; on informing citizens about the use of health data; and on handling research outcomes. We continue our efforts to engage the stakeholders and guide policy development towards a harmonized data-sharing system for secondary use purposes related to the European Health Data Space (EHDS). 

Public Comments submitted in support of the European Data Protection Board Guidelines 1/2026

Public Comment

Comments provided on: June 25, 2026

Comments provided to: European Data Protection Board

Description: The MRCT Center submitted a public comment in support of the European Data Protection Board’s Guidelines 1/2026 on the processing of personal data for scientific research purposes. The comment welcomes the Guidelines as a meaningful step toward clearer interpretation of the GDPR’s research provisions, endorsing the presumption of compatibility for secondary research, broad consent, and a research-specific approach to controller and processor roles. It also asks the EDPB to clarify how the Guidelines interact with the European Health Data Space, to allow GDPR data-processing consent to be included in the clinical trial consent form, to provide clearer examples of when erasure may compromise a trial, and to provide a workable pathway for sharing pseudonymized data.

Public Comments submitted in response to Future Directions for the NLM Information Resource Grants (G08) Program

Public Comment

Comments provided on: June 24, 2026

Comments provided to: NIH National Library of Medicine

Description: The MRCT Center submitted a public comment in response to the NIH National Library of Medicine’s request for information, “Future Directions for the NLM Information Resource Grants (G08) Program.” The comment affirms strong support for NLM’s mission and the trustworthy resources it offers through PubMed, ClinicalTrials.gov, GenBank, and MedlinePlus, and proposes several ways to expand the G08 program with a focus on clinical trials and research. It recommends deploying libraries and librarians as trusted access points that help the public find and interpret research information; extending these resources to rural and historically underserved areas as entry points for digital trial methods and study recruitment; improving the utility of ClinicalTrials.gov through electronic health record integration for point-of-care trial matching, more complete eligibility criteria, plain-language trial summaries, and machine-readable protocol templates; and providing educational resources on the responsible and practical use of AI technologies. The comment urges NLM to foster an AI-ready research information ecosystem grounded in data interoperability standards, computable metadata, benchmark datasets, FAIR research outputs, and systems that protect personal health information.

MRCT Center NLM LM-26-001Download

Public Comments submitted to TEHDAS2 on targeted issues related to the European Health Data Space

Public Comment

Comments provided on: November 30, 2025

Comments provided to: TEHDAS2, coordinated by the Finnish Innovation Fund SITRA

Description:The MRCT Center and Vivli co-host an ongoing, invite-only forum focused on the European Health Data Space (EHDS), bringing together stakeholders to track developments and coordinate responses. The MRCT Center submitted responses to three TEHDAS2 guidance documents offered for public consultation to Health Data Access Bodies:

  1. GUIDELINE FOR HEALTH DATA ACCESS BODIES ON DATA MINIMISATION, PSEUDONYMISATION, ANONYMISATION AND SYNTHETIC DATA 
  2. DRAFT GUIDELINE FOR HEALTH DATA ACCESS BODIES ON IMPLEMENTING OPT-OUT FROM THE SECONDARY USE OF HEALTH DATA
  3. DRAFT GUIDELINE FOR HEALTH DATA ACCESS BODIES ON IMPLEMENTING THE OBLIGATION OF NOTIFYING THE NATURAL PERSON ON A SIGNIFICANT FINDING FROM THE SECONDARY USE OF HEALTH DATA
TEHDAS2 public consultation on Draft guideline for Health Data Access Bodies on data minimisation, pseudonymisation, anonymisation and synthetic dataDownload
TEHDAS2 public consultation on draft guideline for Health Data Access Bodies on implementing opt-outDownload
TEDHAS2 comments secondary useDownload

E21 Inclusion of Pregnant and Lactating Women in Clinical Trials

Public Comment

Comments provided on: September 18, 2025

Comments provided to: U.S. Food and Drug Administration; FDA-2025-D-1797

Description: The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) submitted public comments on the draft ICH E21 guidance regarding the inclusion of pregnant and breastfeeding women in clinical trials. The MRCT Center strongly supports the ethical inclusion of these historically understudied populations and emphasized the need for ethical and rigorous, well-designed research guided by participant and individual protections.

MRCT Center E21 comments 2025Download

Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry

Public Comment

Comments provided on: March 11, 2025

Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-4245

Description: The MRCT Center commented on the FDA’s draft guidance, Study of Sex Differences in the Clinical Evaluations of Medical Products, advocating for the use of real-world data (RWD) and real-world evidence (RWE) to support post-marketing evaluations of sex differences, inclusion of intersex and transgender individuals, additional guidance on the inclusion of pregnant and lactating individuals, and further advice on statistical approaches to detect sex-based differences.

MRCT Center FDA 2024-D-4245Download

Draft Guidance: Considerations for Including Biopsies in Clinical Trials

Public Comment

Comments provided on: February 24, 2025

Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-2402

Description: The MRCT Center’s public comments on the FDA’s draft guidance, Considerations for Including Tissue Biopsies in Clinical Trials, recommend enhanced clarification on biopsy justification, prioritization of less invasive methods, consent specificity for future research, and strengthened IRB considerations to improve ethical rigor and participant protections.

MRCT Center FDA Biopsies in CT FDA-2024-D-2402Download

Comments Submitted: Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

Public Comment

Submitted on: February 4, 2025

Submitted to: Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration

The MRCT Center submitted public comments in response to FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification such as the identification and validation of surrogate endpoints, the rigor and timeliness of confirmatory trials, expansion of public disclosures for regulatory actions, increased transparency regarding decision-making and withdrawal, and global considerations in the absence of international harmonization of these regulations. 

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MRCT Center FDA 2024-D-2033 CLEANDownload

Public Comments submitted: “Ethical Guidelines for Research Using Pervasive Data”

Public Comments

Comments provided on: January 15, 2025

Comments provided to: Chief Counsel, National Telecommunications and Information Administration

Description: The NTIA’s proposed rule on the “Ethical Guidelines for Research Using Pervasive Data” aims to increase U.S. privacy protections with a heightened focus on responsible use. In response, the MRCT Center has submitted a public comment that recommends enhancing safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address data advancements and mitigate risks to individuals and communities. 

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Public Comments submitted: “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice”

Public Comments

Comments provided on: December 13, 2024

Comments provided to: U.S. Food and Drug Administration

Description: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for maintaining scientific rigor and data reliability when using real world data (RWD) amidst diverse healthcare settings. The MRCT Center comments addressed data quality when using clinical (and variable) data, ethical and practical challenges of randomization in clinical settings, vulnerabilities in data privacy and security, and participant safety while promoting innovative approaches and pilot programs to refine implementation strategies for this purpose. 

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