This comment letter responds to the National Institutes of Health (NIH)'s Pause on New Submissions to the NIH Human Embryonic Stem Cell Registry and Request for Information on Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research. The University of California (UC) opposes reducing reliance on human embryonic stem cells (hESCs) at this time, arguing that hESCs remain essential research tools and critical benchmarks for evaluating alternative stem cell technologies. UC recommends that any future transition be evidence-based, adequately funded, and phased in gradually, while also urging NIH to continue accepting new hESC lines into the Registry to support scientific progress, reproducibility, and clinical translation.
This comment letter responds to the Food and Drug Administration (FDA)'s guidance document, Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices. The University of California (UC) expresses concern that the guidance appears to require investigators to report all IND safety reports and certain serious adverse events to Institutional Review Boards (IRBs) as unanticipated problems. UC recommends that FDA clarify that only safety reports meeting the established criteria for an unanticipated problem should be submitted to IRBs, preserving a risk-based approach that focuses oversight on actionable safety concerns and avoids overwhelming investigators and IRBs with excessive reporting.
This comment letter responds to the National Institutes of Health (NIH)'s Request for Information on the Draft NIH Controlled-Access Data Policy and Proposed Revisions to the NIH Genomic Data Sharing (GDS) Policy. The University of California (UC) supports NIH’s goals of strengthening participant protections, harmonizing data-sharing requirements, and promoting responsible data stewardship, but recommends substantial clarification and additional stakeholder engagement before finalization. UC expresses concern about ambiguous policy scope, implementation costs, consent requirements, security obligations, and treatment of de-identified, legacy, and genomic data, and urges NIH to adopt clearer, risk-based, and operationally feasible approaches.
This comment letter responds to the National Institutes of Health (NIH)'s Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs. The University of California (UC) expresses concern that blanket bans or caps on publication costs could restrict researchers' ability to publish in the most appropriate venues and disproportionately burden investigators with fewer resources; instead, UC recommends transparent, federally coordinated negotiations with publishers to reduce publication costs while preserving author choice, research visibility, and broad dissemination of federally funded research.
This comment letter responds to the National Institutes of Health (NIH)'s request for comment on the NIH Electronic Application System for discretionary Certificates of Confidentiality (CoC). The University of California strongly supports NIH’s continued issuance of discretionary CoCs and recommends reinstating the existing electronic application system without changes, emphasizing that these protections are vital for safeguarding sensitive research participant data, supporting ethical human subjects research, and maintaining public trust while minimizing administrative delays.
This comment letter responds the NIH's RFI on their Draft Public Access Policy, issued on June 18, 2024. UC strongly supports NIH’s Draft Public Access Policy and supplemental guidance, especially the government use license language allowing broad reuse and derivative works, and urges HHS/NIH to harmonize this approach with federal grant regulations to support consistent zero-embargo access. UC also asks NIH to clarify and support publication-cost planning, preserve PubMed Central as a no-cost deposit route, create a mechanism for post-award publication costs, and work with universities and publishers to automate multi-repository deposits to reduce administrative burden and compliance risk.
This comment letter responds the National Institute of Health (NIH)'s proposed Framework for Discussion for reforming NIH through structural and policy reform. UC urges Congress to approach NIH reform cautiously, with meaningful scientific-community input and independent review before major structural changes, warning that consolidating institutes, capping F&A costs, limiting PI grant holdings, or broadly pausing gain-of-function research could create serious unintended consequences. UC recommends reducing administrative burden, preserving peer review and basic science, supporting early-career and diverse researchers, adjusting grant-size thresholds for inflation, avoiding duplicative research-security requirements, and using risk-based expert oversight for sensitive research areas.
This comment letter responds to the National Institute of Health (NIH) Office of Laboratory Animal Welfare (OLAW)'s request for information on the NIH Notice Clarification of Animal Activities Exempt from the PHS Policy Requirements for IACUC Review (NOT-OD-23-119). UC supports OLAW’s effort to clarify which animal activities do not require IACUC review and approval, but recommends avoiding the term “exempt” because it may be confused with human-subjects research terminology. UC also asks OLAW to clarify several examples involving observational field studies, commercially available surgically modified animals, and reliance on another institution’s IACUC review, and urges OLAW and USDA-APHIS to harmonize field-study requirements and definitions to reduce administrative burden.
This comment letter responds to the Food and Drug Administration (FDA) and National Institutes of Health (NIH)'s joint request for information on a glossary of terms related to clinical research and clinical study designs. UC asks FDA and NIH to clarify whether the proposed clinical research terminology glossary applies only to FDA-regulated studies using real-world data for medical products, or more broadly to other clinical research and observational studies. If the glossary is intended to apply broadly, UC recommends revising certain observational-study definitions and adding definitions for real-world data and real-world evidence so the glossary can serve as a clearer one-stop reference for clinical research terminology.
This comment letter responds to the FDA’s Guidance for Sponsors, Investigators, and Institutional Review Boards on Key Information and Facilitating Understanding in Informed Consent. UC generally supports FDA’s proposed guidance on key information and facilitating understanding in informed consent, including harmonization with the Revised Common Rule, use of plain language, conflict-of-interest disclosure, and flexibility for study-specific presentation. UC raises concerns that the suggested bubble format may create accessibility, equity, IRB-review, and administrative problems, and recommends adding contact information and clearer language on consent elements while deleting recommendations for glossaries, references, tables of contents, and page-number cross-references that could increase burden and undermine plain-language consent.
