http://www.rssboard.org/rss-specification 720 https://escholarship.org/uc/rpac_ucletters_hhs/rss Recent eScholarship items from U.S. Department of Health and Human Services (HHS) Thu, 3 Sep 2026 03:52:53 +0000 https://escholarship.org/uc/item/9vd827xq This comment letter responds to the Office for Human Research Protections’ draft guidance on the use of a single Institutional Review Board (IRB) for cooperative research. UC supports clearer guidance but recommends additional flexibility and clarification around single-IRB exceptions, selection of reviewing IRBs, local institutional review responsibilities, and reliance agreements, while urging OHRP to reduce administrative burden by developing resources such as a compendium of state laws relevant to human-subject research. https://escholarship.org/uc/item/9vd827xq Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/9sn6m48b This comment letter responds to the FDA’s draft guidance on the use of real-world data and real-world evidence to support regulatory decision-making for drugs and biological products. UC recommends clarifying that certain non-interventional studies using existing real-world data do not require IRB review and further aligning FDA requirements with the Common Rule by permitting appropriate exemptions from IRB review for minimal-risk research, thereby reducing administrative burden while maintaining human-subject protections. https://escholarship.org/uc/item/9sn6m48b Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/9mf9j9bq 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. https://escholarship.org/uc/item/9mf9j9bq Tue, 1 Sep 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/9h75q200 This comment letter responds to the FDA’s proposed rule revising human-subject protection and Institutional Review Board regulations to better align them with the Common Rule. UC supports harmonization but recommends closer alignment on definitions, informed consent, activities preparatory to research, waivers of consent documentation, and continuing IRB review, as well as a longer implementation period for the final rule. https://escholarship.org/uc/item/9h75q200 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/8z99q8c0 This comment letter responds to the FDA’s proposed rule on the protection of human subjects and Institutional Review Boards, intended to harmonize FDA regulations with the Common Rule. UC requests a 60-day extension of the comment period, for a total of 120 days, to allow adequate consultation with researchers, administrators, and compliance and privacy experts regarding the proposal’s implications for human-subject research protections and oversight. https://escholarship.org/uc/item/8z99q8c0 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/8nj635p3 This comment letter responds to the National Institutes of Health’s draft supplemental guidance on protecting the privacy of human research participants when sharing data under the NIH Data Management and Sharing Policy. UC supports a flexible, principles-based framework but recommends greater recognition of consent waivers, clearer and more consistent standards for de-identification and controlled access, broader consideration of legal protections and data-use agreements, and continued NIH investment in field-specific data repositories. https://escholarship.org/uc/item/8nj635p3 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/8m65c5h9 This comment letter responds to the National Institutes of Health’s request for input on its NIH-Wide Strategic Plan for COVID-19 Research. UC recommends expanding the plan to address additional research priorities in COVID-19 biology, testing, treatment, prevention, and health disparities, while calling for sustained federal investment in basic science, research infrastructure, data science, and workforce development to strengthen preparedness for future pandemics. https://escholarship.org/uc/item/8m65c5h9 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/7v11n0rm This comment letter responds to the FDA’s proposed rule requiring single Institutional Review Board (IRB) review for cooperative research and harmonizing FDA requirements with the Common Rule. UC supports greater regulatory alignment but recommends updated analysis of the costs and administrative burden of single-IRB review, clearer exceptions for certain studies and circumstances, greater discretion for local IRBs, and streamlined reliance agreements. https://escholarship.org/uc/item/7v11n0rm Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/7sz8s1zc This comment letter responds to the National Institutes of Health’s request for information on proposed updates and long-term considerations for its Genomic Data Sharing Policy. UC supports modernizing and harmonizing the policy with NIH’s broader Data Management and Sharing Policy but recommends additional public engagement and clearer guidance on genomic data de-identification, privacy risks, data linkage and consent, while seeking to minimize duplicative requirements and administrative burden. https://escholarship.org/uc/item/7sz8s1zc Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/6vx692vq This comment letter responds to the FDA’s draft guidance on Certificates of Confidentiality (CoCs) for protecting identifiable, sensitive information collected in human subjects research. UC supports the guidance’s privacy protections and streamlined CoC process but requests greater clarity on what qualifies as sensitive information, when individual investigators may obtain CoCs, appropriate informed consent language, and the circumstances and options associated with FDA denial of discretionary CoCs. https://escholarship.org/uc/item/6vx692vq Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/637846c7 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. https://escholarship.org/uc/item/637846c7 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/5wz509zr This comment letter responds to the National Institutes of Health’s draft Policy for Data Management and Sharing and supplemental guidance. UC supports NIH’s efforts to expand research data sharing but recommends clearer definitions and implementation standards, standardized data management plan templates and requirements, protections for sensitive data, and adequate funding for both short- and long-term data management, curation, preservation, and infrastructure costs. https://escholarship.org/uc/item/5wz509zr Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/5wd6c2xg 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. https://escholarship.org/uc/item/5wd6c2xg Tue, 1 Sep 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/5ng1c3d5 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. https://escholarship.org/uc/item/5ng1c3d5 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/4p55d0x9 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. https://escholarship.org/uc/item/4p55d0x9 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/4fb874mt This comment letter responds to the Department of Health and Human Services’ request for input on potential revisions to the Public Health Service Policies on Research Misconduct. UC generally supports retaining the existing framework while recommending clearer standards for findings of misconduct, harmonized and flexible investigation timelines, expanded confidentiality protections, and additional guidance on inquiries, investigations, and the application of the six-year limitation on misconduct allegations. https://escholarship.org/uc/item/4fb874mt Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/3rs8v26w This letter requests changes to the Office for Human Research Protections’ IRB Registration Form to allow more inclusive representation of IRB members’ gender identities. UC recommends replacing the form’s binary male/female designation with at least three gender identity options, arguing that the change would better reflect federal requirements emphasizing diversity and nondiscrimination in IRB membership. https://escholarship.org/uc/item/3rs8v26w Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/2ng1337v This comment letter responds to HHS’s establishment of and call for nominations to the NIH Human Fetal Tissue Research Ethics Advisory Board for FY 2020. UC nominates three faculty members based on their expertise and accomplishments in biomedical and stem cell research, science policy, ethics, bioethics, and law. https://escholarship.org/uc/item/2ng1337v Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/2db6h4gd This comment letter responds to the National Institute of Health (NIH) Office of Laboratory Animal Welfare (OLAW)'s request for information on Flexibilities for Streamlining IACUC Review of Protocols and Significant Changes (NOT-OD-23-152) issued on July 11, 2023. UC supports efforts to streamline IACUC review but says OLAW’s proposed flexibilities mostly restate existing guidance or offer only minor clarifications, and UC recommends clearer wording on designated member review, accelerated three-year reviews, alternate member availability, and reporting expectations. UC urges OLAW to pursue more meaningful burden-reduction measures, such as longer or eliminated Assurance renewal cycles, less burdensome Assurance templates, five-year IACUC protocol approvals, and a more flexible NIH Just-in-Time process that allows certification of pending IACUC approval before animal work begins. https://escholarship.org/uc/item/2db6h4gd Tue, 1 Sep 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/28j9736p This comment letter responds to the FDA’s proposed rule on Institutional Review Boards and cooperative research, which seeks to harmonize FDA human-subject protection regulations with the Common Rule. UC requests a 60-day extension of the comment period, for a total of 120 days, to allow sufficient consultation with researchers, administrators, and compliance and privacy experts regarding the proposal’s implications for human-subject research protections and oversight. https://escholarship.org/uc/item/28j9736p Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/0r54j9xv This comment letter responds to the National Institutes of Health’s request for information on research interests and barriers related to studying the health effects of cannabis and its constituents. UC calls for increased and broader research funding, a streamlined federal regulatory framework, improved access to cannabis products representative of those actually used by the public, and coordinated federal resources, infrastructure, training, and regulatory support to expand cannabis research. https://escholarship.org/uc/item/0r54j9xv Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/0p60d992 This comment letter responds to the FDA’s Final Order expanding the list of tropical diseases eligible for the Tropical Disease Priority Review Voucher (PRV) Program. UC supports the announced additions but urges FDA to also include coccidioidomycosis (Valley Fever), arguing that it meets the program’s eligibility criteria and that PRV incentives could encourage development of urgently needed diagnostics, treatments, vaccines, and cures. https://escholarship.org/uc/item/0p60d992 Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/0gr9367z This comment letter responds to the National Institutes of Health’s request for information on developing consent language for the future use and sharing of research data and biospecimens. UC recommends that NIH provide flexible guidance rather than standardized sample language, clarify how the proposal relates to broad consent requirements, avoid a default opt-out approach to future sharing, and address the varying federal, state, and local laws governing informed consent and research privacy. https://escholarship.org/uc/item/0gr9367z Tue, 1 Sep 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/9vw6z5h0 This comment letter responds to NIH Office of Laboratory Animal Welfare (OLAW)'s RFI (NOT-OD-23-063) on updating NOT-OD-05-034, Guidance on Prompt Reporting of Noncompliances to OLAW. UC supports OLAW’s effort to clarify reporting expectations and reduce administrative burden while maintaining animal welfare protections, but raised concerns that the proposed reporting exception for injuries among socially housed animals is overly broad and ambiguous. UC recommends removing the exception or narrowing and defining the covered species, situations, injury severity, separation period, reporting detail, and rationale to avoid unnecessary reporting and misinterpretation. https://escholarship.org/uc/item/9vw6z5h0 Mon, 31 Aug 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/9st228b4 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. https://escholarship.org/uc/item/9st228b4 Mon, 31 Aug 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/99n0x1kk This comment letter responds to the National Institutes of Health, Office of Laboratory Welfare (NIH/OLAW)'s Request for Information on proposed guidance to assured institutions on cephalopod care and use. UC expresses concern on whether OLAW has the authority to expand the application of the U.S. Government Principles or revise the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy). UC recommends several changes to the proposed language to allow for PI input when developing institutional cephalopod policies and SOPs, as well as allowing for flexibility with cephalopod care staff qualifications. https://escholarship.org/uc/item/99n0x1kk Mon, 31 Aug 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/93x6z1b4 This comment letter responds to the NIH Notice NOT-OD-23-091, "Request for Information on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research". UC supports NIH’s plan to eliminate publication embargoes and expand public access, but emphasizes that implementation must reduce author burden, preserve equitable publication opportunities, and address open-access costs for early-career, under-resourced, and underrepresented researchers. UC recommends automated multi-repository deposits, continued and supplemental funding for publication and data costs, accessibility guidance for figures, pressure on excessive publisher fees, institutional infrastructure support, open licensing tools, and broader adoption of persistent identifiers and open metadata. https://escholarship.org/uc/item/93x6z1b4 Mon, 31 Aug 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/7br0n9jb This comment letter responds to NIH's RFI on a proposed simplified review framework for NIH research project grant application. UC supports NIH’s goals of reducing administrative burden and reputational bias in peer review, but questioned whether the simplified framework would actually reduce funding disparities for underrepresented groups. UC recommends real-time outcomes monitoring, robust training and guidance for reviewers and applicants, more diverse study sections, greater funding-transparency data, and added review criteria for team diversity and health-disparities relevance. https://escholarship.org/uc/item/7br0n9jb Mon, 31 Aug 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/6bk2s9gf This comment letter responds to the National Institutes of Health (NIH)'s Request for Information on developing consent language for research using Digital Health Technologies. UC expresses concern that NIH’s sample consent language is too long, too complex, duplicative, and includes issues beyond informed consent, such as DHT terms of use, data ownership, and third-party sharing. UC recommends shortening and simplifying the language, removing technical or out-of-scope content, aligning consent with data management and IRB materials, and offering guidance without a template. https://escholarship.org/uc/item/6bk2s9gf Mon, 31 Aug 2026 00:00:00 +0000 UC Office of the President https://escholarship.org/uc/item/4rw9g2k6 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. https://escholarship.org/uc/item/4rw9g2k6 Mon, 31 Aug 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/3pm6d220 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. https://escholarship.org/uc/item/3pm6d220 Mon, 31 Aug 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/3591b3jz 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. https://escholarship.org/uc/item/3591b3jz Mon, 31 Aug 2026 00:00:00 +0000 UC Office of President https://escholarship.org/uc/item/19t30344 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. https://escholarship.org/uc/item/19t30344 Mon, 31 Aug 2026 00:00:00 +0000 UC Office of President