“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.
Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations
Source: Federal Register The HHS is amending its regulations that govern the protection of human subjects for conformity with 2018 revisions made to the Federal policy for protection of human research subjects.
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FDA Finalizes Guidance on Use of Part 11 Electronic Systems, Records and Signatures in Clinical Investigations
Source: Cooley On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products and new animal drugs.
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Penn State Agrees to Pay $1.25 Million to Resolve False Claims Act Allegations Relating to Non-Compliance with Contractual Cybersecurity Requirements
Source: United States Attorney's Office The Pennsylvania State University has agreed to pay $1,250,000 to resolve allegations that it violated the False Claims Act by failing to comply with cybersecurity requirements.
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Disaster Resource Management
Source: ACS Publications Recently, the powerful earthquake on April 3, 2024, which struck Taiwan, was the most severe in 25 years and caused extensive damage to the chemistry department at National Dong Hwa University, Taiwan.
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Medical Evaluation for Respirator Use—Updated Approaches
Source: Journal of Occupational and Environmental Medicine Respirator medical evaluations are an important component of occupational health practice. Concepts and practices were established 25–50 years ago.
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Indigenous researchers and communities are reshaping how Western science thinks about data ownership
Source: Science Push for “data sovereignty” could reshape how scientists share information.
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Self-driving cars aren’t here yet, but states are getting the rules ready
Source: Aol Early one morning last year, as state Rep. Josh Bray left his small town of Mount Vernon in southeastern Kentucky to make his way to the Capitol in Frankfort, he decided to count how many drivers he saw texting or distracted by something else.
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From State to Global: Comparing U.S. State Laws to the EU’s Comprehensive Approach
Source: Lexology In the past year, we have written several articles about legislation enacted regarding Generative AI (GenAI) systems.
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Facilitating Efficient and Ethical Trials at the Intersection of Research and Clinical Care
Source: JAMA Network Research that is scientifically and ethically sound should gain institutional review board (IRB) approval without difficulty.
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Declaration of Helsinki turns 60 – how this foundational document of medical ethics has stood the test of time
Source: The Conversation The declaration has gone through eight revisions, but it has largely stood the test of time.
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First-Year Enrollments Take a Tumble
Source: Inside Higher Ed A year of blustery headwinds resulted in a sharp drop in freshman enrollment—the first since the pandemic, data shows. The FAFSA fiasco may have played an outsize role.
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