News & Announcements- Conflict of Interest
- Research Misconduct
- Human Subjects Research
- Stem Cell Research
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Conflict of Interest - Clarifying Disclosures of Gifts and Monetary Donations
As federal and state requirements for research transparency evolve, it is critical for Principal Investigators (PIs), Senior/Key Personnel, and research administrators to understand the nuances of reporting outside support. This month, we are focusing on new NIH guidance regarding monetary donations and how these disclosures intersect with the State of California Form 700-U.
Guidance: When is a Donation "Other Support"?
Previous guidance from federal sponsors indicated that “gifts” do not need to be reported as Other Support. However, NIH has provided examples of monetary donations that may require reporting on your Other Support and are not considered gifts. Here’s the key takeaway: Monetary donations (gifts) that are available to support an investigator’s research are reportable as Other Support.
A key distinction between an unreportable gift and a reportable donation lies in the intended use of the funds. A donation must be reported as Other Support if it is provided with the expectation of supporting the researcher's specific research endeavors. Donations are considered “available” to an investigator if they are put into an account that the investigator can directly access or given to the Investigator directly.
- Report as Other Support if the donation is "earmarked" by the donor for a specific research project, a specific researcher’s lab, or for the direct support of a research-related activity.
- Do not report as Other Support if the donation is a "true gift"—meaning it is given to an institution with no expectation of anything in return (e.g., no technical reports, IP rights, or data sharing) and is for general use.
The Conflict of Interest Connection: Form 700-U
While the NIH focus is on accurate reporting of Other Support, the State of California has a separate but related requirement: the Statement of Economic Interests for Principal Investigators (Form 700-U).
A 700-U disclosure is required whenever a UC employee has principal responsibility for research projects funded by a contract, grant, or other funds earmarked by the donor for a specific project or researcher. The reference to “earmarked” funds creates a unique overlap:
- An earmarked donation from a private foundation must be reported both on your NIH Other Support (because it supports your research) and requires the submission of a 700-U disclosure form (because it is funding from a non-governmental source).
- This overlap may help PIs identify gifts received through UCSB that NIH expects to be reported on their Other Support.
Action Items for Researchers
- Evaluate any monetary donations received directly or through UCSB to ensure they are correctly categorized for your next Other Support submission.
- Focus on whether funds from a monetary donation are available to support your research, rather than when the donation was received. If funds are not currently being used but could be deployed at any time to support your research, NIH generally expects disclosure.
- Err on the side of disclosure if you are unsure whether to include something as Other Support. This point comes directly from NIH’s guidance.
NIH has indicated that they will release additional guidance in the future. However, PIs should immediately ensure that they correctly determine whether monetary donations are reportable as Other Support. If you have questions on what should be reported on your Other Support, contact your Sponsored Projects Team or coi@research.ucsb.edu for guidance.
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Research Misconduct - Updates to Research Misconduct Policy
UCSB’s Research Misconduct Policy & Procedures was recently updated to comply with new federal regulations governing research misconduct, specifically the 2024 PHS Final Rule (42 CFR Part 93), which went into effect earlier this year. The federal changes were intended to modernize the process and enhance procedural fairness.
A significant practical change for our institution is a formalized split between the Research Integrity Officer (RIO) and Deciding Official (DO) roles. The RIO serves as a neutral process manager, overseeing the sequestration of evidence and the technical conduct of inquiries and investigations. The DO serves as an independent adjudicator, reviewing the final investigation reports to make the ultimate institutional determination, and is not involved in the day-to-day aspects of cases.
We are pleased to announce that Kelly Caylor, Associate Vice Chancellor for Research will serve as the campus Research Integrity Officer and Rachel Segalman, Vice Chancellor for Research will serve as the Deciding Official.
Here is a summary of changes to our campus policy and procedures:
- Clarified Definition of "Plagiarism": The definition explicitly excludes "self-plagiarism or authorship or credit disputes" from the scope of research misconduct.
- Stricter Standard for Missing Records: Missing records are now only indicative of misconduct under two narrow conditions:
The respondent intentionally destroyed records after being notified of allegations.
The respondent refuses to provide records they claim to possess.
- Narrowed "Subsequent Use" Exception: The exception to the six-year statute of limitations is narrowed to apply only when the respondent specifically "uses, republishes, or cites to" the questioned research.
- Extended Procedural Timelines: The timelines for proceedings have been extended to provide a more realistic framework for thorough due process: 90 days for an inquiry (up from 60 days) and 180 days for an investigation (up from 120 days).
- Mandatory Interview Transcription and Disclosure: The policy now mandates the transcription of all investigation interviews and the disclosure of all witness transcripts to the respondent, enhancing due process. Transcriptions may be redacted to protect the complainant and witnesses from retaliation.
- Expanded Reporting and the "Institutional Record": The new policy adopts the formal federal definition of the "Institutional Record" and updates reporting sections to align with the more rigorous documentation and filing standards required for federal oversight.
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Human Subjects Research - Considerations for Classroom Embedded Research
The increasing practice of researchers using their own students as subjects for Human Subjects Research (HSR) in classroom settings has prompted the need for guidance on identifying common issues and considerations, and ways to minimize risks to participants.
One primary consideration surrounds the inherent power imbalance between an instructor and a student, which can lead to issues with informed consent and perceived coercion. To mitigate this risk, the "Key Review Considerations for Classroom-Embedded Research" table emphasizes that all research must maintain pedagogical relevance, enhance student learning, and not function as the primary vehicle for a researcher's independent goals. Key safeguards outlined in the table include ensuring participation is explicitly voluntary without affecting grades, using third-party data collection, and delaying access to identifiable participation data until after final grades are submitted. If extra credit is offered, researchers must provide an equivalent, non-burdensome alternative. These considerations, along with ensuring Department Chair (when applicable) and IRB approval, help guarantee that students are recruited because they are the appropriate source of data, and not merely a captive audience.
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Human Subjects Research - Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH
The NIH announcement, NOT-OD-26-032, states that Basic Experimental Studies in Humans (BESH) will no longer be classified as clinical trials by the NIH, effective for applications submitted on or after May 25, 2026. This change is intended to reduce administrative burden and reflects a revised interpretation that BESH research, which aims to understand fundamental biological or behavioral processes without the express intent of immediate clinical advancement, does not meet the current NIH definition of a clinical trial. As a result, BESH studies will no longer be subject to clinical trial-specific requirements, such as registration and results reporting in ClinicalTrials.gov. However, BESH studies must continue to adhere to all applicable human subjects protections and the NIH Data Management and Sharing Policy.
NIH has developed additional guidance on clinical trial requirements for investigators to use for due dates on or after May 25, 2026, to help determine whether a project is a clinical trial, basic experimental study involving humans (BESH), or an observational study involving humans.
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Stem Cell Research - NIH Policy on Research Involving Human Fetal Tissue
The NIH policy, updated by Notice NOT-OD-26-028, immediately bans the use of NIH funds for research involving human fetal tissue (HFT) obtained from elective abortions, applying this restriction across both intramural and extramural projects. For currently funded research projects, organizations may rebudget released funds to support research under the same project that is not unallowable under this Policy.
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Stem Cell Research - Updates to the Stem Cell Webpage
The UCSB Research Integrity Stem Cell Webpage has been updated to include information about which activities require hSCRO review and procedures for obtaining stem cell review and approval. As UCI is the hSCRO of record for UCSB, in order to begin the stem cell application process, please email researchintegrity@research.ucsb.edu to gain access to the online protocol application system.
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Upcoming Events
Interested in hosting a human subjects webinar for your department, class, or research team? We can present on a variety of topics from recruitment to informed consent. Contact us at hsc@research.ucsb.edu to schedule a webinar today!
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