Monthly Archives: January 2026

Expanding HRP’s Leadership in AI Research Oversight

HRP Consulting Group is pleased to announce that Tamiko Eto has joined the firm, bringing over two decades of leadership experience in human subjects research protections at world-class institutions.

Ms. Eto is widely recognized as a thought leader in the interpretation and development of policies governing AI-enabled research, bridging the gap between rapidly evolving technologies and established regulatory frameworks. Her work focuses on building institutional capacity for AI oversight through rigorous yet pragmatic approaches that enable research innovation while safeguarding the rights and welfare of research participants.

Advancing Responsible Artificial Intelligence in Human Subjects Research

Throughout her career, Ms. Eto has played a pivotal role in advancing responsible AI use in research oversight. She led the creation of the world’s first agentic AI IRB protocol submission and review platforms, setting a new standard for how institutions operationalize AI governance within IRB and compliance processes.

She has also co-developed numerous CITI Program and PRIM&R AI training programs, helping research administrators, IRB professionals, and compliance leaders worldwide build fluency in AI concepts and their ethical and regulatory implications.

National and Global Leadership in AI Ethics and Policy

In addition to her applied work, Ms. Eto actively shapes the future of AI ethics and policy through key advisory and leadership roles. These include serving on the AI Ethics Advisory Board for the Institute of Experiential AI and as a Senior Teaching and Research Fellow with the Center for AI and Digital Policy (CAIDP), among other national and international engagements.

Her leadership reflects a forward-looking vision for research ethics—one that anticipates the challenges posed by emerging AI technologies while ensuring innovation remains grounded in integrity, transparency, and public trust.

Strengthening HRP’s Support for Institutions Navigating AI Innovation

At HRP, Ms. Eto will enhance the firm’s ability to support institutions navigating the ethical, regulatory, and operational challenges associated with AI-enabled research. Her expertise strengthens HRP’s capacity to deliver practical, strategic guidance that aligns innovation with compliance and participant protections.

HRP Consulting Group is delighted to welcome Tamiko Eto to the team.

On December 31, 2025, the USDA released its first unified General Terms & Conditions (unified T&C’) for Federal Awards.  The unified T&C are intended to replace the patchwork of USDA agency and office specific T&C, giving agencies 45 calendar days to adopt and implement the unified T&C, with any deviations needing to be approved by the Office of the Chief Financial Officer (OCFO).  The 2025 unified T&C applies to all new awards and to significant modifications (as determined by OCFO) to existing awards, to the extent consistent with law.

USDA Press Release – December 31, 2025
USDA Secretary’s Memorandum – December 31, 2025
USDA General Terms and Conditions for Federal Awards – December 31, 2025

Executive Order-related Key Terms & Conditions: Among other terms, the unified T&C formalize the agency’s adoption and implementation of various Executive Orders and Secretary’s Memorandums that were issued in 2025, including:

1. National Security & Unallowable Costs (Section 6.2) – Establishes unallowable costs due to national security concerns with a list maintained at https://www.usda.gov/about-usda/general-information/staff-offices/office-chief-financial-officer/federal-financial-assistance-policy/national-security-and-unallowable-costs, with a requirement for recipient monitoring of the list and agency communications.
2. Foreign Ownership, Control or Influence (FOCI) by a Country of Concern (Section 10.7) – Establishes requirement that recipients certify that they are not, and will not, enter into any subawards, contract, or other agreements with any individual or entity that is subject to FOCI by a foreign country of concern or other foreign adversary. [Note: In considering this term, institutions should refer to the definition of “U.S. citizen or entity subject to foreign ownership, control, or influence (FOCI)” at the end of Section 10.0.]
3. Disclosures (Section 10.8) – Establishes requirements for recipients of awards, and covered individuals working on the award, to complete the Common Forms for Biosketch and for Current and Pending (Other) Support to submit the forms at the time of application and no less than annually.
4. Malign Foreign Talent Recruitment Program (MFTRP) with 10-year look back (Section 10.9) – Establishes requirement for recipients of awards to certify that they, and any covered individuals working on the award are not participating in, and have not within the past 10 years, any MFTRP on the Common Forms for Biosketch and for Current and Pending (Other) Support and to recertify annually.
5. Consequences for Violation of Disclosure Requirements (Section 10.10) – Establishes that violations of disclosure requirements may lead to criminal, civil, and/or administrative consequences. 
6. Dual Use Research of Concern (DURC) and Dangerous Gain-of-Function (Section 10.11) – Establishes requirements for: 
   • compliance with the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC – 2014) and the DHHS Framework for Guiding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework – 2017).
   • recipient agreement to ensure that USDA awards do not support any research that USDA will not fund (with three specified examples).
   • recipients to have an Institutional Biosafety Committee (IBC) or other Institutional Review Entity (IRE) who are responsible for the review of research involving agents covered by the Policy.
   • registration of Policy-defined select agents or other potential pandemic pathogens with the CDC or USDA
   • special award conditions when USDA funds research that involves the creation, transfer, or use of potential pandemic pathogens. 
   • recipient establishment of an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource and agency liaison.
   • record-keeping
     
     Section 10.11 goes on to define “Dangerous gain-of-function research”, “Dual use research of concern”, “Institutional Contact for Dual Use Research”, and “Life sciences.”
7. Civil Rights/Diversity Equity and Inclusion (DEI)/Sex vs Gender Ideology funding restrictions (Sections 12.2, 13.5, and 13.6) – referencing Executive Orders (EOs) and Federal anti-discrimination laws, regulations, and policies that recipients must certify compliance with for the duration of the award.
8. Compliance with Executive Orders and Other Presidential Actions (Section 13.0) – establishes requirements for the USDA and recipient organizations to comply with EOs and other Presidential Actions, listing 12 specific EOs that are “expressly incorporated” into USDA awards.

Other New or Significantly Modified Terms & Conditions – the unified T&C also incorporates several provisions that were either previously unaddressed or that have been significantly modified from prior award requirements, including:

1. Conflict of Interest (Section 1.7) – establishes requirements for the disclosure and resolution of any conflict of interest (COI), including organizational COIs, requiring recipients to notify USDA within five calendar days of discovery and submit their proposed approach for resolving the conflict. Section 1.7 further authorizes USDA to review and determine the effectiveness of the recipient’s conflict management approach, prohibits recipients from requesting payment for costs associated with conflicted transactions pending USDA’s determination, and identifies cost disallowance and award termination as potential remedies for failure to disclose. [Note: Unlike the PHS fCOI framework, USDA requirements apply to any COI, including organizational COI, require agency review and approval of the conflict management approach, impose a five-day disclosure timeline, and prohibit payment requests for conflicted transactions pending USDA’s determination.]
2. Records Retention, Access, and Audit Rights (Sections 5, 8, 9) – clarifies and standardizes USDA’s rights to access, inspect, and audit recipient records, including electronic systems, and clarifies record retention and post-closeout access requirements, representing a more explicit and enforceable framework than many prior USDA agency-specific terms.
3. Expanded Flow-Down Requirements (Sections 5, 10) – requires recipients to flow down applicable USDA compliance, disclosure, and eligibility requirements to subawards and contracts, not solely financial and audit terms, and to actively monitor compliance, representing a broader and more explicit flow-down obligation than many prior USDA agency-specific requirements.
4. Award Termination for Cause, Convenience, and Policy Noncompliance (Section 7) – establishes department-wide authority to terminate awards for cause, convenience, or based on risk, integrity, or policy concerns, representing a broader and more explicit enforcement framework than prior agency-specific requirements which were primarily focused on performance issues or financial noncompliance.
5. Suspension of Payments and Imposition of Special Conditions (Sections 5, 7) – establishes USDA’s authority to suspend payments, impose special conditions, and require corrective actions at any point in an award, not only at renewal or close-out; and requires recipients to maintain effective internal controls and oversight.
6. Remedies Tied to Disclosure and Information Integrity Failures (Sections 7, 10.10) – connects disclosure failures to termination and other remedies, while prior agency-specific terms often treated disclosure errors as correctable administrative issues.
7. Subrecipient/Contractor Noncompliance (Sections 5, 7, 10) – establishes prime award recipient responsibility for downstream noncompliance and establishes remedies when prime recipients fail to sufficiently monitor and for ongoing downstream violations.

Download Summary

Effective January 1, 2026, the U.S. IRS reporting threshold for research participant compensation has increased from $600 to $2,000 per calendar year.  While the institutional reporting threshold to the IRS has increased, the fact that research participant compensation is taxable income remains unchanged.  Reimbursement for documented participant expenses related to participation is not taxable.

New Study Submissions:

Study teams should use the following updated template language in their consent materials when participants will receive financial compensation for participation:

Will I be paid for participation? 

Existing Studies with Active Participants:

For already approved studies with participant payments, study teams should inform active participants of the change in IRS reporting and submit updated consent language for approval with the next amendment, continuing review, or status report submitted to the IRB (whichever comes first).

Active participants, and any newly enrolled participants (enrolled prior to approval of revised consent materials), can be notified of the change using one of the following methods:

• Verbal notification at the time of the next interaction with the participant, using the new template language as a script.  The date and time of participant notification, as well as a summary of the information provided, should be recorded in the study records.
• Provision of the [Institution Name] IRB-approved IRS Reporting Update Information Sheet. For new participants, the Information Sheet can be presented as a Consent Addendum.  For already enrolled active participants, the Information Sheet can be provided at the time of the next interaction with the participant.  The date and time of participant notification should be recorded in the study records, along with a copy of the Information Sheet.

Please note that the IRS Reporting Update Information Sheet is IRB-approved and cannot be modified other than insertion of the PI name, protocol title, and contact information where indicated.

Download Sample IRB Instructions
Download Sample Information Sheet