News

Latest from HRP Consulting Group

• Recent FDA Updates: December 2025 – January 2026
  FDA has recently released several updates – including new and updated guidance documents, technical amendments, and policy clarifications – that may be relevant to research oversight committees (such as IRBs and IACUCs), investigators, and research organizations. To help research professionals stay informed, HRP has compiled the following summary highlighting updates released between December 1, 2025 through January 27, 2026, that may affect research oversight, study design,… Read more: Recent FDA Updates: December 2025 – January 2026
• HRP Consulting Group Welcomes Tamiko Eto
  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.… Read more: HRP Consulting Group Welcomes Tamiko Eto
• USDA General Terms & Conditions of Awards
  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… Read more: USDA General Terms & Conditions of Awards
• Research Participant Payments – IRS Reporting Update
  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… Read more: Research Participant Payments – IRS Reporting Update
• Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders
  HRP’s Commitment to the Research Community HRP stands with our clients and the broader research community as we navigate the evolving political and economic landscape, including sudden grant funding cuts. We are just a few weeks into this journey, and we expect that as some actions are put on hold while litigated, other actions will be quickly taken to achieve the aims of reducing federal research… Read more: Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders
• Understanding the Updated Final Rule on Research Misconduct: Key Changes and Institutional Impacts
  The research community is on the cusp of a significant change with the updated final rule on research misconduct set to take effect on January 1, 2025. This long-overdue revision, the first substantial update in decades, has been meticulously designed to address evolving research practices and enhance integrity within federally funded research projects. As John Baumann, a seasoned research compliance expert with over 25 years of… Read more: Understanding the Updated Final Rule on Research Misconduct: Key Changes and Institutional Impacts
• The Role of AI in Clinical Research: Boosting Efficiency and Addressing Compliance Challenges
  The image provided was generated using DALL-E, an AI-based tool by OpenAI, and is considered free of copyright restrictions. It is provided as a royalty-free asset, meaning you have full permission to use, publish, or modify the image for any purpose, including commercial use on your company website or other platforms. In the latest episode of the On Research with CITI Program podcast, host Justin Osborne speaks with… Read more: The Role of AI in Clinical Research: Boosting Efficiency and Addressing Compliance Challenges
• Exception Process for Revised Common Rule Single IRB RequirementComparison of Common Rule_FDA_Revised FDA_May 2024Exception Process for Revised Common Rule Single IRB Requirement
  The FDA Regulations cited in this table are primarily from 21 CFR 50 and 56 as these regulations refer to human subject protection and institutional review boards (IRBs). The proposed FDA changes cited in this table are from FDA proposed rules Protection of Human Subjects and Institutional Review Boards and Institutional Review Boards; Cooperative Research. The proposals, if finalized would harmonize certain sections of FDA’s regulations… Read more: Exception Process for Revised Common Rule Single IRB RequirementComparison of Common Rule_FDA_Revised FDA_May 2024Exception Process for Revised Common Rule Single IRB Requirement
• Navigating the Complexities of Exception from Informed Consent (EFIC) in Research
  A growing area of research involves exception from informed consent, also known as planned emergency research. Under certain conditions, in an emergency setting, participants can be enrolled in a trial without their consent. This article summarizes the podcast hosted by CITI Program with guest Michael Linke, PhD from the University of Cincinnati and the host Justin Osborne from The HRP Consulting Group where they discussed the… Read more: Navigating the Complexities of Exception from Informed Consent (EFIC) in Research
• Comparison of Common Rule_FDA_Revised FDA_May 2024
  Comparison of Common Rule_FDA_Revised FDA_May 2024 The FDA Regulations cited in this table are primarily from 21 CFR 50 and 56 as these regulations refer to human subject protection and institutional review boards (IRBs). The proposed FDAchanges cited in this table are from FDA proposed rules Protection of Human Subjects and Institutional Review Boards and Institutional Review Boards; Cooperative Research.