Funding Agency Stop Work Orders: Sample IRB Guidelines for Investigators. View Now
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Category Archives: Resources

Recent FDA Updates: December 2025 – January 2026

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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, and regulatory responsibilities. In keeping with our focus on Helping Research Professionals, this resource is intended to offer practical context and useful reference points as FDA guidelines continue to evolve.

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Unified USDA General Terms & Conditions of Awards Summary

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The HRP team has prepared a summary of the first unified General Terms & Conditions (unified T&C’s) for Federal Awards released by the USDA on December 31, 2025.  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.


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Research Participant Payments – IRS Reporting Update. Summary and Sample Information Sheet

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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.

Sample IRB Instructions
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Working with Vulnerable Populations

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This presentation reviews what “vulnerability” means when conducting human-subjects research. “Vulnerability” should be understood broadly and contextually — beyond just legally defined groups — and researchers must proactively identify and mitigate a variety of risks (e.g. power imbalances, coercion, confidentiality, social or economic pressures) to protect participants’ rights, dignity, and welfare.

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Summary DOJ NIH Rules on Sensitive Data Access

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The attached document provides a summary of the new rules from the U.S. Department of Justice (DOJ) and National Institutes of Health (NIH) that tighten controls on access to U.S. “bulk sensitive personal data” and government-related data — forbidding or restricting data transfers to certain “countries of concern” (China, Russia, Iran, North Korea, Cuba, and Venezuela) and associated entities.  

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Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders

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HRP Consulting Group has prepared a set of sample IRB guidelines for investigators whose human-subjects research may be subject to a “stop work” or “pause work” directive from a federal funding agency. It recommends how to assess risk, plan for safe wind-down (or modification) of research, communicate with participants and stakeholders, protect participant safety (e.g. in therapeutic studies), and ensure proper data/ biospecimen and regulatory handling if funding or work is suspended.

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Comparison of FDA Regulations (Current and Proposed) & Common Rule

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This document provides a detailed side-by-side comparison of the regulations under Common Rule and current (and proposed) U.S. Food and Drug Administration (FDA) regulations (21 CFR 50/56 etc.), showing how FDA’s human-subjects-research and IRB requirements could be harmonized — or where they diverge — under the proposals stemming from the 21st Century Cures Act.

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Summary of Proposed Changes – FDA Regulations 21 CFR 50, 21 CFR 56, and 21 CFR 812: Protection of Human Subjects and Institutional Review Boards

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The document outlines proposed revisions (2022–2024) by U.S. Food and Drug Administration (FDA) to its human-subjects and IRB regulations (21 CFR 50, 56, and 812), aiming to harmonize FDA rules with the revised Common Rule — including updates to informed-consent requirements (e.g., adding a “key information” summary up front), expanding consent content (e.g., future use of biospecimens), clarifying definitions (e.g., biospecimen/identifiable information), adjusting IRB membership and record-keeping rules, and modifying continuing-review and consent-documentation provisions.

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Update – Clinical Decision Support Software Final Guidance

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A one page summary to clarify guidance on determining when CDS software is excluded from the definition of a “medical device” under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Only software functions that meet all four specified criteria qualify as “Non-Device CDS” and therefore are not subject to FDA device regulation. If any criterion is not met, the software may be regulated as a medical device.

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