Resources**

Resources

• Working with Vulnerable Populations

  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

  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

  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

  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

  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

  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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• New changes to NIH Guidance on Flexibilities for Conducting Semiannual Program Review and Inspections

  Summarizes the changes to NIH Guidance for IACUC programs that are USDA registered – providing IACUCs greater flexibility in how they conduct semiannual program reviews and inspections.
  
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• Office of Research Integrity – Final Rule Updating the PHS Policies on Research Misconduct

  This 3-page summary highlights key facts, background, and ORI Recommended Next Steps.  Followed by summaries of the different subpart changes including definitions, responsibilities of institutions, and responsibilities of HHS.
  
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• FDA Proposed Rule: Investigational New Drug Applications: Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement or Cosmetic

  The purpose of this overview is to explain a proposed U.S. Food and Drug Administration (FDA) rule that would create formal exemptions from investigational new drug (IND) requirements for certain clinical studies of products lawfully marketed as conventional foods, dietary supplements, or cosmetics.
  
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• FDA Final Rule – Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

  The purpose of the document is to present key facts about the FDA’s new final rule — 21 CFR 50.22 — which allows an Institutional Review Board (IRB) to waive or alter some or all informed-consent requirements for certain clinical investigations that pose no more than minimal risk to participants.
  
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Common Rule Cooperative Review Federal Stop-Work Directives IRB Guidance for Investigators OHRP Single IRB