Research Integrity & Compliance Fundamentals
Research integrity and compliance fundamentals collects the general and introductory material that underlies the more specific sub-topics in this cluster — human subjects protection, animal research oversight, biosafety, clinical trial compliance, research misconduct, conflict of interest, data security, and compliance training. It is the starting point for readers who need orientation to the field before working through a specific regulatory area. Research compliance, as a distinct administrative function, exists because research involving human participants, animals, hazardous materials, controlled technology, or federal funding is subject to a layered set of obligations: institutional policy, funder terms and conditions, and federal or international law. Compliance offices sit at the intersection of these obligations, translating regulatory requirements from bodies such as the IRB and IACUC system, the Office of Research Integrity, and their international counterparts into institutional policy and day-to-day review processes that researchers and administrators actually follow. This sub-cluster covers the shared vocabulary and structures that recur across those specific areas: what a compliance office does, how oversight committees are typically structured and charged, the difference between institutional policy and external regulation, and the basic lifecycle of protocol submission, review, approval, and monitoring that appears in one form or another across human subjects, animal, and biosafety review. Pages here are written for readers new to research compliance administration, or for those who need a cross-cutting reference point before consulting the more specific sub-clusters, each of which is grounded in the particular regulatory framework that governs it.
Guides
How Institutions Staff a Research Integrity Office: RIO, Compliance Director, Research Protections Director
How research-intensive institutions split the research-integrity-and-compliance function into a Research Integrity Officer, Research Compliance Director, and Research Protections Director, with a real 2024 institutional restructuring example.
The Institutional Official (IO): One Role Across IACUC, Research Security, and Misconduct Oversight
The Institutional Official (IO) is the senior signatory who binds a research institution to its federal assurances and certifications across IACUC/animal research, misconduct oversight, and research security — distinct from the RIO, DIO, and Research Security Officer roles that report to it.
Council on Governmental Relations (COGR): What It Is and Its Role in Research Policy
An overview of the Council on Governmental Relations (COGR): what it is, who it represents, and its role in federal indirect-cost, compliance, and research-security policy for U.S. research institutions.
Is NIH Research Peer Reviewed? Grant Review vs. Journal Peer Review
NIH grant applications go through their own scientific peer review (study sections) before funding. The resulting research findings go through a separate, unrelated journal peer review before publication. Here’s how the two differ.
Research Integrity Fundamentals: FFP, RCR, and the Misconduct Process
An orientation to research integrity as a field: how it differs from research ethics and compliance, the FFP misconduct framework, RCR training, and how misconduct investigations actually work.
The Seven Elements of an Effective Compliance Program, Applied to Research Compliance
How the OIG’s seven-element compliance-program framework, drawn from the Federal Sentencing Guidelines and HHS-OIG guidance, maps onto a university research-compliance office’s actual risk areas: misconduct, human subjects, export control, COI, and effort reporting.
NIH’s Simplified Review Framework: What Changed in Grant Peer Review Scoring
NIH’s Simplified Review Framework reorganizes the five RPG peer-review criteria into three factors, effective for application due dates from January 25, 2025.
Sole-Source Justification Letter: Format, Required Elements, and a Worked Example
A sole-source justification letter documents why a purchase using federal award funds is being made from a single vendor without competitive bidding. This guide covers the required elements under 2 CFR 200.320, common justification grounds, review expectations, and a worked structural example.
Federal Grant Closeout: The Process and a Practical Checklist
A practical guide to federal grant closeout under 2 CFR 200.344 — the reporting deadline, final financial and technical reports, property and equipment disposition, patent/invention reporting, record retention, and a step-by-step checklist.
Federal Grant Compliance Checklist: The Practical Basics
A lifecycle-ordered checklist that ties together CASRAI’s individual guides on Uniform Guidance, effort reporting, subawards, F&A rates, and audit prep into one practical overview of what federal grant compliance actually requires day to day.
What a Research Administrator Does: The Role Explained
What research administrators actually do (pre-award, post-award, or both), where the role sits organizationally, the skills it requires, and how it connects to CASRAI’s identifier and compliance standards.
NIH Modular Budgets: How Proposal Budget Development Works
How NIH’s modular budget format works: $25,000 increments, the $250,000 direct-cost threshold, when a detailed budget is required instead, and what justification NIH still requires (personnel effort, itemized consortium/subaward costs) even in a modular submission.
Departmental vs. Central Sponsored Programs Office: How Research Administration Is Organized
How universities organize research administration: departmental (distributed) staff embedded in academic units vs. a central sponsored programs office (SPO/OSP), the hybrid hub-and-spoke model, and how this differs from the pre-award/post-award functional split.
Subaward Agreement Negotiation: How It Works
A practical walkthrough of subaward agreement negotiation between a prime awardee and a subrecipient institution: what gets negotiated, common friction points, and where standardized templates fit.
Institutional Internal Controls for Federal Grant Compliance
What 2 CFR 200.303 requires, the five components of an effective internal control system, and how weak controls surface as Single Audit findings.
Pre-Award vs. Post-Award Office Roles: How the Functions Split
A functional breakdown of pre-award (proposal, budget, submission, compliance review) versus post-award (financial administration, monitoring, reporting, closeout) office roles in sponsored-programs administration, and how researchers interact with each across the grant lifecycle.
FDP Subaward Templates: Cost Reimbursement, Fixed Amount, and Foreign Variants
How the Federal Demonstration Partnership’s standardized subaward templates work, why FDP built them, and how to choose between the Cost Reimbursement, Fixed Amount, and Foreign variants under Uniform Guidance.
Effort Reporting Methodologies: Plan Confirmation, After-the-Fact Activity Records, and Multiple Confirmation Records
Plan Confirmation, After-the-Fact Activity Records, and Multiple Confirmation Records are the three methodologies institutions use to document effort under 2 CFR 200.430 — this guide compares them and their trade-offs.
NIH’s 15% Indirect Cost Cap: What It Meant and How the Fight Ended
What NIH’s proposed 15% indirect cost cap would have changed, the litigation that blocked it, and how the fight concluded in 2026.
Uniform Guidance (2 CFR 200): The Governing Framework for Federal Research Grants
What 2 CFR 200 is, how it consolidated eight prior OMB circulars, its core cost principles, and how it underpins MTDC, F&A rates, the de minimis rate, and the Single Audit.
