Direct comparison
Regulatory Compliance Software for Research
Research compliance software compared: IRB/IACUC, COI, export control, eRA and effort systems — and how they differ from enterprise GRC suites.
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How do Protocol systems (IRB/IACUC), COI disclosure, Research security & export control, eRA / grants management, Regulatory change monitoring compare side by side?
The table below compares Protocol systems (IRB/IACUC), COI disclosure, Research security & export control, eRA / grants management, Regulatory change monitoring across 12 procurement-relevant dimensions, from what it is the system of record for through where ask casrai fits (our own product).
Side-by-side comparison
| Dimension | Protocol systems (IRB/IACUC) | COI disclosure | Research security & export control | eRA / grants management | Regulatory change monitoring |
|---|---|---|---|---|---|
| What it is the system of record for | Human- and animal-subject protocols: submission, committee review, approvals, amendments, continuing review, adverse-event and post-approval monitoring records. | Investigator disclosures of outside financial interests, the institutional review of those disclosures, and any management plan imposed as a result. | Screening records for foreign parties, entities and shipments, plus export-control determinations, technology control plans and restricted-party check evidence. | The award lifecycle: proposal development, budgets, routing and institutional sign-off, award set-up, subawards, and payroll or effort documentation. | Nothing. This category tracks what the rules currently say; it holds no institutional record and produces no auditable submission of its own. |
| The rule it implements | The Common Rule (45 CFR 46) for human subjects; 45 CFR 46.114 requires US cooperative research to rely on a single IRB, with narrow exceptions. Animal work runs on separate committee rules. | The PHS financial conflict-of-interest regulation, 42 CFR Part 50 Subpart F, which turns on the Significant Financial Interest definition in 42 CFR 50.603. | The Export Administration Regulations (15 CFR Parts 730-774, Commerce/BIS) and ITAR (22 CFR Parts 120-130, State/DDTC), plus exclusion checks under 2 CFR Part 180. | The Uniform Guidance, 2 CFR Part 200 — including the standards at 2 CFR 200.430 for documenting salaries and wages charged to federal awards. | No rule requires you to buy this. It exists because the rules above change, and nobody is assigned to notice. |
| What the regulation actually specifies | Composition and function of the review committee and what it must consider — not a piece of software. Paper minutes satisfy the rule; software just makes them findable. | A Significant Financial Interest is remuneration plus equity in a publicly traded entity exceeding $5,000 aggregated over twelve months; for non-public entities, over $5,000 or any equity at all. | What may be shared with whom, based on the substance of the technology and the nationality of the recipient — determined by the item and the person, never by the contract template. | That records support the charges, reflect total activity not exceeding 100%, and follow the institution’s accounting policies. Budget estimates alone do not qualify as support. | Not applicable — but note that ignorance of a changed requirement is never an accepted audit response. |
| What it explicitly does NOT cover | Funding, money, or personnel effort. An approved protocol says nothing about whether the award can pay for the work. | Salary, royalties or IP rights paid by your own institution to its own employee are excluded from the SFI definition outright — a frequent source of over-disclosure. | Publication-track fundamental research is treated very differently from controlled technology; screening software cannot make that determination for you. | No specific effort-reporting system or percentage-of-effort certification is mandated by 2 CFR 200.430 — that is an institutional design choice, not a federal requirement. | It does not file anything, approve anything, or discharge any obligation. Treating a monitoring tool as compliance evidence is a category error. |
| Who works in it every day | IRB and IACUC administrators, committee chairs and members, and the study coordinators or lab staff who submit and amend. | A COI officer or research-integrity office, plus every investigator once or twice a year and within 30 days of a new interest. | Export control officers, and increasingly a named research security lead; also procurement and international travel or shipping staff. | Pre-award and post-award administrators, departmental research administrators, and finance — by headcount the largest user base of any category here. | Whoever is expected to know that a policy changed: office directors, compliance leads, and the person who writes the internal guidance. |
| Well-known systems in this category | Huron (Click) IRB, Advarra, IRBNet, iMedRIS and Cayuse for human subjects; Cayuse Animal Oversight, Topaz and Huron on the IACUC side. | Usually a module of the same suite rather than a standalone buy — Huron, Cayuse Outside Interests, InfoEd and Kuali all ship one. | Descartes Visual Compliance is the widely used dedicated screener; the underlying data is free via the government Consolidated Screening List and SAM.gov exclusions. | Cayuse, InfoEd, Kuali Research, Streamlyne and Huron Research Suite, all of which must interoperate with federal systems such as eRA Commons and Grants.gov. | The Federal Register, Regulations.gov and agency notice feeds are the free primary layer. Ask CASRAI, our own product, sits on top of that layer — see the last row. |
| What an auditor or sponsor asks to see | Approval dates that precede the activity, a complete amendment trail, and evidence that continuing review or post-approval monitoring actually happened. | That disclosures were collected before expenditure, reviewed by someone with authority, and that any management plan was monitored rather than merely written. | A dated screening record for the specific party, and a documented determination for anything that was shared, shipped or accessed. | That payroll charges trace to records meeting the 2 CFR 200.430 criteria, and that changes in effort were promptly recorded rather than reconciled at year end. | Nothing. No auditor will ever ask for your monitoring subscription; they will ask why you missed the change it was supposed to surface. |
| The integration that actually matters | Protocol-to-award linkage, so an award cannot be spent against a lapsed approval — the single most valuable and most commonly missing integration. | Disclosure status surfaced at proposal routing, so a proposal cannot be submitted by an investigator with an unresolved interest. | Screening embedded in purchasing, visitor and subaward workflows. A screener nobody is routed through is decorative. | Payroll and the general ledger. An eRA system that does not reconcile to finance produces two versions of the truth and defends neither. | Human routing. The output has to reach the person who edits the policy, or the alert is just more mail. |
| How this differs from enterprise GRC | Enterprise GRC has no concept of a protocol, a committee of record, or a vertebrate animal. Nothing in a GRC suite maps onto this. | GRC vendors sell conflict-of-interest modules aimed at employee gifts and vendor relationships — a different legal test from 42 CFR 50.603 entirely. | This is the one genuine overlap: trade-compliance screening is a real enterprise category, and general-purpose screeners work here. | No enterprise GRC suite manages federal grant proposals. This is served exclusively by research-administration vendors. | GRC regulatory-change feeds cover banking, HIPAA billing and manufacturing rules — not funder policy notices, which is what research offices actually need. |
| The common failure mode | Buying committee-workflow software to fix a committee-behaviour problem. Slow review is usually agenda and quorum management, not the software. | An annual disclosure campaign with a high completion rate and no real review behind it. Collection is the easy half. | Screening at contract signature only, after the technical exchange has already happened. | A multi-year implementation scoped around the vendor’s demo rather than around the institution’s actual routing approvals and chart of accounts. | Assuming someone else is reading the feed. This category fails silently and is only discovered retrospectively. |
| Buy, subscribe, or do without | Worth buying above roughly a few hundred active protocols; below that, a well-run shared drive and calendar genuinely competes. | Rarely worth a standalone purchase. Take the module in whichever suite already holds your proposals. | Subscribe if you screen at volume; the free government lists are perfectly adequate at low volume, and the audit trail is what you are really paying for. | The anchor purchase of the whole estate, and the one to choose first — every other category is easier if this decision is right. | Subscription or nothing. There is no system of record to build here, only a reading habit to make reliable. |
| Where Ask CASRAI fits (our own product) | Not a fit. Ask CASRAI holds no protocols and is not a system of record — use a protocol system. | Not a fit for holding disclosures. It can answer questions about what the COI rules say, which is a different job. | Not a screener. It does not check names against restricted-party lists and must not be used for that purpose. | Not a fit. It does not route, budget, or submit anything, and it cannot draft a proposal or any other document. | This is the only column where it belongs. Ask CASRAI is our own paid product: a question-answering system grounded in cited sources, specialised for research administration, drawing on CASRAI’s published pages plus daily-refreshed feeds from the Federal Register, Grants.gov, Regulations.gov, NSF News and UKRI. It answers questions and cites them; it is not a system of record, not free, and does not guarantee coverage of every funder or regulator. |
Common questions
Common questions about Protocol systems (IRB/IACUC) vs COI disclosure vs Research security & export control vs eRA / grants management vs Regulatory change monitoring
Is enterprise GRC software ever the right answer for a research institution?
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For the research estate specifically, rarely. The genuine exception is restricted-party and trade screening, where general-purpose commercial screeners work well because the underlying obligation is the same one industry faces. Enterprise GRC is also legitimately the right tool for the information-security frameworks an institution runs alongside its research programme — NIST 800-171, HIPAA, ISO 27001, SOC 2. What it cannot do is manage a protocol, a disclosure under 42 CFR 50.603, or a federal proposal.
What is the single most valuable integration to insist on?
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Protocol-to-award linkage. If your eRA system knows which award depends on which IRB or IACUC approval, a lapsed approval becomes visible before money is spent against it. Institutions that lack this discover the problem during audit or at closeout, when it is expensive. Ask any vendor to demonstrate it with real record types rather than describe it.
Does the Uniform Guidance require an effort reporting system?
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No. 2 CFR 200.430 sets standards for the records that support salary and wage charges — they must be accurate and properly allocated, reflect total activity not exceeding 100 percent, and follow the institution’s established accounting policies. It explicitly states that budget estimates alone do not qualify as support. It does not mandate percentage-of-effort certifications or any particular software. Many institutions run one anyway because it is a defensible way to meet the standard.
What actually counts as a Significant Financial Interest?
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Under 42 CFR 50.603, remuneration received in the preceding twelve months plus equity held in a publicly traded entity, aggregated, exceeding $5,000. For a non-publicly-traded entity it is remuneration over $5,000 or any equity interest at all. Salary, royalties and IP rights paid by the investigator’s own institution are explicitly excluded, as is income from most retirement vehicles the investigator does not directly control.
Do we still need our own IRB software if we rely on a single IRB?
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Usually yes. 45 CFR 46.114 requires US cooperative research to rely on a single IRB for the portion conducted in the United States, but relying institutions still hold reliance agreements, local context reviews and their own non-cooperative studies. The single-IRB rule reduces duplicate review; it does not remove the local record-keeping obligation. Two exceptions exist: where more than single IRB review is required by law, including tribal law, and where the supporting federal agency documents that single IRB review is not appropriate.
Can we do restricted-party screening without buying software?
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Yes, at low volume. The government publishes the Consolidated Screening List, and exclusion checks are available through SAM.gov; 2 CFR 180.300 accepts checking SAM.gov exclusions, collecting a certification, or adding a clause as valid verification methods. What a paid screener buys you is throughput, batch and ongoing rescreening, and a dated audit trail per check — that trail, not the data, is the real product.
Which category should a small research office buy first?
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The eRA or grants management system, if anything. It has the largest daily user base, the most direct financial exposure, and it is the system the others need to integrate with. Choosing it first means the protocol, COI and effort decisions are made against a fixed point rather than in parallel.
Why is regulatory change monitoring treated as a separate category here?
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Because it is the only one that holds no institutional record and produces no auditable output. Every other category on this page exists to create defensible evidence. Monitoring exists to make sure the evidence you are creating still matches what the rules require. That difference matters at procurement time — it should never be funded out of the same expectation, or evaluated on the same criteria, as a system of record.
What can Ask CASRAI do here, and what can it not?
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Disclosure: Ask CASRAI is our own paid product, not a neutral third-party pick. It is a retrieval-based question-answering system specialised for research administration, grounded in cited sources — CASRAI’s published pages plus daily-refreshed feeds including the Federal Register, Grants.gov, Regulations.gov, NSF News and UKRI. It cites a source for every factual claim and will say it does not have something rather than guess. It is not a system of record, it does not draft proposals or any other document, it is not free, and it does not guarantee compliance or cover every funder or regulator. For anything that must be filed, approved or audited, use the systems in the other four columns.
Going deeper
