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Most research institutions evaluating research compliance software already run a system. The question is rarely whether to automate. It is how compliance review and research administration should work together. Vendors answer that in two ways. Some add compliance modules to a research administration suite built first for grants and finance. Others build compliance and research administration on a unified platform, where every module shares data at the core. Both can be the right choice. The difference shows up in daily work: how often investigators re-enter information, how much time staff spend cross-referencing committees, and how clearly the compliance office can see what is happening across its programs.
This article explains that difference, where it matters most, and how to test it before you commit.
Why Institutions Are Reassessing Their Compliance Software
Few R1 or R2 institutions are buying their first system. A reassessment usually starts with problems the current platform cannot resolve:
- Information spread across separate applications : Compliance staff check several systems to track protocols under different committees. Investigators do the same to cross-reference their own studies.
- Reporting that depends on manual work : Leadership asks for review turnaround by committee, and staff export data into spreadsheets to answer the question.
- Forms and workflows that are slow to change : A revised policy or a new review pathway waits in a vendor queue instead of being configured by the office responsible for it.
- Animal program information that does not align : The Institutional Animal Care and Use Committee (IACUC) approves animal numbers in one application, while the vivarium tracks orders, census and per diem charges in another.
- Workload that grows faster than staffing : Protocol volume, amendments and reliance requests increase while coordinator headcount stays flat.
External requirements add to that pressure. Since January 20, 2020, the revised Common Rule has required U.S. institutions engaged in federally conducted or supported cooperative research to rely on a single institutional review board (IRB), with limited exceptions (45 CFR 46.114(b)). The National Institutes of Health (NIH) has expected single IRB review for most domestic multi-site studies it funds since 2018. IRB offices now track studies their own board reviews alongside studies overseen by an external IRB of record. The Food and Drug Administration (FDA) proposed a similar requirement for FDA-regulated cooperative research in 2022.
Investigator time is also at stake. In the Federal Demonstration Partnership (FDP) 2018 Faculty Workload Survey, principal investigators estimated that 44.3 percent of their research time on federally funded projects goes to administrative requirements. Systems that make investigators enter the same study details for several committees add to that burden.
Two Ways Vendors Bring Compliance and Research Administration Together
Compliance modules added to a research administration suite : Many suites began with pre-award and post-award management and added compliance modules over time. The institution gets one vendor across the research lifecycle. The trade-off is that each module may carry its own data structure, and committee-level functionality can vary from module to module. Where data does not flow between modules, staff copy details from one application into another.
A unified platform, integrated at the core : Here, compliance and research administration modules are designed to share data from the start. Personnel, study details, funding and approvals are entered once and referenced wherever they are needed. Users reach every module through the same interface and the same sign-on, and each committee still keeps its own forms and review process.
The useful question is not how many modules a vendor offers. It is whether those modules behave as one system when a study involves several committees and a grant at the same time.
Where the Difference Shows Up in Daily Work
Studies that need both IRB and IBC review : A human subjects study that involves biological agents needs approval from the IRB and the Institutional Biosafety Committee (IBC). When the two reviews run in separate applications, the principal investigator (PI) checks each system to confirm that agents, personnel and procedures match. Committee staff repeat the same check on their side, and both lose time every time the study is amended. On a unified platform, the IBC protocol references the related IRB protocol, so investigators and reviewers work from the same study details and see each other's status.
Visibility across committees : Compliance leaders need to know what is pending, approved, expiring or under corrective action across the IRB, IACUC, IBC and safety committees. If each committee works in its own system, someone assembles that view by hand every week or month. When modules share data, the office can see activity across all committees from the same interface, and leadership can report turnaround by committee without a spreadsheet exercise.
Animal orders checked against approved protocols : Procurement should never exceed the number of animals the IACUC approved for a protocol. When vivarium ordering reads approved numbers directly from the IACUC protocol, the check happens before an order is placed rather than in a later reconciliation. The IACUC and the attending veterinarian also see census and health records against the correct protocol.
Approvals and awards : Sponsored programs staff need to confirm required protocol approvals before award setup, and conflict of interest reviewers need disclosures to line up with proposals and protocols. When those modules share data, confirmation becomes a lookup instead of an email chain.
Depth in each committee's workflow : Integration only helps if each module can run its committee's work. An IRB moves studies through exempt determinations, expedited review and convened review. An IACUC uses designated member review (DMR) and full committee review (FCR). An IBC reviews research involving recombinant or synthetic nucleic acid molecules under the NIH Guidelines. Each needs its own forms, completeness checks, approval periods, amendments, continuing review and post-approval monitoring, configured by the office that owns it.
None of this shifts responsibility. While investigators, reviewers and staff are responsible for the review and conduct of research activities, the institution remains responsible for its human research protection program and its animal care and use program as a whole. The software supports that oversight by keeping dates, documentation and actions organized and traceable.
Four Questions That Show How Integration Really Works
Ask every vendor on your shortlist these questions, whether it offers a suite or a unified platform:
- Protocol and award alignment: Ask the vendor to show how sponsored programs staff confirm IRB or IACUC approval for a specific award, and what happens when that protocol is amended or expires.
- Personnel and training: Ask where training completion data comes from, how it reaches the protocol, and whether the system flags study personnel whose required training has lapsed.
- Conflict of interest: Ask how disclosures relate to proposals and protocols, and which reviewers see a potential conflict.
- Cross-committee studies: Run a study that uses recombinant DNA in animals, which needs IACUC and IBC review. Check whether the investigator enters personnel and study details once, and whether each committee can open the related protocol.
For any system you plan to keep, such as an enterprise resource planning (ERP) or human resources (HR) system, also ask for application programming interface (API) documentation and references at institutions that run the same systems you do.
When Each Approach Is the Right Fit
When the choice is not obvious, ask which office's workload most constrains research growth over the next five years. If the answer is sponsored programs, grants functionality deserves more weight. If it is the IRB, IACUC or IBC office, look hardest at committee depth and at how data moves between committees.
How to Test Both Before You Commit
- Send scenarios in advance: Give each vendor four or five scenarios from your own programs two to three weeks before the demonstration. Good examples include an IRB study involving biological agents that also needs IBC review, an amendment that adds personnel without current training, an animal order that exceeds approved numbers, and a leadership report on review turnaround by committee.
- Ask for a scripted demonstration: Have every vendor show the same scenarios in the same order so your team compares like with like.
- Use a sandbox for the deciding criteria: Reserve hands-on testing for the two or three requirements that decide the selection, such as cross-committee data sharing or integration with your grants system.
- Clarify who changes what: Ask which forms, questions, routing rules and notifications your staff can configure, and which changes require the vendor.
- Resolve integration, security and migration before selection: Interface scope, data migration and your security review belong in the evaluation, not the implementation plan.
- Compare cost over five years: Include licenses, implementation, interfaces and the staff time needed to maintain configuration.
- Talk with peer institutions: Ask references with similar research volume what changed after go-live.
How Key Solutions Approaches Research Compliance and Administration
Key Solutions builds research compliance and research administration software for life sciences research institutions on a unified platform. Its modules are integrated at the core rather than added onto one another, so relevant data is shared across every module.
- Compliance coverage on a unified platform: Human Subjects (IRB), Animal Subjects (IACUC), Biosafety (IBC), Stem Cells (SCRO), Radiation Safety (RSC), Chemical Safety (CSC), Controlled Substances (CS) and Post-Approval Monitoring (PAM). Each committee keeps its own forms and review process. Shared data lets investigators and staff cross-reference related protocols and gives compliance teams visibility across all committees.
- One interface, one login: Users reach every module from the same interface through single sign-on (SSO), whether they submit a protocol, review an amendment or check an award.
- Institution-defined forms and workflows: Institutions set the questions on each committee's protocol form, mark them required or optional, and configure workflows from pre-built options. Policy changes reach investigators through configuration rather than a system rebuild.
- Depth in the animal care and use program: Animal Subjects (IACUC), Lab Animal Resources Software (LARS) and Lab Animal Health Software (LAHS) share protocol information. Animal orders are checked against IACUC-approved numbers before they are placed, and census, per diem billing and animal health records sit against the correct protocol.
- Research administration on the same platform: Grants Management, Post Award Grants Management and Conflict of Interest (eCOI) share data with the compliance modules, including system-to-system (S2S) submission to Grants.gov. APIs support integration with existing HR, financial and ERP systems.
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