ConductCompliance is not an IRB.

An Institutional Review Board (IRB) is the body that reviews and approves human-subjects research protocols under 45 CFR 46. Every study involving human subjects in the US must be reviewed by an IRB before it starts. The IRB checks that the research design protects subjects from harm, informed consent is appropriate, privacy is preserved, and the science is sound enough to justify the risk.

IRBs come in two flavors:

• Institutional IRBs — university IRBs, hospital IRBs, AMC IRBs. Most academic research goes through one of these. They review protocols from PIs at their own institution.
• Commercial IRBs — WCG, Advarra, Sterling, BRANY, Pearl IRB. They review protocols for industry-sponsored trials and for sites without their own IRB. They charge per protocol.

ConductCompliance is software for preparing IRB submissions. We help you:

• Determine which IRB pathway your study qualifies for (exempt, expedited, full board, IACUC, not human subjects research, or consult required) using a citation-grounded engine.
• Generate a rationale packet you can submit alongside your IRB application as supporting rationale.
• Track your study through its lifecycle: amendments, continuing reviews, adverse event reports.
• Cite the relevant regulations in §46, §164, 21 CFR 50/56, NIH policies, and OHRP guidance, with retrieved dates so you know how fresh the citations are.

We then route you to the IRB you actually use. Your IRB reviews your submission and makes the final determination. Your IRB has final authority on every aspect of the determination.

TurboTax prepares your tax return. The IRS files it. TurboTax does not file taxes for you, and it does not replace the IRS. It helps you walk in with a clean, cited submission.

ConductCompliance is the same dynamic for IRB submissions. We help you prepare. Your IRB reviews and approves.

• You are a PI starting a new study and want to know which IRB pathway applies before you draft your application.
• You are an IRB administrator looking to modernize your office's workflow software (we replace IRBNet, iRIS, InfoEd, Sitero Mentor).
• You are a study coordinator managing CITI training compliance, continuing reviews, and amendments across many active protocols.
• You are an IRB chair who wants AI-assisted reviewer summaries instead of forms-on-forms.

• You expect us to approve your protocol. We do not approve protocols. Your IRB does that.
• You expect a definitive answer for every gray-zone case. We defer to consult-required when inputs are ambiguous (Quality Improvement vs research is the classic example). The engine is conservative on purpose.
• You are looking for a service to replace your institutional IRB with a third-party reviewer. That is what commercial IRBs (WCG, Advarra) do. We are software, not a review service.