Feb 18, 2026

New Guidelines on Human Subjects Protection Training

Executive Summary

Currently, UNI’s IRB requires researchers to complete CITI human subjects training only once ("one-and-done"). We are updating our policy to require training renewal every three years. 

This change is necessary to address the significant regulatory changes from the 2018 Revised Common Rule, to align with NIH specific mandates, and to mitigate findings of non-compliance during federal audits.

 

Justification for Change

1. The Regulations Have Changed (The "2018 Rule")

The primary federal regulation governing human subjects research (The Common Rule, 45 CFR 46) underwent a significant overhaul in 2018.

  • The Risk: Faculty trained prior to 2019 are operating under a regulatory framework that no longer exists. They are likely unaware of new exempt categories, new requirements for "Key Information" in consent forms, and changes to continuing review.

  • The Fix: A renewal requirement ensures all active researchers are educated on the current regulations, reducing the burden on the IRB to correct outdated practices in protocol submissions.

 

2. Alignment with NIH Clinical Trial Policies

While the Common Rule implies continuing education, the NIH is explicit. Per policy NOT-OD-16-148, all NIH-funded investigators involved in clinical trials must renew Good Clinical Practice (GCP) training every three years.

  • The Gap: Currently, we have a disconnect where some researchers must renew GCP every 3 years, while others never renew their basic human subjects training. This creates a fragmented compliance landscape that is difficult to track.

  • The Fix: Aligning all human subjects training to a standard 3-year cycle simplifies tracking and ensures we do not accidentally jeopardize NIH funding eligibility.

 

3. Meeting the "Appropriately Qualified" Standard

Our institution’s Federal wide Assurance (FWA) requires us to ensure that research staff are "appropriately qualified."

  • The Audit Risk: In an audit by OHRP or the FDA, presenting a training certificate from 15 years ago is often viewed as insufficient evidence of current qualification. Most peer institutions and major research universities have adopted a 3-year renewal cycle as the industry standard of practice.

 

Implementation Plan: Minimizing Faculty Burden

Researchers who have already completed Human Subjects training can renew their certificates through CITI’s "Refresher" courses rather than requiring the full basic course again.

  • Basic Course: Must be completed by all researchers at least once (~4-5 hours).

  • Refresher Course: May be used to renew human subject training (~2 hours, every 3 years).

  • Current Status: Personnel can check their status by navigating to the CITI Program webpage and logging in. Then click on “My Records” at the top of the page. This will display all your training records, including expiration dates.

Rollout Strategy: We will check that researchers have a current training certificate (within the last 3 years) upon IRB review of any IRB application. The IRB will stop recognizing human subject training certificates older than 3 years beginning July 1, 2026.