September 2024

NEW Interactive Informed Consent Process Module

Scroll through the module for a quick overview or stay and play the topic-specific activities. This is the next offering in a series of guideposts and trainings to regarding the 3 Domains (Institution, IRB, Researchers), 16 Standards, and 62 Elements that make for a fully accredited Human Research Protection Program.

The interactive module addresses the Informed Consent related elements below:

• Element II.3.F. The IRB or EC has and follows written policies and procedures to evaluate the consent process and to require that the Researcher appropriately document the consent process. 
• Element II.3.G. The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation.
• Element II.4.B. The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question. 

Full-Board and FDA-Regulated studies may be approved by the IRB for up to one year.  Continuing review (CR) must be conducted to prevent a protocol approval from expiring. If a protocol expires, the investigator must cease all research activities and may not enroll new subjects in the study. The E-IRB system begins prompting the CR submission around 3 months prior to the expiration date to give investigators ample time to submit and disperse submissions so that the IRB can accommodate the volume. 

How the CR approval date works:

So, while a study is approved for up to a year, some of that time must be used to obtain CR approval. The next cycle starts on the date of the convened meeting in which the study was approved or approved pending minor revisions. Therefore, the next annual cycle will not have identical dates to the first cycle. However, this should not be a concern, as the investigator can continue to conduct research while the CR is pending. 

Why submitting your CR submission early is best practice? 



1. The boards meet every three weeks, but submitting early provides time for the IRB to conduct its review at a convened meeting.
2. If the investigator makes or IRB requests revisions, adequate time is needed for screening and placing the CR on a full-board meeting agenda.
3. Investigators can not submit a modification request (MR) while a CR is pending. 
4. To reactivate an expired protocol, the investigator must complete the CR and resubmit an initial review application.  It is much less work to complete the CR on time. 



To save time, download a sample CR form in advance to begin collecting the information that will be requested with the CR. 

Upcoming ORI Office Hours

Tuesday, September 24, 2024

1:00pm - 2:00pm



The Office of Research Integrity offers consultations by phone, Zoom, or in-person. Consultations are offered for studies in development (with or without an E-IRB submission) as well as approved research projects.