Quick Start Guide: Basic IRB Submission Information
Time Commitment—Training & IRB Application
Researchers new to conducting research in humans should allow sufficient time to complete training and prepare a submission in relation to the target start date. The human research training and IRB review process require some investment of time and careful planning, and there are multiple factors which may come into play that affect the time frame to prepare for and obtain IRB approval.
As a general guide, from preparation of submission to IRB approval:
- Allow 4-6 weeks for basic, minimal risk research in populations which are not considered vulnerable
- Allow a minimum of 10 weeks for more involved longitudinal or complex studies, thesis research, research in the public school setting involving children, international research, and clinical research
Who Needs Training in Human Research?
All research personnel who meet the criteria of interacting directly with human research participants or their identifiable data require training, including:
- Principal investigators
- Faculty advisors
- Research coordinators
- Research collaborators at other sites
- Consultants and thesis committee members, if they meet the criteria above
- Course requirements
- Ethical foundation for preparing submissions and conducting research with humans
It is most effective to complete training in advance of preparing a first IRB application. For those who have completed training more than one year ago, it is beneficial to review the training materials again as a resource for developing human research and IRB applications.
IRBNet Protocol Submission System
The Research Integrity Office uses an online, enterprise electronic system, IRBNet, for submission management and IRB review for the life of a project.
Biomedical Research Collaboration with Community Faculty – Special Instructions
Students and community physicians who wish to collaborate on biomedical research have additional procedural requirements to follow to pursue such research.
Find more information for your area:
The IRB/Administrative Review Process
- An IRB submission is received in IRBNet
- RIO staff assign a primary staff coordinator to handle the review
- The staff coordinator screens the submission within two days of receipt for
- level of review (administrative, expedited, or full board), and
- to determine whether review may proceed or if items must be addressed prior to review
- For RIO administrative level review of submissions, review is completed within eight business days by the staff coordinator
- If expedited or full board level of review is required, the staff coordinator assigns the submission for review by an IRB member
- For expedited review, the reviewer completes a review within 10 business days
- For full board review, the reviewer completes a review by the assigned meeting date for protocol review
- The staff coordinator notifies the researchers through IRBNet of the review outcome
- Researchers respond to the review if revisions are requested
- The staff coordinator or IRB member completes the review of revisions
- The staff coordinator notifies the researchers through IRBNet of the outcome
Basic Principal Investigator & Researcher Responsibilities Post-IRB Review
For studies receiving full board or expedited review, as indicated in the IRB review letter:
- Submit renewal requests for continuing projects for review and approval prior to the expiration date.
- Submit proposed changes for review and approval prior to initiation.
- Submit proposed changes to personnel and study sites for review and acknowledgement
- Report any unanticipated problems which may increase risks to human subjects or unanticipated adverse events to the IRB within five days.
For use of external IRB on all projects and requests, regardless of level of review:
- Request permission to use external IRB for purposes of monitoring and following federal regulations
- Ensure agreement between both IRBs is in place
- Provide a copy of the external approval letter and consent form
- Maintain an accurate and complete protocol file
- Submit a closure request after project completion to the IRB, following the closure process