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IRB Policies and Procedures

Office of Research Assurances

Office of Research Assurances

Physical Address:

Morrill Hall Room 414
Moscow, ID  83844

Mailing Address:
875 Perimeter Dr., MS 3010
Moscow, ID  83844-3010

Phone: 208-885-2142

Email: uifcoi@uidaho.edu

Web: ORA Website

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IRB Policies and Procedures

Step 1 – Does my Project Need IRB Approval?

All University of Idaho individuals whose activities meet both the definition of “human subjects” and of “research” are required to submit a Human Subjects Application Form to the Institutional Review Board and obtain approval or exempt certification prior to engaging in human subjects/participants research activities. If you are unsure whether IRB approval is required for your project, contact the IRB office at irb@uidaho.edu or 208-885-6340.

IRB protocols must be submitted using VERAS. You can request an account using your UI username and password if you are not in the system.
Complete the application by addressing all required components.
Upload all study documents including consent/assent, survey/interview questions, approvals, debriefing form and recruitment materials.

Note:

Have a question about the portal submission process? 
Contact the IRB Coordinator – irb@uidaho.edu or 208-885-6340
Click “Signoff and submit” to send the protocol out for review or to the PI for the final signoff. Students may submit the protocol application but the final submission must come from the primary investigator (PI).

Note:

  • Students are not eligible to serve as PI on IRB protocols. Their faculty sponsor can serve in this role to oversee the project. 
  • Review the APM 45.22 policy for PI eligibility requirement.

The PI and all personnel must have human subjects training on file. We are currently using the CITI program for this training. See registration instructions for creating an account and selecting the course.

Note:

We are implementing a three-year expiration date on all human subjects training beginning Jan. 1, 2016. After this date, protocols may be held for approval until the training has been updated. 

The IRB Coordinator will conduct a pre-review of the application and work with the investigator to make sure it is complete before sending it to the reviewers. 
Revise protocol based on pre-review comments.

IRB members may request additional information during the review process. The coordinator will send the study contacts these requests via the VERAS messaging system. The investigators must respond to and address each request.

Note:

Revisions to the protocol must be completed by editing the application in VERAS. Additional revision requests may be related to the documents.

Final approval is granted once the following have been completed:

All committee requests are resolved
Personnel training is complete
Approvals have been obtained, as applicable. This includes permission from school officials and Tribes to conduct your research.

Note:

Please confirm that your protocol has been approved before conducting any human subjects research. Feel free to contact irb@uidaho.edu if you have any questions about the status of your protocol. 


Any change to the protocol must be approved by the IRB prior to implementation. Amendment requests can be made by using the “Protocol Amendment Request Form” located in the lower left once you open the protocol in VERAS. If your protocol was approved prior to February of 2014 then you can use the IRB Modification Form to submit your request.

Note:

Amendments may include, but are not limited to, changes in procedures/methods, personnel, participant population (age range, number), recruitment methods, survey/interview questions and consent/assent documents.

The PI or study contact is responsible for requesting an annual renewal of a protocol or closing the protocol when complete using the “Continuing Review and Closure Form” in VERAS. The VERAS system will send reminder emails 60 and 30 days in advance of annual protocol expiration.

Investigators must inform the IRB of any complaints from human subjects and adverse events. Please see the UI policy.

Note:

Noncompliance will be reported to applicable oversight agencies, in accordance with DHHS, OHRP, FDA and funding sponsor agreements.

Continuing Review must be conducted at least every 365 days for all nonexempt protocols approved prior to January 19, 2019. Reminder notices will be sent out but it is the investigator’s responsibility to submit the request prior to the expiration date. Failure to obtain extended approval will result in immediate suspension of the protocol and all activities must stop.

Note:

Please close out all protocols once the project is complete. This can be completed by using the “Continuing Review and Closure Form” in VERAS.


University of Idaho Policies
IRB Policies and Procedures

Office of Research Assurances

Office of Research Assurances

Physical Address:

Morrill Hall Room 414
Moscow, ID  83844

Mailing Address:
875 Perimeter Dr., MS 3010
Moscow, ID  83844-3010

Phone: 208-885-2142

Email: uifcoi@uidaho.edu

Web: ORA Website

Map