Protocol Review

Protocol Review

Who is reviewing my protocol?
Protocol review is conducted in many stages and by several reviewers with a variety of expertise. Most review teams consist of a volunteer scientific reviewer, a veterinarian, an OH&S representative, a grant reviewer and an office staff member for administrative items.

Why do I get so many questions for a protocol that has been previously approved?
Each review of your protocol may be conducted by different reviewers. Different review teams may focus on different aspects of the protocol or may have varied undertsanding of the research being conducted. If you ever have difficulty with questions or feel a question has been asked inappropriately, please contact the IACUC office. With the implementation of the new electronic form (eForm), the IACUC hopes to increase consistency and greatly reduce the number of review questions by: refining existing questions, adding required questions that may not have been previously included, and providing more guidance to both the PI and reviewer about the expectations of each question.

How can I help the review process move faster?
The length of the review process is based on 2 main factors: how quickly the reviewers complete the review and how quickly the investigator responds to questions. Other issues such as use of hazardous agents, complexity of the protocol, special requests (outside housing, exemptions, etc.) and incomplete or incorrect forms can also affect review length. To help speed up the process you can:

  • Check all forms for congruency and completeness prior to submission.
  • Respond to all reviewer questions as completely and quickly as possible.
  • Complete training and enrollment as soon as possible.

How do I respond to reviewer questions?
For reviews on paper forms: When responding to reviewer questions there are 2 items to complete: a response memo and a revised form. Response memos should contain the reviewers' questions and your response to them. The forms should contain any needed revisions from the reviewers' questions preferably highlighted or in a different color font. While these 2 items may seem redundant, they can speed up the review process by allowing the reviewers to focus only on your revisions. There have been problems in the past where only a revised form was submitted and after spending a great deal of time reviewing the entire revised document, the reviewers found that not all requested changes were included in the form.

For reviews on electronic forms (eForms): Make the requested changes to the eForm, and upload any supporting documents as needed. Then simply submit. The reviewers will be able to compare the form verisons to see the changes that were made in the response submission.

If I haven't completed training or enrollment should I still respond to reviewer questions? 
Yes. Training and enrollment must be completed before approval is granted, but you should respond to reviewer questions as soon as possible even if training and enrollment are still pending. In the eForm, you will be able to check a person's training certifications as they are added to the form so that you can inform them of any required training prior to submission.

What is the process for review of hazardous materials related to my animal work?
If you will be administering hazardous substances to animals, you will also need to submit paperwork to Occupational Health and Safety (OH&S) for review before you can begin your experiments. You will need to complete and submit the Project Registration Form to OH&S. If they determine that the material you are using requires special handling of the exposed animals, they will create the Animal Use and Safety Information (AUSI) form at the conclusion of their review. You will be contacted by the ARP Health and Safety Specialist to conduct a safety briefing which covers any specific handling rules or precautions and at that time you will receive the final AUSI. Once the briefing has been conducted, the IACUC will notify you that you are allowed to begin your animal work.