General IRB FAQs are given below. More specific FAQs have been separated into the following topic areas to make it easier to find the information you're looking for:
- General Questions about the IRB
- Protection of Human Subjects
- IRB Protocol Application Pitfalls
- Protocol Review
- Types of Review
- Review Process
- Working with Other IRBs
- IRB Implications for International Projects
- Consent and Assent
- Methods Classes and Class Projects
- Personnel Training
- Reporting Requirements
- Regulatory Agency Questions
- Funding Agency Questions
Q1: I need to submit a new application for a project involving human subject research to the board for review. Where do I start?
A: There are usually two basic components to receiving IRB approval; 1) submission and review of your IRB protocol application via IRBNet and 2) ensuring those who will be interacting with human subjects or have access to their identifiable data have received the appropriate training. You can find information on using IRBNet to submit your forms for review by the IRB under the link to the left on "IRBNet (e-file)". All persons working with human subjects or with access to identifiable data must complete the CITI course on the Protection of Human Subjects; see the link on the left under "Training" on how to register for this course.
Q2: I have never used IRBNet before; where do I start?
A: First, you must have an IRBNet account. These are not automatically set up for UAF personnel. If you haven't already registered yourself in IRBNet, visit their homepage and use the 'New User Registration' link. After registering, you will need to respond to an activation message sent to the email address you entered when you registered before you can log in. Then use the "IRBNet (e-file)" link to the left to read more on using IRBNet to submit applications to the IRB for review.
Q3: I submitted an application through IRBNet recently and have now received an email notice saying the board posted a decision. What do I do now?
A: If the board posted an Approval, Modifications Required, or Tabled Without Action letter, log in to IRBNet, click on your project title, and then click on the "Reviews" button in the Project Administration menu. The board's letter will be there for you to download and review. If it's an Approval letter, you may download it for your files. If it's a Modifications Required letter or Tabled WIthout Action letter, you need to submit revisions to your application; follow the instructions posted in the "IRBNet (e-file)" link to the left.
Q4: I submitted an amendment to my IRB a few months ago and it was approved, but I just received an auto-reminder that my protocol will be expiring next month; is this a mistake?
A: No; submitting a modification to your protocol does not automatically renew it for another year; you must submit a separate annual Progress Report through IRBNet to extend the expiration date of your protocol.
Q5: I'm submitting my annual Progress Report through IRBNet and have some minor changes I want to make to the procedures the IRB has already approved; can I submit the renewal and the updated protocol in the same package?
A: No. Annual Progress Reports and modifications to approved procedures must be submitted in separate packages. If you submit a Progress Report along with changes to your protocol, you will be asked to submit a new package with only the Progress Report form in the package.
Q6: I submitted an Annual Progress Report to the IRB a few weeks ago but am still receiving notices that the protocol will be expiring next month or have received a notice that the protocol expired. What happened?
A: First, check to make sure your Progress Report was actually submitted to the IRB; after uploading your Report into IRBNet, you MUST use the "Submit this Package" button in the Project Administration menu in order for the IRB to receive your documents. The IRB cannot review or process any requests if they are only uploaded but not submitted. If your Progress Report was submitted to the IRB and has a status of "Pending Review" then the IRB has your submission. IRBNet does not have the capability of recognizing when a renewal is under review by the board and will continue to send you expiration reminders while your request is pending. If you are within a week of your expiration date, contact the IRB Admininstrator to check on the status of your renewal; firstname.lastname@example.org or 474-7800.
Q7: I have an approved IRB protocol, but never started the work due to funding issues/scheduling issues/etc, and have just received an expiration notice from IRBNet. Can I request that the IRB simply extend my approval since I haven't actually started the work?
A: No. The IRB approval is only good for 365 days from the original approval date. The IRB is required to review a protocol at that point even if the work has not started. If the project has not been cancelled but merely postponed, you will need to file an annual Progress Report to maintain IRB approval. You can simply note on the Report that work has not yet begun.
Q8: I will be hiring some assistants to help me with consenting human subject participants, interviewing participants, or completing analysis of identifiable data for my project; what do I need to do to add them?
A: All personnel who will be consenting or interacting with participants, or will have access to identifiable data under your protocol must take the CITI course in human subject protections; see Q1 above. They will also need to be added to your approved IRB. You do this by submitting a revised Personnel List in IRBNet; see the IRBNet (e-file) link on the left on how to submit revisions to an existing IRB protocol.
Q9: I am teaching a Research Methods class this semester and would like to have my students conduct small projects which will involve interviews, surveys, or questionnaires. Do I need to file an IRB application to cover their projects?
A: For class-based projects like this, we have made available a "Certified Instructor" form in IRBNet which you can file to cover the activities of your students. The course instructor must complete the CITI training, see Q1 above. This form can only be used for research activities that would otherwise qualify for exemption from the Federal Regulations. If a student is conducting research which does not qualify for exemption (for example, interviewing minors or addressing sensitive topics with participants, such as traumatic events or other private, personal behavior) or they are conducting research to be used for their own graduate thesis research, they must file their own IRB protocol application to the IRB for review and approval. The IRB will assist you in determining whether a project is exempt.
Q10: I am having one of the following issues with my IRBNet account: I can't remember my username, I can't get the activation email to function properly, I think I may have created two IRBNet accounts. How do I get this fixed?
A: The UAF ORI staff does not have access to account controls and cannot modify or fix your account for you. You must contact the IRBNet Support staff at 1-877-261-6461 and ask for assistance.