Protocol Review

Getting Started

I've never submitted an application for human subjects research to the IRB before; where do I start? There are two basic components to applying for IRB approval; 1) submitting the protocol application through IRBNet for board review and approval and 2) ensuring those who will be interacting with human subjects or will have access to their identifiable data have completed the required CITI training course. Information on submitting applications through IRBNet can be found in the IRBNet (e-file) link to the left and information on the CITI course can be found in the Training link to the left.

Types of Review

What are the types of IRB review? There are three levels of IRB review (Exempt, Expedited and Full). The Office of Research Integrity staff or designated member of the IRB is responsible for determining the level of review required for each application submitted. PIs may NOT determine the type of review required. For more information on the types of review refer to the IRB Procedures (available from the Forms page of this web site).

My project involves mailing anonymous surveys to adults to assess their level of satisfaction with the medical care available in the Fairbanks community, does this project have to go to the full IRB for review?  No!  There are three levels of review possible for any protocol submitted to the IRB. Which level will be used is based on risk assessment. If the survey is truly anonymous and the risk is minimal this project would qualify for Exemption category #2 or #5 (described in 45 CFR 46).

Review Process

How can I tell if the research I'm planning requires IRB approval? If it is "research" and involves "human subjects" as defined in 45 CFR 46.102 you must submit an IRB protocol for review.  If you have any questions about the requirements, contact the Office of Research Integrity.

Do I need to submit my protocol application in time for the next scheduled IRB meeting? Most IRB protocols DO NOT require Full Review at an IRB meeting. If your project is more than minimal risk (examples include but are not limited to: asking questions about suicide or sexual behaviors, gathering biological samples for genetic testing or health testing, some research involving interactions with minors, etc.) it is best to try and submit your protocol in time for the next IRB meeting in case the board decides a Full review is needed. If your research involves minimal risk or less than minimal risk, your application will be handling using either an Expedited or Exempt review process. These applications are sent out to designated members of the board after they are submitted, independent of when the next meeting takes place.

What kind of pilot study may I do before preparing an application for IRB consideration? None. You cannot collect any data involving human subjects prior to receiving IRB approval. If your study changes after collecting a small amount of data, you should submit modifications to the IRB for review and approval.

Can I share an existing approved IRB Protocol with colleagues working on similar projects? You may share your application with anyone you wish. However, IRB approval only covers the specific research and investigators identified in the approved protocol. Separate projects, no matter how similar, should be submitted independently.

Do I need to list all the researchers or investigators participating in the research project? Yes. All researchers and investigators (faculty, staff, students, collaborators, etc.) who will be collecting or reporting data, have access to personally identifiable information about subjects, or will receive credit as authors, should be included.

Do I still have to go through the IRB even though I’m not applying for funding for my research? Yes. The University's Federal Wide Assurance states that all research conducted at UAF, regardless of funding source, will be subject to the IRB review, approval and monitoring process in order to assure the protection of all human research participants.

Do I have to attend the IRB meeting when my application is reviewed? No. However, IRB meetings are open to the public and PIs or research personnel are welcome to attend. In some cases the IRB may request that the PI be present at the review to answer questions or respond to specific concerns. When appropriate, the Research Integrity Administrator will coordinate this with the PI.

How are multiple researchers, on one project, handled in the application process? The IRB will want to know the name and background of each person on the project but only one person may be listed as the principal investigator (PI). The PI must be a UAF person who meets the criteria established in UAF Policy #05-003 Principal Investigator Eligibility . All correspondence from the Office of Research Integrity and IRB will be sent to the PI. On request, the ORI will copy correspondence to a second person on the project, but the responsibility for responding is solely the PI's. All forms and correspondence must be signed by the PI.

Is it possible to extend the approval period? Yes. Any project in good standing may be extended. IRB protocol approval is valid for a maximum of 365 days. As a courtesy, the Office of Research Integrity will send the PI a Continuing Review form 6 to 8 weeks prior to the application’s expiration date. However, it is the PI's responsibility to insure that the Continuing Review is submitted for all projects that will continue beyond the “approval expiration” date on the most recent approval letter. If you are also proposing changes to your project, be sure to submit a Modification Request including all appropriate supporting materials. Remember that modifications must be reviewed and approved by the IRB prior to implementation.

Do I have to let the IRB know when my project is completed? Yes! Keeping the IRB informed about the status of each approved IRB protocol is the responsibility of the project PI. The IRB requires that PIs formally close their research projects. However, the end of data collection is not necessarily when you should close your IRB Protocol; it should be kept active at least through the analysis portion of the research and often through publication. Please contact the Office of Research Integrity for specific questions about your project.