Submitting a Proposal
Introduction to IRB Review
The UAA IRB reviews Human Subjects Research (HSR) activities, using the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46), and has the authority to approve, require modifications to secure approval, or disapprove of HSR activities conducted by UAA faculty, staff, and students. The institution requires the IRB to determine the level of review necessary for a project. Failure to submit a study involving HSR activities to the IRB or the Office of Research Integrity and Compliance (ORIC) for review may result in the suspension of data collection, loss of external funding, and additional action from institutional administrators.
The IRB is committed to protecting the interests of human subjects and promoting the ethical conduct of research with human subjects. The IRB and IRB administrative staff are here to assist you with any questions related to the submission process, training, post-submission process, etc.
All IRB submissions must complete an administrative intake process to ensure they are administratively complete before being sent for formal content review. There are four types of HSR (ORIC/IRB) review:
Exempt does not mean a study is exempt from review. Studies qualifying for one of the categories of exemption are reviewed by the UAA IRB Administrator.
- Exempt studies require completed HSR training upon submission, periodic check-ins, and final reports. Any amendment to approved exempt study protocols must be reviewed in advance of making the change to ensure the study still qualifies as exempt. Please allow at least ten business days for review of exempt study submissions.
Limited IRB Review
Limited review means a study will qualify as exempt only after the IRB has done a privacy and confidentiality review to ensure reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Limited reviews are performed by the UAA IRB Chairperson or by one or more Designated IRB Member reviewers.
- Studies requiring a Limited review have all the same requirements as exempt studies, but are submitted with the IRB Proposal form rather than the Exempt Application form.
"Expedited" does not mean a study will be reviewed faster than an exempt study or full board study. Expedited studies, with no more than minimal risk, are reviewed by the UAA IRB Chairperson or by one or more Designated IRB Member Reviewers.
- Expedited studies require completed HSR training upon submission, annual check-ins, and final reports. Any amendment to approved study protocols must be reviewed in advance of making the change. Please allow at least ten business days for review of expedited study submissions.
Full Board Review
Full Review does require the majority of the IRB to meet to review studies with more than minimal risks to human subjects or most vulnerable populations.
- Full board studies require completed HSR training upon submission, annual progress reports, and final reports. Any amendment to approved study protocols must be reviewed and approved in advance of making the change.
- The IRB meets every third Friday of the month during the academic year, and the agenda is set and closed two weeks prior, on the first Friday of the month. Special exceptions can be made with advance notice to the IRB Chair and IRB Coordinator.
For examples of these IRB review categories, check our IRB Review Categories page.
Additional documents may be required for approval depending on the type of research being conducted. You may also be required to have your study reviewed and approved by a separate ethics review committee if you are conducting research off campus. If you are planning to conduct research with any resources or employees from the Alaska Native Medical Center, the Anchorage School District, or Providence Hospital, please look at our External Research page.
Required Documents Upon Submission on IRBNet
What to include in a new study submission:
- Required: A completed IRB Proposal form in Word format. For studies requesting Exempt Review, instead of the IRB Proposal form fill out the Exempt Application Form.
- Required: HSR training certificates for anyone directly involved with the research.
- If you are a student, your research/thesis advisor will also need to complete and provide documentation of HSR training.
- Required: Consent form with the basic elements included in Word format.
- Consent forms for studies Reviewed by the Full IRB or by Expedited Review procedures must meet the requirements set forth in 45 CFR 46.116, OHRP's Regulation on Informed Consent. While it omits some newer required elements, you can also view OHRP's Informed Consent Checklist for a more user-friendly list of informed consent requirements, both the basic elements and additional elements required as appropriate to the study.
- Sample UAA consent forms are available on IRBNet. Please refer to these sample consent forms for appropriate language.
- Waiver of written consent: If the research presents no more than minimal risks to subjects, and the research could not practicably be carried out without the waiver, the researcher can request for the IRB to waive the requirement for a signed consent form. The reason to request a waiver of written consent must be clearly justified in the IRB proposal form.
- Please double check the reading level of your consent form. The reading level may need to be at a 6th- to 8th-grade reading level, depending on the subjects involved in the study.
- Required: Recruitment materials or invitations to participate, including flyers, advertisements, or recruitment scripts in Word format.
- May be Required: Assent form (for under 18 subjects) and guardian consent form (for parents of the under 18 subjects) in Word format.
- May be Required: On campus or off campus mental health resources. For example, if you are asking participants about suicide, depression or any topic which might evoke emotional distress, resources should be made available to those participants. These resources can be in the form of toll-free numbers, online resources, or in-person resources. UAA's Student Health and Counseling Center maintains a list of Mental Health Resources, both at UAA and in the community.
- May be Required: Signed Letters of support if you are planning to conduct research off campus or with controlled university information. These letters should include the off-campus organization or agency's letterhead, and the authority's title, signature, and contact information.
- May be Required: Approval memo from external ethics review committees, including research involving Providence Health & Services (Hospital), the Alaska Native Medical Center, and the Anchorage School District. For more information about research involving external agencies or organizations, please look at our External Research page.
What to include in a modification request submission:
- A completed modification request form in Word format.
- New documents for review or revised documents in Word format with changes highlighted in yellow.
- For substantive changes to study protocols, include an updated IRB Proposal form, with all changes from the previously approved iteration highlighted in yellow.
What to include in a progress report submission:
- A completed progress report form in Word format.
What to include in a final report submission:
- A completed final report form in Word format.
IRBNet Submission Instructions for subsequent reviews:
- Login to IRBNet and select the original project under "My Projects."
- Click the button near the bottom of the left hand menu that says “Create New Package”.
This will create a dash two (ex: [1234567-2]) or subsequent package for you to upload
any new and revised documents.
NOTE: “Package” and “Project” have very specific and different meanings in IRBNet. Projects are represented uniquely by the first six or seven numbers, such as “1234567” in [1234567-2]. A Package is associated with a Project, and is represented by the “-1”, “-2”, etc. An IRBNet Project can have any number of Packages. If one is not careful, these differences can cause confusion and delays in the review process.
- Go to the "Designer" page on the left hand menu, and use the "Attach New Document"
tool to upload the new or revised documents.
NOTE: Form templates for most types of subsequent submissions can be found in the UAA IRBNet Forms and Templates Library for Researchers.
- Sign the package by clicking the Sign This Package button on the left, and going through the subsequent prompts.
- Submit the package for review by clicking the Submit This Package button on the left.
The Institutional Animal Care and Use Committee (IACUC) and the IRB use the same submission system. In other words, you have the option to submit your project to the IACUC or IRB when logged into IRBNet. Please double check to make sure submissions are sent to the correct committee for review!