Introduction to IRB Review

The Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) grant the UAA IRB with the authority to approve, require modifications to secure approval, or disapprove of human subjects research covered by this policy. The institution requires the IRB, not the researcher, to determine whether a study is exempt from review. Failure to submit a study involving human subjects research to the IRB 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 human subjects research. The IRB and IRB administrative staff is here to assist with you any questions related to the submission process, post-submission process, training, etc.

There are three levels of IRB review:

  • Exempt does not mean a study is exempt from review. Exempt studies, with no foreseeable risks to participants, are reviewed by the UAA IRB Administrator.
    • Exempt studies require completed IRB training upon submission, annual progress reports, and final reports. Please allow up to two weeks for review of exempt studies.

  • 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 Co-Chair.
    • Expedited studies require completed IRB training upon submission, annual progress reports, and final reports. Please allow up to two weeks for review of expedited  studies.

  • Full Board Review does require the majority of the IRB to meet to review studies with more than minimal risks to human subjects. Depending on the risks to the subjects and the subjects involved in the research, the IRB may require progress reports to be submitted more than once annually, per federal regulations.
    • Full board studies require completed IRB training upon submission, annual progress reports, and final reports. The IRB meets every third Friday of the month during the academic year.

For examples of these IRB review categories, click here.

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, click here.

Required Documents Upon Submission on IRBNet

What to include in a new study submission:

  • Required: A completed IRB proposal form in Word format.
  • Required: IRB training certificates for anyone directly involved with the research.
    •  If you are a student, and your research/thesis advisor plans to have direct access to the raw data, he/she will also need to complete IRB training.
  • Required: Consent form with the basic elements included in Word format.
    • Click here for OHRP's informed consent checklist - basic and additional elements.
    • 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, the researcher can 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 parental 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. For a list of UAA mental health resources and costs for UAA students, click here.
  • May be Required: Letters of support in Word or PDF format if you are planning to conduct research off campus. 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, click here.

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.
  • To submit a modification request for an existing study on IRBNet, login to IRBNet and click the project title. Click the button that says Project History on the left hand side. At the bottom of the Project History page, click the button that says Create New Package. This will create a dash two (ex: [000000-2]) or subsequent package for you to upload the completed modification request form and any new and revised documents. Sign the package by clicking the Sign This Package button on the left. Submit the package for review by clicking the Submit This Package button on the left.

What to include in a progress report submission:

  • A completed progress report form in Word format.
  • To submit a progress report for an existing study on IRBNet, login to IRBNet and click the project title. Click the button that says Project History on the left hand side. At the bottom of the Project History page, click the button that says Create New Package. This will create a dash two (ex: [000000-2]) or subsequent package for you to upload the completed progress report form. Sign the package by clicking the Sign This Package button on the left. Submit the package for review by clicking the Submit This Package button on the left.

What to include in a final report submission:

  • A completed final report form in Word format.
  • To submit a final report for an existing study on IRBNet, login to IRBNet and click the project title. Click the button that says Project History on the left hand side. At the bottom of the Project History page, click the button that says Create New Package. This will create a dash two (ex: [000000-2]) or subsequent package for you to upload the completed final report form. Sign the package by clicking the Sign This Package button on the left. Submit the package for review by clicking the Submit This Package button on the left.