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Applications for Review
The Determination of Human Research form should be used when it is unclear if the proposed activities require review by an Institutional Review Board (IRB). This form is required if the proposed study involves the following activities and it is unclear whether these activities require IRB review:
- Access to an electronic medical record;
- Use or disclosure of Protected Health Information (PHI);
- Requests for data or specimens from the Banner Clinical Research Data Warehouse (CRDW);
- The project is or will be supported by federal funds;
- The information will be used to support an application to the FDA or involves the use of a test article in a human;
- IRB certification for access to materials from dbGap; OR
- The project involves Native American/Alaskan Native or international indigenous populations.
To provide additional assistance on whether the proposed study needs IRB review, review our guidance on What is Human Research. If the proposed study is Human Research, do not complete this form. Instead, please submit the appropriate application for review and approval by the IRB. The Human Subjects Protection Program will provide a written determination which can be used to provide sponsors, collaborators, journal editors, and others with verification from an impartial source as to whether or not the proposed activities require IRB approval.
Application for Human Research
Application for review of a proposed study involving collection of data from or interaction with human subjects, study involving existing records review, data abstraction, and analysis and requests that IRB oversight be deferred to a non-University of Arizona IRB. Please note, the List of Research Personnel (below) is required with this application submission.
Request for investigators who are not affiliated with the University of Arizona to access University resources to conduct human research. See UA Site Authorization for guidance.
Appendix for Vulnerable Populations
This form should be used when Children/Wards, Prisoners, Native American or Indigenous Research and Pregnant Woman and Neonates are engaged in the research.
- See the guidance page for information on each of these vulnerable populations.
Appendix for Devices
This form should be used when the Human Research is a clinical investigation of a device which is "any experiment that involves a test article on one or more human subjects that either (1) requires FDA approval, or (2) is intended to be submitted to or inspected by the FDA for research or a marketing permit." (21 CFR 50.3(c)(link is external))
Appendix for Drugs
This form should be used when the Human Research is a clinical investigation of a drug, which is "any experiment that involves a test article on one or more human subjects that either (1) requires FDA approval, or (2) is intended to be submitted to or inspected by the FDA for research or a marketing permit." (21CFR 50.3(c)(link is external)
Appendix for Alterations/Waivers of Consent or PHI
This form is used when a waiver of informed consent, alteration of consent, or alteration or waiver of protected health information (PHI) is needed. This form is also used when a waiver of documentation of informed consent is needed, such as when verbal or online consent is obtained with no signature.
Appendix for Exception from Informed Consent (EFIC)
This form is used when an exception from informed consent is needed.
Appendix for Multi-Site Research
This link takes you to our Single IRB Research and Forms webpage where Single IRB Research Forms are located. This form should be used when the University of Arizona IRB will review research activities for an investigator or research staff who are not affiliated with the University. This form is NOT needed if each research site will obtain their own IRB approval. Each additional site will need to have its own Appendix for Multi-Site Research.
Project Update Form
This form is for projects that have been transitioned to the Revised Common Rule or deemed Minimal Risk because the project is not federally funded or supported or FDA regulated. Only use this form when directed to by a Project Update Reminder Notification.The Project Update Form allows the HSPP to capture a small amount of information about a study to keep records updated.
Renewal/Closure for Human Subjects
All federally funded or supported or FDA regulated non-exempt Human Research must receive IRB review and approval at intervals appropriate to the degree of risk, but not less often than once a year.
- Renewals submitted more than 45 calendar days prior to the project's expiration date will be reviewed and approved as soon as possible after receipt and the project will be given a new period of approval with a new expiration date.
- Renewals submitted 45-30 calendar days prior to expiration will be reviewed as normal, maintaining the same period of approval and expiration date.
- Renewals submitted within 30 calendar days of the project's expiration date are not guaranteed review or approval by the project's expiration date. If the project is not reapproved by its expiration date, it will be administratively closed
Investigators are responsible for concluding human research activities as soon as possible after a project if completed and/or no longer involves human subjects. Projects not concluded after the expiration date of the project are considered administratively closed by HSPP.
See Concluding Human Research for guidance.
Multi-Site Renewal/Closure of Human Research
This link takes you to our Single IRB Research and Forms webpage where Single IRB Research Forms are located. This document should be completed by each site for which the UA IRB is the IRB of record. It will need to be provided alongside the Renewal/Closure for Human Subjects that is submitted.
Amendments and Reportables
Amendment and Reportable to Approved Human Research
This form is used to request approval to an amendment of previous approved human subject research.
- For minor amendments (typographical errors, updates to contact information, etc.).
- When there is change to the project personnel.
- To notify the IRB when there are items that need to be acknowledged.
- Used to report information (events) that may be problematic to the conduct of the research to the IRB. See the Adverse Events Flowchart for information.
- Used to report protocol violations/deviations due to the investigator or research staff. See the Reporting Local Information guidance for more information.
See Amending Approved Research for guidance.
List of Research Personnel
Senior/Key personnel, as defined by the National Institutes of Health, must be included on the list and have current CITI training before they may conduct any activities related to the human research.
The HSPP requires that the List of Research Personnel also include information on:
- Any person consenting subjects
- Any person with access to identifiable data
- Faculty advisors for student research
- Study coordinator/contact person
Multi-Site List of Research Personnel
This link takes you to our Single IRB Research and Forms webpage where Single IRB Research Forms are located. Site specific list of Senior/Key personnel, as defined by the National Institutes of Health, must be included on the Multi-Site List of Research Personnel and have current CITI training before they may conduct any activities related to the human research. Each additional site will need to have its own Multi-Site List of Research Personnel.
External Site Authorization (Word)
External Site Authorization approval, in the form of an authorization letter, is required from a site external to the University of Arizona if a University employee or student will be conducting research at that external site. The letter must be on file with the IRB prior to conducting research at the external site.
The authorization letter must include:
- The investigator’s name and title, the title of the research protocol, and a brief summary of the protocol to confirm site understanding of the study.
- A statement that the site will receive a copy of the IRB-approved, stamped consent document.
- A definition as to whether the investigator or their staff will contact and/or recruit employees and if permission is granted to collect data at the location.
- A statement explaining what the site has agreed to allow the investigator or their staff to do, including any restriction or limitations and what responsibilities, if any, the site is assuming.
- A statement as to whether or not the site will receive any benefits, including a copy of any aggregate results.
- The time frame involved or any time restrictions.
The authorization letter or email must be on company letterhead and include the title and signature of the company representative giving the authorization.
Institutional Certification for NIH Genomic Data Sharing
The National Institutes of Health (NIH) issued the Genomic Data Sharing (GDS) policy to ensure the broad and responsible sharing of genomic research data. This policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. See the NIH's Supplemental Information to the National Institutes of Health Genomic Data Sharing Policy for a summary of the policy.
Certification from a University of Arizona Organizational Official is required before an investigator can submit materials as required by the GDS policy. Complete the Institutional Certification for NIH Genomic Data Sharing and submit to HSPP for signature.