HSPP Forms for Submission

IRB Protocol for Determination of Human Research v2023-12

The IRB Protocol for 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 any of 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 that involve people;
• 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, see our guidance on What is Human Research. If the proposed study is Human Research, do not complete this form or submit in eIRB. Instead, please submit the appropriate IRB Protocol for review and approval in eIRB. 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.

IRB Protocol for Human Subjects Research v2024-08

IRB Protocol for review of a proposed study involving prospective collection of data from or interaction with human subjects. 

IRB Protocol for Human Subjects Research Retrospective Data Review v2023-12

IRB Protocol for review of retrospective data review study involving existing records review, data abstraction, and analysis. 

IRB Protocol for Projects Using External IRBs v2023-12

IRB Protocol for requests that IRB oversight be ceded to a non-University of Arizona IRB.

118 Request Form v2022-07

IRB form for acknowledgment of intention of IRB approval to satisfy sponsoring agency requirements or to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects. Funds may not be used to conduct research with human subjects until an IRB application has been reviewed and approved.

Request for University of Arizona Human Research Site Authorization (RedCap)

Request for investigators who are not affiliated with the University of Arizona to access University resources to conduct human research. 

Appendices for Vulnerable Populations
These forms should be completed when Children/Wards, Cognitively Impaired Individuals, Native American or Indigenous Populations, Prisoners, and/or Pregnant Women and Neonates are included in the research. Please refer to our guidance webpage for information on each of these vulnerable populations.

• Document

  Appendix for Children_Wards v2023-06.docx
• Document

  Appendix for Cognitively Impaired Individuals v2021-09.docx
• Document

  Appendix for Native Americans and Indigenous Populations v2022-06.docx
• Document

  Appendix for Prisoners v2021-09.docx
• Document

  Appendix for Pregnant Women, Neonates, and Fetuses v2021-12.docx

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))

This form should be completed 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))

This form should be completed when a waiver of informed consent, alteration of consent, or alteration or waiver of protected health information (PHI) is needed. This form can also be used when a waiver of documentation of informed consent is needed, such as when verbal or online consent is obtained with no signature.

This form should be completed to request an exception from informed consent.

Appendix for Multi-Site Research

This form should be completed 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 its own IRB approval. Each additional site will need to have its own Appendix for Multi-Site Research.

Appendix for Department of Defense (DoD) Research

This form should be completed for human research sponsored or funded by the DoD. All DoD human research must meet the criteria outlined in the DoD Instruction 3216.02 and federal regulations (32 CFR 219) as outlined in the form. 

Continuing Review Supplemental Document v2024-07

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. Continuing Reviews are submitted in eIRB. This form should be used when additional information is needed to explain outstanding items that occurred during the previous Continuing Review period. This form is required in eIRB for Continuing Reviews reviewed by the convened IRB committee.

Investigators are responsible for concluding human research activities as soon as possible after a project is completed and/or no longer involves human subjects. Projects not concluded after the project expiration date are considered administratively closed by HSPP. Please refer to our guidance on Concluding Human Research. 

Advisor/Co-I Attestation Form

Approval from an Advisor/Co-I is required upon IRB submission when the Principal Investigator (PI) does not meet RII PI Eligibility. This form can be used to document Advisor/Co-I attestation. This completed form can be uploaded to eIRB as an "Institutional Approval". Note, the Advisor/Co-I providing approval on this form must be the same Advisor/Co-I listed in eIRB for the study. 

Department/Center/Section Review Attestation Form

All new human research protocols submitted in eIRB require approval from the Principal Investigator’s home Department/Center/Section reviewer. PI changes and Reportable New Information (RNI) submissions also require updated Department/Center/Section Review attestation. This form can be used to document Department/Center/Section Reviewer attestation. This completed form can be uploaded to eIRB as an “Institutional Approval.”

Scientific/Scholarly Review Attestation Form

To justify the inclusion of human subjects in research, and to assess the balance between any risks that may be imposed upon human subjects, an assessment is required to evaluate the scientific question and the appropriateness of the methods planned to answer the scientific question. Attestation from a Scientific/Scholarly Reviewer is required upon IRB submission. This completed form should be uploaded to eIRB as an “Institutional Approval.”

Responsible Physician Attestation Form

When a project involves medical procedures for which the Principal Investigator is not licensed to conduct, a Responsible Physician must be appointed. This completed form can be uploaded to eIRB as an “Institutional Approval.” Note, the Responsible Physician providing approval on this form must be the same Responsible Physician listed in eIRB for the study. 

Request for University of Arizona Human Research Site Authorization (RedCap)

Request for investigators who are not affiliated with the University of Arizona to access University resources to conduct human research. 

External Site Authorization
External Site Authorization approval, in the form of an authorization letter or email sent from the professional email address of the person granting permission, 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 authorization must be on file with the IRB before conducting research at the external site.

The authorization 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 restrictions 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 site 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 and 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 VPR-IRB@arizona.edu for signature.