Senior/Key personnel, as defined by the National Institutes of Health, must be included on the F107 and have current CITI training before they may conduct any activities related to the human research.
The HSPP requires that the Verification of Human Subjects Training Form also include information on:
- Any person consenting subjects
- Any person with access to identifiable data
- Faculty advisors for student research
- Study coordinator/contact person
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 must be on company letterhead and include the title and signature of the company representative giving the authorization.
HSPP has provided a template to assist you in drafting the authorization letter.
Institutional Certification for NIH Genomic Data Sharing (Word)
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.
See HSPP's NIH Genomic Data Sharing for NIH Grant Submission for guidance.