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Regulatory Affairs Checklist for Human and Animal Subjects

As the official recipient of the award, HJF is required to collect the documentation outlined below.

Documents Required Prior to Release of Funding:

• Copy of approved protocol and approved informed consent and HIPAA Authorization form (if applicable).
• Copy of approval letter(s) from all Institutional Review Boards (IRBs) and Institutional Animal Care and Use Committees (IACUCs) involved in the study (i.e., USU approval letter, WRAMC approval letter, NNMC approval letter, Animal Use Committee letter, etc.).
• Copy of signed FDA-1572 (if applicable).
• Current copies of CVs for PI, associate PIs, collaborators, coordinators and any other personnel listed on the protocol.
• Documentation of completing human subjects protection training. As of June 1, 2002 the human subjects protection training can be completed at https://www.citiprogram.org. When registering for this online course, please check HJF as your affiliation.

An easy way to remember what to submit to the Office of Regulatory Affairs and Research Compliance is to submit a copy of whatever is submitted to and received by the IRB or IACUC.

Documents Required Throughout the Funding Period:

• Copies of any protocol amendments along with their approval letters and revised approved consent form (if applicable). This also includes notification to the IRB/IACUC of any change in PI, associate PI or others listed on the protocol, as well as or change in location of study activities.
• Copies of all adverse events submitted to IRBs, if study involves human subjects. (All adverse events must be reported whether or not they are related to the study).
• Copies of advertisements and recruitments of human subjects and the IRB approvals.
• Copies of approved presentations and publications resulting from the study. This includes all submissions accepted and not accepted for publication. IRB approval must be obtained prior to submission of publications and prior to presentations.
• Copies of program progress reports, if your grant is required to submit these on a quarterly or annual basis. These progress reports must include financial status detailing cumulative funds spent, funds spent during the budget period covered by the report and remaining unspent balance by budget category. If you do not have a format, please use the USU Form 3210.
• Copies of continuing reviews for individual protocols submitted to the IRB/IACUC and the approvals for the reports. A copy of the stamped approved informed consent forms (if human subjects protocol) must be attached to the continuing review.
• Copy of investigator brochure (if applicable).
• Copies of any audit reports from audits performed by IRBs/IACUCs, clinical investigation departments or other regulatory agencies.

If you have any questions or concerns, please contact our Regulatory Affairs Department.