HOW TO SUBMIT TO THE USAFA INSTITUTIONAL REVIEW BOARD (IRB) OR HUMAN RESEARCH PROTECTION PROGRAM (HRPP) IF NON-USAFA PERSONNEL ARE ENGAGED IN THE RESEARCH
This includes ONLY full protocol research
USAFA is required to comply with numerous regulations regarding the use of human subjects in research. DoDI3216.02 Enclosure 3, 2. States the following: “In complying with the requirements of section 32 CFR 219.103.., a non-DoD institution that is engaged in DoD-supported non-exempt research involving human subjects … have a Federal assurance … Alternatively, if the institution does not have a federal assurance, the researcher may use an Individual Investigator Agreement to associate with an institution having a Federal assurance…”. Non- USAFA personnel on engaged in the research are either covered by a Federal assurance from their employing organization or need to be covered by USAFA’s Federal assurance. In the former case, the organization of the non-USAFA personnel must agree to USAFA conducting the IRB review. In the latter case, the USAFA Authorized Institutional Official (AIO) must agree to cover the non-USAFA personnel with USAFA’s Federal assurance.
Follow the steps below:
1. You ensure USAFA will support your study by providing the resources necessary for you to execute it. Refer to Procedures to Obtain Resources and Survey Approval for detailed instructions on how to secure appropriate approvals.
2. You determine if the non-USAFA personnel engaged in your research are covered by a Federal assurance. You execute one of the two choices below and when you send the agreement to the HRPP Organizational Box.
If the non-USAFA personnel are covered by a Federal assurance, the non-USAFA personnel’s organization must sign an Institutional Agreement for IRB Review (IAIR) that allows USAFA to be the IRB/HRPP of record. This must be signed before USAFA reviews the research or amendment to include USAFA. You will secure signatures from the non-USAFA personnel’s IRB/HRPP and return the signed IAIR and include a paragraph describing the research study to the HRPP Organizational Box, email@example.com with “IAIR Required” in the subject line. If you do not use the correct subject line, your submission might not be viewed.
If the non-USAFA personnel are NOT covered by a Federal assurance, you send a signed Individual Investigator Agreement (IIA) and include a paragraph describing the research study to the HRPP Organizational Box, firstname.lastname@example.org with “IIA Required” in the subject line. If you do not use the correct subject line, your submission might not be viewed.
3. USAFA HRPP Support Personnel will staff the IAIR or IIA for AIO signature and return the signed document to you.
4. You ensure ALL investigators are current in their annual human subjects protection training. Refer to USAFA IRB Training Instructions for step-by-step instructions.
5. You review the resumes of your investigators to ensure they have the appropriate experience to execute the study in compliance with HRPP requirements. As PI, you are responsible for any breaches in human subjects protection that occur. NOTE: If you have never conducted human subjects research before, you CANNOT be a PI; you must find an experienced researcher to be the PI and mentor you as the Associate Investigator (AI).
6. You complete the USAFA HRPP Determination Request and the USAFA Informed Consent Document (ICD) AND secure the required signatures. You can request a full or partial waiver of informed consent per 32 CFR 219.116(c). However, you must include in the HRPP Determination Request how your research meets all the required qualifications.
7. You submit your completed protocol package to the HRPP Organizational Box, email@example.com with “Full Protocol Submission” in the subject line by the monthly submission deadline. If you do not use the correct subject line, your submission might not be viewed. This package must include
a. the completed HRPP Determination Request with all signatures.
b. a separate informed consent document or a request for waiver of informed consent in the protocol that discusses how your research meets all the required qualifications.
c. evidence of resource approval.
d. current training certificates for all engaged researchers.
Note: the IRB office does not keep these “on file.” Please submit a complete packet. If a complete packet is not submitted, the HRPP Support Personnel will return your submission.
8. Once a complete submission is received, your protocol will be included in the read-ahead for the monthly meeting. The Friday prior to the IRB meeting date, the read-ahead is provided to IRB members and all protocols are posted on the HRPP SharePoint site for two weeks to allow Mission Elements (ME) time to review and provide comments prior to the Authorized Institutional Official (AIO) signing the permission memo. This posting is required by your AIO and exists outside of the IRB review process.
9. You attend the IRB meeting in which your research is reviewed either in person or by telephone.
10. At the IRB meeting, the Board can make any of the following determinations, per section 32 CFR 219.109.
a. Approve the research.
b. Require modifications to the research.
c. Disapprove all research activities.
11. HRPP Support Personnel will accomplish the following:
a. Draft and finalize the meeting minutes
b. If modifications are required per the meeting minutes, send a letter with a change table to you
c. Staff permission memo for approved or conditionally approved research with ME comments and IAIR and/or IIA to AIO
12. If modifications to the research are required, you will return the completed change table to the HRPP Organizational Box, firstname.lastname@example.org. Upon receipt, the HRPP Support Personnel will forward the completed change table to two IRB members to ensure all required modifications have been addressed appropriately. If modifications were required to the Informed Consent Document (ICD), one of the reviewing IRB members will be the Legal Representative. All additional information or clarifications required by the reviewers will be coordinated through the HRPP Support Personnel.
13. If the research is disapproved by the IRB, you will receive a letter that includes the reason for the disapproval and information on how to appeal the decision. The PI may appeal the decision by sending a memorandum to the HRPP Organizational Box email@example.com addressing reasons for disapproval and providing substantive information (e.g., new information) for why the IRB should reconsider the decision.
14. If the AIO permits the research, you will receive the IRB approval letter and the AIO Permission Memo for each permitted research protocol and the research can commence. If the AIO does not permit the research, you will receive a letter that includes the reason for the disapproval and information on how to appeal the decision. The PI may appeal the decision by sending a memorandum to the HRPP Organizational Box firstname.lastname@example.org addressing reasons for disapproval and providing substantive information (e.g., new information) for why the AIO should reconsider his/her decision.