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IU IRB review for non-affiliated research personnel or external sites
Quick Guide: IU IRB Review for Non-Affiliated Research Personnel or External Sites
You may request that IU IRBs review non-affiliated research personnel or external performance sites. When you ask the IU IRBs to provide IRB review for non-affiliated individuals or external performance sites, the IU IRBs have to ensure the research personnel fulfill IU’s requirements and are appropriately qualified and trained to participate in the research.
Words to Know
- IU-affiliated research personnel - research personnel who are Indiana University faculty, staff, and students or employees and staff of IU affiliate institutions that have contracted with the IU IRBs for review and oversight of human subjects research. IU affiliate institutions include Goodman Campbell Brain & Spine, Eskenazi Health, Indiana State Department of Health, IU Health, Purdue Pharmacy Practice, Regenstrief Institute, Rehabilitation Hospital of Indiana, Roudebush VAMC, and Sigma Theta Tau International.
- Non-affiliated research personnel - research personnel who are not faculty, staff, or students of IU, or employees or staff of IU affiliate institutions.
How it works
If you ask IU IRBs to review non-affiliated research personnel or external sites, you agree to take on additional responsibilities. An IU study team making the review request is responsible for:
- collecting the required IRB information from external sites and research personnel
- compiling the required information for the IU IRB
- making IRB submissions on behalf of sites and research personnel
- communicating IRB decisions and approved documents back to the sites and research personnel
Many study teams are not fully prepared to handle the level of coordination and communication required when the IU IRB is being used for multiple sites, so the IU Human Subjects Office (HSO) requires that you contact the HSO reliance team before making an offer to utilize IU IRBs for this purpose (see contact information below).
HSO strongly recommends that you add non-affiliated research personnel or external sites via a stand-alone amendment (i.e. the only change is the addition of the non-affiliated research personnel or sites) after initial review, not with the new study submission. Completion of the required agreements can take several weeks and may delay initial approvals or approvals of amendments that include additional changes.
To add non-affiliated research personnel or sites, submit an amendment updating the following:
- Personnel tab: If research personnel will conduct the entire protocol at the external site, add the Site-Specific PI via the Address Book. See the The Address Book within the KC Instructional Guides for specific instruction.
- Under Person Details, choose Affiliation Type of Non-Affiliated.
- Questionnaire C: Update question ID 704 to Yes to indicate that the IU IRBs are being asked to provide IRB review for external investigators or sites, and complete all subsequent questions.
Be prepared to provide the following information:
- Name of non-affiliated research personnel and their associated institutions
- Role in the research or procedures to be performed by the non-affiliated research personnel
- Plan for management and communication of IRB-related information to sites and/or non-affiliated research personnel, to ensure:
- non-affiliated research personnel are familiar with and will follow IU policies and procedures
- required reporting and requests for amendments by non-affiliated research personnel are submitted to the IU IRB
- IRB decisions and approved documents are communicated.
- If the non-affiliated research personnel are not associated with an institution or are not conducting the research on behalf of an organization (e.g. acting as a volunteer, student not receiving credit), the individual must complete the Non-Affiliated Research Personnel Attestation. This agreement must be signed by the research personnel and the PI.
- If the research is federally funded and the non-affiliated research personnel are not associated with an institution which holds a federalwide assurance (FWA), IU must extend its FWA to cover the non-affiliated research personnel. The study team must complete and submit the Non-Agreement to Extend FWA to Non-Affiliated Research Personnel, which must be signed by the PI, the non-affiliated research personnel, and an IU official.
If HSO determines that reliance is not appropriate, the non-affiliated research personnel or external sites must obtain IRB review from another IRB.
When reliance is accepted, federal regulations require the relationship to be documented by a written agreement called a reliance agreement. If the non-affiliated investigators are not associated with an institution or are not conducting the research on behalf of an organization (e.g. acting as a volunteer, student not receiving credit), the relationship is documented via the Non-Affiliated Research Personnel Attestation.
When necessary, the HSO reliance team will facilitate completion of the reliance agreement.
Reliance agreements can take several weeks to complete due to the complexity and institutional officials involved.