External Collaborations

UofL allows investigators to utilize the following commercial IRBs for industry-sponsored, multi-center, clinical research studies for which one of the following approved commercial IRBs have been appointed as the commercial IRB by the Sponsor or CRO and the commercial IRB has already approved the study.

• Western IRB
• Advarra

UofL also relies on NCI CIRB for cooperative group studies funded by the NIH (e.g. Children’s Oncology Group (COG), SWOG, NRG).

UofL will review requests to rely on Institutional IRBs (e.g. other university IRBs) based on the four criteria described above.

When UofL IRB relies on an external IRB (WIRB, Advarra, or an institution), UofL does a local context review which includes a review of the consent/assent forms. Any areas of question/concern related to the language will be noted.

When preparing the consent form, the following items are reviewed for local context. Refer to the UofL consent templates for the language to insert.

• Investigator contact information and phone number
• local study sites
• local cost language
• local research related injury language
• payment language, if applicable
• conflict of interest language (If industry sponsored or if a study team member has COI language required by their management plan)
• questions/concerns/complaints language
• HIPAA authorization language (If using local template language, do not remove necessary language that the participant needs that is outlined in the external IRB/sponsor’s template. If the external IRB is serving as the privacy board and the external IRB’s HIPAA language is used, UofL IRB will do a review to ensure it meets requirements).
• local acknowledgement paragraph and signature lines

• If UofL IRB is serving as the privacy board (as marked in the iRIS application), the UofL IRB will review the HIPAA waiver form.

When relying on NCI CIRB, there are specific requirements. The language in the NCI CIRB local context document is the only language that can be inserted into the consent form (for the Spanish translation).

NCI CIRB will not serve as the privacy board and requires a separate document for the HIPAA Research Authorization. Please contact hsppofc@louisville.edu if you need this template.

Instructions for Submitting in iRIS

All requests to rely on an external IRB are submitted to the UofL IRB in iRIS following the steps below:

1. Login to https://iris.louisville.edu using your UofL email and password
2. Once in iRIS, follow the instruction under “study personnel requirements” to ensure your CV is uploaded and you’ve completed an Attestation and Disclosure Form, and have completed the required Human Subjects training. Everyone on the study team is required to have completed all three items before the IRB can approve the request. https://louisville.edu/research/researchers/compliance/irb
3. To start the study application select “study assistant”, “add a new study”, “IRB Application”, and then begin the application.
4. Follow the application instructions to add the investigators department, study team, etc. In section 4 for the type of submission select “IRB Authorization Agreement (IAA)- Another IRB is IRB of Record”. Fill out the questions, attach the documents approved by the external IRB and the external IRBs approval letter (that also includes the expiration date).
1. If you will be consenting subjects locally, please include a draft of the local consent form that will be reviewed by the IRB of record for our site.
2. If protected health information is involved be sure to include details on who will be approving HIPAA documents such as the signed HIPAA research authorization and/or HIPAA waiver for screening.
5. Submit the application by clicking through to the end of the application and selecting “sign off and submit”. If you are not the Principal Investigator (PI) on the study, it will route your submission to the PI to sign off on before the IRB receives it. Only the PI can do the first submission on a study. After that, anyone on the study team can.
6. Once the IRB receives the submission, it will be reviewed to determine if reliance is appropriate. If so, the IRB will reach out to the external IRB to sign an IRB Authorization Agreement. Once the agreement is finalized, an acknowledgement letter will be sent in iRIS documenting the reliance.

When submitting a proposal for the UofL IRB to serve as the single IRB for relying sites, the HSPPO will review the request to ensure adequate resources are in place to serve in that capacity. The following information is reviewed:

• IRB number
• Institutions who will rely on UofL as the single IRB
• Summary of research activities that will take place at the relying institutions
• UofL research plan for communication and oversight of the relying institutions

Contact the HSPPO office early in the planning process by completing the sIRB Consultation form. During this consultation, the UofL IRB will review the sIRB request, assist with developing the sIRB, and assist with determining the sIRB fees to include in grants/budgets. Investigators are responsible for understanding their responsibilities as the lead site and investigator. The Overall Principal Investigator/Lead Study Team Guidance and Checklist from SMART IRB provides a list of those responsibilities.

Instructions for Submitting in iRIS

Requests for UofL to provide IRB oversight for external institutions are made in the iRIS IRB Application “External Collaborations” section. You can make this request at initial submission or by submitting an amendment to update the iRIS IRB application.

Mark the “External Collaborations” section “yes” and provide the information requested. The IRB will review the request, and if approved, contact the other institutions to sign an IRB Authorization Agreement (IAA).

If the study is already approved by the UofL IRB, you can submit an amendment updating this section of the IRB application following the steps below:

1. Login to iRIS Login to https://iris.louisville.edu using your UofL email and password
2. In the IRB “study assistant” module, click to open the specific IRB# you need to submit the request on.
3. Create a “Request Application, Protocol, or Document Change” form in iRIS.
4. In section 1.8 of the amendment form mark “application change”.
5. In section 1.9 of the amendment form create and attach a revised IRB application. Revise your IRB Study Application, “External Collaboration” section (last section) to answer “yes”.
6. Complete the fields that populate for external sites, including listing the external study personnel.
7. Existing study documents may need to updated as well to reflect the collaboration. Attach an informed consent for the external site for IRB review.
8. Once the IRB receives the submission, it will be reviewed to determine if reliance is appropriate. If so, the IRB will reach out to the external IRB to sign an IRB Authorization Agreement.

The UofL IRB will review requests for external research collaborators, who are not affiliated with an external university, to participate in UofL human subjects research activities. This information is also submitted to the IRB in the iRIS Application “External Collaborations” section.

All research personnel, including those participating from an external site, must be approved by the IRB before they can take part in any activity.

An IRB Authorization Agreement likely will not apply in this situation. The following policies may apply to this scenario and are further explained in the External Collaborations Guide:

• Sponsoring a Visiting Student for Research Purposes
• Sponsoring a Visiting Scientist/Scholar for Research Purposes
• Individual Investigator Agreement with liability coverage