Off-Boarding Information for PIs/Researchers

1. Additional details for taking animals off of the protocol:
   1. If animals are to be transferred to another PI:
      1. Be sure that the same species/ strain matches the other PI’s protocol. An amendment may need to be submitted and approved to add the species/ strain to the protocol before the animals can be transferred.
      2. Be sure that the other PI has enough animals on the protocol to accommodate the transfer. If not, an amendment will need to be submitted and approved for the additional animal numbers, before the animals can be transferred.
      3. Initiate the request by completing the “Animal/Protocol Transfer” through the iLab System
   2. If using up the animals on the study: If using the animals for the study, and they will be euthanized in accordance to the protocol, no additional actions will need to be taken. However, if a different euthanasia method will take place, an amendment will need to be submitted to the IACUC Office and Approved prior to euthanizing the animals.
   3. If animals will be transferred to a different institution:
      1. Please complete the “DLAM Animal Shipping Record” to request the shipping of animals to another institution. This takes time, so do this as soon as possible. If the request is not approved prior to your departure, the animals may need to be transferred to the DLAM holding protocol.
      2. Coordinate with HSC OSP Contracts for any material transfers that may be needed. 
2. Additional details for transitioning projects to another PI:
   1. Before transitioning the project to another PI, be sure the PI is eligible and willing to serve as PI for the study.
   2. Coordinate with the other PI and the IACUC Office to copy the IACUC Protocol over to the new PI.
   3. The PI may make any needed edits to the protocol prior to submitting the protocol for review by the IACUC.
   4. If there are not any major changes made to the protocol, the PI may submit a request to the IACUC Chair (copying the IACUC Office) for Designated Member Review (DMR) of the protocol. Otherwise, the protocol will be reviewed at the next fully convened IACUC meeting.
3. Additional details for closing out an IACUC protocol:
   1. Projects that are not transferred to another PI, will need to be closed.
   2. Prior to closing out the protocol, ensure that there are no animals housed on the protocol.
   3. Log into GRAMS.
   4. Select the Protocol Name of the study you would like to close.
   5. Select “Request Closure” from the left menu.
   6. Complete the form, and click “OK” for our office to receive the form for review.
   7. For funded projects, keeping the project open/active until appropriate IACUC review/approval has been secured by the receiving institution; plan to securely transfer data and materials – this would need to be discussed with grants/contracts, etc.

*For additional information regarding IACUC protocols, please visit the “Animal Research -> For Investigators” page, or email IACUC@unthsc.edu.*

1. Additional Details for transitioning or closing out NTR IRB projects:
   1. Research project remains active at NTR IRB affiliated institution: A proposed transition plan is needed for each project remaining active at the NTR IRB affiliated site including who will be the new Principal Investigator (PI) and the appropriate documentation (see below for specifics) needs to be submitted to the IRB for approval. Ideally, this is approved prior to PI’s departure in case the IRB has any questions for the departing PI as we finalize the closure.
      1. IRB Submission Requirements (via the NTR IRB electronic submission system, i.e., IRBNet):
         • Signed memo from both previous and new PI requesting the transfer
         • All relevant and applicable study documents appropriately updated to reflect the new PI (e.g., Protocol Synopsis, Consent/Assent documents, Recruitment items, etc.)
         • New PI’s Curriculum Vitae (or Resume);
           1. If not already on the protocol as research personnel, please include with the IRB submission: Evidence of current human subject protection training and a signed conflict of interest disclosure form (for Expedited and Full Board research projects)
      2. IRB Office Recommendation/Pro-Tip: PIs acquiring the project should ensure they have electronic copies of all the research/regulatory documents, they are following the appropriate data storage/security plan and remove former PI’s access to research project within IRBNet as well as data if the PI will longer be involved in the project.
   2. Research Completed or Study Closed Out: To formally close out a study with the NTR IRB, please submit a signed close out form / final report.
      1. IRB Guidance: Note that in order to close out a study all identifiers including any HIPAA identifiers/protected health information must have been removed or discarded from the research datasets.
      2. IRB Office Recommendation/Pro-Tip: Investigators should give themselves sufficient time to appropriately de-identify the data (as this is a requirement to close out a study). .
      3. Research Record Management: Please consult with your institution regarding policies and procedures related to data record retention and management. However, at a minimum, and per the regulation, IRB/regulatory records should be maintained for 3 years, and 6 years if the research was subject to HIPAA regulations.
         • At HSC: Please click here for additional information or guidance related to this topic.
   3. Transferring Research Projects: For projects that are being transferred to another institution/organization, in which case the data need to remain identifiable, the researchers need to coordinate with the IRB, and possibly include other research supporting offices, such as HSC OSP Contracts, to discuss next steps (e.g., keeping the project open/active until appropriate IRB review/approval has been secured by the receiving institution; plan to securely transfer identifiable data – this would need to be discussed with grants/contracts, etc.).
      1. IRB Guidance: Researchers will need to develop a plan on how to securely and appropriately transfer data to another institution/organization while maintaining the utmost care and attention to the privacy and confidentiality of research participants. Researchers should also reach out to their new institution/organization to discuss this plan with the appropriate departments/units (e.g., local IRB, sponsored programs) to ensure their policies and requirements are also being met.

 *For additional information regarding NTR IRB protocols, please visit the “North Texas Regional Institutional Review Board” page, or email NorthTexRegIRB@unthsc.edu.*

1. If you are a departing employee who is a Foreign National returning to your home country:
   1. Contact the Export Controls office to determine what (if any) data may be taken back to your home country.
   2. If transporting/transferring Export Controlled data or materials out of the U.S. – you will also need to complete an Export Controls Attestation Form, prior to the transport/transfer.
2. If you are a departing employee who is a U.S. Citizen (or Permanent Resident):
   1. Contact the Export Controls office if you intend to transfer Export-Controlled equipment, materials, biologics, and/or data to another institution/entity.
      1. Note: You may also need to contact other relevant offices, such as the Office of Sponsored Programs Contracts office, prior to transferring any equipment/materials/biologics/data.
   2. If you are retiring and wish to retain Export-Controlled data, please complete an Export Control Attestation Form prior to your retirement/termination from HSC. 

*For additional information regarding Export Controls, please visit the “International Compliance – Export Controls” page, or email Crystal.Perez@unthsc.edu or Research.Compliance@unthsc.edu.*

1. For PIs/Researchers who have an Active Management Plan:
   1. Please reach out to the RCOI Office (via email) stating that you are leaving the HSC, and informing the office of your last day. The RCOI Office/Committee may have additional questions or need additional information prior to closing out your management plan.
   2. Please also notify the Research Monitor of your departure from HSC (you will need to let the RCOI Office also know that you have informed the Research Monitor of this).
2. Pending RCOI Disclosures:
   1. Review the RCOI Disclosure system to ensure any pending or unsubmitted RCOI disclosures have either been submitted (if applicable/appropriate) or addressed (if there are any outstanding comments/questions from the RCOI Committee).

 *For additional information regarding Research Conflict of Interest, please visit the “Research Conflict of Interest” page, or email Research.Compliance@unthsc.edu.*