Collaborative Research and IRB Reliance
成年人深夜福利在线观看 Tech University participates in collaborative, multi-institutional human subjects research. In cases where a 成年人深夜福利在线观看 Tech researcher is conducting collaborative, non-exempt (i.e., Expedited or Full Board) research involving human subjects with an institution that has a federalwide assurance (FWA), it may be possible to establish a reliance agreement which allows a 成年人深夜福利在线观看 Tech researcher to rely on IRB review conducted by the other institution. 成年人深夜福利在线观看 Tech does not have the staff or resources to serve as the reviewing IRB or IRB of record for a multi-site study.
Ceding IRB Review to Another Institution
Before you can participate in a study being conducted through an external IRB of record, the 成年人深夜福利在线观看 Tech IRB must first review your cede review request to verify that you meet all the institutional requirements (such as CITI training) and decide whether it will agree to cede review to the outside IRB of record based on your research activities. If 成年人深夜福利在线观看 Tech agrees to cede review to another institution鈥檚 IRB, a reliance agreement (also called an IRB Authorization Agreement or IAA) will be signed by both institutions.
All reliance agreements are established on a case-by-case basis. 成年人深夜福利在线观看 Tech does not enter into reliance agreements for the following protocols:
- Exempt research
- Development Only/Just-in-time applications that lack definite plans for the involvement of human subjects at the time of protocols submission
- Projects where 成年人深夜福利在线观看 Tech researchers are not considered engaged in human subjects research
成年人深夜福利在线观看 Tech does not enter into reliance agreements with non-U.S. (international) institutions, IRBs, and research ethics boards or committees.
成年人深夜福利在线观看 Tech is a participating institution of the SMART IRB platform. SMART IRB can be utilized to complete the reliance process for a study being conducted with another SMART IRB participating institution. Please review the list of to see if your collaborator is a member of SMART IRB.
成年人深夜福利在线观看 Tech researchers must be prepared to follow the policies and procedures of the reviewing IRB. They are responsible for understanding the policies and procedures of the reviewing IRB and conducting the research accordingly. Specifically, it is important for 成年人深夜福利在线观看 Tech researchers to understand the reviewing IRB鈥檚 expectations for reporting adverse events, deviations, noncompliance, and other problems to the reviewing IRB, as well as expectations for updating personnel and enrollment status, submitting amendments, and tracking subject enrollment and status.
Below are the steps required for 成年人深夜福利在线观看 Tech researchers to request ceding IRB review to another institution鈥檚 IRB. The time frame for the process varies, based on whether your submission packet is complete, how long it takes to coordinate the reliance agreement with the reviewing IRB, etc. As such, please allow sufficient time for processing and review, as these steps involve multiple levels of coordination and compliance verification.
Step One: Submit a 鈥淩equest to Cede IRB Review鈥� Packet
The 成年人深夜福利在线观看 Tech researcher must submit a complete Request to Cede IRB Review packet to the IRB Administrative Office at IRB@tntech.edu. This should only be done after the research study has been approved by the reviewing IRB.
Step Two: IRB Administrative Office Intake and Processing
Upon receiving the cede-review request, the 成年人深夜福利在线观看 Tech IRB Administrative Office will check the submission for completeness. If the submission is complete, the office will forward the complete packet to the IRB Chair for review.
Step Three: Review and Determination by the IRB Chair
The IRB Chair will evaluate the request and determine whether 成年人深夜福利在线观看 Tech is Engaged in Human Subjects Research.
- If 成年人深夜福利在线观看 Tech is not engaged, no reliance agreement may be required. The faculty member will receive a Non-Engagement Determination Email.
- If 成年人深夜福利在线观看 Tech is engaged, the IRB Chair will determine whether ceding review is appropriate.
Step Four: Reliance Agreement
If 成年人深夜福利在线观看 Tech is engaged and ceding review request is approved, the IRB Administrative Office will coordinate the execution of a reliance agreement with the reviewing IRB. Once the reliance agreement is fully executed, the 成年人深夜福利在线观看 Tech faculty member will receive an official IRB Reliance Authorization Notice via email confirming that:
- 成年人深夜福利在线观看 Tech will rely on the reviewing IRB, and
- The 成年人深夜福利在线观看 Tech faculty member may begin human subjects research.
Questions?
Please contact the IRB Administrative Office at IRB@tntech.edu.