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Question: My non-exempt research study (i.e. a study for which review by the full board or review by expedited procedures will occur) will involve key personnel (e.g. investigators, study coordinators, persons obtaining informed consent) from UConn Health and UConn Storrs. Do I need IRB approval from both places?
Answer: One IRB must grant formal approval and the other IRB must agree to rely upon that approval. UConn Health and UConn Storrs have entered into an IRB Reliance Agreement (also referred to as a Cooperative Agreement) whereby only one of the IRBs has to conduct a formal review and the other IRB conducts a one-time facilitated review. The IRB conducting the formal review is referred to as the IRB of Record and the IRB conducting the one-time facilitated review is referred to as the Relying IRB. Once a facilitated review has been completed, the investigator then only deals with the IRB of Record.
Question: How is it determined which IRB is the IRB of Record and which IRB is the Relying IRB?
Answer: In most cases the IRB of Record will be the IRB of the institution at which the majority of subject enrollment will occur. Other factors such as the place of employment of the Principal Investigator or which institution is the recipient of a grant award may also be considered. For example, if subject recruitment will occur primarily at UConn Health and involve UConn Health patients, the UConn Health IRB is likely the more appropriate IRB to request as the IRB of Record. Conversely, if recruitment will occur primarily at Storrs and a UConn Health person will assist in data analysis, the IRB at UConn Storrs is likely the more appropriate IRB to request as the IRB of Record. Within the IRB application form, the PI may indicate which IRB s/he prefers to be the IRB of Record but the decision is ultimately made by the IRBs.
Question: What is facilitated review, how is it requested, and why is it necessary?
Answer: Facilitated review is the process through which one IRB officially agrees to rely upon the oversight of another IRB (e.g. UConn Health IRB relying upon UConn Storrs IRB or vice versa). While there is an IRB Reliance Agreement in place between the two institutions, the decision to defer IRB oversight for non-exempt research must still be made on a case-by-case basis. Once the initial determination is made by the Relying IRB to defer oversight, the investigator only deals with the IRB of Record from that point forward. Before the research begins, the Principal Investigator must obtain approval from the IRB of Record and confirmation that the Relying IRB has deferred oversight to the IRB of Record.
Once formal IRB approval has been obtained from one IRB (i.e. the proposed IRB of Record), a request for facilitated review is submitted to the other IRB. A request for facilitated review typically requires completion of an abbreviated application form and attachment of the documents that have been approved by the IRB of Record. When UConn Storrs is the requested IRB of Record, the UConn Storrs IRB will submit the request for facilitated review through iRIS to the UConn Health IRB on behalf of the Storrs faculty. When UConn Health is the requested IRB of Record, UConn Health personnel are responsible for submitting a request for facilitated review to the UConn Storrs IRB by attaching the approved material to an email to irb@uconn.edu
Facilitated review is necessary because each institution is still responsible for knowing about and reporting on all research with which it is involved. Once the facilitated review has been completed, the IRB of Record will communicate directly with the Relying IRB about the status of the study. For example, the IRB of Record may copy the Relying IRB on correspondence that informs the Principal Investigator that a study has been approved for continuation.
Question: Does my research have to comply with HIPAA because UConn Health is involved?
Answer: It depends. While the majority of the UConn Storrs campus is not a covered entity under the HIPAA regulation, the entire UConn Health campus is a covered entity under the HIPAA regulation. Therefore any use or disclosure of protected health information for a research purpose requires that the study be in compliance with HIPAA. However it is possible to have a cross-campus collaboration that does not involve the use of protected health information (e.g. research about educational activities) in which case HIPAA would not be applicable.
Question: I have completed the training for protection of human subjects as required by my IRB (e.g. the UConn Storrs IRB). Do I have to complete this training again if I request that the UConn Health IRB be the IRB of Record (or vice versa)?
Answer: Typically no, satisfying the training requirement on one campus will serve to satisfy the requirement for either IRB. However, when your home institution is not the IRB of Record, it is recommended that evidence of completion of that training be included in the submission made to the requested IRB of Record. Also, each IRB reserves the right to require additional training if it deems it appropriate. For example, if a study proposes to include prisoners as subjects the IRB has the right to require completion of a training module specific to the additional protections for the inclusion of prisoners as subjects.
Question: My cross-campus collaborative research project was determined to be exempt by the UConn Storrs IRB, do I need to obtain an exemption from the UConn Health IRB as well (or vice versa)?
Answer: Yes, when UConn Health is engaged in exempt research the UConn Health IRB must also grant an exemption (or vice versa). The IRB Reliance agreement pertains to non-exempt research so a request for exemption should be made to each campus. It is recommended that the determination be obtained from one campus and then the approved documents and exemption letter be included in the submission to the other campus.
Question: Where do I find instructions about making IRB submissions and who do I contact for help?
Answer: Information, instructions and contacts for the UConn Health IRB are available from the web at https://ovpr.uchc.edu/services/rics/hspp/ Information, instructions and contacts for the UConn Storrs IRB are available from the web at https://ovpr.uconn.edu/services/rics/irb/