Below are some frequently asked questions regarding cross campus collaborations.   Each section also contains links for webpages and contact information.

If your question is not addressed in the sections below, please contact either Christine Kaminski at kaminski@uchc.edu or Jen Przybyszewski at jennifer.przybyszewski@uconn.edu for further assistance.

FCOI Webpage

FCOI Contacts

Question:  How is the financial conflict of interest disclosure requirement on a proposal handled when there is a cross-campus collaboration involving a faculty member with a dual appointment at UConn Health and UConn (Storrs, Regionals, School of Law, School of Social Work)?

Answer:    A faculty member may be considered compliant with the financial disclosure requirement as long as the faculty member has a current financial disclosure on record at the campus of their primary department/school.  FCOI training is incorporated into the disclosure forms at both campuses.

Question:  How is the financial conflict of interest disclosure requirement on a proposal handled when there is a cross-campus collaboration involving a faculty with dual appointment at UConn Health or UConn and another local institution (e.g., JAX, CCMC)? 

Answer:  The University FCOI policy applies to faculty members involved in research activities at the University.  Thus, they must have a current financial disclosure on file within the University’s electronic disclosure submission system at the campus of their department/school.

Question:  How are reviews of potential financial conflicts of interests for cross-campus research handled?

Answer:  All University faculty investigators responsible for research activities on a cross-campus research project would have a current financial disclosure on record.  The Financial Conflict of Interest in Research Committee (FCOIRC) at the campus of the faculty members’ department/school would review any disclosed significant financial interests when the project involves research activity at that campus.

IACUC Webpage

IACUC Contacts

Cener for Comparative Medicine Webpage

Center for Comparative Medicine Contacts

Question: If there’s a collaboration using animals, who needs to hold the protocol?

Answer: There should be an animal protocol in place at the campus where the work will be performed. Personnel from the collaborating campus can be listed on that protocol.

Question: If the collaboration requires an animal to be used at both institutions as part of the study, who needs to hold the protocol and who owns the animal?

Answer: A protocol should be in place at each institution to describe the work that is specific to that site. The overarching collaboration should also be described in both protocols, and animal ownership should be transferred when an animal is moved to the secondary institution.

Question: If I will be listed on a protocol at my collaborator’s institution, will my home campus training be valid at the collaborating institution?

Answer: It depends. The general IACUC training and Occupational Health and Safety Program enrollment is portable, but training specific to the institution where the animal work will be performed may also be necessary (e.g. facility orientation).

Question: If there is a PHS funded grant describing a collaboration between the two campuses, who is responsible for assuring congruency between the grant and the animal protocol?

Answer: The “Prime” institution has the responsibility of assuring congruency.

IBC Website

IBC Contacts

Question: I am a PI at UCH, but have some research that is conducted at UConn (Storrs and/or regionals). Does my UCH IBC registration cover my research at UConn?

Answer:  No. UConn and UCH have separate IBCs, with different requirements. Therefore IBC registration processes are different between the two campuses. If research is being conducted at UConn by a UCH PI, please contact ibc@uconn.edu, for additional information and assistance in completing the appropriate registration forms. If you are a UConn PI, contact rwallace@uchc.edu .

Question: I have samples coming from UCH, and my personnel are conducting the analysis at UConn. Which IBC do I need to contact to complete a registration?

Answer:  If the samples are being analyzed at UConn, an IBC registration will need to be completed through the UConn IBC. If there are any analyses being conducted at UCH, the UCH IBC should be contacted to determine if an IBC registration is necessary.

Question:  I am a PI at UCH, but I teach a course at UConn which includes lab teaching activities that involve biological materials. Do I need an IBC registration with the UConn IBC or UCH IBC?

Answer:  A UConn IBC registration is required for these activities. At UConn, all experimental or teaching activities involving biological materials must be registered with the UConn IBC. It should be noted that biological materials includes but is not limited to: recombinant or synthetic nucleic acid molecules (rsNA), bacteria and their phages and plasmids, viruses, biological toxins, fungi, mycoplasmas, prions, and parasites; human and non-human primate tissues, body fluids, blood, blood byproducts, and cell lines, transgenic and wild type animals and plants, animal remains and insects that may harbor zoonotic pathogens. Teaching activities being conducted at UCH may require an IBC registration. The UCH IBC should be contacted to determine if an IBC registration with them is necessary.

Question:  I have already taken Biosafety and Bloodborne Pathogens Training at UCH. Do I have to take these trainings at UConn as well?

Answer:  Yes, if you are working at UConn and also at UCH, applicable EHS trainings must be completed for each. Though Biosafety and Bloodborne Pathogens Training is similar between the two, they incorporate site specific information that is distinct to each. Therefore, applicable trainings do not count for both.

Question:  I am a researcher using human embryonic stem cells (hESC) and/or human induced pluripotent stem cells (hiPSC). Do I need to register both with the Stem Cell Research Oversight committee (SCRO) and the IBC?

Answer:  It depends. For work at UConn, you need to register with both the SCRO and IBC. At UCH for hESC, you need to register with the SCRO but not the IBC if your experiment is exempt under the NIH Guidelines. If you will be using animals or viral vectors with the cells it is definitely not exempt and you will need to register with the respective (UConn or UCH) IBC. For other experiments with rsNA, it’s always a good idea to consult with the respective IBC. As with any human cells, you need to work at BSL-2 containment and have fulfilled Bloodborne Pathogen (BBP) training and HBV immunization requirements (documented titer or declination). For hiPSC it’s the same as hESC except for certain uses no SCRO is required. Also, if the cells were reprogrammed with a HIV-based lentiviral vector that was not removed, the cell line will have remaining HIV sequences from the vector which are Risk Group 3 (RG-3) sequences. There is no exemption for working with (even just culturing) cells containing RG-3 rsNA sequences. hiPSC reprogrammed with Sendai vectors or plasmid vectors eventually contain no rsNA and are technically not recombinant, though they remain human and fall under the BBP rules.  hiPSC reprogrammed with retroviral vectors have residual viral sequences (not RG-3). They are recombinant and fall under the exemption for culturing, but certain other experiments, such as transfer into animals require an IBC registration.

Human Subjects Research Website

Human Subjects Research Contacts

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/