The Conflict of Interest Committee for Management of Institutional Financial Interests in Research

The University of Virginia Vice President for Research appoints members to the COI committee. The COI committee is made up of two faculty members, one senior administrator, and various non-affiliated community members, representing diversity of expertise needed to adequately review potential institutional conflicts of interest. This committee reviews cases in which an institutional official or the institution itself holds a significant financial interest that may affect or appear to affect the results of a research project and determines whether the research can be conducted at the University and any resulting management strategies. Management strategies are developed and implemented to address conflicts of interest and to assure that the institution may satisfy any research obligations in an objective manner and to avoid and/or mitigate concerns of bias. Approved management plans are forwarded to the IRB by the COI to communicate any requirements for disclosure in informed consent documents. The COI may recommend that the research may not be conducted at the University of Virginia.

The University has an established Radiation Safety Committee (RSC) to oversee all uses of radioactive material permitted by its licenses. This committee, through appointment of a subcommittee (HIRE-Human Investigations Involving Radiation Exposure), reviews any research that involves use of X-ray, radioisotopes or lasers. The RSC is administratively located in the Environmental Health and Safety Office (EHS) and provides expertise with regards to accepted radiation protection practices and regulations. This committee reviews any research that involves the use of X-ray, radioisotopes, or lasers. Approval by the IRB is contingent upon approval by the RSC; however, review by the two committees may occur concurrently. The RSC is charged with ascertaining that all experimental or research uses of radioactive materials and/or ionizing radiation in or on human subjects conform to the currently accepted radiation protection regulations and practices, and the University of Virginia Radioactive Material Licenses on file with the U.S. Nuclear Regulatory Commission and the Virginia Department of Health. If RSC review is completed after the IRB review, the IRB chair reviews any RSC comments. If the chair believes the suggested changes are appropriate and qualify as minor modifications, the IRB chair reviews these through an expedited process. If changes exceed minor modifications, the IRB chair refers the application back to the full board for review. The protocol will not be opened to enrollment until IBC approval is received by the IRB-HSR.

The IBC is administratively located in the office of the Vice President for Research (VPR)  and reviews all University research and teaching activities conducted by faculty, staff, students and/or visiting scientists on University property that involve the use of biological agents. Biological agents are defined as microorganisms, recombinant DNA experiments as defined by NIH Guidelines, materials derived from human and non-human primates, or biological toxins. Registration with the IBC is required prior to initiation of research with biological agents. If applicable, the IBC notifies the IRB of its approval of projects using biological agents , but deliberations of the IBC are not shared with the IRB unless there are specific subject protection issues raised by the IBC. IRB approval is contingent upon IBC approval when the research involves gene If IBC review is completed after the IRB review, the IRB chair reviews any IBC comments. If the chair believes the suggested changes are appropriate and qualify as minor modifications, the IRB chair reviews these through an expedited process. If changes exceed minor modifications, the IRB chair refers the application back to the full board for review. The protocol will not be opened to enrollment until IBC approval is received by the IRB-HSR.

The role of the PRC is to review all studies involving patients with cancer that have not received a NIH or equivalent peer review. NIH-equivalent peer reviews would include those by the American Cancer Society, Department of Defense, or National Science Foundation. In practice, the Committee reviews all studies involving patients with cancer that are sponsored by drug companies and in-house studies. The Committee does not provide a formal review of Cooperative Group protocols (COG, RTOG, ECOG, NSABP, ACOSOG, and Coalition of National Cancer Cooperative Groups) because these studies have already received an exhaustive peer review by the National Cancer Institute through its Cancer Therapy Evaluation Program (CTEP) Branch. IRB approval is contingent upon approval of the PRC.

Staff of the IRB and OSP SOM Grants and Contracts Office will share contract and study information as necessary for each industry sponsored protocol to ensure that protocol, consent, and contract language are consistent with language required by 45 CFR 46.116 and 21 CFR 50.20 and .25

Staff of the IRB and IRB members may consult with the University Privacy Officer on matters concerning the management of personal health information (PHI) as it relates to the enforcement of Health Insurance Portability and Accountability Act (HIPAA) of 1996 research regulations.

An approval from the School of Medicine Clinical Trials Office will be required if:

• The UVA PI is the PI for all sites in a multi-site trial
• The UVA PI is the holder of the IND or IDE ( will also check need for IND/IDE)
• IND/IDE held by outside PI

The determination of whether or not an IND application is required is made by the IRB-HSR.

The School of Medicine Clinical Trials Office (SOM-CTO) staff is available to assist the investigator in contacting the FDA and writing a position statement to the IRB-HSR regarding the need for an IND.

If it is determined that an IND is required, the SOM-CTO personnel are also available to advise researchers regarding the application preparation.

In addition the IRB requires researchers to obtain SOM- CTO approval for these types of studies. The SOM-CTO review includes careful attention to the Data Safety Monitoring Plan, and Data Collection Forms. This review must take place before the IRB will allow subjects to be enrolled.

The UVA office of Information Security (InfoSec) is responsible for the review and approval of the Data Security Plan in selected circumstances.  Some examples of criteria that would result in InfoSec review being required are: 

1.  The study team is collecting data using an individual use device (personal laptop, camera, tape recorder, a medical device that stores data or images, cell phones etc.)
2. The study team is storing data on a server that is on the list of InfoSec-approved servers, or on individual use devices as described above.

The Data Security Plan is generated in CRCONNECT.  At the time of prereview by the UVA IRB Administrative staff, if Infosec review and approval is required, the UVA administrator will notify CRCONNECT who will subsequently notify Infosec of this review requirement.  This initial communication to Infosec is done via CRCONNECT only.   

InfoSec reviews the Data Security Plan to be sure that:

1. The collection and storage of data is consistent with HIPAA regulations (if applicable)
2. The data are being collected and stored in such a manner that the intellectual property is protected from theft.

To contact Infosec regarding questions related to data safety and security, please email:

UVAHealth-IT-RA@hscmail.mcc.virginia.edu

InfoSec welcomes early discussion for studies involving the use of cell phones, website collection of data etc.  For more information on InfoSec