Because of guidance updates from federal regulatory agencies and the Institutional Review Board (IRB) accreditation process, the UNMC IRB is making many changes to the process of human subject protection at UNMC, The Nebraska Medical Center, and the University of Nebraska at Omaha. Continuing education of the research community is an important part of the IRB accreditation process. Today’s topic is performance sites.
What is a performance site?
A performance site is described as a location where the research study will be conducted. Primarily, the IRB assumes that the research will be conducted on the campus of UNMC, The Nebraska Medical Center or UNO unless otherwise notified.
Quite often research will be conducted at other locations that are not connected to the campus of UNMC, The Nebraska Medical Center or UNO. Sometimes these locations are referred to as “off-sites.” The following situations may occur:
1) UNMC/The Nebraska Medical Center/UNO PI and/or other study personnel plan to travel to the performance site and directly interact with the subjects, obtain consent and collect data, or
2) The UNMC IRB has assumed regulatory responsibility for an off-site participation in a research study. Personnel located at the off-site directly interact with the subjects, obtain consent and collect data. This happens most frequently in multi-site studies where UNMC, The Nebraska Medical Center, or UNO serves as the lead site, responsible for data collection from all sites, data analysis, and adverse event tracking for the entire study. The UNMC IRB will assume regulatory responsibility for those performance sites that do not have an IRB.
The definition of performance site does not include multi-site trial locations that have their own IRB or multi-site trials that are sponsored by outside agencies where UNMC, The Nebraska Medical Center, or UNO does not serve as the lead site.
Important information regarding performance sites
- If UNMC, The Nebraska Medical Center, or UNO PI and/or other study personnel travel to the performance site to conduct the study and:
— If the performance site does not have its own IRB, the UNMC IRB requires a letter from the authorized official at the site granting permission to conduct the research at that site be attached to the IRB application.— If the performance site has their own IRB, the UNMC IRB will only require a copy of the off-site IRB approval letter before subjects can be enrolled. For instance, a UNMC PI will conduct a study both at UNMC and the VA Medical Center. In addition to UNMC IRB approval, the VA Medical Center IRB must review and approve of the study at their site. The UNMC IRB requires a copy of the VA IRB approval letter before subjects can be enrolled at the VA.
- If UNMC, The Nebraska Medical Center, or UNO serves as the lead site for a multi-site protocol and research will be conducted at off-sites by participating investigators and personnel an Inter-Institutional Agreement (IIA) must be signed by the authorized official at the site and attached to the IRB application. Each participating physician must sign a Non-Institutional Investigator Agreement. These agreements are available on the UNMC IRB Web site forms page. Additionally if the off-site has their own IRB, a copy of the IRB approval letter and consent document used to enroll subjects in the trial must be provided to the UNMC IRB to provide assurance that appropriate human subject protection is provided.
(More information about Inter-Institutional Agreements and Non-Institutional Investigator Agreements will be provided next week.)
If you have further questions about performance sites, call Gail Paulsen at 55-6463.