I am conducting my study at non-KUMC locations
When KUMC investigators conduct research at non-KUMC locations, the legal arrangements will depend on the type of activities being proposed. The following are the most common scenarios:
- The non-KUMC location provides space for the KUMC study team to conduct the research.
- Personnel at the research location might post or distribute materials that explain the research, but they do not actively recruit and do not obtain informed consent.
- If the non-KUMC location was not approved with the initial submission, KUMC investigators should create a modification in eIRB. Upload information about the location, the activities that will occur there, and a letter from leadership at the location confirming permission for the study team’s activities.
- The non-KUMC location provides access to patient/client information for KUMC’s recruitment efforts.
- Non-KUMC personnel allow access or provide individually identifiable records to the KUMC study team, but they are not otherwise involved in study activities.
- If the non-KUMC location was not approved with the initial submission, KUMC investigators should create a modification in eIRB. Upload information about information being provided by the location.
- If the information being provided is covered by HIPAA, then an official of the non-KUMC location must confirm permission for the study team’s access. A sample letter is available from the KUMC IRB office.
- When the study involves informed consent, the consent form discusses access to the location’s records and the research-specific use of the information.
- Employees of the non-KUMC location are members of the study team.
- Please refer to instructions in the section entitled “I would like to add non-KUMC personnel to my study”
- Distance learners conduct their research at non-KUMC locations.
- The research typically happens at another hospital or agency where the student is employed.
- The non-KUMC location is providing patient/client records and therefore bears the greater compliance risk.
- For research that is not considered exempt, KUMC will consider reliance on the non-KUMC institution's IRB.
- The student should first work with the IRB of their employer to secure approval. The KUMC IRB office will conduct an administrative review for HIPAA, data security and other applicable compliance requirements.