Who needs to be listed on an IRB protocol?
Who needs to be listed on an IRB protocol? Do all researchers (including collaborators) need to be listed?
Add personnel to UVA protocol to any position other than Department Contact if they are faculty, staff or students of UVA, who will be doing any of the items listed below. This is true regardless of where the study is being conducted.
- intervene with subjects by performing research procedures
- manipulate the environment for research purposes
- participate in the recruitment and/or selection of subjects
- participate in the informed consent process
- collect or report subject identifiable data; or
- have access to subject identifiable study data
Also list them if they are NOT faculty, staff or students of UVA, but they will have contact with subjects or identifiable data from this study AND all of the following apply:
- they are not under the oversight of a PI at another site with which you have a contract,
- the study will not be approved by their IRB, ethics board etc.
- their institution does not have a Federal Wide Assurance(FWA) number
Personnel listed as Department Contact may NOT have access to subjects or their identifiable data for research purposes. If they require such access, they should also be listed in another position.
Do NOT add personnel to UVa protocol if:
- Personnel will only receive data that meets the criteria of a Limited Data Set ( e.g will receive health information and the only HIPAA identifiers shared will be dates and/or town or city, state, zip code). The recipient will need to sign a Material Transfer Agreement written by Grants and Contracts. Any electronic data set shared will need to be reviewed by the CDR to confirm the data meets the criteria of a Limited Data Set.
- Personnel will only receive data that meets the criteria of being de-identified under HIPAA regulations ( e.g NO HIPAA identifiers). Any electronic data set shared will need to be reviewed by the CDR to confirm the data meets the criteria of being de-identified.
NOTE: HealthSouth or nutrition services employees are not employees of UVa. Some employees may have a joint appointment. If your research team should change once the project is approved, you must submit a modification to your protocol adding the new investigator(s) or removing those no longer involved.
Do I need to include my research staff or student researchers on the protocol?
Anyone who has direct contact with subjects and/or access to subjects' identifiable data in the context of research must be listed on the protocol.
For staff personnel - if the individual's role on the project is part of his or her regular paid duties (i.e. phlebotomist, x-ray technician) and involvement in the project is limited to performing those duties without contributing to the research endeavor, then such individuals need not be listed as sub-investigators or research personnel.