Who needs to be listed on the protocol?  Do all researchers (including collaborators) need to be listed?

Add personnel to UVA study 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 and even if a non-UVA IRB is the IRB of Record.

  • 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.

Also do NOT add personnel to UVA study 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 Agreement written by OSP or SOM Office of Grants and Contracts.  Any electronic data set shared will need to be reviewed by the IS Decision Support Office 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 IS Decision Support Office to confirm the data meets the criteria of being de-identified. To obtain their review send a request to researchdata@hscmail.mcc.virginia.edu.  The recipient will need to sign an Agreement written by OSP or SOM Office of Grants and Contracts. 

NOTE: UVA Encompass Health Rehabilitation Hospital or nutrition services employees are not employees of UVA although some employees may have a joint appointment.

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 with the following exception 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.