Who should be listed on the eProtocol application?

The Protocol Director (PD) decides whom to list in the personnel section of the eProtocol application.

Considerations:

- The PD might want to add personnel who are e.g., involved in the consent process, other aspects of human subject protection, handling private health information (PHI).
- The first four (4) people listed on the eProtocol application have update access to the application. All others listed have view access only.
- Whenever there is a change to listed personnel an eProtocol Modification must be submitted.
- The Human Subjects training requirement is not limited to those personnel listed on the eProtocol application, but extends to all research staff as described on CITI Required Tutorial.

NIH funded studies: NIH guidelines state:

“Participants in a grant or application who contribute substantively to the scientific development or execution of a project. Key personnel contribute a specified level of time (contrast with other significant contributor) whether or not earning a salary.
Key personnel include the principal investigator as well as any consultants who meet the definition above.”
See also http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm:
Key personnel: “The PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if their involvement meets this definition. Consultants also may be considered key personnel if they meet this definition. “Zero percent” effort or “as needed” is not an acceptable level of involvement for key personnel.”