All modifications/changes in a project must be received and approved by the Institutional Review Board before they are initiated except where necessary to eliminate apparent immediate hazard to the subject. This includes changes to key personnel associated with a research study.
To help streamline the approval of changes to key personnel changes, the "Cover Letter For Request Change/Modification to an Approved Study — Key Personnel Changes Only " has been created.
The Cover letter can be used for making changes to key personnel associated with the study only where those changes do not require revision of the consent/permission/assent form(s) and/or the change is not to the PI of the study. Revised Application Facesheets and Research Plan documents would not be required to be submitted until the next submission of either or both of these documents, when the revised document(s) would need to reflect the current personnel and appropriate information about those personnel .
As noted on the Cover Letter, the definition of key personnel includes people who are engaged in research with living human beings, identifiable human tissue samples or identifiable private information. Examples include persons who enroll individuals; obtain subjects' informed consent by doing more than handing out or collecting forms or telling subjects how to get in touch with the investigators; as part of the research team intervene or interact with subjects by performing invasive (e.g., drawing blood) or non-invasive (e.g., survey) procedures on them (excludes UCSD Medical Center workforce members performing commercial services or services on behalf of the UCSD Medical Center); collect data directly from or follow-up directly with participants; collect identifiable private information from participants; have access to information that links participants' names or other identifiers with their data; or act as authoritative representatives for the investigators.
The PI is reminded that by signing the Cover Letter, the PI certifies the following:
In order to Add Key Personnel, the following information must be provided:
When removing Key Personnel, only the name of the person and their role/responsibilities on the study are required.
Note: If the Cover Letter does not provide sufficient information and/or is not signed by the PI, it will be considered incomplete. Incomplete Cover Letters may be returned to the PI without review or the PI may be contacted to provide additional information/documentation, which will likely delay review and possible approval of the personnel changes .