A major operational goal of the human subject protection program at the USU is to minimize, if not eliminate, the need for passbacks by establishing processes, including training and advice, that result in the submission of high quality documents.
To achieve that goal, the Office of the Vice President for Research (VPR) designed a multistep program.
- Flagging submissions that are candidates for exemption determination with a prefix code of EXM before the protocol title.
- Preparation of instructional material to provide a high quality submission for various use cases. The instructional material will be available on the upcoming revised USU VPR website
- In person teaching sessions for the USU community to be held quarterly.
- Identification, training, and support for IRB submission enablers distributed across the programs and departments to function as the first line for preparation of submissions, to respond to questions, and to provide initial support.
- Shifting the USU IRB Analysts to function as second level support for IRB submission preparation so that they will devote most of their time to processing submissions, teaching, and quality improvement.
On an operational basis, the general problem is mapping information from often multiple sources into a structured document. The mapping is neither simple nor straightforward. The process has a learning curve and USU VPR encourages limiting the number of people in a given program, department, or center who perform the mapping and data entry to increase the proportion of people with sufficient experience and expertise by fostering a system where fewer people do more submissions.
The IRB submission process begins with a study team entering data into the EIRB system.
A more comprehensive checklist for the study team to follow in preparing a new submission follows in Table 2 entitled "Detailed Generic Checklist for study team initial submission of EIRB documents".