Director, Human Research Protections Program Northwestern State University of Louisiana Natchitoches, Louisiana, United States
Background: In spring 2022, a university academic program reported to the IRB that 1. Some publishers in the field had developed policies to require formal IRB documentation of study approval for Non-human Subjects Research (NHSR) protocols; 2. The program also wanted their students to experience the IRB process as a professional development opportunity.
Program
Description: An NHSR application and review process was designed and approved for 2022-2023. The program would specifically address the issues reported by the academic program: 1. Develop a procedure for providing formal IRB approval and documentation to researchers for NHSR studies; 2. Provide the opportunity for students to receive professional development in research practices via participation in the IRB submission and approval process. In addition, the NHSR process would help to reach several other goals identified by the HRPP Director: 3. Ensure that protocols deemed by researchers to be NHSR were in fact eligible for that status. 4. Determine ways to streamline the IRB process for researchers and the IRB, and especially for student researchers (NOTE: 90% of all protocol applications submitted in 2021-2022 were from student researchers). 5. Report the collected data to the administration for use in program assessments, accreditation reports, and strategic planning, to provide a fuller picture of the human subject research activity at the university. The five goals shown above were the basis for the assessment.
Program
Assessment: 1. For 2022-23, the NHSR system provided a formal letter for each approved protocol for publication purposes as requested by the academic program (see Background). 2. The academic program’s students submitted the new application form and demonstrated basic understanding of the IRB and the submission process. 3. All protocol applications submitted to the IRB in 2022-23 were evaluated on the NHSR determination criteria. The ones that met the criteria were approved as NHSR; all others were sent to Exempt review. 4. The NHSR application form was 1.5 pages in length (when printed), and approximately 15-30 minutes were needed to complete it, significantly shorter than the eight-page Exempt review form, which typically required multiple hours to complete. Overall, 56% of all application approvals in 2022-23 were designated as NHSR. This is significant since, before 2022-23, all submissions were sent to, at minimum, Exempt review. Based on these initial results, the NHSR application system was extended to the entire institution for 2023-2024. During that year, 43% of all study approvals were NHSR (the drop in the NHSR approval percentage appears to be, at least in part, the result of increases in other submission types, such as amendment and site approval requests; see Limitations, below). Interestingly, the majority of the 2023-24 NHSR studies were submitted by the College of Arts & Sciences, which typically submits a lower number of applications compared to other Colleges and Schools at the institution. In addition, some NHSR protocols were submitted as “course-related activity”; that is, research assignments required in specific courses. 5. These results provided important details about the extent of human subject research at the institution that was not documented routinely in the past. The assessments for 2022-23 and 2023-24 were shared with the IRB membership, the public (via the IRB website), the Institutional Official as well as others in the administration.
Limitations:1. The data cover only two academic years (2022-2024), so it is unclear at this time if the results constitute any long-term trends or can be attributed to other factors; more time using the system will clarify those issues. 2. For 2023-24, the IRB switched to a new electronic submission system; it is unclear whether the new system affected protocol submissions.
Discussion: For the original five goals, our initial results indicate that the NHSR process has been a success. Researchers received official approval documentation for their NHSR studies and increased their understanding of research practices and the IRB process. The IRB was able to ensure that NHSR studies were eligible for that status, and fewer protocols went on to the longer Exempt/Expedited review process. Overall, the time and effort spent by researchers on the IRB application process was reduced, and similar gains were found in protocol reviews for IRB staff. Finally, the data collected on the NHSR system increased awareness of the breadth of the institution’s research activity. Based on our experience with the NHSR system, in 2024-2025 we instituted a new Quality Improvement application process; our data indicate that QI is a common study type at the institution. The QI program is designed to streamline the IRB application process further while still collecting the data needed to make effective decisions. Finally, we believe that other HRPPs/IRBs should consider adding an NHSR and/or QI application and review process. While not required by the federal rules, the program can be useful for the purposes and needs of the research administration program and the institution.
