Director, Human Research Protections Program Northwestern State University of Louisiana Natchitoches, Louisiana, United States
Introduction: Northwestern State is a regional Master's university. The NSU IRB handles approximately 150 Social-Behavioral-Educational applications per year, and we did not provide Non-Human Subjects Research (NHSR) review. In spring 2022, a university academic program made a request to 1. Allow students to submit NHSR protocols for IRB review as a professional development opportunity; 2. Provide an official IRB approval letter for the NSHR studies. (Some academic journals required documentation to publish any study employing human subjects.)
Objectives: 1. Develop a university-wide NHSR review system as a pilot project for 2022-23; 1.a. Conduct background research on existing policies and procedures, including criteria for NHSR protocol review; 1.b. Use the background data to develop a policy and procedure that fit with current NSU IRB policies and SOPs; 2. Devise a plan to incorporate the NHSR data into regular program reports; 3. Use the NHSR experience as an opportunity to determine additional ways to streamline the IRB application and review process for all university researchers and reviewers.
Program
Assessment: 1. 2022-23: A. The NHSR pilot project was instituted in fall 2022 with the requirement that all human subject researchers fill out the NHSR application form first (as a “pre-review”). B. 56% of all 2022-23 protocol approvals met the eligibility criteria. C. The NHSR application form was approximately 1.5 pages in length; in comparison, the Exempt review form was approximately 8 pages in length. 2. 2023-24: A. The NHSR system was included in the new online review system started that fall; B. 55% of all protocol approvals met the eligibility criteria; C. Data analysis identified possible methods for further streamlining of the IRB application and review system.
Discussion: The results for the two academic years indicate that the NHSR pilot program has met the objectives. 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 (For example, in 2022-23, Exempt reviews decreased 60% and Expedited dropped to 0% [zero] compared to 2021-22). Both of these results appear to be due to the requirement that all IRB applicants must fill out the NHSR application first. Overall, the time and effort spent by researchers on the NHSR application process was reduced (compared to the Exempt review process), in large part due to the shorter application form, and reductions were also indicated in IRB review time. Finally, the data collected on the NHSR system increased awareness in the university community and administration of the breadth of the institution’s human subject research activity that, previously, was undocumented and largely unknown.
Limitations: 1. The collected data cover just two academic years (2022-2024); it is unclear at this time if the results constitute any long-term trends or can be attributed to other factors; more time with 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.
Future Plans: For 2024-2025, we instituted a new Quality Improvement application process; our data indicated that QI is a common study type at the university. The QI program is designed to streamline the IRB application process further while still collecting the data needed to make effective decisions to protect human subjects from harm.
Conclusion: Other HRPPs/IRBs should consider adding an NHSR and/or QI application and review process. The programs can be useful for the purposes and needs of the research administration program and the institution.
