38 - Establishing a Human Research Protection Program SOP Process Within an Institution

Background:  After a full turnover of staffing in the institution’s Human Research Protection Program (HRPP) in 2022–2023, new department staff were not able to provide consistent, detailed guidance to principal investigators (PIs) in a timely manner due to a lack of up-to-date standard operating procedures (SOPs).

Program

Description:  The HRPP sought to develop and distribute new SOPs for the PIs. The goal was for the new SOPs to provide answers to the frequent questions researchers have about HRPP processes. Over the following year, the HRPP team implemented multiple measures to facilitate the development of seven new SOPs outlining HRPP programs.

Before drafting, HRPP staff collected information from regulations, training materials, and subject matter experts (SMEs). HRPP staff then worked collaboratively to document the purpose of each procedure, incorporate required documents, and provide a step-by-step description of the review workflow. SOPs were written with the PI as the target audience to ensure that information provided was clear, concise, and helpful. Throughout the development process, HRPP staff held weekly meetings to discuss questions, review draft SOPs, and plan. As a final step, research staff were invited to review the draft SOPs for clarity and provide feedback.

Program

Assessment:  In an understaffed HRPP office, investing the required time needed to write SOPs was a significant challenge. SOP reviews also required time and attention from SMEs, stakeholders, and leadership. The HRPP team faced hurdles with ensuring all key stakeholders were present at weekly meetings to give input on SOPs in development.

The HRPP team successfully used a collaborative platform for SOP drafting. Draft documents were placed on Microsoft Teams, where all stakeholders were able to view and edit the documents together in real time. This ensured strict version control of each SOP, preventing staff time and effort lost working on incorrect documents.

To streamline the SOP drafting process, the HRPP team used a standardized template for all new SOPs. The template comprised four main sections: References, Purpose, Forms, and Procedure. These sections were described in concise language to give PIs a quick understanding of when this process should be initiated, what forms or documents would be needed, and which steps to follow.

Limitations: The success of the SOP drafting and distribution was limited by HRPP staff availability since the work was done in conjunction with primary job functions. The Institutional Official’s availability also contributed to delays in SOP approval. The distribution of SOPs across the institution was limited by communication methods, given that emails are often unread and training sessions are not always attended.

Discussion:  PIs will always inquire about the process to complete a required HRPP procedure. If the SOP is written, maintained, and readily available for distribution and reference, it will mitigate back and forth between the HRPP team and PIs. The time saved can be spent on other tasks the HRPP staff need to complete. When institutional leadership provides the HRPP the necessary resources to write the HRPP SOPs, it allows for HRPPs to document the required process to assist the PIs in following federal, institutional, and local human subject research regulations.