In addition to maintaining our Standard Operating Procedures, our IRB Office faced the ongoing challenge of developing and maintaining current, relevant guidance for staff and board members. In many instances, development of such materials fell to a single individual and was subject to the time constraints of that individual’s primary roles and responsibilities. To address these concerns, we developed a Practice & Guidance Committee (Committee) to create standardized, version-controlled documents related to existing and new practices and procedures. With time, the Committee also began developing pilot projects designed to expand on current practices.
The Committee is composed of staff members, including three permanent and five volunteer members. In selecting composition, the Committee seeks to achieve representation from each team and each position within the office. The Committee is charged with developing three types of documents: Practices & Guidance (PGs), Companion Pieces (CPs), and Statements of Practice (SPs).
PGs are internal-facing documents written to address new practices or to standardize existing practices employed by staff and board members. PGs may also afford the opportunity to document and pilot new practices. CPs are intended to supplement PGs by providing step-by-step instructions for implementation. These documents are also internal-facing, and serve as additional resources for existing staff members while aiding in education of new staff members. SPs are external-facing documents designed as resources for the research community. SPs formalize or acknowledge existing standards and also afford the opportunity to pilot new practices.
Practice & Guidance documents are drafted either by a Committee member or by a subject matter expert, and then distributed to the Committee for consideration. After initial review, draft documents are presented to IRB staff for additional input. Certain documents require further consideration, such as by the legal or compliance office. Finalized documents are version-controlled, including approving entity, approval date, effective date, and version number. Once finalized, further education is provided at all-staff meetings
Now into its third year, the Committee has developed and finalized nearly 60 documents. Cumulatively, these documents serve as standardized resources for IRB staff, board members, and the research community. Additionally, these documents have become an invaluable educational resource for new staff members joining our office.
The efforts of the Committee have been well-received by the staff and board members, and the research community. The Committee is now generally regarded as the starting point for the development and implementation of standardized practices.