Chapter 27 - Maintenance of Standard Operating Procedures
The University of Pittsburgh HRP functions independently through the authority granted by the University Chancellor, through the Senior Vice Chancellor for Research to the Vice Chancellor for Research Protections. The Vice Chancellor for Research Protections serves as the Institutional Official.
The HRP maintains a current Federal Wide Assurance (FWA) and follows the regulations and guidance of the Office of Human Research Protections (OHRP) for all studies conducted under that Assurance. Research that is not federally funded is afforded equivalent protections. The IRB follows the regulations and guidance of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), International Conference on Harmonization (ICH), and other regulatory agencies.
It is necessary to maintain Standard Operating Procedures (SOPs) to ensure the consistent application of ethical and scientifically sound conduct of human subject research.
Procedures for Review, Revision, and Approval of SOPs
Changes to regulations, federal guidelines, research practices, or University of Pittsburgh policies and procedures may require a new SOP or a revision of a previously issued SOP.
Each approved SOP will be reviewed no less than three years from the date of approval as described in this policy. The review date is determined as three years from the last date of approval.
Members of the Regulatory Division are responsible for maintain up-to-date SOPs based on new or updated regulations, guidance from federal agencies, changes to University policy, or changes to procedures within the Human Research Protection Office (HRPO). Minor changes can be reviewed by designated members of Committee F without being placed on a meeting agenda. New policies, as well as significant changes to existing policy, require review and approval at a fully convened Committee F meeting.
The review and approval of a new or revised SOP is documented by members of the Regulatory Division by affixing the revision date. The revision date is the effective date.
Procedure for SOP Dissemination and Training
When new or revised SOPs are approved, they will be disseminated to the appropriate individuals and departments. The HRP website as well as PittPRO will be updated as necessary. Policies affecting IRB staff or board members will be disseminated by the Associate Director, who will also keep a record of any applicable training required.
Procedure for Creation and Use of IRB Forms
Forms are essential tools for use by the research community, HRP staff, and IRB members to ensure that applicable regulatory requirements are considered during the drafting and reviewing of research applications. Forms include the PittPRO application, documentation forms, checklists, and templates and are maintained on the IRB website or in PittPRO as applicable.
Decisions regarding the implementation of new forms or revisions of previously approved forms are made by HRP Leadership. Depending on the nature of the form, approval by Committee F may also be required. Updates to the PittPRO application will be made by Data Analytics and IT division of the Office of Research Protections.