Chapter 27 - Maintenance of Standard Operating Procedures

The University of Pittsburgh Institutional Review Board (IRB) functions independently through the authority granted by the University Chancellor, through the Provost to the Vice Provost for Research Conduct and Compliance. The Vice Provost for Research Conduct and Compliance serves as the Institutional Official.

The IRB 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 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 new date of approval as well as the version date. The approval 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 Manager of Technology and Instructional Development will update the HRPO website and, if necessary, OSIRIS. Policies affecting IRB staff or board members will be disseminated by the Associate Director of Education, 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, HRPO staff, and IRB members to ensure that applicable regulatory requirements are considered during the drafting and reviewing of research applications. Forms include the OSIRIS application, documentation forms, checklists, and templates and are maintained on the IRB website or in OSIRIS as applicable.

Decisions regarding the implementation of new forms or revisions of previously approved forms are made by IRB Administration. Depending on the nature of the form, approval by Committee F may also be required. Updates to the OSIRIS application will be made by the IT division of the Research Conduct and Compliance Office.

 

version 11.6.2015