IRB Protocol Changes Coming

An image of the revised HRP-591 "Protocol for Human Subject Research"
A sample of the revised HRP-591 "Protocol for Human Subject Research," which will now be accessible to screen readers


Office for Research Protections     |     Institutional Review Board (IRB)

Changes are coming to some of the most frequently used IRB submission documents: the protocol template for human subject research (HRP-591) and the study team member qualification template (HRP-509). Updates are being made to the documents in response to user feedback. The IRB hopes the revisions to both templates will better guide investigators and reduce the number of clarification requests IRB staff ask of study teams.

The protocol template has been improved with revised instructions, reorganized sections, and a new look: no more gray boxes! Instructions will now be in a different color to distinguish them and there will no longer be gray boxes with instructional text. The new study team member qualification template includes checkboxes for indicating a person's role on a study; users should select all checkboxes that apply to the person's role on the study.

Both documents will now also be accessible to those with visual impairment and able to be read by a screen reader. Previous versions of the templates have not been fully accessible for those researchers with a visual impairment.

Both templates are part of the CATS IRB Library: the full set of documents used by the IRB. The Library includes checklists, worksheets, and numerous templates for use by researchers. There are different protocol templates for researchers conducting secondary data research; research with test articles or devices; and non-human subjects research. The Library can be found in CATS IRB from the link in the left side menu. Note that documents starting with "HSPO" are only for research conducted at Penn State Hershey Medical Center and the Penn State College of Medicine only. Researchers at other Penn State locations should use the “ORP” templates in CATS IRB Library. Most documents have no prefix, indicating that they can be used by any site.

More template revisions and Library updates will be coming this summer, including other protocol templates.