IRB Notes: New tools for investigators

Analyst Notes

The OHSU Institutional Review Board website has new resources for investigators regarding the retirement of the Lay Summary and a new Minimal Risk Protocol Template.

Brief Project Description Replaces Lay Summary

As part of ongoing efforts to streamline submission and review processes, the IRB is replacing the six-question Lay Language Protocol Summary with a simplified Brief Project Description document. The new document contains the following instructions:

Provide a brief (one page maximum) description, of the central question the research is intended to answer, the primary objectives, and the methods used. Use non-technical language. IRB members, IRB staff, and others use this document to get an overview of your study. It is not to be distributed to research subjects.

The Brief Project Description can be found on the IRB Forms website. It is required for every new study as of December 1, 2013. As of that date, the Lay Summary will no longer be accepted. Requests for Determination do not require a Brief Project Description.

Studies that have already been approved with a Lay Summary are not required to transition to the new form. We will continue to re-approve your Lay Summary at Continuing Review, unless you prefer to submit a Brief Project Description to replace it.

VA studies may use the VA abstract instead of the Brief Project Description.

Minimal Risk Protocol Template now available

In the past, the IRB has permitted researchers to use the Lay Summary in lieu of a full protocol for simple, minimal risk studies. The IRB has developed a Minimal Risk Protocol Template to replace the Lay Summary for this purpose. It contains more detailed guidance on what information the IRB needs in order to approve your study. Sections not pertinent to your particular study may be deleted and for many studies, such as chart reviews, the protocol will be just 1-2 pages long. This document is also available on the IRB Forms website. As of December 1, 2013, the IRB will no longer accept the Lay Summary as the protocol for new minimal risk study submissions. Currently approved studies do not need to transition to the new template.

See the IRB website for more information and links, or feel free to contact the IRB office with questions at 503-494-7887, option 1.