IRB (Institutional Review Board)
Exempt Studies Continuing Reviews
Every Three Years
The IRB has changed its continuing review requirements for Exempt studies. Instead of being asked to complete a continuing review on an annual basis, Exempt determinations will be valid for three years. You will still receive automated reminders from the eIRB system when your continuing review is due.
Effective December 1, 2013, new Exempt determinations will be given a three-year expiration date. During the month of December, currently open Exempt studies will have their expiration dates changed to three years from the last continuing review. You will receive a notification from the eIRB system if one of your studies is affected.
You still need to submit a modification for any changes to your Exempt study so the IRB can determine whether the modification affects the study's Exempt status.
Goodbye Lay Summary...
Hello Brief Project Description!
Coming soon – available now and effective December 1:
·Brief Project Description will replace the Lay Language Protocol Summary.
·The Lay Summary will no longer be accepted as a protocol; use the new Minimal Risk Protocol Template instead.
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 will be required for every new study submitted on or after 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.
Tips for writing a great Brief Project Description:
·Keep your description as simple as possible without omitting key details. Imagine you are calling the IRB with a question. What would you tell us about your study over the phone to help us understand your question?
·Know your audience. This document is frequently referenced by non-scientists. If the IRB staff reviewing your study can't understand your description, they will return it for revision. It does not need to be 8th grade language, but should use nontechnical language, and explain any complex medical terminology.
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. Starting December 1, 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.
Feel free to contact the IRB office with questions at 503-494-7887, option 1.
What is Human Subject Research?
The Code of Federal regulations defines Research as:
"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]
and defines Human Subjects as:
"...living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual , or (2) identifiable private information." [45 CFR 46.102(f)(1-2)]