Protocol Summary Integration: FAQ

April 10, 2012

The IRB is continually monitoring the progress of the recent protocol summary integration update in ERICA as study teams complete new studies, amendments, and continuing reviews. We feel that the process is working smoothly as we address questions and concerns.

Through this process, we have identified some common problems or mistakes that can be avoided by study teams in order to improve IRB review quality and review time. These problems are discussed below.

Problems at Continuing Review

• At continuing review, please copy and paste the information from your protocol summary into the appropriate new questions of the Update Study Application. This will ensure that the IRB can find the appropriate information in your application without the appearance that your study has changed. See additional instruction.
• At continuing review, if your study has completed enrollment or is only performing data analysis, you must still answer all of the questions in the Update Study Application for activities you performed in the past. The Update Study Application must show a complete picture of the study, not just the activities you are working on now.
• If you have an existing waiver of consent or waiver of authorization in your Update Study Application, please use the "Update" button next to the existing waiver at continuing review, instead of adding a new waiver. If you would truly like to request a new waiver, this must be clearly described in an amendment, or it will be deleted from your application.

Problems at Amendment

• Study teams are not providing enough information in amendment applications about the changes they wish to make. You must provide the IRB with a detailed response regarding the following items:
  1. What are you changing?
  2. Why are you making this change?
  3. Where are these changes reflected in your application (Update Study) and your study documents?
  It is helpful if you make a list of all of the changes, grouping changes that go together (i.e., administrative changes, risk changes, procedure changes, consent changes, etc.), and then make sure the questions above are answered for each change. Provide this list in the amendment application
• Also at amendment, the IRB will still accept a tracked copy of the protocol summary if you attach it under "Other Documents". This will help you to communicate the changes to the IRB as well as help the IRB conduct an efficient review.

Additional Guidance for Answering the New Questions

• On the Contacts and Title page, questions 1 and 3, be sure to indicate which members of your study team will be obtaining consent from participants. Later in your application on the Consent Process page, question 1, the individuals obtaining consent will appear in a pre-populated list. Do not re-enter these individuals into the text box on the Consent Process page, question 1. Only use the text box for individuals who will obtain consent and are not internal members of the study team.
• On the Resources and Responsibilities page, questions 1 and 2, the IRB will not accept "not applicable" as an answer. Please use the help text provided in order to answer each question. If you would like additional information about how these questions should be answered for a specific study, please contact the IRB.

We continue to encourage use of the ERICA tutorials available on the IRB website. If you have any questions about the ERICA update or the information provided above, please contact the IRB at 801-581-3655 or irb@hsc.utah.edu. We are happy to assist you.

Thank you.