Here are a few helpful hints for you and your research staff when submitting a document to the IRB office. Please share these with your research staff.
|A. The url address for the Butler IRB website is: http://www.butler.org/irb/. All current documents (latest versions) can be found at this website. All investigators are advised to download the latest version of the protocol, consent forms, or adverse event reporting forms before submitting them to the IRB.
|B. New Protocols and PHI Waivers
- The Principal Investigator (PT) must be a Butler Hospital employee and must sign all written documentation before submitting to the IRB.
- For new submissions, send new protocols or PHI Waiver requests as an email attachment to Manda Nongauza. For a list of protocol submission due dates, click here.
- A primary reviewer will be assigned to your protocol.
- The primary reviewer will send requested changes and comments to the PI prior to the IRB meeting. Once the changes have been made, a revised clean copy should be sent electronically as an email attachment to Manda Nongauza. Also, send a signed original print version and one print copy. These materials should be submitted by the pre-determined submission deadline– roughly 1 ½ weeks prior to IRB meeting date.
- The PI must appear in person at the IRB meeting to present his/her protocol and answer questions from the Board members. PI’s are not required to present PHI Waiver requests in person.
- Proof of research ethics training is required for all investigators and recommended for all other research personnel. On-line research ethics training courses can be accessed using either of the following two links:
OHRP Human Subject Assurance Training
Protecting Human Research Participants, NIH Office of External Research
- A Full Approval letter, a Provisional Approval letter or a Disapproval letter will be sent within approx. 2 weeks after the IRB meeting.
|C. Amendments to Existing Protocols and other items for Expedited Review
- There is no submission deadline for expedited reviews.
- Send signed memo as print versions to Manda Nongauza along with consent forms (one copy with tracked changes and one clean copy), advertisements and any other relevant materials. If changes are to the protocol, only submit one copy of the protocol with tracked changes.
- Submissions are reviewed and an approval letter or comments will be sent back to you within 2 weeks.
|D. Annual Reviews
- You will receive an email notification that your protocol is due for its annual review. Your submission must include an electronic component and a print component. The electronic component should consist of an email with the following attachments:
|(a) the completed annual review form;
(b) a copy of the consent form to be re-approved with an unendorsed IRB validation box;
(c) copies of all correspondence you have sent to the IRB since the last approval (including all local unanticipated problems or serious adverse events); and
(d) copies of all advertisements for the study. The print component should consist of one signed original and one copy of each of the items listed above. Any changes to the protocol or the consent form require the submission of separate copies with and without track changes.
- An approval letter or comments will be sent back to the PI within 2 weeks. Begin using the newly approved version of your consent form(s) upon receipt.
- If the protocol is being closed, send
(a) an email with an attachment consisting of the completed annual review form and
(b) a signed original print version and one print copy of the completed annual review form. Consent forms are not required when closing a protocol.
**Please note: Each page of the consent form should include a version date in the month/day/year format. This version date should be updated with each amendment.