Date completed: Click here to enter a date. / Reviewer Name: Click here to enter text.
REVIEWER ATTESTATION: By entering your name above, you confirm that you have reviewed this study and entered all recommended stipulations into IRBIS.
Amendment Description
Protocol changes complete and clearly described / ☐Yes / ☐*No
Notes: Click here to enter text.
General Information
Conflict of Interest—Disclosure completed by new members of research team (as required) and if applicable details of the management deemed appropriate and implemented as described. / ☐NA / ☐Yes / ☐*No
Notes: Click here to enter text.
46.111/56.111 Criteria
Risks to subjects have / ☐Increased / ☐Decreased / ☐Remained Unchanged
Benefits to subjects have / ☐Increased / ☐Decreased / ☐Remained Unchanged
Risks to subjects are minimized by using procedures which are consistent with sound research design and are reasonable with anticipated benefits, if any. / ☐Yes / ☐*No
Selection of subjects remains equitable. / ☐Yes / ☐*No
Provisions for monitoring the data collected to ensure the safety of subjects remains appropriate. / ☐NA / ☐Yes / ☐*No
Provisions to protect the privacy of subjects and to maintain the confidentiality of data remain appropriate. / ☐NA / ☐Yes / ☐*No
Additional safeguards for vulnerable subjects remain appropriate. / ☐NA / ☐Yes / ☐*No
Notes: Click here to enter text.
Re-Consenting
This modification includes changes to the protocol or new information that may affect the subjects' willingness to participate, rights, welfare or safety. (If “yes” complete the remainder of this section. If “no”, this section is complete. / ☐Yes / ☐No
All future subjects must be consented using the revised consent form AND/OR, / ☐Yes / ☐No
Current subjects must be re-consented using a consent form addendum AND/OR, / ☐Yes / ☐No
All previously enrolled subjectswho received treatment or intervention must be provided with new information. / ☐Yes / ☐No
Process for re-consenting subjects is appropriate / ☐Yes / ☐*No
Notes: Click here to enter text.
Required Documents
“Additional” required attachments (e.g., consent forms, questionnaires, surveys, scripts, advertisements) have been attached to the IRBIS application / ☐NA / ☐Yes / ☐*No
Notes: Click here to enter text.
REVIEWER RECOMMENDATIONS
New or revised regulatory findings: Click here to enter text. / ☐NA
☐Approvalwithoutstipulations ☐Contingent approval (with stipulations)
☐Deferral ☐Disapproval
*Response requires the addition of stipulations in IRBIS.
Open-ended stips (e.g. explain X, clarify Y, define Z) = Deferral.
Once you have completed your review:
- Save the completed checklist using the following naming convention: IRB#_Submission type_Reviewer last name. Example: “16-6666_Initial_Jones”
- Email as attachment to the IRB Analyst by 8 a.m. the morning of the meeting.
- If you have not already done so, the IRB staff will convert your checklist to a PDF to “lock it down.”
IRB Reviewer Checklist - ModificationPage 1 of 2 Version: October 7, 2016