Because of guidance updates from federal regulatory agencies and the Institutional Review Board (IRB) accreditation process, the UNMC IRB is making many changes to the process of human subject protection at UNMC, The Nebraska Medical Center, and UNO. Continuing education of the research community is an important part of the IRB accreditation process. Today’s message will discuss continuing review and tips for completing the report.
Continuing Review
Federal regulations require that the IRB review all studies no less often than annually to assess the current risks, safeguards, risk/benefit relationship, and the accuracy of the consent documents. Unfortunately the IRB is not allowed to grant extensions, even for one day. There is only one Continuing Review Application and it has been updated to more closely answer the questions asked by the Board. The following are some points to keep in mind while completing the application:
- Pay close attention to the questions involving the number of subjects enrolled in the study and the demographics of those subjects. The Continuing Review Coordinator will compare the previous year’s numbers with this year’s to determine if the numbers “add up.”
- “Not applicable” or “N/A” is not an acceptable answer. Please answer all of the questions with a complete response.
- Let the IRB know if there are any problems with obtaining or documenting informed consent. Also, if the IRB has approved an alteration to the standard informed consent process at an earlier date, restate the process and provide the date the IRB approved the alteration for easy reference.
- Changes to study personnel can be made at this time without submitting a Request for Change. Indicate new personnel by an asterisk (*) and understand that the new personnel must be CITI trained before the IRB will approve the continuing review.
- The copy of the consent form signed by the last subject consented must have the subject name and birth date removed to protect subject confidentiality. Subject initials can remain on the bottom of each page. The signature page should keep the dates and signatures of the witness and investigator.
- Two originals of each consent form must be printed, single-sided, and included with the continuing review application. When submitting the consent forms, keep these questions in mind:
1) Is this the most current version of the consent form?
2) Is the consent printed on the correct letterhead? All clinical studies must now be printed on The Nebraska Medical Center consent stationery (available from General Supply).
3) Are there any typographical errors or formatting problems in the consent? (Do not leave big, blank spaces at the bottom of pages. Leave only enough room at the bottom of each page for the initials blank and the IRB stamp.)
4) Does the authorized study personnel section listed at the end of the consent form correspond with the personnel listed in the continuing review application?