Social and Behavioral Sciences Institutional Review Board
Submitting a Continuation/Renewal or Closure via e-mail
Note: Principal investigators are sent e-mail reminders to continue or close a protocol 1-2
months prior to the expiration date. Studies may not be conducted beyond the current expiration
date unless all pending issues have been resolved and IRB approval is obtained for renewal of the
project. Once a protocol has been closed by either the investigator or the SBSIRB, it may not be
reopened. A new submittal must be made and approved by the SBSIRB in order to continue the
research.
Both pdf and rtf formats are provided for most items on this site. In order to save any changes
you make to downloaded documents, you will need to use the file type compatible with your software
editor. Acrobat Reader cannot save changes made to pdf files, you will need Acrobat Writer or other
software to do this. Rtf files can be edited and saved using Word.
Process for submitting a renewal to the SBSIRB via e-mail.
- Download/Save the SBSIRB Forms File
Rename the file using the last name of the Primary Investigator for the first part of the file name.
This file contains tabs for all for the required SBSIRB forms. Be sure to fill in all pages
needed for the type of submittal you are making as specified on the Directions Page. Extraneous
forms should be left in the workbook and NOT deleted in case they are discovered to be necessary
at a later point in time.
- Section 2 of the SBSIRB renewal form (the Documentation Checklist) gives an indication of any other materials that need to be provided to the IRB with your renewal materials. The renewal worksheet is interactive so as you provide information, the boxes in section 2 will often become shaded blue if it is anticipated that additional documents will be necessary.
Due to the requirements of the AAHRPP accreditation process and the UB SOP, the SBSIRB now requires that a file containing the full set of materials (including protocol, consent documents, recruitment materials, study instruments, etc.) be provided to the SBSIRB for review of any substantive amendments and renewal applications that are not in “data analysis only” status. In addition, the SBSIRBChecklist page of the Excel package must be completed for renewal of most protocols. The HS1A Excel file provides interactive prompts in the guidance column to remind researchers to provide these materials when needed based on the researcher's answers in the Excel forms.
- When submitting substantive materials electronically to the SBSIRB, the number of attachments should be minimized by combining all files of the same file extension type (ex. .doc, .pdf) into a single file with the last name of the Primary Investigator for the first part of the file name. Submittals with an inordinate number of attachments that could have been combined into a single attachment will be returned to the investigator at the discretion of the SBSIRB staff before sending for review. In all cases when materials cannot be sent electronically or if you would like to send materials in a file format other than .doc, docx or .pdf, the SBSIRB staff should be contacted prior to submitting materials in order to discuss how to proceed.
- Send an e-mail to the SBSIRB (SBSIRB@research.buffalo.edu) requesting a continuing review. Provide as one attachment the excel form file containing the forms that you completed in step 1 above. Provide as a second attachment any substantive materials necessary. Please limit your application to these two (2) attachments unless the study is funded in which case a third (.doc or .pdf) file containing the grant or contract narrative (minus appendices, just the study description- the IRB does not need the budget, CV’s, etc.) if it differs from the one previously submitted to the SBSIRB.
- If all application materials are complete, the SBSIRB Administrator will notify the investigator via e-mail that the materials have been sent to the reviewers. Once reviews are received, the Principal Investigator (PI) will be notified of any changes requested or further materials needed.
- After an application has been approved by the board, the PI and faculty sponsor will be notified via e-mail of the action. For Closures, the e-mail will acknowledge the closure and no attachments will be provided. For Renewals, This the e-mail will contain an attachment consisting of an approval memo, HS1A summary pages and the approved research protocol materials as a single password protected pdf document with a University at Buffalo Crest watermark indicating approval by the IRB. All pages of this document will also contain a footer that includes the approval and expiration dates of the current documentation. When documentation is provided in this manner the project is approved and no signatures of the investigator, faculty sponsor or IRB representative are required to further document approval by the University at Buffalo IRB.
The approved pdf file should be printed and placed in the investigator’s indicated repository. This document must be used with the watermark and footer to produce copies of consent documents to be signed by participants when signed documentation of consent is a part of the approved protocol. It is recommended but not required that any advertisements, consent information sheets or other printed materials approved as a part of this protocol also be used with the watermark and footer present.
This document will not be signed unless an investigator needs a signed document in order to meet the requirements of research sponsors or other persons outside of the University at Buffalo. In these cases the investigator must send or bring one hard copy of this full document to the IRB administrator who will provide an appropriate signature and date.
The document will be password protected, but the file may be copied. If for any reason the researcher needs to produce an electronic file with less than the full document, pages in a copy of this file may be deleted using the Acrobat writer.