Social and Behavioral Sciences Institutional Review Board

Submitting new protocols to the SBSIRB via e-mail.

Process for submitting a new protocol via e-mail:

Note: 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.

1. The Investigator, faculty sponsor and all key study personnel must complete the Educational Requirements. Copies of CITI tutorial certificates can be pasted into word or adobe files and e-mailed as doc or pdf attachments to SBSIRB@research.buffalo.edu at any time. Hard copies may also be sent to the IRB through campus mail at any time.
2. Download/Save the Forms File . Rename the file using the last name of the Primary Investigator for the first part of the file name. Signatures should be left blank at this time. Be sure to fill in all pages needed for the type of submittal you are making.
3. Create a second (doc or pdf) file with the last name of the Primary Investigator for the first part of the file name containing the following material. In all cases when materials cannot be sent electronically or if you would like to send materials in a different file format, the SBSIRB staff should be contacted prior to submitting materials in order to discuss how to proceed. The research team is responsible for providing all copies needed for review of any materials that cannot be distributed electronically for each step of the review process.
   
   1. Protocol/Project Description (Required) The project description must follow the format and address all of the issues in the required template.
   2. Informed Consent Document(s) or Study Information Sheet(s) to be provided in lieu of consent documents (when signed consent will not be obtained)
   3. Recruitment materials- letters, scripts, advertisements, posters, e-mail texts, etc.
   4. Debriefing or feedback materials (where applicable)
   5. The study instruments (e.g., questionnaires, surveys, a list of interview questions, etc.)
   6. Waiver of Consent Forms (If Applicable)
   7. Any other information pertinent to the documentation of the project
   8. If hard copies of letters of support from institutional representatives are required (e.g., a letter from a principal for research in a school), the protocol should note that the    letters have been requested and will be delivered to the SBSIRB with the final paper copies of the application.
4. E-mail the SBSIRB (SBSIRB@research.buffalo.edu requesting a review of the materials and attach the two (2) files that you have just assembled. Limit your application to these two (2) attachments unless you are also sending an electronic copy of your grant application. 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 they are sent for review.
5. Students submitting materials should also ask their faculty sponsor to e-mail the SBSIRB Administrator confirming that they have read the materials submitted and are ready to sign off on the application. This e-mail needs to include the student investigator's name, title of the project and faculty sponsor's name and position. Student submittals will not be sent to the reviewers until this e-mail is received.
6. 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.
7. After an application has been approved by the board, the PI and faculty sponsor will be notified via e-mail that the protocol has been approved. This 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 consecutive pagination along with 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.