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: No subjects may be contacted, recruited, or enrolled in a study until the investigator obtains IRB approval.

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 study personnel involved with human participants 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. This file contains tabs for all for the required SBSIRB forms. Signatures should be left blank at this time. 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.
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. You should save a copy of this file for use in later revisions. It may also be needed at the time of renewal or amendment submittal. 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. 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. Any other information pertinent to the documentation of the project
   7. 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.

   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.

4. 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. 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.


5. E-mail 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 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.) must also be included. Thesis and dissertation projects should not be submitted until after dissertation committee approval so that major changes in the IRB materials do not occur while the IRB review is in progress.


6. Students submitting materials should also ask their faculty sponsor to e-mail the SBSIRB Administrator at SBSIRB@research.buffalo.edu confirming that they have read the materials submitted and are ready to sign off on the application. For thesis or dissertation projects, this approval should not occur until after the dissertation committee has approved the project so that major changes in the IRB materials do not occur while the IRB review is in progress. 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.


7. 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.


8. 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 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.