When and why you need IRB approval for your research:

When: any research that engages human subjects: questionnaires interviews (audio or video) focus groups participation observation reviewing of academic or private data Oral history

Why: comply with federal regulations to conduct research ethically to ensure rights are protected

For more information see this document for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research: http://www.buffalo.edu/content/dam/www/research/pdf/Compliance/IRBToolkit/General/HRP-103-Investigator%20Manual.docx

For you to get your project submitted through IRB you will need to do the following:

Social and Behavioral Responsible Conduct of Research Course:

1) Complete CITI training for Social and Behavioral Responsible Conduct of Research course (all online). You can find these courses by logging onto your CITI account (affiliated with the University at Buffalo).

• To create and account and register: https://www.citiprogram.org/
• Select Institution: SUNY - Buffalo (University at Buffalo) from the participating Institution drop-down list.
• Follow the instructions for selecting username and password, filling in your name, and providing an email address. Click the SUBMIT button
• On the ‘Select Curriculum’ page:
• Check to be sure that the top of the page indicates that your institution is SUNY Buffalo (University at Buffalo).
• Under Question 2, select Social & Behavioral Research track. Click the SUBMIT button.
• Completion of the CITI Basic course takes approximately 4 hours. However, the program need not be completed at one time. [Please Note: Registrants who begin the course but do not log in again for 30 days may be deleted from the system and will have to re-register.]
CMEs for completion of the CITI program are available through the University of Miami. Details are available on the CITI site: https://www.citiprogram.org/citidocuments/cme/index.htm. (https://www.research.buffalo.edu/rsp/irb/cyirb/guidelines/education_training.cfm#1)
• The course covers a variety of modules on various topics (consent, privacy, risks, etc.)

2) Documents that will need to be submitted to IRB:
• HRP-503 Template Protocol available on the IRB Toolkit here: http://www.buffalo.edu/research/research-services/compliance/irb/policies-procedures-toolkit.html under the Templates section (include example protocol) • Consent document – for surveys/questionnaire this is often included in the email asking people to participate. (include example) • Recruitment materials – email soliciting participants (same as above)
• Survey or questionnaire instrument

3) Register for Click training at: https://www.buffalo.edu/research/research-services/training/training-workshop/irb-module.html

Submit your project to IRB via the Click IRB Module. http://www.buffalo.edu/research/research-services/training/training-workshop/irb-module.html (Green login button)
• You will need to register / log in to this system with your UBIT info.
• Click on the Create New Study and complete the basic Information form
• You will be attaching the forms in #2 above in various sections
• Protocol will be attached on Basic Information first screen
• Consent and Recruitment page
• Survey instrument under supporting docs

IRB Protocol Development Assistance: https://www.buffalo.edu/research/research-services/behavorial-research/irb-protocol-development-assistance.html