IRB Protocol Development Assistance
We have compiled several self-help resources to assist you in develooping IRB protocols. Please review these materials before contacting our office with additional questions. Students and residents also need to work with thier advisors in developing protocols.
Human Research Education Presentations
BRO is available to present to units or classes on IRB protocol development. Please contact us to schedule a time and discuss content for a presentation.
Review of Non-Clinical Human Research
BRO will be coordinating the scientific review process for many non-clinical departments. The process will be posted once confirmed and operational.
This quick reference helps with information commonly used in Click IRB.
Illustrated step-by-step guide to most common Click IRB transactions. While we are still developing additional sections for this guide, we did not want to delay publication of the sections that are complete.
The guide contains directions, examples and sample text for filling out HRP-503, the protocol template. It correlates with the IRB template to be released in January 2016. It will be updated to correspond more exactly with the HRP-503 template once the IRB posts a finalized version of HRP-503.
*If you are using an earlier version of HRP-503, the information is the same although the numbering might be off. You can use keywords to assist in your search.
Using the checklists helps ensure that you have included everything the IRB needs to review your submission.
If applicable, please submit the following with the information on your clinical studies.
The following are some of the most commonly used IRB items. The complete toolkit is available within the Click IRB system or on the IRB Toolkit page.
1. Write your protocol first because every human subject study will need to include one of the following:
2. When your protocol is complete, start working on consent documents.
*UB researchers cannot use the short, signed-consent form except in very limited and well defined circumstances.
You must include an HRP-504 when you or a member of your research team will be entering a school.
If you are merely mailing or sending information, documents or materials to students then do NOT use an HRP-504.
Use the HIPAA templates when working in a health care setting or accessing protected health information from medical/clinical records.
Use the HIPAA templates when working in a health care setting or accessing protected health information from medical/clinical records.
Do NOT submit your worksheets and checklists in the Click Portal IRB. Rather, use them as guides to understand the IRB regulatory criteria used in approving a study so you can construct your protocol accordingly.
Do NOT submit your worksheets and checklists in the Click Portal IRB. Rather, use them as guides to understand the IRB regulatory criteria used in approving a study so you can construct your protocol accordingly.