Human Research at UB
UB's Human Research Protection Program protects the rights of research volunteers, guided by a 1964 World Medical Organization declaration: “In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.”
All Continuing Renewals will need to be submitted by choosing “Create Modification/CR” in Click. Then, “Modification and Continuing Review” MUST be chosen as the submission purpose. Also, under “Modification Scope,” select both “Study team member information” and “Other parts of the study.”
Requirements prior to starting human research
To help protect volunteers, investigators must complete training and receive project approval from a university Institutional Review Board (IRB) before beginning their work.
- IRBs, comprised of faculty peers and community members, can approve, modify or reject proposed research based on its perceived risks and benefits to prospective subjects.
- IRBs review the studies at least annually and may modify or suspend the research if it decides that risks to subjects are greater than initially understood.
- Individuals planning quality assurance/quality improvement (QA/QI) projects can complete the “QA/QI Self-Assessment Tool” and receive instant notification if the project is QA/QI or not. If a project is determined to be QA/QI, the project lead will receive an email that describes this determination, and that IRB review is not required. If your project does not meet criteria for QA/QI, the tool will guide you to appropriate next steps. Be sure to familiarize yourself with the “University at Buffalo Guidance on Quality Assurance and Quality Improvement Projects” included in the assessment tool to learn more about what constitutes QA/QI, in order to prevent non-compliance if a project is later determined to constitute human research.
- Using this tool does not provide an official IRB determination.
IRB submission guidelines
- The Institutional Review Boards (IRB) will not review incomplete protocols.
- The IRB staff determines when the protocols are complete and ready for the agenda. They encourage researchers to submit early, allowing for pre-review and updates.
- The official review of a completed proposal takes about two months, so please plan accordingly.
Click Portal: IRB and managing compliance
The Click Portal is an online administrative tool designed to help researchers and administrators better manage grants, integrating all aspects of grants management into a single system, including IRB, IACUC, grants management, financial conflict of interest, research agreements and safety.
Click IRB contains instructions and the basics for you to complete and submit for:
- Initial Review
- Protocol
- Consent form
Researchers and administrators can sign on using their UB credentials. UB students and non-UB staff who need access to the Click Portal can register for an account here.
IRB submission policies and procedures toolkit
Investigators may need additional forms that can be accessed on this website and submitted through the Click Portal.
UB helps investigators identify and manage any potential financial conflicts of interest or significant obligations so we prevent bias and safeguard research objectivity.
Stem Cell Research Oversight
UB and Roswell have created a Stem Cell Research Oversight (SCRO) Committee to help investigators maintain the highest ethical standards while engaging in research using pluripotent human stem cells (pHSC).
The reported times are median times from submission of a protocol to full approval. These times include both the time of IRB review and the time when the investigator is providing clarifications.