Human Subjects Research and COVID-19


Guidance for the Continuation of Human Subjects Studies with Regard to COVID-19

Guidance for Human Subjects Research

FDA Guidance during COVID-19 Pandemic

To help protect volunteers, investigators must complete training and receive project approval from a university Institutional Review Board (IRB) before beginning their work.

  • The 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 “” 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 “ÃÛÌÒ´«Ã½ 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.
IRB Submission Guidelines

-- The Institutional Review Boards 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
    12/18/24
    The Click Portal is a new online administrative tool designed to help researchers and administrators better manage grants.
  • Policies and Procedures (Toolkit)
    3/11/25
    Information related to the IRB submission process.
  • Stem Cell Research Oversight
    12/18/24
    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).
  • Median IRB Review Times
    12/18/24
    Two year running medians of IRB review times for the three types of protocol reviews: Full Committee, Exempt, and Expedited.
  • Contact
    2/7/25
    The Office of Research Compliance covers a broad range of topics, assisting investigators and administrators in developing and managing ethical and responsible research.