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.
  • The IRBs also look at quality assessment/quality improvement (QA/QI). The QA/QI administrator collaborates with investigators, research volunteers and administrators on behalf of the university in its efforts to meet regulatory requirements and maintain the highest ethical standards.
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
    10/16/17
    The Click Portal is a new online administrative tool designed to help researchers and administrators better manage grants.
  • Policies and Procedures (Toolkit)
    6/29/20
    Information related to the IRB submission process.
  • Stem Cell Research Oversight
    6/24/20
    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).
  • Contact
    9/17/19
    The Office of Research Compliance covers a broad range of topics, assisting investigators and administrators in developing and managing ethical and responsible research.