Human Subjects Research Protections

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Vocab

  • Human Subjects Research (HSR)
    • living person
    • data through intervention or interaction
    • identifiable private information
  • Research - a systematic investigation designed to develop or contribute to generalizable knowledge.
  • Clinical research protocols
  • Institutional Review Board (IRB) - a regulatory committee that must approve HSR before it begins.
  • Office of Human Subjects Research Protections (OHSRP)

Links

Module 1: What is HSR and what permissions are required

  • IRB approval is required BEFORE you start working with human subjects or data.
    • Only commence work on an IRB-approved protocol
  • Required for PIs, AIs, collaborators, using NIH infrastructure.
  • HSR defined by
    • Have access to identifiable human data or specimens from living individuals, or coded specimens that you can link to the subjects' identity
    • Interact or intervene with human subjects to collect their materials or data for the purposes of research
    • All HSR requires IRB review before the research may commence and at least annually while the protocol is ongoing
  • IRB focuses on
    • Ethical concerns related to participant's rights, safety, welfare, and their ability to freely choose to participate or not.
    • The protocol that describes the research plan
    • informed consent document used to inform human subjects about the research when they join a study
  • 12 IRBs at the NIH
    • IRB meetings are open

Module 2: Understanding the Scope of the Research

Module 3: Privacy and Confidentiality

Module 4: FDA-regulated Research Requirements

Module 5: Your responsibilities