Investigator Requirements

Responsibilities

Researchers are responsible for:

  • Protecting the rights and welfare of prospective subjects: 
  • Ensuring that pertinent laws, regulations, and institution procedures and guidelines are observed by participating investigators
  • Obtaining informed consent and ensuring that no human subject is involved in the research prior to obtaining their consent
  • Ensuring that all research involving human subjects receives IRB review and approval before commencement of the research
  • Complying with all IRB decisions, conditions, and requirements
  • Ensuring that protocols receive timely continuing IRB review and approval
  • Reporting unexpected or serious adverse events to the IRB
  • Obtaining IRB review and approval before changes are made to approved protocols or consent forms
  • Seeking IRB assistance when in doubt about whether proposed research requires IRB
  • Assure that research is performed in compliance with Federal Good Clinical Practice Consolidated Guidelines

IRBNet

Required Materials

  • New Protocol Submission Form(Available in IRBNet Forms and Templates Library under “Researcher Forms”
  • Complete copies of the protocol or COPC/QI proposal
  • Informed consent if applicable (or request for waiver of consent)
  • Any materials that are meant for the public (recruitment/advertising)
  • Any materials for participants (instructions, survey instruments, etc.)

Informed Consent

  • Consent template and regulatory guidelines available in IRBNet Forms and Templates Library under “Research Forms”

Investigator鈥檚 Guide

  • WCGME-IRB Investigator Guide (Pending)

Research Protocol Development Templates