INVESTIGATORS REQUIREMENTS

Responsibilities

Researchers are responsible for:

  • Protecting the rights and welfare of prospective subjects: Protecting Human Research Participants NIH Office of Extramural Research
  • 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

All materials must be submitted at least two-and-one-half (2 1/2) weeks before the IRB meeting. Submission dates are listed under Scheduled Meetings.

Required Materials

  • Complete copies of the protocol
  • Informed consent

AND

Informed Consent

WCGME-IRB Investigator’s Guide (Revision 2006)

WCGME Clinical Trial Protocol Development Template (Revision 2008) and Informed Consent Development Sheet

 Related Pages