Investigator 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
IRBNet
- All materials must be submitted via IRBNet at least two-and-one-half (2 1/2) weeks before the IRB meeting.
- Submission dates are listed under Scheduled Meetings.
- How do I create an IRBNet account?
- How do I upload my submission?
- What do I submit?
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’s Guide
- WCGME-IRB Investigator Guide (Pending)
