Additional Responsibilities

Additional Investigator Responsibilities Include:

1. Adherence to the Belmont Principles Ethical Code.
2. Understanding and following the federal, state and local regulations and University of Idaho policies and procedures governing human subjects research.
3. Continuing responsibilities that human researchers have including:

• Enrolling only those subjects that meet IRB approved inclusion and exclusion criteria
• Properly obtaining and documenting informed consent
• Informed consent (a primary ethical requirement of human research and reflects the basic principle of “respect for persons”):
  
  • Is an ongoing process, not just a signed consent form
  • Must take into account cultural differences among subjects 
  • Informed consent requires three components:
    • The subject must understand the information
    • Consent must be voluntary and continuing
    • The subject must be capable of making decisions
• Obtaining prior approval for any deviation from the approved protocol
• Keeping accurate records
• Records relating to research which is conducted shall be retained for at least three years after completion of the research
• Promptly reporting to the IRB any unanticipated problems and adverse events involving risks to subjects or others
  Submit IRB protocols and receive approval for each project prior to engaging in Human Participants Research.
• Current turnaround time for expedited reviews is 18 days, and for exempt reviews is five days. Please submit protocols four to six weeks in advance of when you plan to start Human Participant research activities to ensure enough time for approval.