Human Research Protection Program (HRPP)

Office of the Vice President for Research

Guidance for Special Topics

Research
- When is IRB Oversight Necessary?

Investigations New Drugs (IND)
- Is An Investigational New Drug (IND) Application Required?

Bioavailability or Bioequivalence Studies

Investigational Device Exemptions (IDE)
- Is An Investigational Device Exemption (IDE) Required?

Custom and Diagnostic Devices

Authorization Agreements
- Is an IRB Authorization Agreement or Individual Investigator Agreement Necessary?