Developing a proposal that includes work with animals or human participants requires careful planning. It may require institutional approval, may be regulated at the federal or state level, or may require specialized infrastructure or controls.
IRB:
All research meeting the regulatory criteria for “Human Subjects Research” must receive IRB approval prior to any work being conducted.
HHS defines “Human Subjects Research” as any systematic investigation designed to develop or contribute to generalizable knowledge, involving living individual(s) about whom an investigator either obtains information or biospecimens through intervention or interaction or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
The FDA defines “Human Subjects Research” as experiment(s) that involve a test article and one or more individual(s) who are or become a participant in research, either as a recipient of a test article or as a control, where this work is subject to the Investigational New Drug (IND) or Investigational Device Exemption (IDE) regulations or collects data to be submitted to or held for inspection by the FDA.
Review the guidance on What Types of Research Require IRB review to help determine whether IRB review is necessary.
Review the engagement criteria to help determine whether Lehigh or its agents will be considered “engaged” in HSR.
IACUC:
IACUC review is determined by work involving live vertebrate animals.