Is IRB Review Required?
The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definitions (DHHS and FDA) of human research. These definitions are outlined in detail in the IRB’s guidance linked below.
Does the activity/project meet the definition of research with human participants?
Anyone unsure about IRB review requirements and whether their proposed activity constitutes “human research” should review the Is IRB Review Required? Guidance and contact the IRB with any follow up questions. If the project may be quality or performance improvement, consider reviewing the Quality / Performance Improvement (QI/PI) Guidance.
If needed, the IRB staff will determine if the activity is human research upon submission of the Human Subjects Research Determination form. Given the complexities noted in the guidance under Research with Existing Private Data or Specimens, investigators are not allowed to self-determine that research with existing private data or specimens is not human subjects research. A request for verification should be submitted to the IRB with the Human Subjects Research Determination Form or through HSERA.
If an activity does not meet the regulatory definition of human research, the IRB will, upon request, issue a letter stating that the project does not require IRB review or approval.
Is the institution engaged in human research?
Sometimes there are situations in which Penn, by way of its “employees and agents” may or may not be “engaged in human research.” Being engaged means that the organization’s human research protection program is responsible for the human research.
Penn is always engaged in research under the following conditions:
- The organization receives an award through a grant, contract, or cooperative agreement directly from a federal agency for the human research, even where all activities involving human participants are carried out by employees or agents of another organization.
- The organization’s employees or agents obtain the informed consent of human participants for the research.
Penn may be engaged in research when Penn employees or agents do ANY of the following for research purposes, but there are exceptions:
- Intervene with any human participant of the research by performing invasive or noninvasive procedures; or
- Intervene with any human participant of the research by manipulating the environment; or
- Interact with any human participant of the research; or
- Obtain identifiable private information or identifiable biological specimens from any source for the research.
Note: In general, an organization’s employees or agents obtaining identifiable private information or identifiable specimens for human research are considered engaged in the research, even if the they do not directly interact or intervene with human participants.
The Engagement In Research Determination Form can help investigators and IRB staff determine whether the institution is engaged. This form is based on OHRP’s Guidance on Engagement of Institutions in Human Subjects Research, October 16, 2008.