This guidance is to assist with understanding different types of research that require different levels of review.
Human Research - Is IRB Review Required?
Is IRB Review Required?
The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definition of human research. Anyone unsure about IRB review requirements and whether their proposed activity constitutes “human research” requiring IRB review should contact the Office of Regulatory Affairs. (Click here for guidance) The IRB staff will determine if the activity is human research. 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
For further information please contact:
- Amanda O'Hara
- Stephanie Lesage
- Jessica Yoos
Emergency/Compassionate/Treatment Use of a Test Article
Requests for emergency uses of investigational drugs or devices: Call 215.746.6272 or 215.868.3114.
For additional assistance, please contact: Tracy Ziolek.
Investigational Devices: Early & Expanded Access
Investigational Devices - IDE Requirements
Single Patient Treatment Use
When a physician is seeking to obtain an unapproved drug for an individual patient for treatment purposes, the following materials will be required to be included with the submission to the IRB.
- A Single Patient Treatment Use Cover Letter outlining appropriateness of the request for the targeted patient
- Single patient treatment use consent form
- Protocol outlining how the drug will be used with the single patient
- Any other supporting documentation needed for the request (i.e. information about the drug, etc.)
Please note: The Conflict of Interest Assurance document must be submitted to the IRB prior to IRB review. In the event that the patient has donated money to the Institution an assessment will be conducted to determine appropriateness of approving the IRB submission.
Social Media Guidance
Government Funded Research
Studies that are funded by the following governmental departments have additional regulations for study teams and PI's to be aware of:
These checklists have been developed to assist research teams conducting research that is subject to these additional regulations.
Greater Than Minimal Risk Research which Excludes Pregnancy
The IRB has developed this document to assist researchers in addressing the many components that the IRB routinely looks for when pregnancy is an exclusion criteria in greater than minimal risk research. Before submitting for initial approval of a study that qualifies - research teams should review this document to ensure the protocol, HSERA application and informed consent forms include all of the appropriate information and plans that are needed in relation to:
- Providing an appropriate rationale for the exclusion
- Outlining the plan for pregnancy testing
- Describing contraception requirements
- Establishing a plan for an incidental pregnancy