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

Physician request for an individual patient IND under expanded access for emergency or nonemergency use

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

Download guidance.

For further assistance: please visit the Office of Clinical Research for additional information.

Investigational Devices - IDE Requirements

If your study uses an experimental device a Significant/Nonsignificant Risk Device Determination may be required.

Download FDA guidance.

For additional assistance, please contact: Tracy Ziolek or Patrick Stanko.

Investigational Drugs

Sponsor-Investigator held Investigational New Drug (IND) Applications.

For further assistance: please visit the Office of Clinical Research for additional information.

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.

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:

-Environmental Protection Agency

-Department of Defense

-Department of Justice

-Department of Energy

-Department of Education

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

Click here to download the document