Institutional Review Board (IRB)

The IRB of St. Luke's University Health Network (St. Luke’s) is dedicated to safeguarding the rights and welfare of individuals participating in human research. The IRB reviews proposed research at monthly meetings, ensuring compliance with ethical standards and federal regulations.

St. Luke’s IRB operates under Pennsylvania and New Jersey laws, as well as regulations from the Department of Health, Department of Health and Human Services, and the U.S. Food and Drug Administration. The IRB follows guidelines from ICH-GCP (Good Clinical Practice), the Belmont Report, and the Declaration of Helsinki. The IRB is under the authority of St. Luke’s General Council and Federal Wide Assurance (FWA) with the Department of Health and Human Services.

The IRB's primary role is to review, approve, and oversee biomedical and behavioral research involving human participants while also complying with federal and other pertinent regulations that pertain to human research participant protection. The IRB ensures ethical principles are upheld and federal regulations are met. The IRB reviews research St. Luke’s is sponsoring, conducting and directing direction at any St. Luke’s property or facility. The IRB also reviews research that involves the use of St. Luke’s nonpublic information, patients or facilities, regardless of the source of funding and the location at which the research is performed.

All research involving human participants or their information must be approved by the St. Luke’s IRB before initiation. The IRB has the authority to approve, modify, or disapprove research activities. It may also impose restrictions, require progress reports, and observe the consent process or conduct of the research.

The SLUHN Institutional Review Board convenes on the first Tuesday of each month. In rare cases, when a secondary session is required (typically due to high submission volume), it is usually scheduled for the third Wednesday of the same month. Expedited and exempt reviews occur three - five days prior to full board meeting.

To be considered in the next review cycle, completed submissions must be received by the 20th calendar day of the preceding month. Occasionally, this deadline may be adjusted, with notice provided accordingly.

For questions or concerns, contact Jayne Silva, Manager of Human Research Protections, IRB at 610-658-0918 or Jayne.Silva@sluhn.org.

Investigators must have current CITI training completion certificates (GCP and HSR Modules), a completed Conflict of Interest Disclosure form, and an NIH Conflict of Interest Tutorial Certificate for their research applications to be considered complete.