Institutional Review Board

The Institutional Review Board (IRB) of St. Luke's University Health Network (SLUHN) is a standing committee empowered to protect the rights and welfare of individuals recruited to participate in human research activities conducted under the auspices of the Institution. Except when an expedited or exempt review procedure is used, the IRB will review proposed research at a convened meeting at which a quorum is present. The IRB meets monthly, with an additional “back-up” meeting per month if necessary based on the number of items to be reviewed (45 CFR.103 (b) (4); 46.108).

The SLUHN IRB has been established in accordance with the laws of the State of Pennsylvania and New Jersey; the regulations of the Department of Health, the Department of Health and Human Services, and the U.S. Food and Drug Administration; the Medical Staff Bylaws; and in accordance with the guidelines of ICH-GCP (Good Clinical Practices); the Belmont Report, and the Declaration of Helsinki. The IRB is under the authority of the SLUHN General Council and the SLUHN Federal Wide Assurance (FWA) with the Department of Health and Human Services.

The purpose of the IRB is to protect the rights and welfare of human participants in biomedical and behavioral research conducted at SLUHN. The IRB is responsible for the review, approval and oversight of such research to assure that it meets the ethical principles established for research involving human participants, and that it complies with federal regulations that pertain to human research participant protection at 45 CFR, Part 46 and 21 CFR, Part 56 and any other pertinent regulations and guidance.

The function of the IRBs is to review and approve biomedical and behavioral research involving human participants that is conducted by SLUHN employees, utilizing SLUHN patients, or utilizing SLUHN facilities regardless of the source of funding and the location at which the research is performed. The authority to carry out this mandate is stated in 21 CFR 56.108(a(1); 108(b)(3); 109(a) (f); 113 and 45 CFR 160, 164. Consequently, the IRBs will review all research that:

• is sponsored by St. Luke’s University Health Network
• is conducted by or under the direction of any faculty of SLUHN in connection with his/her institutional responsibilities
• is conducted by or under the direction of faculty of SLUHN using any property or facility of the St. Luke’s University Health Network
• involves the use of the SLUHN nonpublic information to identify and contact human research participants
• involves the use or disclosure of protected health information

The SLUHN IRB may approve, require modifications to secure approval, or disapprove all human participants in research activities overseen and conducted by the organization (45CFR46.109(b)). In addition, the IRB has the authority to place restrictions on a study or require progress reports from the investigators and observe, or have a third party observe, the consent process (21CFR56.109(f)) and/or the conduct of the research (21CFR56.109(f)). They may also suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants (45CFR46.113).

SLUHN requires that all research involving human participants, or material or personal information from living humans, be reviewed and approved by the SLUHN IRB prior to initiation of any research activities. No intervention or interaction with human participants in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol.

“Human subjects research is any activity that either 1) meets the HHS definition of “research” involving “human subjects” as defined at 45 CFR 46.102(d)(e)(f) or 2) meets the FDA definition of “clinical investigation” involving “human subjects” as defined at 21 CFR 56.102(c)(e).

The regular session of the SLUHN Institutional Review Board convenes on the 1st Tuesday of each month. In rare cases where a secondary session is needed (usually due to high volume of submissions), the meeting time is usually on the 3rd Wednesday of the same month.

In order for a study to be considered during the next research cycle, the completed submission must be turned in prior to the 20th calendar day of the preceding month. On occasion, this cut-off date may change, accompanying by a corresponding notification.

Please contact Jayne Silva, Manager, Human Research Protections, IRB with any questions or concerns (610-776-4832; Jayne.Silva@sluhn.org).

Please note the following:

“All investigators are required to have a current / valid CITI training completion certificates (GCP and HSR Modules) and completed Conflict of Interest Disclosure form and NIH Conflict of Interest Tutorial Certificate in order for their research applications to be considered complete.”