Ancillary review assists the IRB with matters related to research feasibility, risk, regulatory requirements and research compliance. Not all studies require ancillary review. If ancillary review is required, documentation of IRB approval cannot be released until all ancillary reviews are completed.
The eIRB system automatically routes submissions requiring an ancillary review to the appropriate departments or committees for approval.
Regulatory Ancillary Committees
Institutional Biological Safety Committee (IBC):
All research studies that involve the use of recombinant DNA, gene therapy, the formation of transgenic animals, or biohazardous agents require review and approval, as mandated by the National Institutes of Health. Biohazardous agents include blood and any other biological specimen that will be handled in a research laboratory. This does not apply to e.g. blood or urine that gets sent to a clinical lab (e.g. blood for sodium level or urine pregnancy test which will be analyzed in the clinical lab and then discarded). For studies involving human source material (blood, cells, etc) stored in a research lab at CHOP (including storage for future use), the investigator must complete a human source material registration with the IBC. Once registered, a PI doesn't need to re-register each time they submit a new protocol involving biohazardous materials; the IBC only needs to confirm that a registration is in place.
UPenn Radiation Safety Committee:
All research studies that involve the use of ionizing radiation as a research procedure require the review and approval by this committee. Radiology procedures that involve ionizing radiation and are part of participants' routine care do not require review and approval by the committee.
Other CHOP Ancillary Committees
Ancillary review assists the IRB and the CHOP Research Institute with matters related to research that not related to research regulatory requirements. Many of ancillary review committees are concerned with the feasibility of the services requested (e.g., radiology, pathology, pharmacy) as part of the proposed research study.
The Office of Collaborative and Corporate Research Contracts (OCCRC) negotiates Clinical Trial Agreements (CTAs) for industry-funded studies; this includes both industry-initiated and investigator-initiated projects. All CTAs for new studies and amendments will be triaged through eTRACK to one of the contract administrators.
All studies that involve a CHOP Sponsor or Sponsor-Investigator (i.e. a CHOP investigator holds the IND or IDE), as defined in the FDA regulations (21 CFR 312.3(b) and 812. 3(o), require institutional approval.
Medical Device Committee:
All studies that involve investigational devices (devices not approved for marketing by the FDA) and devices that are not used clinically at CHOP require review and approval by the Medical Device Committee. The Device Committee often requires additional information regarding the devices to be used. This may include completion of a Manufacturer Disclosure Statement, and a Request for Information Form.
All studies that involve retrieval of specimens from Pathology as well as research protocols that include the entry of patient identifiable test results from labs other than the CHOP Clinical Lab and CHOP-approved reference labs into the EMR require ancillary pathology approval. View the list of non-CHOP labs approved for use in clinical trials by clicking the hyperlink.
All studies that utilize CHOP's Investigational Drug Service (IDS) to receive, store, control, or dispense an investigational agent require ancillary pharmacy approval.
All studies that utilize Radiology resources (including retrieval of existing radiology studies) require ancillary radiology approval.
All studies that plan to recruit in the primary care network at CHOP require review and approval by the Pediatric Research Consortium (PeRC) Project Review Committee. The PeRC Project Review Committee prefers that researchers contact them prior to submission to the IRB. Researchers can contact Jim Massey, PeRC Network Director, at 267-426-5167 or masseyj [at] email.chop.edu.
Many investigators would like to recruit teenagers from the Adolescent Specialty Care at 3550 Market St. or the 5 West Adolescent Inpatient Service. If recruiting from either site and not a member of the Division of Adolescent Medicine, the investigators need to obtain approval from the Division of Adolescent Medicine for their plans to recruit at these sites.
All studies that involve storing biospecimens in the CHOP Biorepository require ancillary approval from The Biorepository Core (BioRC).
CHOP Cellular Therapy and Transplant Section (CTTS):
All studies involving a cell, including immune- or gene, therapy product to be processed and/or infused at CHOP Cellular Therapy and Transplant Section (CTTS) requires their ancillary approval.
GI Endoscopy Suite:
All studies recruiting from the GI Endoscopy Suite or during GI procedures in places such as the Operating Room or Interventional Radiology require ancillary approval from the GI Endoscopy Suite.