Other CHOP Regulatory and Internal Review Committees

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Determine if your protocol requires ancillary review and approval from other CHOP review committees.

Please note that the eIRB system will automatically do the following:

  • Route all applications that involve radiation as part of the research procedures to the RDRC. Investigators need to only indicate in eIRB Section 2.02 (1.0) and (2.0) that Radiology Review and Radiation Safety review are needed.
  • Route applications to Pathology, Pharmacy, BioRC, IBC, Cellular Therapy and Transplant, and Medical Device Committee.
  • Direct investigators to complete the eCHPS application if CHPS services will be used during the study.

The goal of CHPS is to provide the resources and environment to support high-quality clinical research. CHPS supports the facilities in which the research is conducted, the trained personnel necessary to support the investigator. CHPS also provides administrative support to assist in solving the logistical problems of clinical research. All protocols are approved by the CHPS Resource Committee through eCHPS.

All studies requesting the use of CHPS services must fully submit the resource requests in eCHPS so that the services can be added to the OnCore budget. If you will be using research services provided by the CHPS, please make sure that you select "yes" to the CHPS question in Section 1.03 (3.0) of the IRB submission. By submitting "yes" in IRB, a link to eCHPS will be created for the study team to complete the CHPS resource requests sections. The CHPS resource requests must be completely filled out in order for the CHPS services to be added to the research budget. Any delays in submitting the resource request in eCHPS may result in a delay in the budget.

The study team can request changes to CHPS services by submitting an amendment through eCHPS. CHPS administration is able to assist in reviewing your protocol needs and how to best complete the resource request.

Key Reminders

  • Please ensure that your OnCore study is fully signed-off and is released/open to accrual (log in required) in OnCore before registering or scheduling subjects for CHPS visits. The study must be fully approved in OnCore so that the study build in EPIC can be completed for visit registration and scheduling.
  • CHPS cores will not be able to link to the study or schedule CHPS visits (log in required) if it has not been built in EPIC.
  • A Start Up Meeting must be scheduled with both CHOP and Penn CHPS before patient enrollment.

If the human subjects involved in your study will receive radiation or radioactive substances of an investigational nature (i.e., exposure other than that given in standard nuclear medicine, diagnostic radiology, or radiation therapy procedures, or exposure resulting from standard procedure but independent of standard practice for patient care) a safety review is required. Radiology procedures that involve ionizing radiation and are part of subjects' routine care do not require review and approval by the committee.

All human subject protocols submitted to the CHOP IRB for review must be reviewed and approved by the UPenn's Radioactive Drug Research Committee (RDRC) if they meet the following criterion:

Use of radioactive materials and energized equipment for research purposes at CHOP is managed through a contract with the University of Pennsylvania's Environmental Health and Radiation Safety office (UP-EHRS). Basic and clinical research activities involving radioactive materials/ionizing radiation must be appropriately registered with UP-EHRS. UP-EHRS' policy on radiation safety states that the philosophy of the program is to maintain all radiation exposures As Low As Reasonably Achievable (ALARA). Contact [email protected] for further assistance.

The UP-RDRC review must occur simultaneously with the review of the IRB. The UP-RDRC is administered by UP-EHRS. The Radiation Safety Office should be contacted directly regarding the guidelines for protocol submission, including, but not limited to:

  • Informed consent
  • Risk/ Benefit
  • Procedures with exposures less than: 3 rads (total body) per study and 5 rads (total
    body) per year or 5 rads (per organ) per study and 15 rads (per organ) per year.
  • Procedures with exposures greater than: 3 rads (total body) per study and 5 rads
    (total body) per year and 5 rads (per organ) per study and 15 rads (per organ) per
    year.
  • Procedures that use X-rays only.
  • Procedures that use Radioactive Materials (RAM) only.
  • Procedures using both RAM and X-ray.

Any revisions or modifications required by the RDRC must be incorporated into the protocol submitted to the IRB before full approval is given.

All protocols involving radioactive materials must be submitted for full IRB review.

Any study requiring a physician or service from the Department of Radiology must be approved by the Radiology Scientific Review Committee (RSRC) and the Radiology Research Committee. In the eIRB application, complete Section 2.02 - Study Required Approvals: Radiology. Once submitted to the IRB, the study will automatically be directed to the Radiology Research Committee for radiology ancillary approval.

This includes:

  • X-Ray
  • CT
  • Interventional Radiology
  • MEG
  • MRI
  • Nuclear Medicine
  • Ultrasound
  • Database utilization
  • Professional readings

Depending on the type of the study and funding source the submission may or may not undergo a full review. It is important to include the name of the radiologist co-investigator if there is one in the submission. If there is no radiologist co-investigator, state none. For research studies that require full readings or special measurements, a radiologist would need to be assigned or agree to work with the research team for the study. Once the study has been reviewed, the ancillary approval will be directly submitted online or in case of questions or full review the PI or research coordinator will be contacted.
After the study is approved by the RSRC, Clinical Trials Finance Management will include these services in the budget plan and negotiations. Questions regarding the billing plan can be addressed to [email protected].

Once radiology ancillary approval has been granted, a Radiology Billing Analyst will request a Start Up Meeting with the study team and specific radiology service area staff to review the following:

  • Study specific requirements
  • Study specific radiology information
  • Scheduling
  • Billing
  • Radiology will create a study specific and patient specific Radiology Request Form. This form is to be given to the Radiology Technician at the time of the test.

All research studies that involve the use of recombinant DNA, gene therapy, the formation of transgenic animals, or biohazardous agents require IBC review and approval. Biohazardous agents include blood and any other biological specimen that will be handled in a research laboratory. This does not apply to 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.

New protocols, amendments and renewals can be submitted electronically to the IBC committee through the eIBC portal.

  • Key Reminders: If your PI is going to process any human samples (blood, blood products, tissue, cell lines) in his/her lab, they must register their work with the IBC.
  • Ancillary approval from IBC is required if your study involves gene transfer, biohazardous substances, xenotransplantation, or stem-cell research.

Contact [email protected] for more information.

All oncology protocols, protocols conducted by investigators within the Division of Oncology (with some exceptions) and non-oncology cell, transplant or gene therapy studies must be reviewed by the PPRC or OSRC. The committees meet once monthly and the submission process is the same for both the committees.

Protocols and study information can be submitted within OnCore using the ePRMS Submission Console. Access to the ePRMS Submission Console will be granted upon completion of a supplemental training, which is provided by the OnCore Support Team. Requests for ePRMS Submission Console training and access can be sent to [email protected].

Alternatively, you can email the protocol and study details to the OSRC and PPRC Coordinator, Kimberly Krieger at [email protected] who will make the determination and submission on your behalf.

Please remember that when you are submitting protocol amendments to the IRB, changes to the protocol should be submitted to this committee.

Prior to evaluation, purchase or use of all new medical devices, products or equipment, the Medical Device Committee of Supply Chain's CHOPtimize Program (log in required) , reviews and approves all items that introduce either new technology or change to existing technology to the organization.

Any device or machine not currently used at CHOP needs to be reviewed by the device committee. This includes blood pressure machines, ECG machines, medication delivery pumps, or any type of equipment provided by the sponsor that will be used on patients and is not currently used in the hospital for clinical care.

  1. Complete appropriate section (8.02 Device Information) of the eIRB application pertaining to an Investigational Device.
  2. Contact the Office of IND/IDE for guidance on IDE exemption.
  3. Once you complete Section 8.02, Device Information, in the eIRB application, print out a copy and send to the CHOPtimize Program (log in required). Once the request is received, they will work with the requestor(s) and schedule an appearance at the next Medical Device Committee meeting.

Please note:

  • Plan accordingly. The Medical Device Committee meets once a month.
  • Any external machine provided by sponsor (ex ECG machine, medication infusion pump) for a clinical study must be approved by the Medical Device Committee as well as Biomedical Engineering Department before they are used on research subjects. These devices will be inspected on an annual basis by Biomedical Engineering Department (log in required).

Studies that requires ancillary department or unit-based nursing support or a bedside nurse to assist with study procedures should contact the respective department or Unit Nurse Managers (login required) for approval. Consult with unit clinical nurse leaders if study procedures are feasible within the patient care workflow. Determine the process or standard operating procedures for bedside nurse responsibilities such as research lab collection, delivery or study form completion. It is recommended to include bedside nurse time in your budget for research related needs.

CHPS and IRB utilize the same electronic protocol submission process for new submissions.

The OnCore Clinical Trial Management System provides a single, comprehensive application for ...

Investigators register new IBC protocols, amendments and 3 year renewals electronically.

eIRB is mandatory for all IRB submissions.