Other CHOP Regulatory and Internal Review Committees

The goal of the CHPS is to provide the resources and environment to support high-quality clinical research by qualified investigators. The CHPS grant to the hospital supports the facilities in which the research is conducted, the trained personnel necessary to support the investigator and offsets some of the costs for research tests and studies. The 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 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.

CHPS at CHOP and University of Pennsylvania Health System, merged to introduce new programs and services. Some procedures for adult patients (e.g. ECHO interpretation for subjects ages 21 years and above) may have to be done at Penn CHPS. A Start Up Meeting must be scheduled with both CHOP and Penn CHPS before patient enrollment.

The study team can request changes to CHPS services by submitting an amendment through eCHPS.

Key Reminders

• Please ensure that your OnCore study is fully signed-off and is released/open to accrual 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 if it has not been built in EPIC.

Key Reminders

• Please ensure that your OnCore study is fully signed-off and is released/open to accrual 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 if it has not been built in EPIC.

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.

All human subject protocols submitted to the CHOP IRB for review must be reviewed and approved by the UP-Radioactive Drug Research Committee (RDRC) of the University of Pennsylvania 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 ehrs@ehrs.upenn.edu 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. 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.
Once 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 CTFM@chop.edu

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.

If your study involves recombinant DNA, gene therapy, or human blood/tissue collection

The Institutional Biological Safety Committee (IBC) is responsible for:

• Formulation of policy and procedure related to the use of recombinant DNA and biohazardous agents including human pathogens, human blood and body fluids, oncogenic viruses, and all other infectious agents.
• Review and approval of work involving the generation of recombinant DNA, gene therapy and the formation of transgenic animals, as mandated by the National Institutes of Health.
• Maintaining an updated register of biohazardous agents used within CHOP Research Institute facilities.
• Review and approval of the safe practices and procedures for work with potentially infectious materials and recombinant DNA. All potentially infectious materials and recombinant DNA to be used in the labs or by staff must be registered with and approved for use by the IBC.
• Overseeing the Institutional Review Entity (IRE) subcommittee for review of Dual Use Research of Concern (DURC).

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

Please note: 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.

Contact IBC@chop.edu 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 oncore@chop.edu

Alternatively, you can email the protocol and study details to the OSRC and PPRC Coordinator, Kimberly Krieger 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, 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. 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.

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 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.