Review Process

To request approval to utilize CHPS resources, an investigator must submit an online application through the appropriate institution's (CHOP or UPENN) electronic protocol submission process. Only one CHPS submission is required, regardless of the location of services requested. However, the application should be submitted to the institution where the majority of the CHPS services are being provided. CHPS Administration staff will share resource information needed between the two programs. 

To submit a proposal via the CHOP CHPS:  The CHOP eCHPS electronic application system is a part of the eResearch/eIRB system for IRB submissions and can be found at eresearch.chop.edu. (Access to the CHOP Intranet is needed).

Once submitted, the CHPS reviews all protocol submissions  The CHOP CHPS holds monthly Resource Committee meetings where all requests for CHOP CHPS resources are reviewed.   The IRBs and CHPSs at both institutions have established a joint scientific protocol review process between the two entities.  Proposals cannot utilize the CHPS until they receive both IRB and CHPS approval.

CHPS will consider emergency protocol approvals under certain circumstances, guidelines are here.

The respective IRBs have also made accommodations for protocols that require services at both institutions. For more information, refer to  IRB SOP 305 on the IRB Policies and Procedures page.

Submission and Review Guidelines for External Institutions using CHPS Services:

PENN (or other external institution) based investigators using CHOP CHPS services

There are two main scenarios that determine the submission process when investigators outside of CHOP request CHOP CHPS Services:

CHOP is not engaged in research (CHPS resources are being purchased and there are no study staff members based at CHOP)

PI/study team must converse with the Core Director and CHPS Administrator and will be asked for the following information in order to consider and approve requests.

  • Contact information of PI and study team. Email address and contact information for billing.
  • Confirm with PENN (other external institution) and CHOP IRBs that CHOP is not engaged in research
  • Electronic copies of the external IRB approval letter, IRB approved protocol and consent.
  • Funding information – grant number(s), award dates
  • Specify test type and quantity of tests for enrolled subjects
  • Provide age information, it is required for reporting to NIH.  

Once the CHPS study is approved, External PI/Study Team will receive:

  • CHOP CHPS will enter the data into eRESEARCH
  • The approval letter listing services and billing details
  • A copy of the CHPS application listing the services
  • Instructions how to schedule subject appointments at the CHPS
  • The External PI/Study Team will be expected to provide annual continuing review  (CR) information such as a progress report, a copy of the IRB CR approval, any revised protocol or consent documents.
CHOP is engaged in research (usually indicated by a CHOP investigator on the project who will have access to data)

PI/Study Team must provide:

  • Contact information of PI and study team. Email address and contact information for billing.
  • You must inform the External and CHOP IRBs that research will be done at CHOP; they will determine if CHOP is engaged in research and if it is a cooperative agreement study. Usually there will be a CHOP Investigator who is involved in reviewing the data. The CHOP Investigator will have to enter the protocol into CHOP’s eRESEARCH system and create the link to the eCHPS module.  PI will have to supply materials such as:
    • Electronic copies of the External IRB approval letter, IRB approved protocol and consent.
    • Funding information – grant number(s), award dates
    • Enrollment information and specify tests required
  • If Penn-based PI:  Will the study use PENN CHPS Services and receive a CHPS review at PENN? A copy of the PENN CHPS review with NIH score will be obtained by CHOP CHPS Administration.

 

Contact CHPS Administrative Staff for assistance:

John Krall, LCSW
Administrative Director, CHOP CHPS
267-425-1790 (office)
267-426-5430 (fax)
krallj [at] email.chop.edu


Sharon Carbonara, RN, BSN
CHPS Protocol Submission Questions:
267-425-1383 (phone)
carbonara [at] email.chop.edu

Updated July 2017