The CHOP Research Institute requires scientific review of certain protocols. The Office of Clinical and Translational Research is responsible for this initiative. For more detailed information go to the Clinical and Translational Research webpage entitled Scientific Review of Protocols.
There are some exceptions from the requirement for independent internal scientific review by a CHOP SRC. The following categories of research are exempt from scientific review:
- Protocol/grants that have had peer review by a Federal-funding agency (e.g., NIH, CDC, DOD)
- Protocol/grants that have had peer review by a national foundation (e.g., American Heart Association)
- Protocols written and conducted by an industry sponsor (e.g. pharmaceutical or device trials)
- Research that does not require direct involvement of human subjects (e.g., chart review or research exempt from IRB review))
Why is Scientific Review Required?
Since 2008, the CHOP Research Institute has required that certain research undergo scientific review prior to submission to the IRB. Established committees include:
- Existing CHOP or UPenn SRC (e.g., Cancer Center)
- Existing Divisional or Departmental SRCs
- SRCs constituted by or between Departments, Divisions, or Centers of Emphasis
- A separate scientific committee provides scientific review for protocols that are being conducted under a CHOP investigator-held IND/IDE
The IRB is required by regulation to take into account the scientific basis for the proposed research when evaluating the risks and benefits associated with the proposal. Research that is not scientifically sound and that cannot achieve its stated objectives is not considered ethical research.
Under the oversight of the Office of Clinical and Translational Research, Departments, Divisions and research affinity groups within CHOP have established a number of scientific protocol review committees. The goals of the scientific review process to accomplish the following:
- Protect the rights and welfare of human research subjects by improving the scientific quality of clinical research conducted at CHOP;
- Decrease the burden on the IRB by providing a process to vet protocols prior to submission;
- Decrease the time to IRB approval by ensuring that only scientifically sound protocols are submitted for review;
- Support CHOP's assurance to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) that it will follow best practices for protecting human research subjects.
What do investigators need to do?
Investigators need to do the following:
determine if their submission requires scientific review
if scientific review is required, then the final, completed scientific review form (available on the Office of Clinical and Translation Research's intranet page) completed by the SRC and indicating their approval, should be attached to Section 2.01 (3.0) in the eIRB application;
if the SRC required minor modifications, the investigator should also attach a letter outlining the changes that have been made to the protocol to address the SRC's concerns and issues;
if the SRC requested major changes, the protocol must go back to the SRC for review and approval prior to submission to the IRB.