The purpose of Scientific Review is to ensure the research plan has scientific merit and a reasonable likelihood of successful implementation and outcome.
The depth of the Scientific Review is intended to be at the level of a manuscript review for publication, with special attention to study merit, design and to PI qualifications.
Two categories of review are required of all clinical research studies.
- Scientific Review
The Scientific Review is an assessment of the research plan or science and investigator qualifications.
- Resource Review
The Resource Review is an assessment of the departmental resources necessary for execution of the research plan (divisional budget, personnel, space) and assessment of the environment of care in which clinical patient care will be performed
For guidance with these reviews, please email Nicholas Ferraio, MS, MPA.
Three levels of approval are required for clinical research proposals in the Department of Pediatrics.
1. Division Chief
Approval of research plan, budget, use of divisional resources, and environment of care in which the clinical activities will be performed.
Approval of resources, budget and documentation of scientific administrative review.
3. Office of the Chair
Approval of the research plan and the project in entirety on basis of PCRO recommendation.
Elements of Scientific Review
Scientific Review Standards
The Scientific Review Standards in the Department of Pediatrics are designed to ensure that the clinical research proposal:
- Is evaluated for the appropriateness of the research
- Protects the overall safety of research subjects
- Assesses the appropriateness of the environment of care in which the clinical activities will occur
The Scientific Review includes the following components:
- Sufficient background and justification
- Reasonable hypothesis
- Study design
- Statistical plan
- Likelihood of answering the hypothesis
- Environment of care assessment
- Feasibility of successful study completion
- Investigator qualifications
- Major safety concerns
- Major data monitoring concerns
- Major conflict-of interest concerns
Methods of Scientific Review
The methods of Scientific Review that are acceptable for departmental sign-off on IRB applications submitted by investigators from the Department of Pediatrics are:
- Certified Pediatric Division Review Committee
- Review by an internal University group (e.g., Clinical research Center (CRC), Cancer Center (URCC/CTO), Perinatal Review Committee)
- FDA review of Investigator-Sponsored IND or IDE application
- External peer review by a scientific body (e.g., NIH)
- Review by a NIH funded collaborative study group (e.g., COG, ACTG)
- Review by PCRO Scientific Review Committee or PCRO Administrative Review
- Thesis/dissertation Committee Review
Evidence of Scientific Review
Evidence of Scientific Review is required before departmental approval and signature by the Office of the Chair of Pediatrics on IRB applications. The list below provides a summary of the documentation acceptable as evidence of Scientific Review:
- Letter of approval from an internal University Review Group (e.g., CRC, URCC/CTO, Perinatal Committee)
- Letter of approval from a Divisional Review Group
- Letter of approval by PCRO Scientific Review/Administrative Review
- Notification of funding by intramural grant program
- Letter of approval from Thesis/Dissertation Committee
- Notification of approval for funding by a federal sponsor (e.g, NIH Just-In-time notification)
- Notification of study approval by NIH-funded collaborative study group (e.g., COG, ACTG)
Scientific Review through the PCRO
The PCRO Scientific Review Committee is available to review proposals for which:
- No other method of peer Scientific Review is available
- The investigator is a division chief and no other method of review is available
- The division chief does not wish to review the proposal and requests PCRO Scientific Review
To arrange Scientific Review, contact Nicholas_Ferraio@urmc.rochester.edu
Overview of Scientific Review Approval Process
Request for Scientific Review