Investigator-Initiated Protocols
Review Board Version | Pilot Studies
Protocols may be considered by the Scientific Advisory Committee before submission to the Institutional Review Board at the Children's Hospital Medical Center of Cincinnati. IRB approval must be obtained before any activity can take place.
If adults are to be studied as inpatients or outpatients at the General Clinical Research Center, the protocol must be initially approved by the review board at the University of Cincinnati and subsequently by the review board at Children's Hospital Medical Center of Cincinnati.
Investigators should consult James E. Heubi, MD, program director, before submitting a protocol to the review board and/or the Scientific Advisory Committee to determine feasibility of the study and to determine any special nursing, dietary, and laboratory needs.
Investigators should also consult a biostatistician for statistical guidance. The protocol is expected to show rigorous statistical design, data analysis, and study sample calculations -- or adequate reasons as to why this may not be possible for the proposed study. Following the statistical guidelines will expedite protocol review.
Each principal investigator must submit all documents on the "GAC Checklist". Also, a copy of a two-page, curriculum vita, formatted according to National Institutes of Health guidelines, for the principal investigator and major co-investigators must be included. If any of the required documents is missing on the deadline for submission for an Advisory Committee meeting, review of the protocol will be delayed until the first meeting after the full submission has been received.
The Protocol Submission Form (PDF | Word) requires information regarding human subjects and gender and minority inclusion, as requested in the National Institutes of Health grant application guidelines. Investigators can include this information within the protocol or as an addendum. If addressed within the protocol, investigators can simply indicate the page numbers where this information can be found in the Human Subjects section of the protocol submission form.
For protocols involving financial sponsorship by for-profit sector (pharmaceutical) organizations, the Scientific Advisory Committee reviews appropriate correspondence and budgetary documents to determine whether the protocol is investigator- or industry-initiated. Priority for industry-initiated protocols is lower than for investigator-initiated protocols.
Return to top Review Board Version of the Protocol
In individual cases, it may be appropriate to submit the review board version of the protocol for Scientific Advisory Committee members to review and provide copies of the whole or parts of an original grant submission which provides greater detail on scientific questions to primary reviewers. Any suggested revisions should be incorporated into the version submitted to the Scientific Advisory Committee.
Return to top Pilot Study Protocols
Submission of a protocol as a pilot study is acceptable under appropriate circumstances. However, such a protocol should describe how the information from the pilot will be used for subsequent proposals. The investigator may choose to elaborate a tentative plan for study size, request resource approval for a pilot study, and then submit those preliminary data in the future to request the resources necessary to complete the study.
Pilot studies often receive a lower priority; however, pilot studies that may lead to meritorious, extramurally funded protocols are given high priority.
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For more information, please contact Amy Hartkemeyer, administrative manager, 513-636-4273.
