• Investigator-Initiated Protocols

    Protocols may be considered by the CTRC Scientific Advisory Committee before submission to the Institutional Review Board at the Children’s Hospital Medical Center of Cincinnati. The reason we recommend submitting to the SAC first is that there may need to be changes, in some cases, substantial changes, to your protocol and consent documents. If you submit to SAC first, you will not need to submit a second time to the IRB for the revised documents. CCHMC IRB approval must be obtained before any research activity can take place.

    If a UC-based Principal Investigator plans a study involving inpatients or outpatients at the Clinical Translational Research Center, the protocol must be initially approved by the review board at the University of Cincinnati and subsequently approved by Children’s Hospital Medical Center IRB.

    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 “SAC Checklist.” Also, a copy of a two-page curriculum vita, formatted according to National Institutes of Health guidelines, for the principal investigator and major coinvestigators must be included. If any of the required documents is missing on the deadline for submission for a CTRC Scientific Advisory Committee meeting, review of the protocol will be delayed until the first meeting after the full submission has been received.

    Protocol Submission Form

    The Protocol Submission Form 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.

    Review Board Version of the Protocol

    In individual cases, it may be appropriate to submit the review board version of the protocol for CTRC 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 CTRC Scientific Advisory Committee.

    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.

    How to Reach Us

    For more information, contact Amy Hartkemeyer, business director, 513-636-4273, amy.hartkemeyer@cchmc.org.