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NHGRI Institutional Review Board
IRB Review ProcessProcessThe Principal Investigator (PI) prepares the Initial or Continuing Review packet with all required elements and attachments, and obtains original signatures on the 1195 or 1195-1 form (see Guide to Completing Form 1195 There are several training modules for new investigators that cover the ethical and regulatory requirements for conducting research with human subjects. Investigators must complete the required training activities before they will be permitted to submit protocols for review.
Types of Submissions - Scientific Review CommitteeAll protocols undergo review by the Scientific Review Committee (SRC) at the time of initial submission and then again every three years. The SRC provides investigators with a written review and a summary of outstanding comments and concerns. The PI must address these concerns in a memorandum to the Branch Chief, whose signature on the 1195 or 1195-1 form indicates that the response is satisfactory. Required elements for SRC Submission:
Initial ReviewsAn administrative pre-review is conducted by the IRB staff of initial protocol applications, and these submissions are requested one-week prior to the usual IRB submission deadline. (See the SRC and IRB Submission Calendar.) The IRB staff will also make a preliminary determination of whether IRB review can be expedited. Upon completion of IRB review, the IRB staff notifies PIs of the IRB actions, stipulations and recommendations. Upon receipt of final IRB approval and documentation of all other required approvals, the IRB staff forwards the protocol packet to the NIH Office of Protocol Services (OPS). OPS obtains necessary approvals from the Clinical Center, assigns a protocol number, prepares date-stamped consent / assent forms and posts the approved consent / assent forms on the Web [cc.nih.gov]. Required elements for initial protocol submissions to the IRB:
Expedited ReviewsExpedited review is a process by which the review of a submission (initial, continuing, triennial or amendments) is performed by the IRB Chair, Vice Chair or other IRB members designated by the Chair / Vice Chair, rather than by the full Board. As specified in 45 CFR 46.110 [hhs.gov], submissions may be considered for expedited review if the procedures present no more than minimal risk to human subjects and fall within specific categories [hhs.gov]. Expedited review may be requested by the PI or may be initiated by the IRB chair. Those performing expedited review exercise all of the authorities of the IRB, except they may not disapprove the research. Disapproval requires full IRB review. Expedited review actions are reported by the IRB Chair to the full IRB at its next scheduled meeting.
Continuing ReviewsAll open IRB protocols must be reviewed at least one a year by the IRB. Reminder memos with deadlines will be sent to the PIs by both the Office of Protocol Services and the IRB staff. Required elements of continuing review submissions to the IRB:
Triennial ReviewsAll ongoing protocols undergo a more extensive review, including review by the Scientific Review Committee (SRC), every three years. At this time, protocols should be rewritten and updated to account for any changes in the study design as well as changes in the corresponding scientific field that have an impact on the study. Required elements of triennial review submissions to the IRB:
TerminationsPIs must submit a termination request when all subject accrual, data collection, and data analysis (ie., primary study aims) are completed. Required elements for termination submissions:
AmendmentsAny changes to approved protocols, consent forms and associated documentation must be reviewed by the IRB via an amendment submission. Amendments may be submitted at the time of continuing review or during the period between these reviews and must be approved by the IRB, Cilnical Director and the Office of Protocol Services. Required elements of amendment submissions:
Adverse EventsA serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others. A serious adverse event is considered unexpected if it is not described in the protocol, in the informed consent document, or in the Package Insert or in the Investigator's Brochure (for Food and Drug Administration (FDA) investigational agents). An adverse event report must be submitted to the IRB as soon as possible, no later than seven (7) days in the case of death or life-threatening serious adverse events or within fifteen (15) days after the occurrence of all other forms of serious adverse events. The IRB office will immediately forward a copy to the Clinical Director. In addition, PIs should continue to follow FDA and the NIH Office of Biotechnology Activities (OBA) reporting requirements if the research involves an Investigational New Drug or Device (IND / IDE) or gene transfer. Elements for adverse event report to IRB:
Deviations / ViolationsA protocol deviation is any change, divergence or departure from the study protocol that has not been approved by the IRB. A protocol violation is a deviation that may affect the subject's rights, safety or well being and/or the completeness, accuracy and reliability of study data. (See Examples of Protocol Deviations and Violations.
ExemptionsThe NIH Office of Human Subjects Research is authorized to determine that some research activities are exempt from IRB review or are not considered to be research involving human subjects. If a PI thinks his/her research activities fits into one of these categories, s/he should fill out the Request for OHSR Review of Research Activity Involving Human Subjects
Other Reviews (External to NHGRI)Radiation Safety Committee (RSC) All studies that expose subjects to ionizing radiation for research purposes must undergo review by the Radiation Safety Committee (RSC). Protocols may be submitted for radiation safety review at any time during the IRB review process, but IRB review is not final and the study cannot begin until all required approvals are in place and documented. Food and Drug Administration (FDA) An IND or IDE is required for some studies using pharmaceuticals or devices. It is the responsibility of the PI to determine if an IND / IDE is needed and, if so, to obtain approval. Protocols may bee submitted for FDA review at any time during the review process, but approval is not final and the study cannot begin until all required approvals are in place and documented. The IND / IDE number must be provided to the IRB. Recombinant DNA Advisory Committee (RAC) and Gene Transfer Research To view the To view the
Last Updated: January 30, 2009 |
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