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IRB Application Instructions

INSTRUCTIONS FOR COMPLETING APPLICATION FOR IRB REVIEW AND APPROVAL OF A RESEARCH PROPOSAL

 

Prospective investigators are requested to review and be prepared to comply with the Cone Health Institutional Review Board Operating Policies and Guidelines, especially noting “Requirements for Investigators” before submitting an application to the IRB for project review.

All research proposals involving the use of human subjects within the Cone Health, its various divisions, departments and units must be submitted to the Institutional Review Board (IRB) - the Committee for Human Research Protections - for review and approval.  These Sections of the application must be completed and submitted:

Section I:
  Research Proposal Review Face Sheet
Section IA: Principal Investigator Agreement and Statement of Commitment
Section II:   Considerations to Assure Protection of Subjects and Personnel
Section III:  Summary Statement of Proposed Research
Section IV:  Proposed Informed Consent Document 
Section V:  Peer Review Statement
Section VI:  Administrative Advance Approval (if necessary)
Section VII:  Financial Statement and IRB Fee Schedule

To expedite the IRB process please call the IRB Coordinator (336-832-2330) for assignment of protocol number.

Please allow two to five weeks for the review process.  The duration depends upon the date of submission and the complexity of the project.

Do not substitute other applications or research protocols in place of required forms.  When appropriate, these documents may be used as supplementary materials.  Standardized consent forms approved by the FDA (for certain groups; e.g., SCCC; CALGB; GOG) may be supplemented but may not be altered; however, additions can be implemented to comply with Cone Health IRB requirements.   Standardized consent forms or one supplied by other outside sponsors should be reviewed and, if necessary, revised to conform to the particular study and to Moses Cone IRB requirements.  A statement of requirements for informed consent and the Moses Cone standard consent template are included in this packet following these instructions.

All forms are available from the IRB office or online.  If completed from hard copy, please assure legibility because of the need for photocopying.  The application forms are also available as Microsoft Word documents which can be electronically transmitted from the IRB office to applicants. 

THE ORIGINAL WITH APPROPRIATE SIGNATURES AND 17 COPIES OF ALL FORMS (FULL BOARD REVIEW ONLY) MUST BE SUBMITTED AT LEAST TWO WEEKS BEFORE THE NEXT SCHEDULED IRB MEETING TO THE IRB COORDINATOR.  Please contact the IRB Coordinator for time and place of meeting and to confirm that the proposal has a place on the agenda.

 

INSTRUCTIONS FOR NOTIFICATIONS TO THE IRB
SUBSEQUENT TO APPROVAL OF PROJECT

RENEWALS:   Each research proposal is approved for a period of no more than one year.  If  the project is to be continued beyond that time, a renewal application must be submitted.  The IRB Coordinator will send a renewal reminder memorandum to the Principal Investigator (PI) about six weeks prior to the date of expiration of approval.  The PI must then file Form R-01 or R-02 with appropriate attachments with the IRB. Please allow four weeks for the renewal process.  Failure to receive approval of renewal from the Board by the end-date of previous approval will result in an order to terminate the research.  Projects which required full Board approval originally will require full Board approval of renewal.  Projects which qualified for expedited approval may receive expedited renewal.  Please refer to OHRP “Guidance on Continuing Review” (July 2002) in Appendix to IRB Policies for details.

REVISIONS:  During the course of the research activity it may be necessary to alter the protocol or its procedures from those which were initially approved by the IRB.  These changes will be considered as revisions to the original protocol.  The PI should submit to the IRB Chair IRB Form A-01 which provides for descriptions of any revisions, amendments, addenda or other changes to the protocol and or the approved Informed Consent Document.  The PI will be notified of IRB approval and update of IRB files.

SAFETY AND SERIOUS ADVERSE EVENT REPORTS:  These should be reported to the IRB Chair using IRB Form S-01.   The PI will be notified of the Chair’s review and update of IRB files.

USE OF INVESTIGATIONAL DRUG OR DEVICE IN A LIMITED NUMBER OF PATIENTS:  Refer to this entry under “Other IRB Procedures and Actions” in the IRB Procedures and Guidelines for information on this usage and reporting to the IRB Chair using IRB Form C-01.  The PI will be notified of  the Chair’s review and approval and report to the IRB.

EMERGENCY USE OF INVESTIGATIONAL ITEMS:  See the entry in IRB Procedures and Guidelines about the special procedures and prohibitions required in such instances.

Please transmit completed forms electronically, by Health System inter-campus mail, or by regular mail to the IRB Coordinator: Sharon Norwood, IRB, The Moses H. Cone Memorial Hospital, 1200 N. Elm Street, Greensboro, NC 27401.