APPENDIX I: Submission Instructions and Closing Out the Project

New Submissions Which Require Review By The Full Institutional Review Board - Prospective Patient Contact

NOTE: All sections of the BBH-IRB Application for Approval of a New Research Project form may not be applicable to your research project. Only complete and copy sections relevant to your study. On all BBH-IRB applications, do not abbreviate the project name. The full name of the project as it appears on the study protocol should always be used as a consistent identifier for the Board. Also, please respond to all questions in the application. The application form must be signed (no signature stamps) by the Principal Investigator. The BBH-IRB office distributes the proposals to all regular and alternate members of the committee who review the protocols for compliance with Federal regulations in accordance with BBH-IRB policies and procedures.

NEW PROJECT APPLICATION CHECKLIST

  • A cover letter explaining what materials are attached
  • New Project Application signed by the Principal Investigator (no signature stamps)
  • Informed consent document (that has been corrected to include the required BBH-IRB criteria.)
  • Study protocol
  • FDA form 1572 for drug studies (IND) or Investigator's Agreement for device studies (IDE)
  • Investigator's Brochure
  • Curriculum Vitae of the Principal Investigator and Sub-investigators.
  • Text of any advertisement to recruit subjects, if applicable
  • Radiation Safety Committee approval, if applicable
  • Institutional Biosafety Committee approval, if applicable
  • Text of questionnaires/survey tools, if applicable
  • Surrogate Consent Exception Form, if applicable

DEADLINES AND MEETING LOCATION
The Institutional Review Board meets the second Friday of the month. The meeting locations are the videoconference rooms of the Brookwood Baptist Princeton Medical Center and Grandview Medical Center. NOTE: The Principal Investigator must be present during the BBH Institutional Review Board consideration of his/her proposal. Materials that need review by the entire Institutional Review Board should be submitted to the Institutional Review Board office by the submissions deadline. There can be no exceptions to the submission deadline. (Always check with the IRB office since deadlines are subject to change due to holidays, vacation, etc.)

THE SUBMISSION
In order for the BBH-IRB to conduct its review, the Investigator must submit the original signed documents. The documents must be received prior to the submission deadline.

HOW TO SUBMIT YOUR APPLICATION

IRB submissions are to be submitted electronically via email to the IRB office at Vyvette.Isabelle@bhsala.com.

  • One study number document(s) per email.
  • Include a Word version of the informed consent form (for track changes).
  • Attach each component of the study submission separately (i.e. Attachment for protocol; Investigator’s brochure, etc.).
  • Title the Submission: IRB Submission (NEW IRB Submission if it is a new study)
    • After a submission has been approved and the approval letter has been signed; the study documents will be released.
  • Title Adverse Event Submissions: AE Submission or Adverse Event Submission

NOTIFICATION
The committee may ask for modifications to the protocol or informed consent document or both. When this happens, the project may not begin until all the contingencies have been satisfied and the committee or the Chairman, whichever is appropriate, gives full approval to the project. At this time, the Principal Investigator will receive an approval letter signed by the Chairman or his designee. If there are no contingencies and the new project request is approved, the Principal Investigator will receive an approval letter signed by the Institutional Review Board Chair or his designee. The informed consent document will be stamped "approved," dated and sent along with the approval letter. All approvals for investigational studies are filed in the official Institutional Review Board study files.

SINGLE PATIENT TREATMENT "COMPASSIONATE USE

  • New Project Application signed by the Principal Investigator (no signature stamps)
  • Informed consent document (that has been corrected to include the required BBH-IRB criteria.)
  • Study protocol - This is a detailed plan of the scientific experiment including: background, objectives (scientific questions to be answered and study endpoints), inclusion and exclusion criteria, treatment plan, and follow-up procedures.

SINGLE PATIENT EMERGENCY TREATMENT
Emergency treatment of subjects with FDA regulated drugs or devices does not need prior approval from the Institutional Review Board. However, certain procedures are to be followed prior to treatment of the subject. Contact the Institutional Review Board office for assistance. The Institutional Review Board is to be notified after the treatment of the subject.

  • Report of Emergency Use of a Test Article
  • Informed consent document that has been corrected to include the required criteria from the IRB Office
  • Study protocol - This is a detailed plan of the scientific experiment including: background, objectives (scientific questions to be answered and study endpoints), inclusion and exclusion criteria, treatment plan, and follow-up procedures

New Submissions Which May be Eligible for Exempt Or Expedited Review Status

EXEMPT AND EXPEDITED CHECKLIST
The Institutional Review Board will determine whether the submission is eligible for Exempt from Continuing Review Status or for Expedited Review. If it is determined that it is not eligible, it will be scheduled to be reviewed at the next meeting of the Institutional Review Board.

  • A cover letter explaining what materials are attached
  • New Project Application signed by the Principal Investigator (no signature stamps)
  • Expedited Application signed by the Principal Investigator (no signature stamps)
  • Informed Consent document if applicable (that has been corrected to include the required BBH-IRB criteria.)
  • Informed Consent Waiver form if applicable
  • Study Protocol (submit one complete copy)
  • Investigator's Brochure or packet insert
  • Curriculum Vitae of the Principal Investigator and Sub-investigators.
  • Text of any advertisement to recruit subjects, if applicable
  • Text of questionnaires/survey tools, if applicable

CHECKLIST FOR EXPEDITED REVIEW FOR AMENDMENTS ON IRB PREVIOUSLY APPROVED STUDIES

  • A cover letter requesting expedited review and explaining the request
  • Appropriate completed BBH-IRB Application Form

Continuing Review

Use "APPLICATION FOR CONTINUING REVIEW OF A PREVIOUSLY APPROVED PROJECT" form to request continuing review. As a courtesy, the Institutional Review Board office may send Investigators a reminder letter before the end of the current approval period. However, it is the Investigator's responsibility to make sure that the continuing review application is submitted before the submission deadline the month before the approval expires.

CONTINUING REVIEW CHECKLIST
· Use "APPLICATION TO REQUEST SCHEDULED-CONTINUATION APPROVAL OF A PREVIOUSLY APPROVED PROJECT" form signed by the Investigator (no signature stamps)

  • A copy of the current informed consent form if the project is still in the enrollment phase
  • Any other pertinent information

Adverse Events

ADVERSE EVENT CHECKLIST
All incidents of injury or other adverse effects experienced by subjects in research conducted at a Brookwood Baptist Health facility must be reported to the Brookwood Baptist Health Institutional Review Board. This report should be submitted as soon as possible, but NO LATER THAN 5 WORKING DAYS after first awareness of the problem. Submit only SERIOUS UNEXPECTED Adverse Events. The investigator should provide his/her opinion and support for any proposed changes in the protocol and/or consent form. On "inside" AEs, submit each on a separate form. Do not put AEs "within" the system on the same form as "outside" the BBH system. Make sure that the subject identifiers have been removed.

Submit only one study per application form.

For multi-site studies, adverse events occurring outside Brookwood Baptist Health are to be reported promptly to the Institutional Review Board as soon as the investigator is made aware of adverse events reported to other IRBs, the FDA, or the sponsor. Multiple AEs may be reported on one form for outside studies. Attach all pertinent backup material, i.e., AE reports to the sponsor, lab reports, chart notes, MedWatch reports, safety letters from the sponsor, etc.

Amendments/Modifications

CHECKLIST FOR AMENDMENT APPLICATION

  • "AMENDMENT TO A PREVIOUSLY APPROVED PROJECT" form (submit one study per application)
  • Appropriate materials that are being amended. For a revision to the informed consent form, send a marked-up copy of the old informed consent form and an original revised consent form (in word) that can be stamped with the IRB approval stamp and returned. For amendments to the protocol send one complete copy and one copy showing track changes.

Closure

Requirements for Final Reporting Upon Study Completion

FINAL REPORT:
If the study has been completed or otherwise terminated during the approval period and the Investigator does not wish to apply for renewal of approval, the Investigator should complete the "APPLICATION FOR TERMINATION OF A PREVIOUSLY APPROVED PROJECT."

CLOSURE OR TERMINATION CHECKLIST

  • Completed "APPLICATION FOR TERMINATION OF A PREVIOUSLY APPROVED PROJECT."
  • Letter from the sponsor terminating the project, if applicable.
  • Close Out Fee (File Storage)...$200