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Appendix I

APPENDIX I: SUBMISSION INSTRUCTIONS

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

FEE SCHEDULE FOR EXPEDITED AND FULL BOARD SUBMISSIONS
The fee for review of industry funded or sponsored protocols submitted for BHS HRRB expedited review is $750 and full board review is $1500. This fee is a one-time non-refundable charge. This administrative fee covers initial review, amendments, periodic continuing reviews, adverse event reports and IND safety letter submissions for the life of the protocol. The fee is due at the time of submission of the protocol. Investigators should inform potential sponsors of the fee during contract negotiations.

NOTE: All sections of the BHS-HRRB 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 BHS HRRB 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 BHS HRRB 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 BHS HRRB 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)
  • Check for $750 for Expedited Review and $1500 for Full Board Review payable to the Baptist Health System HRRB, if sponsored
  • Informed consent document (that has been corrected to include the required criteria from the HRRB Office)
  • Study protocol (submit one complete copy of the protocol-statistical data need not be copied)
  • 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
  • An executed indemnification agreement
  • 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 Human Research Review Board meets the second Friday of the month. The meeting locations are the videoconference rooms of the Baptist Medical Centers. NOTE: The Principal Investigator must be present during the BHS Human Research Review Board consideration of his/her proposal. Materials that need review by the entire Human Research Review Board should be submitted to the Human Research Review Board office the Wednesday before the Friday two weeks prior to the meeting. There can be no exceptions to the submission deadline. (Always check with the HRRB office since deadlines are subject to change due to holidays, vacation, etc.)

THE SUBMISSION
In order for the BHS HRRB to conduct its review, the Investigator must submit one signed original collated packet of material.The packet must be received prior to the submission deadline.

WHERE TO SUBMIT YOUR APPLICATION
Submit to:
Baptist Health System
Human Research Review Board
Suite 1000 Ridge Park Place
1130 22nd St. South 
Birmingham, Alabama 35205
 

NOTE: Email a copy of the completed informed consent document to Vyvette Isabelle, HRRB Coordinator, prior to making copies (email: Vyvette.Isabelle@bhsala.com).

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 Human Research 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 Human Research 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 criteria from the HRRB 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.

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

  • A cover letter explaining what materials are attached
  • New Project Application signed by the Principal Investigator (no signature stamps)
  • Check for $750 for expedited review payable to the Baptist Health System HRRB, if sponsored
  • Informed consent document (that has been corrected to include the required criteria from the HRRB Office)
  • 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
  • An executed indemnification agreement, if required
  • Text of questionnaires/survey tools, if applicable

CHECKLIST FOR EXPEDITED REVIEW FOR AMENDMENTS ON HRRB PREVIOUSLY APPROVED STUDIES

  • A cover letter requesting expedited review and explaining the request
  • Appropriate completed BHS Application Form
  • One copy of materials that are being submitted

Continuing Review

Use "APPLICATION FOR CONTINUING REVIEW OF A PREVIOUSLY APPROVED PROJECT" form to request continuing review. As a courtesy, the Human Research 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
  • A collated original of all materials clipped together

Adverse Events

ADVERSE EVENT CHECKLIST
All incidents of injury or other adverse effects experienced by subjects in research conducted at a Baptist Health System facility must be reported to the Baptist Health System Human Research 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 BHS 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 Baptist Health System are to be reported promptly to the Human Research 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.

A collated original of all materials clipped together.

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 that can be stamped with the HRRB approval stamp and returned. For amendments to the protocol send one complete copy.
  • A collated original of all materials clipped together.

Closure

CLOSURE OR TERMINATION CHECKLIST

  • Completed "Application for Termination Of A Previously Approved Project."
  • Final report from the sponsor
  • A collated original clipped together.

     

 

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