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Institutional Review Board Submitting to the IRB

 
Submit a Protocol for Retrospective Chart Review Research
Step 1:
Review the following guidelines to decide if your proposed research is eligible for Exempt or Expedited Review and whether or not you are authorized to conduct the research. Research based on reviews of patient records is subject to IRB review. The method for and the type of data to be collected will dictate the category of IRB review that is appropriate:


Note: Submit ALL CHART REVIEW PROPOSALS to the IRB prior to initiation. The IRB has the final authority to determine a study’s exempt or expedited review status.

Exempt Retrospective Chart Research Review

Review of existing patient records may be considered exempt if the data is collected without identifiers or a link to identifiers; specifically, there is no possible way to go back later to the records. Additionally, the record review must be conducted by an individual (investigator) who would normally have access to the records as part of the patient’s routine clinical care.

In most cases, a retrospective chart review that does not record identifiers falls under the following allowable exempt category:

“Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.”

Expedited Chart Review Studies: Research

Retrospective review of patient records involving collecting identifying information or maintaining a link to the data source require expedited review. Only an individual (investigator) who would normally have access to the records as part of the patient’s routine clinical care may conduct the record review.

Step 2:
Complete Retrospective Chart Review Research Application. Type all forms. The forms may be downloaded to your computer and completed.

Forms for Retrospective Chart Review Research
Form 3 Conflict of Interest Disclosure Questionnaire for Research (One per investigator/key personnel)
Form 4d Application for Approval of Retrospective Chart Review Research
Attach:     
  • Investigators seeking IRB at TMH approval, who receive or have submitted application for federal funding, submit one complete copy of the grant/continuation application/NIH Progress Report applicable to this study.
  • Resumes/Curriculum Vitae (CV) for each key person associated with the study.
  • Copy of certificate showing proof of Protecting Human Research Participants Rights Education or equivalent for each key person associated with the study.
  • Data Collection Forms
  • Any written information to be provided to study participants, i.e., brochures, ID cards, educational material, etc. – if applicable.
  • Any advertising or recruitment materials including print and/or all audio advertisements flyers, colleague letters, etc. Photographs of scales, bags, key chains, etc. with descriptions of the items are acceptable.
  • Surveys, questionnaires, diaries and/or other research instruments.
  • BLANK - Camera ready, Informed Consent/Assent Form(s), including any foreign language consent/assent form(s), if applicable. These will receive the IRB approval stamp when study is approved – if applicable.
  • The Research Protocol – This is the detailed plan describing the objectives, study design, methodology, inclusion/exclusion criteria, statistical plan, subject protections, etc.

Form DUA Data Use Agreement (If applicable)
Form 6 Fee Form


Step 3:
Assemble your submission packet. The submission packet must include all completed IRB submission forms in numerical order as presented in the previous table.

Step 4:
Submit your complete packet to the Office of Research/IRB, Tallahassee Memorial HealthCare on the ground floor of the hospital. If you have questions, please contact Mary Sandell, Regulatory Readiness Coordinator, at 850-431-5676, mary.sandell@tmh.org or Kearston Jones, Administrative Coordinator, kearston.jones@tmh.org, at 850-431-3816.

Step 5:
Once the study is reviewed by the IRB Chair or designee and approved, smaller packets of the study materials are required for the fully convened Board to review. The Board Packets are printed front to back with three holes punched on the left side and stapled in the upper left corner, when possible, for placement in the IRB review notebooks. Twenty-four copies are required. Assemble the Board Packet in the following manner:

Forms to Include in Board Packet
Form 4d Application for Approval of Retrospective Chart Review Research
Attach:     
  • Investigators seeking IRB at TMH approval who receive or have submitted application for federal funding, submit one complete copy of the grant/continuation application/NIH Progress Report applicable to this study.
  • Data Collection Forms
  • Any written information to be provided to study participants, i.e., brochures, ID cards, educational material, etc. – if applicable.
  • Any advertising or recruitment materials including print and/or all audio advertisements flyers, colleague letters, etc. Photographs of scales, bags, key chains, etc. with descriptions of the items are acceptable.
  • Surveys, questionnaires, diaries and/or other research instruments.
  • BLANK - Camera ready, Informed Consent/Assent Form(s), including any foreign language consent/assent form(s), if applicable. These will receive the IRB approval stamp when study is approved – if applicable.
  • The Research Protocol – This is the detailed plan describing the objectives, study design, methodology, inclusion/exclusion criteria, statistical plan, subject protections, etc.
Form DUA Data Use Agreement (If applicable)


Directions to the Office of Research/IRB