Research
Temple Institutional Review Board (IRB)
IRB APPROVAL MUST BE OBTAINED BEFORE YOU LOOK AT ANY
PATIENTS’ INFORMATION, INCLUDING ELECTRONIC MEDICAL RECORDS.
Types of Research Studies
Retrospective Chart Review (valid for one year)
(Review of the patient chart to extract data from visits that have already occurred, No new data is collected from the patient)
Forms Required
Go to: http://www.research.temple.edu/irb
- Request for Protocol Review
- Study Outline Form
- Excel Format Data Collection Sheet (No patient names or MRN#s)
- IRB Human Subjects Certificate (s) for all research personnel
- Letter to IRB Chair
Complete all forms and email to: joanne.donnelly@tuhs.temple.edu
I will check for accuracy, obtain signatures (Dr. Thoder), and make copies. I will hand-deliver to IRB office, located in the Hudson Building, 3rd floor, on Carlisle Street.
- The IRB will either approve your study as submitted and send you via inter-office memo, your IRB Approval Letter. Study will be approved for a period of one year.
- The IRB can ask you for more information or to clarify information before they grant approval.
- All of this correspondence MUST be kept in your research binder in case of an audit. There must be a track record between you and the IRB.
- Any changes or new information pertaining to your research MUST be communicated in writing to the IRB.
Prospective Chart Review (valid for one year)
(New data that needs to be obtained from patient that currently is not in the chart)
NOTE: If the retrospective study was IRB approved, reference that IRB approval number in your letter to IRB chair and state the need to collect new data not found in that retrospective study)
Forms Required
Go to: http://www.research.temple.edu/irb
- Request for Protocol Review
- Initial Review Submission Form
- Informed Consent
- HIPAA Consent
- Human Subjects Certificate
- Letter to Patient
- Letter to IRB Chair
- Copyright Permission for validated research ©questionnaire
Note: Coopyright permission for: DASH©, WOSI©, IKDC©,SF36©,SMFA©,ASES©,
LYCHOLM©,KOOS©,WOMAC©,UCLA SHOULDER SCORE© are available.
|
