This application is used for research using existing, i.e., on the shelf at the time of IRB review, confidential records, data or specimens. All research using living human subjects, or samples or data, obtained from them, directly or indirectly with or without their consent, must either be approved in advanced by the Mount Carmel Institutional Review Board (IRB), or be found tmeet narrow criteria for exemption from IRB oversight by the IRB office. This Form will help the Principal Investigator tdetermine if the project is likely tmeet the criteria for exemption, tpresent the case for exemption and tdocument the decision on the request.
IRB applications for research protocols that fall intthe appropriate exempt categories will be reviewed by the IRB Chair, or the Chair's Designee when appropriate. Exempt IRB applications are reviewed as they are submitted and usually take only a few days for feedback from the IRB. Turn-around time largely depends on the Investigator's response time tthe IRB's request for any clarifications or revisions.
You must alscomplete a HIPAA COMPLIANCE WORKSHEET FOR RESEARCH PROTOCOLS AND APPLICATION FOR WAIVER OF AUTHORIZATION if you intend tuse the personal health information of subjects. This form will assist you in assembling all information that you need tcomply with HIPAA requirements pertaining tany clinical research or research that requires access tidentifiable health information of patients/subjects. You should complete this form for any research project that you are undertaking that involves the treatment of patients or the gathering, use or disclosure of any person's health information that has identifiers associated with it.
Under HIPAA, a researcher may not have access tidentifiable health information for research purposes unless he/she obtains from the subject a valid HIPAA authorization or a Waiver of Authorization from the IRB.
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