This application form is used for new studies requiring full board review and for new studies that meet expedited review criteria.

• How to Apply
• Guidelines for Writing a Research Protocol
• Application for Research Involving Human Subjects
• Drug Biologic Addendum
• Device Addendum
• Vulnerable Populations – Adults with Decisional Impairment Addendum
• Vulnerable Populations – Children Addendum
• Vulnerable Populations – Pregnant Women, Fetuses, Neonates Addendum
• Vulnerable Population – Prisoner Addendum
• Research Administration and Financial Obligation Form
• Conflict of Interest – Part A
• Conflict of Interest – Part B
• Research Billing and Patient Tracking Grid
• Preliminary Medicare Coverage Determination

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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This form should be completed tdetermine if the research project meets criteria for expedited review.

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This form will assist you in assembling all the information that you will 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 protocol 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, a Waiver of Authorization, or a Review Preparatory tResearch from the IRB. If you are applying tthe IRB for a Complete or Partial Waiver of Authorization or a Review Preparatory tResearch, then you alsmust complete the Application for Waiver of Authorization at the end of this form. This form must be submitted tthe IRB.

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Limited data sets in conjunction with a data use agreement allow the investigator tsend at least some individually identifiable information tsponsors for research purposes.

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A checklist used tprepare consent forms that are easy-t-read.

• Consent Template – Mount Carmel
• Consent Template – Fairfield Medical Center
• Request for Waiver of Informed Consent, Documentation of Informed Consent or Elements of Informed Consent

Any changes tyour research plan must be submitted tthe IRB for review and approval prior timplementation of such change. Examples of amendments include changes in:

• Procedure
• Drug dose
• Number of participating subjects
• Length of participation
• Principal Investigator/c-investigator
• Administrative issues

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Emergent problems, unexpected side effects, serious adverse reactions and deaths, whether or not study-related, should be reported tthe IRB within five (5) days of the event (or upon gaining knowledge of the event or receipt of notification from the sponsor).

• Internal- Local Adverse Event Report
• External- Nonlocal Adverse Event Report

Deviations from the approved protocol must be reported in writing. Examples of serious incidents include:

• Enrolling a person in a study before obtaining informed consent
• Administering an investigational drug/device outside protocol, i.e., without a signed informed consent
• Administering higher or lower dosages of an investigational drug ta subject than is specified in the protocol

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Usually a study is temporarily closed tenrollment of subjects during a planned interim analysis or occasionally for review of adverse events by a data safety monitoring board. The study is still approved by the IRB, however nnew subjects are enrolled during the closure. Subjects currently enrolled in the study may still receive treatment/intervention.

A study may be a placed on-hold (suspended) for many reasons, including a request by the sponsor, regulatory agency (FDA), or for noncompliance. Nsubjects may be enrolled during the suspension period and nstudy activities may take place, excluding treatment/interventions for currently enrolled subjects for which stopping the treatment/intervention may cause undue harm tthe subject.

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The principal investigator is responsible for reporting tthe IRB when the study protocol is finally terminated.

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Emergency use is defined as the use of a test article on a human subject in a life-threatening situation, in which nstandard acceptable treatment is available, and in which there is not sufficient time tobtain IRB approval for the use. The Investigator is still required tobtain informed consent under these circumstances.

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The IRB is required by the Food and Drug Administration (FDA) tconduct periodic reviews and/or renewal of all approved protocols. Approximately 60 days prior tthe review date a Progress Report/Continuing Review Form will be mailed tyou. Please complete the form and return it tthe IRB Coordinator. FDA guidelines governing research state that failure tcomplete the form will result in termination of your protocol. If you have not heard from the IRB regarding your renewal prior tthe expiration date, please contact the Human Subject Protection office immediately.

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• Humanitarian Use Device Application
• Humanitarian Use Consent