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Forms

The various forms on this webpage are used by the IRB and researchers at Mount Carmel. If you have any questions, please contact Mount Carmel's Office of Research Affairs at 614-546-4325.

Descriptions of most forms are available by clicking on the form name. To access the forms, click on the Word file. You must have Microsoft Word installed on your computer in order to view the documents on this page.

The various forms on this webpage are used by the IRB and researchers at Mount Carmel. If you have any questions, please contact Mount Carmel's Office of Research Affairs at 614-546-4325.

Descriptions of most forms are available by clicking on the form name. To access the forms, click on the Word. You must have Microsoft Word installed on your computer in order to view the documents on this page.

Initial Submission

Application for Exemption

Please contact the Office of Research Affairs at 614-546-4325 or irb@mchs.com to request a form.

Expedited Review Categories

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

Conflict of Interest

HIPAA

This form will assist you in assembling all the information that you will need to comply with HIPAA requirements pertaining to any clinical research or research that requires access to identifiable 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 to identifiable health information for research purposes unless he/she obtains from the subject a valid HIPAA authorization, a Waiver of Authorization, or a Review Preparatory Research from the IRB. If you are applying the IRB for a Complete or Partial Waiver of Authorization or a Review Preparatory Research, then you also must complete the Application for Waiver of Authorization at the end of this form. This form must be submitted to the IRB.

Data Use Agreement

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

Exempt Study Status Report

Informed Consent Template

Amendment/Revision/Modification Request

Any changes to your research plan must be submitted to the IRB for review and approval prior to implementation 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

Adverse Event Reporting

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

Protocol Deviation/Violation

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 test subject than is specified in the protocol

Protocol Closure-Suspension Report

Usually a study is temporarily closed to enrollment 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 no new 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. No subjects may be enrolled during the suspension period and no study activities may take place, excluding treatment/interventions for currently enrolled subjects for which stopping the treatment/intervention may cause undue harm to the subject.

Protocol Termination Report

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

Emergency Use of Test Article

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

Progress Report/Continuing Review

Please contact the Office of Research Affairs at 614-546-4325 or irb@mchs.com to request a form.

Humanitarian Use

Request for Waiver of Informed Consent

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