The various forms mentioned 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.
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
- Device Study Addendum
- Drug-Biologic Addendum
- Vulnerable Populations - Adults with Decisional Impairments Addendum
- Vulnerable Populations - Children Addendum
- Vulnerable Populations - Pregnant Women, Fetuses, Neonates Addendum
- Vulnerable Populations - Prisoner Addendum
- Application for Exemption
This form should be completed to determine if the research project meets criteria for expedited review.
- Conflict of Interest Annual Financial Disclosure Form
- Conflict of Interest Financial Disclosure Form IRB Member Staff or Consultant
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.
- HIPAA Waiver of Authorization Form
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.
A checklist used to prepare consent forms that are easy-to-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 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:
- Drug dose
- Number of participating subjects
- Length of participation
- Principal Investigator/c-investigator
- Administrative issues
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).
- Internal- Local Adverse Event Report
- External- Non-local 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 test subject than is specified in the protocol
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.
The principal investigator is responsible for reporting the IRB when the study protocol is finally terminated.
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.
- Emergency Use Application
- Research Study Continuing Review
- Humanitarian Use Device Application
- Humanitarian Use Consent