Mount Carmel Institutional Review Board

Human Subject Protection Office
Mount Carmel Corporate Services Center
6150 East Broad Street
Columbus, OH 43213
Phone: 614-546-4325 | Fax: 614-546-4328 | Email:

Request for Waiver of Informed Consent,

Documentation of Informed Consent or

Elements of the Informed Consent

Study Title:
Sponsor Protocol Number: / Version Date:
Proposed length of research study: / Start: / End:
Research Site(s):
Mount Carmel West Mount Carmel East Mount Carmel St. Ann’s
Mount Carmel New Albany Surgical Hospital Fairfield Medical Center Physician’s Office
Other, specify:
1. Principal Investigator Information
Name:
M.D. Ph.D. R.N. Other, specify:
Human Subject Protection Training Completed? Yes No
Address:
Telephone: / Fax: / E-mail:
2. Study Contact Information (check one of the following): Coordinator PI NA
Name:
M.D. Ph.D. R.N. Other, specify:
Human Subject Protection Training Completed? Yes No
Address:
Telephone: / Fax: / E-mail:

Request for Waiver of Informed Consent

The IRB may waiver the requirement to obtain informed consent, if one of the two following sets of criteria is met. Check the box next to the applicable criteria and provide explanations/justification in your protocol.
Research or demonstration project is to be conducted by or is subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in methods or levels of payment for benefits or services under those programs;
And
The research could not practicably be carried out without the waiver or alteration.
Or (all of the following must be met)
1.  The research involves no more than minimal risk to the subjects.
2.  The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3.  The research could not practicably be carried out without the waiver or alteration.
4.  Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Request for Waiver of Documentation of Informed Consent

The IRB may waive documentation of informed consent for some or all of the subjects if one of the following conditions is met. Check the box next to the applicable criteria and provide explanations/justifications in your protocol.
The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
OR
The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

Request for Waiver of Elements of Informed Consent

If it can be justified, the IRB may approve a consent procedure which does not include or which alters some of the required elements of informed consent. Which elements of informed consent do you wish to be waived and why:

PI’s Signature

Date
Print Name
Signature

Request for Waiver of Informed Consent, Documentation of Informed Consent or Elements of the Informed Consent (10.26.2007)

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