MTSU IRB mandates informed consent be administered for all of the studies reviewed under the EXEMPT mechanism.  The fundamental philosophy behind this mandate is "if you can't tell people what you will be doing, then the study cannot be exempt!" However, minor alterations to the exempt informed consent script will be entertained on a case-by-case manner.  Request for such alterations must be made in the exempt application form in appropriate fields.  

Waiver and major alterations to the IRB-approved consent scripts can be only made in the expedited or full review mechanisms provided the following conditions are met.

Approval for Consent Waiver or Permission to Alter the Consent Process

In certain cases, the Federal Regulations allow for approval of procedures which alters the elements of informed consent or waives the requirement to obtain any informed consent. A waiver must be completed and submitted with the application form. The following criteria must apply:

• The research involves no more than minimal risk to subjects;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects;
• The research could not practicably be carried out without the waiver or alteration;and
• Whenever appropriate, the subject will be provided with additional pertinent information after participation.

The request for waiver/alteration must be made in the expedited/full review application form in the informed consent section.  Additional information on the proposed waiver/alteration can be made in appropriate appendix section(s) cited in the form. 

Waiver of Obtaining Signed Consent Forms

Federal regulations allow for approval of a waiver of obtaining signed consent forms if:

• 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 the subjects and involves no procedures for which written consent is normally required outside of the research context.

A waiver request must be in the application form and a justification for seeking the waiver must be provided in the appropriate appendix section.  The IRB decision on waiver/alteration is final and may not be appealed.

Other Questions about Informed Consent?

See The US Department of Health Office for Human Research Protections FAQ section on Informed Consent (http://answers.hhs.gov/ohrp/categories/1566)