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Expiration Date to be Removed from Informed Consent Document Watermark

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Beginning Jan. 1, 2016, the MUSC IRB will no longer include expiration dates on Informed consent documents. Consent documents will only include an approval date. The approval for the consent document will last the life of the study, or until it is amended—whichever comes first.

 

Below is an explanation of this policy for new, amended, and continuing review research studies.

 

New Research Study: The MUSC IRB will issue the new consent document with the initial approval date only.  This consent document will be for the life of the study or until it is amended. The consent document will not have an expiration date.

 

Change in Research (amendment) with a revised consent document: The MUSC IRB will issue a consent document with a Change in Research (amendment) approval date. This approval date will last for the life of the study or until there is a further amendment with consent document revisions. The consent document will not have an expiration date.

 

Continuing Review with no changes to consent document: If at continuing review an informed consent still displays an expiration date, the MUSC IRB will issue a consent document with the approval date of the continuing review. The document will not have an expiration date and no further consent document will be issued for the study, unless it is amended.

 

Reminder: It is the responsibility of the principal investigator and the research study team to monitor the expiration date of the study for continuing review purposes. It is also the responsibility of the principal investigator and the research study team to ensure that no participant is enrolled if the expiration date for the study’s MUSC IRB continuing review has been exceeded