Consent/Assent Issues

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Q.1.  In INSPIR 1, every time I created an amendment or a progress report a new version of the consent form was created, even if there were no changes made to the consent form. Will this happen in INSPIR II?

A.1.  No, in INSPIR II, when you create an amendment, the system does not automatically attach a consent form. With each amendment, if you determine that a consent form revision is needed, you will need to create a revised consent form, make the necessary changes and submit the consent form with the amendment.  If the amendment does not involve any changes to the consent form then you do not have to submit a new consent form with the amendment.

For progress reports, you do not need to submit revised consent forms when you submit progress reports (unless you wish to modify the consent form to be reviewed with the progress report).  If you do not submit revised consent forms with your progress report, and if the IRB does not require any consent form changes at the time of review, then the IRB will stamp the current versions of the consents with the new approval and expiration dates.