If one of the Relying Institutions does not submit the necessary information for continuing review in advance of the expiration date, will all Relying Institutions be affected?
If the Reviewing IRB requests an audit of a study conducted at a Relying Institution, will the Relying Institution receive documentation that the audit was conducted, regardless of the result?
What if an amendment could be affected by state law or other local institutional requirements?
How is it ensured that all study teams are aware of new amendments and know when the Reviewing IRB has approved them?
Does the Relying Institution have a role in the review of amendments (changes of protocol)?
How are changes in study personnel handled?
What if a change of protocol only affects one or some of the participating sites?
Who is responsible for submitting amendments (changes of protocol) to the Reviewing IRB?
What if my institution wants to see the minutes for a study we ceded to a Reviewing IRB?
If study team members from a non-federal Relying Institution identify potential financial conflict of interests relevant to the research reviewed by the Reviewing IRB, do they have to disclose this information to their local IRB?

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Can Relying Institutions use their own template consent form?

Jeremy Lavigne, MA, CIP

February 26, 2025 22:21
Updated

When informed consent documents (ICDs) are required for a study reviewed under the SMART IRB Agreement, all Relying Institutions must use the Reviewing IRB’s ICD template(s) unless the Reviewing IRB agrees to review and approve a Relying Institution’s template.

Within the Reviewing IRB's template, the relying institution may utilize their own template language over limited areas of the ICD (e.g. costs, research related injury, contact information) to cover local, state, and federal requirements.

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