Consent documents: templates and site-specific language

Applies to: Agreement V3.0 · SMART IRB SOPs

Whose template? When written consent is required, all Relying Institutions use the Reviewing IRB's consent template(s), unless the Reviewing IRB agrees to review and approve a Relying Institution's own template. The Reviewing IRB provides the approved documents for use by each site.

What a site may customize. Within the Reviewing IRB's template, a Relying Institution may substitute its own language in a limited set of areas:

• compensation for research-related injury,
• availability of treatment for injury,
• payment or reimbursement of subjects' costs,
• local study team contacts,
• local conflict-of-interest disclosures, and
• language required by local, state, or federal law or by a federal agency's policies or processes.

Version 3.0 also requires the Reviewing IRB to consider a Relying Institution's requests on other sections of the form where they are needed to address legal or regulatory issues, federal department- or agency-specific requirements, or institutional requirements (§5.6). Once a site's consent form is approved, the site may not change it without re-review (§6.7).

When is it inserted? During the initial review. The Relying Institution's Point of Contact (or the Relying Site Study Team, per your Communication Plan) provides the site-specific information to the Lead Study Team or the Reviewing IRB's POC, who incorporate it into the site version of the consent submitted for approval.

HIPAA authorization language is handled separately from consent customization — see How HIPAA works under Version 3.0.

Injury language must match the funding agreement — and that is the Relying Institution's job (§6.9). The Reviewing IRB is not party to the grant or contract, so the Relying Institution must ensure that what the approved consent says about coverage for research-related injury is consistent with its funding agreement. Two ways to do that: review both documents against each other, or negotiate a clause in the funding agreement providing that, where the two conflict, the IRB-approved protocol and consent control if they are more protective of subjects. The second approach shifts the consequence of any inconsistency to the sponsor.

See also - Local Considerations and Other Considerations - The Communication Plan - Amendments and personnel changes