Boilerplate Language Q & A

WHAT IS BOILERPLATE LANGUAGE?

It’s the institution’s standard template language that is inserted into a CIRB-approved model consent form. Boilerplate language is not the same thing as your institution’s template consent form.

Some examples of boilerplate language are:

• Local contact information.
• State and local laws pertaining to informed consent.  
• Institutional policy related to research on NCI-funded studies as allowed in the CIRB Quickguide.

WHAT SHOULD BE CONSIDERED BEFORE SUBMITTING BOILERPLATE LANGUAGE?

Include only the language used for the studies to be opened by investigators using the CIRB and limit the boilerplate language to the scope of research sponsored by NCI and that is part of the Networks. Additions to the model consent form must be documented in the boilerplate language and approved.

WHAT SHOULD NOT BE SUBMITTED AS BOILERPLATE LANGUAGE?

• Changes to the NCI Consent Form Template.
• Changes to the section titles.
• Language stating the sponsor will pay for an injury.
• Deletion of template language.
• Wordsmithing.
• Changes to the standard risk tables for study drugs.
• Additions that do not comply with the Guidelines for Permitted Boilerplate Language Additions.

HOW DO I INSERT BOILERPLATE LANGUAGE INTO A MODEL CONSENT FORM?

• All boilerplate language are additions.

• The only deletion permitted is to reproductive risk language for faith-based institutions. Faith-based institutions must indicate what boilerplate language replaces current language.

• If boilerplate language applies only in certain situations, provide this instruction. Examples include noting that language is used for pediatric studies only.

HOW DO I CHANGE MY BOILERPLATE LANGUAGE?

Use a revised Annual Signatory Institution Worksheet to submit your changes via IRBManager to the CIRB for review and approval. Document the changes from previously approved boilerplate language, using a Microsoft Word document with the track / highlight change feature. For more information, go to Completing the Annual Signatory Institution Worksheet.

Submit a revised Worksheet for approval every time information is updated.

WHAT SHOULD I DO WHEN A STUDY IS AMENDED?

When the Network distributes an amendment to a study, any changes to the consent form included as part of the amendment need to be made. Within 30 days of an amendment, the Signatory Institution must update any CIRB-approved boilerplate language not already implemented in the consent document for all studies open to enrollment. If the only change to the consent form as a result of the amendment is the Protocol Version Date, the Protocol Version Date must be updated in the institution’s consent form.

Changes already approved as part of the amendment and changes to the Protocol Version Date do not require further CIRB review.