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You can insert a model consent form into the following consent templates, whether when the NIH is the reviewing IRB, or we are relying on an external IRBthe NCI CIRB.

The NCI CIRB has approved specific local context forms into which the model consent should be inserted:

For all other external IRBs or for a study where you receive a model consent and the NIH is the reviewing IRB, use the following local consent template when research will occur in the Clinical Center (CC):

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For a study where you receive a model consent and an external IRB is reviewing, add NIH required language to the model consent template provided. Do NOT insert the external IRB’s model consent into an existing NIH template.

Contact the NIH Reliance and sIRB team at nih-reliance-sirb@nih.gov if additional guidance is needed.

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What if the NIH is the Lead Site and/or Sponsor and needs to write a model consent form to distribute to participating sites?

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