When is local language inserted into the consent documents?

When an institution agrees to rely on a Reviewing IRB for oversight of a study, it will provide that IRB with site-specific information that includes the institutional requirements and local issues. During the IRB review process, the Relying Institution will work with the Lead Study Team and/or the Reviewing Institution’s POC to provide information for the sections of the ICD that can be modified to be site specific. Site-specific language in the ICD is generally limited to:

• Compensation for injury
• Availability of treatment for injury
• Payment or reimbursement of research costs incurred by subjects
• Local study team contact(s) for questions about the study
• Local conflict of interest disclosure
• Language as required by local, state, or federal law or per federal agency policy/processes.

HIPAA authorization language is addressed separately from ICD language, and is described further in the “HIPAA Privacy Rule” section of the SMART IRB Standard Operating Procedures (“SMART IRB SOPs”).