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

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”).