Default vs. flexible implementation

Applies to: Agreement V3.0

The Agreement's text cannot be changed, but a number of its provisions can be implemented differently by mutual agreement of the institutions in a given arrangement. Version 3.0 keeps this flexibility from earlier versions and gives it a vocabulary and a set of forms.

Default implementation means the standard terms of the Agreement and the SMART IRB SOPs apply with no adjustments. Nothing further needs to be documented, although institutions sometimes record default terms that are easy to overlook — whether HIPAA applies, for example.

Flexible implementation means the institutions have agreed to exercise one or more of the Agreement's flexible options. Common examples:

• waiving the insurance requirement for a study,
• having the Reviewing IRB make HIPAA waiver/alteration determinations or use its own authorization language on the Relying Institution's behalf,
• using a different set of SOPs,
• assigning who drafts external reports,
• fee arrangements, and
• excluding a study from the Indemnification Addendum.

How to document it. Before Version 3.0, institutions often wrote their own "flexible terms addendum." Now use either the Implementation Checklist, completed jointly by the two Points of Contact, or the Flexible Implementation version of the Letter of Acknowledgment. Both list the available options and let you strike what does not apply. Institutions using IREx record the same choices in the Study-Specific Reliance Plan.

See also

• The Implementation Checklist
• The Letter of Acknowledgment (three versions)
• How HIPAA works under Version 3.0