Adoption Date: December 7, 2000
Policy: All IRBs will require new applications and consent documents for ongoing studies at regular five-year intervals. The new protocol file will incorporate all intervening changes made during any five-year period. This policy will go into effect on 1 March, 2000.
Rationale: The new protocol submission will incorporate all intervening changes to the research made during the preceding five years. This policy provides the investigator with the opportunity to comply with all changes that have been made in the protocol application form and in the human research protection policies and guidelines since the original submission and makes it easier for IRB reviewers to track protocol changes over time for long-term projects. This policy will be incorporated into each IRB’s policy documents, protocol application forms, guidelines, and reminder letters.