Mail from the PI to the servicing IRB's Chair that explains the need for the amendment. Supporting documentation might include a request from the sponsor, a revised protocol or consent form, or a data summary from the current protocol. The servicing IRB's Chair can authorize minor amendments by an approval letter. Controversial or questionable amendments will be subjected to full review by the servicing IRB with referral to the FAA IRB if exempt or expedited criteria are not met. Reasons for the withdrawal or termination should be explained.
Federal regulations require that reports of subject injuries be maintained for at least three years.
It would also be advisable to archive the original signed consent forms for at least five years. If research is judged exempt, no further action is required. Otherwise, the COTR must ensure that appropriate language is inserted in the contract to require adherence to 49 CFR Part 11. This requires that the institution being contracted provide an Assurance document outlining its compliance plan. Documentation of human-use compliance by contract research including an IRB approval letter, Organizational Assurance, and protocol should also be forwarded to the FAA IRB Chairperson for archiving.