Brigette White - Comment

I understand the rationale to include this as an essential element of the informed consent due to the vast majority of trials this effects. However, given that some clinical trials don't meet the requirement for registration with clinicaltrials.gov, should the proposed required statement for the informed consent be revised to include an alternate statement to the effect that 'this trial is not required or will not be included in the databank'? It would be necessary for the informed consent document/process not to state an inclusion in the database if one will not occur. If this rule is approved as an essential element, is the requirement that existing consents are to be revised to include this information or will it only apply to new consents post approval?