The law provides that prior consent requirements for the administration of investigational new drugs (IND) to members of the armed forces may be waived by the president in two cases:
Requirement for Participation
If the administration of such drug is a requirement for participation in certain military operations.
Department of Defense
If the IND is sponsored by the Department of Defense.
Please note that only the president has this privilege of waiving the consent.
The president’s right to waive the consent is granted in the following three circumstances where the president provides a written declaration confirming the following:
- One, it is not feasible to obtain consent
- Two, obtaining consent is not in the best interests of the military personnel
- Three, obtaining consent may compromise national security
Determination to Waive Consent
The determination to waive consent on the basis of feasibility and it not being in the best interest of the military personnel must:
- First, be guided by the standards and criteria in the FDA’s regulation which speaks to the waiving of prior informed consent
- Second, be succeeded by a request from the Secretary of Defense requesting the receipt of that determination from the president
- Third, be preceded by certified documentation to the president that the required specific standards and criteria have been adhered to
These standards include what has already been discussed and what will be discussed at length in the next section of this course.