The exception received wide support from research groups, medical associations and manufacturers. However, patients rights groups expressed concern that the FDA was acting under undue pressure from the research community. Others opposed this exception asserting that informed consent should never be waived under any circumstances. Given the need to protect patients' rights, the FDA imposed significant procedural safeguards to which hospitals must adhere to qualify for the waiver. IND approval is required whether or not the medication or device has been previously approved for other purposes.
Available treatments are unproven or unsatisfactory.
The collection of valid scientific evidence is necessary to determine the safety and effectiveness of an intervention. Obtaining informed consent is not feasible due to the patient's medical condition or time limitations and it is not possible to identify likely patients in advance. The patients are likely to be benefitted based on animal trials and based upon the risks and benefits of the standard treatment compared to the proposed treatment. Clinical investigators must be committed to obtaining patients' informed consent either from the patient or the patient's legally authorized representative. If this is not possible, the regulations require the investigator to attempt to contact the patient's family members, when feasible, to ask whether or not the family members object to the patient's participation in the study.