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. Any objection precludes participation.
Additional safeguards protect the rights and welfare of potential test subjects.
First, the regulations require consultation with community representatives in areas where the clinical trial will be performed and from which participants may be drawn. Community involvement may include holding public meetings to discuss the protocol, creating a community panel, adding community representatives to the IRB and developing other means of involving the community in the decision making process. Second, prior to beginning the trial, public disclosure must be made to the affected communities describing the investigation and the potential risks and benefits. Third, after the completion of the trial, the IRB must inform the community and other researchers of the results. Fourth, an independent data monitoring committee must oversee the clinical investigation.