The CPHS/IRB has adopted special rules that apply when research subjects are mentally disabled. Most of the general requirements for approving research with human subjects apply, but some research involving more than minimal risk to the subjects is prohibited. Additional requirements pertain to informed consent.
For the purposes of IRB review, a mentally disabled individual is person who, because of mental illness, mental retardation, emotional disturbance, or senility, is incapable of giving informed consent. Of course, some persons who have these conditions are also able to give informed consent, but the CPHS/IRB cannot determine the capacity of persons with these conditions on the basis of labels alone. Therefore, whenever proposed research involves subjects who have been diagnosed with one of these conditions or who may have such a condition, the researcher should explicitly tell the CPHS/IRB whether the subjects are able to give informed consent because of the condition. If the subjects are able to give informed consent, the special rules in this section do not apply, and only the general requirements for research with human subjects must be satisfied.
