Assent of the subjects
Ordinarily, a mentally disabled person may not be the subject of research unless the person gives assent. The CPHS/IRB may waive the assent requirement if 1) the capability of some or all of the subjects is so limited that they cannot reasonably be consulted or 2) the intervention involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the subjects that is available only in the context of the research.
Permission from competent adults acting on behalf of the subjects
Ordinarily, a mentally disabled person may not be the subject of research unless permission is obtained from the person's guardian. For purposes of these rules a guardian cannot be associated in any way with the research or the investigator(s). If the mentally disabled person is a ward of the state or any other agency, institution or entity, a person associated with the entity cannot be a guardian for purposes of these rules.
The parent of a mentally disabled person below the age of 18 is presumed to be the person's guardian. If the mentally disabled person is older than 18, the parent is not automatically the guardian. If the subjects are mentally disabled adults who have not formally had legal guardians appointed for them, the researcher should propose a procedure for securing permission from a competent adult acting solely in the interests of the mentally disabled person. This procedure must be consistent with federal, state, and local law.
Information that must be provided in requests for assent and permission and documentation of informed consent
Mentally disabled participants and the competent adults acting on their behalf must be given the same information that is generally required when informed consent for participation in research is sought, and their permission and assent must be documented in writing. The assent form for the mentally disabled subjects should, of course, be written in language appropriate to their level of understanding.
In circumstances in which the CPHS/IRB may waive or alter the usual requirements for securing and documenting informed consent when the subjects are competent adults the CPHS/IRB may also waive or alter the requirements for seeking permission and assent when subjects are mentally disabled.
