Share

Plan For Obtaining Surrogate Consent

Plan for obtaining Surrogate Consent (Include something like this in Section 5 of the Protocol Narrative)

Whenever possible, investigators will attempt to obtain informed consent directly from the subject. If the potential research subject is obtunded, unconscious or otherwise obviously lacking in decision-making capacity, the investigator shall document that observation in the research record and in the subject’s medical record and will proceed with the steps required by state law for Identifying Persons to Provide Surrogate Consent.

If the potential research subject has questionable capacity to consent but is not unresponsive, the investigator shall: consistent with the standard consent process, describe the research to the subject and perform and document an assessment of the participant’s decisional-capacity relevant to the information provided about the research. If lack of decisional capacity is evident, the investigator shall inform the potential research subject of the investigator’s intent to obtain surrogate consent. If the subject expresses resistance or dissent to participation or to the use of surrogate consent by word or gesture, the subject shall be excluded from the research study. If no resistance or dissent is expressed by the potential research subject, the investigator shall document this fact, and will document that the description of the research project was communicated to the subject by placing a note in the medical record and in the research record. The investigator will then proceed with the steps required by state law for Identifying Persons to Provide Surrogate Consent.

suggestions and comments