Risk/Benefit Are the risks to subjects in this research no more than minimal? Yes No Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Indicate if the research includes any of the following (check all that apply): Interactions with subjects Interventions or procedures (for the research) Manipulations of the subjects’ environment Observation of subjects Deception Review of private information or records Review of mental health records Review of psychotherapy notes or records If the research involves greater than minimal risk to subjects, does the research offer the prospect of direct benefits to the individual subjects? Yes No NA If yes, describe: Consent Is a waiver of consent being sought for some or all subjects? Yes. Complete Supplement E to request a waiver of consent. No. Answer the following: Describe the procedures to be used to determine the individual subject’s capacity to provide consent (e.g., assessment by Principal Investigator, evaluation by independent practitioner, use of University of California San Diego Brief Assessment of Capacity to Consent (UBACC), use of MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), etc.): NOTE: Unless obvious (e.g. person is unconscious), the decision-making capacity of individual subjects should not be assumed because of a condition or diagnosis. When at risk for impaired decision making capacity or when capacity is in question, the capacity of individual subjects to provide consent for research should be determined through the use of a standardized measure or evaluation by a qualified professional. When it has been determined that a subject lacks the capacity to provide consent: Describe who may provide surrogate consent and how their qualification to do so will be determined (i.e., who may serve as Legally Authorized Representative
Risk/Benefit Are the risks to subjects in this research no more than minimal? Yes No Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Indicate if the research includes any of the following (check all that apply): Interactions with subjects Interventions or procedures (for the research) Manipulations of the subjects’ environment Observation of subjects Deception Review of private information or records Review of mental health records Review of psychotherapy notes or records If the research involves greater than minimal risk to subjects, does the research offer the prospect of direct benefits to the individual subjects? Yes No NA If yes, describe: Consent Is a waiver of consent being sought for some or all subjects? Yes. Complete Supplement E to request a waiver of consent. No. Answer the following: Describe the procedures to be used to determine the individual subject’s capacity to provide consent (e.g., assessment by Principal Investigator, evaluation by independent practitioner, use of University of California San Diego Brief Assessment of Capacity to Consent (UBACC), use of MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), etc.): NOTE: Unless obvious (e.g. person is unconscious), the decision-making capacity of individual subjects should not be assumed because of a condition or diagnosis. When at risk for impaired decision making capacity or when capacity is in question, the capacity of individual subjects to provide consent for research should be determined through the use of a standardized measure or evaluation by a qualified professional. When it has been determined that a subject lacks the capacity to provide consent: Describe who may provide surrogate consent and how their qualification to do so will be determined (i.e., who may serve as Legally Authorized Representative
Research%20Involving%20Subjects%20with%20Impaired%20Decision%20Making%20D.docx