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Participants with Diminished Capacity to Consent

This section addresses adults whose ability to understand, appreciate, and weigh the risks and benefits of a study and knowingly give consent to participate is in question. Some may lack this ability from birth while others may inherit it with age. Assessing capacity to consent is not only vital for including these participants in a study but also for treating them with an appropriate level of care and respect.

The rules for including children in a research study are clear: anyone under the legal age for consent must have parental/ legally authorized representative consent. However, the dividing line for determining the capacity to consent for adults with a diminished mental capacity is not as easy to define. The level of risk presented in the study coupled by the capability of the person to understand the risks will vary with each study and study population.  For example, an adult with mild dementia may be capable of consenting to a minimal risk survey but may not be capable of consenting to a complex clinical trial. Researchers and the IRB-SBS must walk a careful line in order to protect participants but not to stigmatize them or diminish their capability for participating in a study. This section provides a general guideline for adults where capacity to consent is in question; if you need further assistance, contact our office so that we can better address your specific needs.

Please note that there is additional guidance for abused adults with diminished capacity to consent.  

Section Topics

Why Are Adults with Diminished Capacity Unable to Consent?
Who is a Legally Authorized Representative?
Can an Individual with Diminished Mental Capacity Participate in My Study?
Special Rules for Using Participants with Diminished Mental Capacity

Additional Topics

Abused Adults with Diminished Capacity to Consent

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