Cognitively Impaired| Human Subject Research Office | University of Miami

Guidelines for Research Involving Cognitively Impaired Individuals 


Individuals with Impaired-Decision Making Capacity

A cognitively impaired person is defined as having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia), or a developmental (e.g. mentally disabled) disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.

In addition, persons under the influence of or dependent on drugs or alcohol, persons suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.  

Cognitively impaired individuals could be vulnerable to coercion and may lack the capacity to provide consent. Capacity is defined as the “ability of an individual to understand the choices presented, to appreciate the implications of choosing one alternative or another, and to make and communicate a decision.”

There must be specific evidence of individuals’ incapacity to understand and to make a choice before they are deemed unable to consent. If cognitive impairment cannot be determined, then mental status testing should be included in the research design. The investigator must develop a plan to determine whether or not the prospective adult subject has the capacity to consent and if they do not, there must be a method to determine whether there is a designated LAR who can consent on the adult's behalf.

If it is determined that consent cannot be obtained from the subject, Proxy Consent must be obtained and a plan for Assent must be considered.

Proxy Consent
When a subject cannot consent (cognitively impaired adults), Florida recognizes that a proxy (a substitute, competent decision maker in the event the patient is incompetent or incapacitated) may consent (where the patient has not executed an advance directive, or designated a Surrogate to make heath care decisions) to experimental treatment, provided, the experimental treatment has been approved by an IRB, and the proxy reasonably believes that the patient would have made the decision under the circumstances. SOP:Legally Authorized Representatives, Children, and Guardians (SOP-013).

Whenever possible the Investigators will obtain the assent of adults who are not capable of consenting for themselves. When assent is obtained, it will be documented in the consent form. To have the capacity to assent, the subject must be able to understand the general purpose of the research and the nature of the procedures and must be able to understand the concept of voluntariness. If the capability of some of the participants is limited so that they cannot reasonably be consulted, assent will not be obtained; the investigators will document it on the consent form.

Reviewing Research Protocols

The IRB will consider the following in reviewing research with cognitively impaired individuals (CHECKLIST: Cognitively Impaired Adults (HRP-417)

The research involving cognitively impaired adults has anticipated direct benefit to the subject:

  • Subjects have a disease or condition for which the procedures involved in the research hold out a prospect of direct benefit to the individual subject that is unavailable outside the research context. OR
  • The objectives of the trial cannot be met by means of study of subjects who can give consent personally.

The research involving cognitively impaired adults will have NO anticipated direct benefit to the subject.

  • Subjects have a disease or condition for which the procedures involved in the research are intended.
  • The objectives of the trial cannot be met by means of study of subjects who can give consent personally.



  • What is the scientific and/or scholarly justification of the inclusion of this population?

  • What are the additional safeguards included to protect the rights and welfare of subjects?

  • Who will determine if the subject is able to provide informed consent? This should be a researcher or consultant familiar with cognitive impairment and qualified to assess and monitor capacity and consent in such subjects on an ongoing basis

  • How will capacity to provide consent be determined?

  • Are subjects likely to regain capacity during the study, and if so, what will be the process to obtain consent?

  • If subjects may lose decision-making ability during the study, describe the process to identify the Legally Authorized Representative (LAR), when this will be done, how the LAR will be notified, and how the LAR will be involved in the study. Also describe how decision-making ability will be monitored over the course of the study.

  • For studies that are only minimal risk, do the consent forms have appropriate signature lines for the Legally Authorized Representative (LAR)?

  • For studies that are greater than minimal risk, are proxy consent forms uploaded?