Informed Consent With People Who Have Dementia

Original Editor - Rania Nasr Top Contributors - Rania Nasr and Kim Jackson

Introduction

Informed consent consists of two sections: information paper and consent certificate. In order to give informed consent, a person must have the ability to fully understand the research objectives or treatment through the information provided, and have the power of free choice that allows to consent or decline voluntarily.

Getting informed consent from people with dementia depends on their mental capacity. Dementia symptoms like difficulties with concentration and understanding, problems in short term memory, makes their ability to give informed consent questionable. These symptoms become more of a problem as the disease progresses. It would be appropriate to involve relatives if a person with dementia does not have the capacity to consent. However, it is necessary to understand that having dementia does not mean undoubtedly a person lacks the capacity to consent. Therefore, it is important to conduct a mental capacity assessment for people with dementia[1].

The Mental Capacity Act

The enactment of the Mental Capacity Act (MCA) in 2010 provides a statutory framework for assessing decision-making capacity. During the evaluation of a patient who may lack mental capacity, one must apply the following five statutory principles of the MCA:

  1. A person must be assumed to have capacity unless it is established that he lacks capacity.
  2. A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been taken without success.
  3. A person is not to be treated as unable to make a decision merely because he makes an unwise decision.
  4. An act done, or a decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests.
  5. Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action[1].

Assessment of Mental Capacity

There are two evaluation stages[2]:

  1. Does the patient have dementia? MMSE can be used and testing letter and word fluency.
  2. Regarding a specific decision, is the patient able to understand the decision to be made? Give reasons for the decision made and communicate the decision?

Determining whether a person has the capacity to give informed consent

The components of informed consent:

  • The possession of competence: competence refers to the legal capacity to make decisions in a certain realm and may be legally defined or determined in court. This is usually but not always linked to cognitive capacity. For example, many people under the age of 18 may have the cognitive capacity to make medical decisions but are not considered legally competent to do so (DuBois, 2008).
  • Voluntariness: not having been forced to make a particular decision.
  • The provision of information: clear and truthful information, covering among other things details of any potential risks, benefits and alternatives to participants.
  • Enrollment: freely deciding to participate in the study on the understanding that the participant can withdraw at any time without having to justify his/her decision or suffering any negative repercussions.

The criteria for competence:

Part of the process of obtaining informed consent involves determining whether a person has the necessary competence. A person’s cognitive status or score on an assessment of mental status (such as the MMSE) cannot be taken as sufficient proof of their ability to give informed consent (Orwig et al., 2011). 

The assessment of competence involves paying attention to four main abilities:

  1. The person must have sufficient capacity to understand the information. If the study involves a considerable degree of risk, more information must be provided, particularly about possible risks and benefits, and the potential participant must be able to understand such information.
  2. The person must be able to retain, use and weigh up such information long enough to be able to make a decision. In addition, they must also be able to understand what the decision is about, why they are being asked to make it, and what the consequences of making or not making that decision might be.
  3. Possible benefits, risks and inconvenience linked to participating in research must be understood and weighed against the person’s own values and goals, which means that the person must understand how participating might affect him/her personally (High, 1992 and Stanley et al., 1984 in Olde Rikkert et al., 1997).
  4. The person must have the ability to communicate his/her decision.

Consent as a Process

It is advised to gain consent each time we interact with people with dementia for research or treatment purposes, rather than just once. This is to overcome the short-term memory problems and variable capacity. It is important to always make sure to obtain consent from people with dementia as described by Buchanan and Brock (1990), there are 2 main values governing the need to obtain informed consent as being 1) to promote and protect the person’s well-being, 2) to respect the person’s self-determination.

Resources

References

  1. 1.0 1.1 Nursingtimesnet. Nursingtimesnet. [Online]. Available from: https://www.nursingtimes.net/Journals/2013/07/17/l/w/u/170713-Involving-people-with-dementia-in-research.pdf [Accessed 4 June 2019].
  2. Hegde S, Ellajosyula R. Capacity issues and decision-making in dementia. Annals of Indian Academy of Neurology. 2016 Oct;19(Suppl 1):S34.