Presented here are a set of guidelines to be used by the UCSD researchers and the Institutional Review Board for projects where the design of the study is expected to recruit from populations with disorders known to be associated with impairment of decision-making capacity. Also included here are examples of post-consent assessment instruments that can be used to help document decisional capacity.
These guidelines are the work of a Task Force for Recommending Procedures for Determination of Decisional Capacity in Subjects Participating in Research Protocols that included the following members: Dilip Jeste, M.D. (Chair), David Braff, M.D., Daniel Masys, M.D., Barton Palmer, Ph.D., Martin Paulus, M.D., Lucille Pearson, Larry Schneiderman, M.D. This Task Force was convened by Lew Judd, M.D., Chairman of UCSD's Department of Psychiatry at the request of the UCSD Human Research Protections Program. Before these guidelines are implemented, we are seeking input and feedback from UCSD researchers. The text of these Guidelines can also be downloaded in Microsoft Word and PDF format for convenient printing.
It is universally agreed that persons signing valid research consent forms must have adequate decision-making capacity to do so. Yet the procedures for ensuring such capacity have not been formally specified or mandated. Provided here are flexible guidelines with options for the wide variety protocols that exceed minimal risk. The guidelines presented here apply not only to primary conditions of cognitive impairment, such as dementia or psychosis, but also to conditions in which patients might reasonably be expected to have cognitive impairments as a consequence of severe pain or anxiety or confusion, such as cancer or trauma or life-threatening illness. Excluded from consideration here are pediatric subjects as well as emergency research since there are separate sets of guidelines for these areas. We have, at this stage, limited the application of the procedures for evaluating decisional capacity to those studies that, by design, would be expected to recruit a "significant" number of decisionally impaired individuals. This is a test of a prototype approach to this issue, and until it has been shown to be practical and robust in the protection of human research participants, we would not mandate this approach for all human subjects research.
Below, we explain some basic underlying concepts and then briefly describe the flexible guidelines proposed.
Three essential components of informed consent are:
The phrase “decision-making capacity” refers to a potential participant's ability to make a meaningful decision about whether or not to participate. It is generally thought to include at least the following four elements:
"Decision-making capacity" should not be confused with the legal concept of "competence." Incompetence is a legal determination made by a court of law. While the court may consider information about a patient's decision-making capacity in making a competency determination, the terms are not synonymous. For example, someone who is judged legally incompetent to handle their financial affairs may retain sufficient decision-making capacity to make meaningful decisions about participating in a particular research protocol. As well, persons who have normal cognitive functioning may be put into circumstances where their decision-making capacity is temporarily impaired by severe pain or overwhelming anxiety or confusion.
Decision-making capacity is protocol- and situation-specific. Thus, a subject may have capacity to consent to a low-risk research protocol in usual circumstances, but not have the capacity to consent to a high-risk protocol or when he or she is confused or under duress.
- Any study involving more than "minimal risk" (as defined by federal guidelines on research involving human subjects) and;
- The protocol is specifically intended for participants at least a proportion of whom can be reasonably expected to have diminished decision-making capacity. Such diminished capacity may be due to significantly impaired cognitive abilities (as in cases of dementia or psychosis), or due to conditions whereby participants may feel desperate for an experimental treatment and/or hopeless about their future (as in patients with severe chronic pain, cancer, etc.) or selected emergency and trauma studies.
In such cases, either all the research participants may be assessed for decisional capacity, or there may be a 2-step process. The first step may involve a quick determination of the need for a detailed assessment — for example, the subject may be asked: "Can you tell me what this study is about?" An adequate answer to this question may eliminate the necessity for further evaluation of the decisional capacity.
Alternatively, a standardized cognitive test may be used for this purpose — an example is the Mini-Mental State Examination or MMSE (Folstein et al., 1975). Subjects with scores of 24 or higher on the MMSE may be exempted from having a further assessment of decisional capacity. (Acceptable scores may change in the future if additional data validates decisional capacity for lower MMSE scores.)
Repeat assessment of decisional capacity would be indicated when there is an Institutional Review Board (IRB)-mandated re-consent.
The assessment of decision-making will be protocol-specific. Thus, subjects' capacity to understand, appreciate, reason with, and express a choice about the specific protocol to which they are being enrolled must be determined. This can be done with at least one of the following methods:
Effective January 1, 2003 the State of California Health and Safety Code Section 24178 was amended to provide for surrogate consent. Researchers who wish to have the option of consent by legally authorized representatives of the potential research participant must specifically request this option in their research application to the IRB, and require a Self-Certification to be filled out by the person giving the surrogate consent, in addition to the signing of a standard consent form. See the UCSD Surrogate Consent Guidelines web page).
Stated simply, a researcher has two options in obtaining informed consent in the setting of questions about a potential participant's decisional capacity: either demonstrate by a documented assessment measure that the participant does have sufficient decisional capacity, and use a standard consent signed by them, complemented in the research record by the documented results of their assessment, or; demonstrate by a documented assessment measure that they do not have decisional capacity, inform participant of the researcher's intent to seek surrogate consent if possible, and then obtain signed consent from a person authorized by California law to serve as a surrogate, along with that person's self-certification as the decision-maker, archived in the research record.
Presented here in graphical format is a decision tree (flow diagram) of the options and sequence of actions for research protocols that would reasonably be expected to recruit persons with diminished or questionable decision-making capacity.
Whenever there is a question about the need for assessing decisional capacity or about the procedures to be employed, investigators are urged to contact the UCSD Human Research Protections Program office by phone [858-246-HRPP (858-246-4777) ] or send an e-mail to firstname.lastname@example.org. Even without investigator-initiated queries, the Institutional Review Board may require, based on its analysis of risks and benefits of a research plan, that a decisional capacity assessment be performed as a component of the research.