Recommendations from the Subcommittee on the Inclusion of

Individuals With Impaired Decision-making in Research

(SIIIDR)

March 27, 2008

David H Strauss, M.D. and Laurie Flynn, SIIIDR Co-chairs

Overview/Roadmap

Recommendation I:Defines the term “consent capacity” and calls for its use in guidance materials.

Recommendation II: Calls for detailed guidance on the nature of consent capacity and its impairment.

Recommendation III: Details recommendations for guidance related to the identification of individuals who may have impaired consent capacity and for the assessment of capacity to consent.

Recommendation IV (in development):Draws upon and elaborates upon existing OHRP materials to provide consolidated guidance on the meaning of “legally authorized representative.”

Recommendation V (in development):Provides guidance on the roles and responsibilities of surrogate decision-makers involved in research decision-making.

Recommendation VI (in development):Guides research practice to maximize the involvement of individuals with impaired consent capacity in the research decision-making process “to the extent possible and consistent with their abilities and desires.”

Recommendation VII (in development):Will consider recommendations to HHS to explore federal mechanisms to promote or support the development of state legislation, model state legislation, or other approaches to necessary to address the current regulatory void at the local level.

• Recommendation VIII,IX,X etc. (planned):

Will provide guidance on approval criteria and acceptable risk in relation to research participation by individuals with impaired consent capacity.

Introductory Statement and Recommendations I,II,III

Introductory Statement

The Subcommittee on the Inclusion of Individuals with Impaired Decision-making in Research (SIIIDR) recommends that HHS support the development and dissemination of practical guidance for institutions, IRBs, and investigators involved in the conduct and oversight of research with adults who may be unable to provide legally effective informed consent because of impairment in “consent capacity.”

Recommendation I.

Guidance should adopt the term “consent capacity” (following the document developed by NIH[1]) to denote the specific abilities necessary for a prospective or current research participant to understand and use information relevant to consent. [1] NIH Points to Consider, Working Draft Document, January 16, 2008

Recommendation II.

Guidance should provide information for institutions, IRBs and investigators on the nature of consent capacity and its impairment as it relates to research participation.

Specifically:

IIa.

An individual’s consent capacity is not simply present or absent; capacity is best understood as occurring along a continuum.

IIb.

Impaired consent capacity occurs in a wide range of conditions and disease states.[1] To respect the rights and welfare of all research participants, guidance should encourage the development of policies that acknowledge the many manifestations of impaired consent capacity and not be limited to consideration of specific disorders.

[1]For example, impairment occurs commonly in patients in intensive care units, and in individuals with Alzheimer’s dementia, delirium, acute psychosis, acute intoxication, and traumatic brain injury.

IIc.

Consent capacity is task-specific and depends on the nature and complexity of the relevant decision-making process. Therefore, a judgment regarding an individual’s capacity to consent may not be the same for all research studies.

IId.

In many individuals, impairment in capacity to consent is not a static phenomenon. During the course of a research study, a research participant’s consent capacity may improve, fluctuate over time, or worsen with changes in the individual’s underlying condition. Guidance should encourage the development of policies on consent, the assessment of capacity, and the use of surrogate-based consent procedures to reflect this fact.[1]

[1] Final guidance may benefit from the use of case examples.

Recommendation III.

Guidance should address the implementation of appropriate safeguards related to the identification of individuals who may have impaired consent capacity. Such safeguards can be applied prior to participant enrollment, and as appropriate, throughout the course of research participation.

Specifically,

IIIa.

For all studies, investigators and research staff who obtain consent should consider each prospective participant’s capacity to consent to the research. In studies where the recruitment of individuals with impaired consent capacity is not anticipated, the judgment that prospective participants have the capacity to consent to the research can ordinarily be made informally during routine interactions with the participant during the consent process.

IIIb.

The method used to assess capacity, and when appropriate, the documentation of this assessment, should be tailored to the study population, the level of study risk and the likelihood of the involvement of participants with impaired consent capacity.

IIIb.(i)

When it is anticipated that the research will include individuals who have impaired consent capacity, researchers should assess prospective participants’ consent capacity and determine whether it is adequate to permit informed consent. This determination should be documented, as appropriate.

IIIb.(ii)

Formal methods such as questionnaires, structured instruments, or independent evaluators can be used to support or supplement an assessment of consent capacity by the researcher. [1]

[1] There are many structured and unstructured approaches to the assessment of consent capacity. Some may have advantages in particular circumstances or with particular populations. Some instruments have demonstrated reliability, validity and other psychometric properties in specific contexts. No scale, instrument, or other method for the assessment of capacity has emerged as the standard in the field, and no single approach is likely to be universally applicable.

IIIb.(iii)

The likelihood of impaired consent capacity and the manifestations of that impairment will vary depending on the proposed study population and the setting in which the research is conducted. The choice of the method used to assess capacity must be informed by these considerations.

IIIb.(iv)

The level of capacity required for consent will depend on the anticipated benefits of participation in the study, the degree to which the study protocol departs from ordinary practice or clinical care, and the likelihood and magnitude of foreseeable risks associated with participation. These factors should be carefully considered in policy and practice.

IIIb.(v)

Investigators and research staff responsible for the consent process and consent capacity determinations should be appropriately qualified and trained.

IIIc.

Specific enhancements to the consent form and process may serve to improve a prospective participant’s understanding and enable some individuals who otherwise lack consent capacity to make capable decisions.[1] Consent enhancements should be adapted to the needs of the specific study and study population.

[1] Guidance may benefit from examples.

IIId.

In selecting methods to ascertain consent capacity, it is important to note more intensive approaches may involve burdens for participants and researchers alike. Therefore, such methods should be reserved for situations in which impairment is more likely to be present, anticipated benefits are fewer, and foreseeable risks are greater.

IIIe.

When changes in participants’ consent capacity are anticipated or discovered during the course of a study, requirements for the re-disclosure of relevant information, re-consent, and re-assessment of consent capacity should be considered. The frequency of any necessary re-consent procedures should be appropriate to the circumstances.