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Assessing the Consent Capacity of Adults with Mental Retardation: 

Assessing the Consent Capacity of Adults with Mental Retardation Celia B. Fisher, Ph.D. Principal Investigator Christine Cea, Ph.D. Project Coordinator Fordham University Advisory Board Meeting Wednesday June 5, 2002

The Informed Consent Challenge: 

The Informed Consent Challenge Involving persons with MR in research raises complex ethical questions regarding their capacity to give informed, rational, and voluntary consent Scientists must balance: Respect for an individual’s right to make autonomous decisions Protection from inadequate understanding or poorly reasoned decisions that might lead to participant harm or exploitation

Elements of Informed Consent for Interview & RCT Research: 

Elements of Informed Consent for Interview andamp; RCT Research Research Design Purpose of Research Generalized Knowledge Nature of Procedures Participant, Investigators Experimental Nature of Treatment Nature of Placebos or other Controls Random Assignment Human Subjects Protections Research Risks Research Benefits Extent andamp; Limits of Confidentiality Voluntary Nature of Participation Compensation

Psycho-Legal Levels of Consent(Appelbaum & Grisso, 1995): 

Psycho-Legal Levels of Consent (Appelbaum andamp; Grisso, 1995) Requires the ability to: Understand disclosed information about the nature of the research project and its procedures Appreciate the effects of agreeing or refusing to participate on one’s own situation Make a reasoned decision based upon a comparison of alternatives in light of their consequences Communicate a choice to consent or dissent to participation

Applicability of Psycho-Legal Framework : 

Applicability of Psycho-Legal Framework Appelbaum and Grisso’s model was Developed to assess consent for treatment and treatment research. Tested on adults with normal intelligence suffering from psychopathology (e.g., depression, schizophrenia) or early and later stages of Alzheimer's. Uses a clinical interview format Questions: Are distinctions between understanding and appreciation and comparative reasoning relevant to non-clinical research? Are the psycho-legal levels relevant and/or fair for adults with MR?

Goals of Phase I: 

Goals of Phase I Primary Goal [ACC-RCT]: Assess the ability of adults with mild and moderate MR to comprehend and respond to consent relevant aspects of a hypothetical treatment study. Secondary Goal [ACC-IR]: Assess the ability of adults with mild and moderate MR to consent to non-treatment interview research.

PARTICIPANTS: ADULTS WITH MR: 

PARTICIPANTS: ADULTS WITH MR 50 adults with mild and 50 with moderate MR Male and female; ethnically diverse; Mean age = 42 (SD 11) Etiology: Genetic chromosomal (13%); other prenatal (7%); postnatal (9%); Unknown (71%) K-Bit IQ Mild = 60.3 SD 12.7; Moderate = 48 SD = 10.5 The majority scored in the low range of adaptive functioning on 2 or more Vineland Domain scores. Living arrangements: Individualized residential alternative (62%); or community residences (15%); intermediate care (9%); supported living (4%) NYC: [YAI/NIPD; AHRC/NYC; Lifespire] and Rochester (ARC) Competitively employed, working in a sheltered workshop, or attending a day treatment or habilitation program.

Psychological Characteristics of Adults with MR: 

Psychological Characteristics of Adults with MR

Adults without MR: 

Adults without MR 50 Fordham College students Male and female; ethnically diverse (majority non-Hispanic white) Age 19.5 (SD 1.1) K-Bit IQ = 106 (SD 7.4) 46% had a family member or experience with someone with MR 66% had participated in a research study

Procedure: 

Procedure Obtained consent from guardians in compliance with residence policy Explain reason for andamp; request permission to tape Consumers accompanied by residence staff Disclose consent information and assess capacity to consent to the study [ACC-IR] Consumers (n = 9) who dissented or gave an 'I don’t know response' were thanked and excused Present hypothetical vignette and assess consent comprehension [ACC-RCT] Administer K-BIT Site staff filled out Demographic questionnaire andamp; Vineland

The Assessment of Consent Capacity- Interview Research (ACC-IR): 

The Assessment of Consent Capacity- Interview Research (ACC-IR) The ACC-IR presents information through 12 disclosures that describe and ask questions to tap understanding of: The purpose of the research Research procedures (what the participant, the investigator, and others will do) The nature of confidentiality Compensation for participation The right to refuse participation and withdraw at any time without penalty Research benefits and risks Following a summary of this information, participants are asked to make a participation choice and to provide a reason for their choice. Inter-rater reliability Kappa = .68 - .97

Understanding the Purpose and Nature of Interview Research: 

Understanding the Purpose and Nature of Interview Research

Do Consumers Understand the Purpose and Nature of Interview Research?: 

Do Consumers Understand the Purpose and Nature of Interview Research? Most adults with mild and moderate MR found it very difficult to understand the purpose of research designed to produce generalizable knowledge. Most adults with mild and half with moderate MR understood procedures involving their own actions (name andamp; match pictures, spell) Consumers had greater difficulty responding to procedures describing the actions of the investigator (reading a story, asking the participant or others questions).

Human Subjects Protections: 

Human Subjects Protections

Conclusions: Understanding Participant Rights in Interview Research: 

Conclusions: Understanding Participant Rights in Interview Research The majority of adults with mild MR and on average 50% of adults with moderate MR understood: Nature of confidentiality Compensation for participation Research benefits * Research risks The right to refuse andamp; withdraw from participation * Consumers, especially those with moderate MR had greatest difficulty understanding the indirect benefits of interview research

Participation Decisions: 

Participation Decisions All adults with MR were able to communicate a yes/no decision regarding participation. The majority with mild and half with moderate MR were able to give a logical reason for agreeing to participate.

Reasons For & Against IR Participation: 

Reasons For andamp; Against IR Participation Legitimate reasons to participate expressed by adults with and without MR included: Getting the McDonald’s certificate/$15 Helping the researcher or others Learning something or participating in something interesting 'Nothing else to do.' Only 1 adult without MR gave a comparative reason for participation 2 mild and 5 moderate MR adults responded 'No' to participation. Reasons for the refusal included: The task would be too difficult, too unfamiliar, or too boring, or 'I don’t know.'

Summary of IR Consent Capacity: 

Summary of IR Consent Capacity Consumers find it difficult to understand The purpose of research designed to produce generalizable knowledge Research Procedures involving investigator behaviors The majority of adults with mild and half with moderate were able to: Understand research procedures involving their own behaviors, Understand human subjects protections Generate a logical reason for their participation decision All consumers were able to communicate a choice

The Assessment of Consent Capacity- Randomized Clinical Trials (ACC-RCT): 

The Assessment of Consent Capacity- Randomized Clinical Trials (ACC-RCT) The ACC-RCT presents information through 19 disclosures that describe and ask questions about consent relevant understanding of a hypothetical study using a placebo control to test a medication to control aggressive behavior Participants are then asked to generate reasons why the participant should or should not participate, make a participation choice, and provide a reason for their choice. Inter-rater reliability Kappa = .68 - .94

ACC-RCT ITEMS: 

ACC-RCT ITEMS Disclosures and questions address: The psychosocial history of the hypothetical participant The purpose of the research (to test the medicine) The purpose of the placebo condition andamp; random assignment Nature of treatment (taking pills twice a day) andamp; assessment Potential benefits to the participant and science/society Research risks (side effects), placebo risks (no potential benefits) The nature of confidentiality The right to refuse participation and withdraw at any time without penalty Inter-rater reliability Kappa = .68 - .94

ACC-RCT Understanding Psychosocial History: 

ACC-RCT Understanding Psychosocial History **A3 'The Behavior Plan is not working, so Tom’s doctor gave him medicine to help him control his behavior.' (Partial responding indicated comprehension of underlined)

Conclusion: Understanding Psychosocial Background: 

Conclusion: Understanding Psychosocial Background The majority of mild and half of the moderate MR consumers had sufficient understanding of the psychosocial/behavioral history of the hypothetical research participant.

Understanding the Purpose & Nature of RCT Research: 

Understanding the Purpose andamp; Nature of RCT Research

Do Consumers Understand the Purpose & Nature of RCT Research?: 

Do Consumers Understand the Purpose andamp; Nature of RCT Research? The majority of consumers understood the nature of treatment (2 pills, twice a day) Most adults with mild and half with moderate MR understood the assessment procedures (asking the consumer and others about his/her behavior) and appreciated the personal consequences of randomization (will not know if s/he receives paygo or placebo) At least 50% of mild and the majority of moderate MR adults found it difficult to comprehend the purpose of the placebo (to test the effect of paygo) and the purpose of RCT research (to produce generalizable knowledge). Many participants with and without MR gave responses indicating the 'therapeutic misconception' that the purpose of the study was to help Tom/Susan, although when prompted 100% of non-MR adults also indicated that the purpose was to produce generalized knowledge.

Understanding Human Subjects Protections in RCT Research: 

Understanding Human Subjects Protections in RCT Research

Do Consumers Understand Human Subjects Protections for RCT Research?: 

A majority of consumers understood: Treatment risks and benefits The right to refuse or withdraw from participation Most adults with mild and 30- 50% with moderate MR understood: Placebo Risks Nature of Confidentiality Consumers found it most difficult (50% mild; 66% moderate) to understand: Scientific/Societal Benefits of Research   Do Consumers Understand Human Subjects Protections for RCT Research?

Reasons For & Against Participation: 

Reasons For andamp; Against Participation Only 12% Mild , 18% Moderate, and 6% non-MR adults decided that Tom/Susan should not participate in the RCT.

Major Reasons For & Against Participation: 

Major Reasons For andamp; Against Participation Participation may help: Tom/Susan get better, improve behavior, or keep job People with DD/Bob with his work Adults without MR gave equal emphasis to helping T/S and other people;Adults with MR focused on benefits to T/S Participation may risk: Physical side effects Getting the fake medicine Ineffective or unwanted treatment All adults emphasized physical side effects

Conclusions:Reasons For & Against RCT Participation: 

Conclusions: Reasons For andamp; Against RCT Participation The majority of consumers can communicate a participation choice. The majority of adults with Mild MR and one third of those with Moderate MR can give a logical reason for agreeing to participate in an RCT study. It is more difficult for adults with mild (54%) and moderate (26%) MR to generate reasons not to participate in a treatment study.

Weighing Research Risks & Benefits: 

Weighing Research Risks andamp; Benefits Inability to generate reasons against participation suggests that adults with MR may not weigh risks against benefits when consenting to treatment research. However, no consumer and only 6 non-MR adults spontaneously generated comparative risk-benefit reasoning. And most adults with and without MR agreed to study participation. Inattention to research risks may not in itself make adults with MR more consent vulnerable in RCT research.

Summary of RCT Consent Capacity: 

Summary of RCT Consent Capacity Consumers find it difficult to Understand the purpose of RCT research. Many have a 'therapeutic misconception.' Understand the purpose of assignment to placebo groups Generate reasons against participation Weigh research risks against benefits Consumers were able to: Understand treatment benefits andamp; risks and voluntary nature of participation Communicate a participation choice Generate reasons for participation Most consumers with mild and 30-50% with moderate MR understood: Placebo risks Confidentiality

Does Repetition of Consent Information Improve Comprehension Responses?: 

Does Repetition of Consent Information Improve Comprehension Responses? For each item, consent information and the question were repeated at least once for participants who responded with a no-credit answer on the first query. The information and question were repeated a second time if the participant continued to give a no-credit response.

Average Improvement with Repetition : 

Average Improvement with Repetition Choice Items: IR: Only 3 participants with moderate MR required prompts: All received full credit. RCT: No adult without and 20% and 18% of adults with mild and moderate Required a prompt. Only 6% of moderates continued to receive no credit.

Conclusion: Repetition: 

Conclusion: Repetition Repetition facilitates consent comprehension responding for a significant proportion of adults with MR and should be incorporated into consent procedures.   Continued poor comprehension despite repetition for many adults with MR suggests that short term memory deficits are not exclusively responsible for vulnerabilities in consent capacity.

Goals for Enhancing Consent Comprehension : 

Goals for Enhancing Consent Comprehension Increase Understanding of Human subjects procedures, especially for adults with moderate MR The purpose of research as production of generalizable knowledge (reduce therapeutic misconception) The purpose of placebo Increase attention to: Procedures involving the behavior of others Weighing of risks and benefits for participation decisions

Implications for Enhancing Consent Comprehension & Assessment: 

Implications for Enhancing Consent Comprehension andamp; Assessment GOALS Increase understanding of the purpose of Research as production of generalizable knowledge Random assignment to treatment and placebo groups Increase attention to Procedures involving the behavior of others Weighing research risks and benefits in consent decisions Techniques Repetition (and perhaps reason for repetition) Focus attention on the behaviors of others and others as receiving help from generalized knowledge (pictures, actions) Obtain more sensitive measures of memory (recall v. recognition) Facilitate non-verbal responding

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