Decision-Making Capacity and Consent
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1 Decision-Making Capacity and Consent Achieving Excellence in DoD HRPP: Taking an Active Role 27 June 2008 Marianne M. Elliott, MS, CIP Department of the Navy Human Research Protection Program Alion Science and Technology
2 The opinions reflected in this presentation are those of the author and do not reflect the official policy of the Department of the Navy, the Department of Defense, the United States Government, or Alion Science and Technology.
3 Learner Objectives 1. Describe four factors that affect or alter individual s decision-making capacity 2. List three types of subjects whose decision-making capacity may be affected or altered, and methods to address this 3. Describe two strategies for assessing potential research subjects decisionmaking capacity
4 Ethical Framework Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979
5 The Belmont Report Ethical Principle Related to Informed Consent Process and Decision-Making Capacity Respect for Persons Treat individual with autonomy Protect individuals with diminished autonomy possible over protection? Informed consent process to degree possible, give opportunity to choose what happens or not to them
6 Regulatory Framework.legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. 32 CFR
7 Elements of informed consent Information Informed consent and decision making Comprehension Voluntariness - Choice The Belmont Report 1979
8 Elements of informed consent and factors in decision making Informed consent and decision making Information Factors Who presents What is presented When presented Where presented How presented
9 Elements of informed consent and factors in decision making Informed consent and decision making Comprehension Factors Reading, seeing, or hearing ability Language level & appropriateness Maturity Cognitive ability
10 Elements of informed consent and factors in decision making Informed consent and decision making Voluntariness - Choice Factors Who is involved When decision made Social-cultural context
11 What is Decision-Making Capacity? Is an individual s ability to make a decision about whether to participate in research Is not competence of an individual in the legal sense as determined by court
12 Decision-Making Capacity Situational Factors affecting decision making capacity Organizational structure & relationships Social & cultural context Potential Decisional impairments
13 Decision Making Factors affecting decision making Situational Pregnant women* Pre-surgery or procedure Emergency medical situation Abusive or violent situations Prisoners* * DoDD implements the additional requirements of 45 CFR 46 Subparts B and C
14 Decision Making Factors affecting decision making Organizational structure & Relationships Student-teacher Employee-employer Military chain of command* Mentor-mentee * DoDD describes additional requirements
15 Decision Making Factors affecting decision making Social & cultural context Children Parent-child relationship Family structure Native American tribes International populations * DoDD implements the additional requirements of 45 CFR 46 Subpart D
16 Decision Making Factors affecting decision making Potential Decision-making Impairments Durable Down syndrome Progressive diseases or disorders Mental illness or disorders Neurological disorders PTSD, TBI
17 Other factors to consider State Laws Legally Authorized Representative (LAR) Not defined in 32 CFR 219 Many states have not defined LAR (rare exceptions) Legal Age of Majority Generally 18 years of age: also 19 & 21
18 What would you decide? Teens Having a Blast You are invited to participate in a study to find out if an active denial system is safe to use in dispersing a crowd of people. You will be asked to stand with about 30 people in a fenced outdoor area where the researcher will randomly shoot sponge-like bullets into the crowd. The risks to you include cuts or bruises from contact with your skin, possible injury to your eyes if you do not wear the eye protectors; possible injury to your head resulting in headache, dizziness, and rarely loss of consciousness.
19 What would you decide? Butter or Bullets? You are invited to participate in a study to find out if an active denial system is safe to use in dispersing a crowd of people. You will be asked to stand with about 30 people in a fenced outdoor area where the researcher will randomly shoot spongelike bullets into the crowd. The risks to you include cuts or bruises from contact with your skin, possible injury to your eyes if you do not wear the eye protectors; possible injury to your head resulting in headache, dizziness, and rarely loss of consciousness.
20 What would you decide? Senior Shots You are invited to participate in a study to find out if an active denial system is safe to use in dispersing a crowd of people. You will be asked to stand with about 30 people in a fenced outdoor area where the researcher will randomly shoot spongelike bullets into the crowd. The risks to you include cuts or bruises from contact with your skin, possible injury to your eyes if you do not wear the eye protectors; possible injury to your head resulting in headache, dizziness, and rarely loss of consciousness.
21 What would you decide? Baby on Board You are invited to participate in a study to find out if an active denial system is safe to use in dispersing a crowd of people. You will be asked to stand with about 30 people in a fenced outdoor area where the researcher will randomly shoot spongelike bullets into the crowd. The risks to you include cuts or bruises from contact with your skin, possible injury to your eyes if you do not wear the eye protectors; possible injury to your head resulting in headache, dizziness, and rarely loss of consciousness.
22 Assessing Decision-Making Capacity
23 Early thoughts. On occasion, it may be suitable to give some oral or written tests of comprehension. The Belmont Report 1979
24 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
25 Affirming no dissent Least comprehensive approach Usually a leading yes-no question Do you have any questions? Presumes understanding
26 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
27 2 step consent Adds time for potential subject: to consider information talk with family, friends, others Sets stage for conversation between potential subject and researcher
28 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
29 Post-consent written test Be sure test questions actually tests understanding and not reading skills Can be intimidating especially if no conversation included Criteria for passing or failing Over coaching
30 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
31 Standardized cognitive tests Mini Mental State Examination (MMSE), BECK Depression scales, etc. Tests for specific populations or individuals, or purposes Supplement screening or assessment
32 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
33 Other methods Researcher-initiated alternatives Novel approaches
34 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
35 MacArthur Competence Assessment Tool (MacCAT-CR) Standardized and validated Can be tailored to research protocol Takes about minutes to administer Requires trained personnel Good general choice (Appelbaum and Grisso, 1995 & 2001)
36 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests
37 UCSD Brief Assessment of Capacity to Consent (UBACC) 10 item scale About 5 minutes to administer Easy to use and score Identify subjects who may have questionable decision-making capacity Can be tailored to research protocol
38 UCSD Brief Assessment of Capacity to Consent (UBACC) The 10 questions assess: understanding of protocol procedures What is the purpose of the research Describe some of the risks or discomforts..
39 UCSD Brief Assessment of Capacity to Consent (UBACC) The 10 questions assess: appreciation of significance of the risks Do you have to be in this study if you do not want to? Is it possible that being in this study will not have any benefit to you? Who will pay for medical care if you are injured.?
40 UCSD Brief Assessment of Capacity to Consent (UBACC) The 10 questions assess: reasoning What makes you want to consider participating.?
41 Assessing Decision-Making Capacity Independent assessment Affirming no dissent 2 step consent UCSD Brief Assessment of Capacity to Consent (UBACC) Methods oral & written Post-consent written test MacArthur Competence Assessment Tool (MacCAT-CR) Other methods Standardized cognitive tests)
42 Independent assessment Some one outside the research team Research personnel Clinical personnel IRB Chair or member Research Subject Advocate
43 Focus on: the process, not the document understanding, not the signature
44 Think outside the box.. to enhance decision-making capacity Adult Assent (AA) A picture is worth a 1,000 words Do the Timeline (children become adults) Informed Consent Check up Guardian Angels
45 Closing thought.
46 April 2001 Ellen Roche - 24 year old technician/healthy volunteer working at a JHU research center - volunteers for research project to study induced airway relaxation by inhalation of hexamethonium, a ganglionic blocker One day after inhalation, Ellen develops cough an then respiratory distress. She is the third subject to do so. 46
47 Ellen died June 2,
48 Would the following have changed Ellen s decision to volunteer.? Information, Understanding, and Choice Hexamethonium is a chemical, not a medication and not FDA-approved Known toxic effects on humans not found on google search (literature review) Problems with prior subjects not reported or disclosed to new subjects Possible undue influence 48
49 For more information Jeste, et al., Arch Gen Psychiatry. 2007:64(8): UCSD Procedures for Determination of Decisional Capacity in Persons Participating in Research Protocols January 7, 2003 Secretary Advisory Committee on Human Research Protections Subcommittee of Inclusion of Individual with Impaired Decision-making in Research (SIIIDR) Report - October 29, 2007
50 In appreciation..to volunteer human research subjects who give of themselves. to IRB members who work diligently without recognition other than self-satisfaction to researchers who respect and protect subjects who volunteer for research... to my colleagues for sharing their knowledge, insight, and friendship: Paul Braunschweiger, Gary Chadwick, Jeff Cohen, Ed Gabriele, Dale Hammerschmidt, Karen Hansen, Mark Hochhauser, Dan Nelson, Susan Rose, and many others.
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