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Enhancing the Informed Consent Process for Research: The answer is we dont know Laura B. Dunn, M.D. Associate Professor Director of Psycho-Oncology Department.

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Presentation on theme: "Enhancing the Informed Consent Process for Research: The answer is we dont know Laura B. Dunn, M.D. Associate Professor Director of Psycho-Oncology Department."— Presentation transcript:

1 Enhancing the Informed Consent Process for Research: The answer is we dont know Laura B. Dunn, M.D. Associate Professor Director of Psycho-Oncology Department of Psychiatry University of California, San Francisco

2 Acknowledgments Barton Palmer, Ph.D. Paul Appelbaum, M.D. Paul Holtzheimer, M.D. Laura Roberts, M.D. Dilip Jeste, M.D. Research support (2001-present) NIMH Career Development Award (K23) NARSAD Young Investigator Award National Institute on Aging (R01), NIMH (various) Greenwall Foundation

3 Outline Problems with current informed consent practices and oversight Vulnerability in context of informed consent Enhancing informed consent –Evidence base –Sample approaches –Recommendations

4 Problems with Current Informed Consent Practices & Oversight Ongoing problems with readability, length, complexity IRB issues (see Emanuel et al. Ann Intern Med 2004) Rigid requirements discourage experimentation with methods to better enact process model Distracts from more serious ethical problems in clinical research

5 Problems with Current Informed Consent Practices …IRBs often spend much time scrutinizing informed consent documents and producing excessively long detailed forms, even for relatively simple, minimal-risk research. This focus on informed consent documents negates the widely accepted notion that informed consent is a process, does not always improve the informed consent process, and diverts limited IRB time from consideration of other serious ethical issues. Emanuel et al. Ann Intern Med 2004)

6 As consent forms become increasingly lengthy and complicated and come to include more and more information … the very existence of such consent forms may obstruct rather than improve the process of obtaining informed consent. - Roth et al., 1982 (Roth et al. Int J Law Psychiatry 1982;5:29-50)

7 Respect for Persons (Belmont Report) Two Components individuals should be treated as autonomous agents persons with diminished autonomy are entitled to protection

8 any subject or class of subjects who are either unable to provide informed consent or who are at substantial risk of being unable to provide informed consent for a particular study (Rosenstein & Miller, Psychopharmacology 2003) Evidence that some proportion of the population has difficulties with decision- making capacity Cognitive impairment, poor insight, instability (medical, psychiatric, cognitive) Who is vulnerable?

9 Methods of assessing decision-making capacity Clinical interview Cognitive/Neuropsychological tests (e.g., MMSE) Decisional capacity scales or structured interviews: –Questionnaires –Scales or structured interviews

10 Decisional capacity scales 23 published in the literature (1980 to 2004) (Dunn et al. Am J Psychiatry 2006) –10 assessing research consent capacity –15 treatment-related capacity –(2 both) –Comprehensive assessment of all four dimensions was rare among the instruments for research UCSD Brief Assessment of Consent Capacity (UBACC) (Jeste et al. Arch Gen Psychiatry, 2007) –10 items assessing understanding and appreciation

11 MacCAT-CR Semi-structured interview – adapt to specific protocol – takes minutes Four subscales: –Understanding: 13 items –Appreciation: 3 items –Reasoning: 4 items –Expression of a Choice: 1 item Psychometrics: Reliability – ICCs Samples have included: SCZ, MDD, AD, Ca, HIV, DM, controls Requires reliability training; manual available MacArthur Competence Assessment Tool for Clinical Research (Appelbaum & Grisso, 2001)

12 Methods for enhancing informed consent Consent forms Briefer Structured, reviews, advance organizers Educational sessions Provision of multiple learning trials Multi-modal/multi-media disclosure Computer aided disclosure Hands on demonstrations Visual presentation (video, DVD) Dunn & Jeste, Neuropsychopharmacology, 2001

13 Informed consent: intervention studies Wirshing et al., 1998 Repeated learning trials, corrected feedback improved comprehension/retention Carpenter et al., 2000 Educational remediation improved impairments on MacCAT-CR Understanding subscale; Appreciation, Reasoning also improved. Dunn et al., 2001, 2002 PowerPoint-enhanced consent associated w/better performance (20-item comprehension test) vs. routine paper consent

14 Informed consent: intervention studies Wirshing et al., 2005 Improved understanding, using instructional videotape re: important aspects of informed consent Dunn et al., 2006 Better understanding of placebo controls among schizophrenia patients who received educational module about placebos vs. those receiving routine information as part of consent Moser et al., 2006 Simplified computer-based intervention led to better MacCAT-CR (Understanding and Reasoning) scores in SCZ group. Post- intervention, SCZ pts did not differ from controls on any of 4 domains of capacity

15 Assessment of Capacity to Consent to Research Among Older Persons with Schizophrenia, Alzheimer Disease, or Diabetes Mellitus Palmer BW, Dunn LB, Appelbaum PS, et al. Arch Gen Psychiatry :

16 Sample characteristics SCZ (n=35) AD (n=30) DM (n=36) Age (yrs)66 (5)77 (7)71 (6) Education (yrs)12 (3)15 (3)14 (2) % Men57%73%97% % Caucasian80%90%72% Age of onset (yrs) 29 (12)72 (7)54 (13) Palmer et al. Arch Gen Psychiatry 2005; 61:230-6

17 3-item Questionnaire Consent process for hypothetical double-blind placebo RCT of cognitive enhancer (Plakmin) 3 Item Questionnaire (3 Q) (1) "What is the purpose of the study? (2) "What are the risks? (3) "What are the benefits?" Each item rated 0 (incapable), 1 (questionable/intermediate), or 2 (capable) MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Palmer et al. Arch Gen Psychiatry 2005; 61:

18 3 Q: Total scores by dx group % of Subjects 3 Q Total (mean of two independent raters; possible range 0-6)

19 Sensitivity and specificity of 3 Q 3 Q Total Mean Score Percent

20 Implications of 3 Q study Brief questionnaire may be a sensitive, and adequately specific, screening instrument for identifying potential research participants who warrant more in-depth capacity evaluation and/or educational interventions Can be easily integrated into consent process for any study Cut-point may need to be adjusted for different studies (i.e., more research needed)

21 Simple But Effective: Talk With Patients or Potential Research Participants 7 Volunteer Protocols7 Volunteer Protocols Reviewed each protocol to identify 5 essential elements, i.e.:Reviewed each protocol to identify 5 essential elements, i.e.: –Purpose –Procedures –Risks –Benefits –Voluntary Pause during consent process, ask potential participant to paraphrase essential information.Pause during consent process, ask potential participant to paraphrase essential information. Re-explain missed infoRe-explain missed info Re-evaluate understandingRe-evaluate understanding Re-explain againRe-explain again Re-evaluateRe-evaluate (Palmer et al. 2008; IRB: Ethics & Human Research)

22 Medication Adherence Among People with Schizophrenia Ages 40 (N=63) Trial 1 Trial 2 Trial 3 Purpose Procedure Risk Benefit Voluntary (Palmer et al. 2008; IRB: Ethics & Human Research)

23 Exercise for Patients with Osteoarthritis (N=10) Trial 1 Trial 2 Trial 3 Purpose Voluntary100 Duration100 Risks100 Confidentiality (Palmer et al. 2008; IRB: Ethics & Human Research)

24 RCT Type II Diabetes (N=13) Trial 1 Trial 2 N/A Purpose92100 Procedure Randomization77100 Risks85100 Voluntary100 (Palmer et al. 2008; IRB: Ethics & Human Research)

25 Blood Proteins in CHF (N=6) Trial 1 Trial 2 N/A Purpose50100 Procedure67100 Risks83100 Benefits83100 Voluntary100 (Palmer et al. 2008; IRB: Ethics & Human Research)

26 Implications Utility of brief assessment instruments for screening for issues with understanding of consent in diverse research studies Methods of administering consent can and should be used as educational opportunities Need more experimentation with other methods Premature to draw conclusions about what works best, for whom Consider cognitive impairment, physical limitations, pain, psychosocial issues, and subjects and families concerns

27 Images, video, multimedia Useful for showing things that are hard to describe in text or are difficult concepts for many people study procedures probabilities Should not replace in person, individualized consent, but may be a helpful supplement. Jeste, Dunn, Folsom et al., J Psychiatr Res 2007.

28 Key Study Procedures Screening Psychiatric Interview Blood Draw Spinal Tap Cognitive Testing MRI

29 Study Medication Risks Headache Bruising Dizziness Sleepiness Constipation Liver Damage/Death

30 Explaining randomization

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32 Internet tools to enhance consent Video consent process - ability to pause, review Online library of video/images for consent Click through for more detailed information Matching/tiling/multiple choice questions to assess understanding of key facts, concepts Chat functions with investigators Need to fund this kind of research, while simultaneously dismantling barriers to conducting research on informed consent itself Different individuals will prefer different methods of learning about studies

33 Informed consent as a process: DBS for depression 6 minutes into consent: Subject asks question about compatibility of two companies DBS devices, and whether she would be able to get a replacement part if needed. Investigator: Probably yes you will be able to get one, probably yes. Because the chance that nobody would--even if [Company A] decided to stop making it--we dont know. The answer is we dont know.

34 Informed consent as a process: DBS for depression 29 minutes into consent: (Following a question from subjects significant other about mechanism of action of DBS.) Investigator: Were probably providing a--and again, this is all conjecture--were probably providing essentially a pacemaker within some mood regulation network that prevents it from falling into a depressed rhythm.

35 Informed consent as a process: DBS for depression 53 minutes into consent: Investigator: …We cant say with any confidence that we know that this works versus doesnt work. Even though the response rates are striking in this patient population, it could all be placebo. And I believe that. I mean I believe that that is a possibility. I dont think its a probability, I believe that its a possibility. That said, there is no good evidence. Theres anecdotal evidence.

36 Informed consent as a process: DBS for depression Invest.: Improvement is by no means guaranteed, but it is a possibility...of... Subj: Considering the type of people you are treating, 50 to 60% response rate is extremely impressive. Invest.: We believe that in this population that that is a very good response rate. But from a patient's standpoint coming into the study, recognizing as I know you do that there's a chance you could do this and it'd be no different except for having two holes in your head. Subj: I understand that.

37 Recommendations for informed consent Test for understanding of risks (likelihood, seriousness) Ask what the subject expects and hopes for in terms of benefits Assess perceptions of risks and benefits to ascertain if risks may be underestimated or benefits overestimated Ask about motivations for participation Retest later (in ongoing protocols) Highlight key differences between research and usual clinical care Dunn & Gordon, JAMA, 2005;293:

38 Research Agenda: Enhancing Informed Consent Emphasis on process and overall understanding, rather than on signature Allowing for innovation by researchers, departments, research units; allow for collection of data on informed consent (without requiring additional consent for such research) Effects of clarity re: minimal risk research for informed consent (i.e. allow waivers but collect data on understanding) Study IRB processes

39 Revitalize Informed Consent Informed consent should be an ongoing process that focuses not on a written form or a static disclosure event, but rather on a series of dynamic conversations between the participant and the research staff that should begin before enrollment and be reinforced during each encounter or intervention. Multidisciplinary approaches should be tailored to individual differences in participant education and learning capabilities. Institute of Medicine : Responsible Research: A Systems Approach to Protecting Research Participants (2002)

40 Revitalize Informed Consent The informed consent process should be an ongoing, interactive dialogue… involving the disclosure and exchange of relevant information, discussion of that information, and assessment of the individuals understanding of the discussion. The informed consent conversation(s), as well as the written consent document, should not be obscured by language designed mainly to insulate the institution from liability. Rather, the process should ensure that participants clearly understand the nature of the proposed research and its potential risks and benefits to them and society. Institute of Medicine : Responsible Research: A Systems Approach to Protecting Research Participants (2002)

41 Excessive literary production is a social offence. - George Eliot

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