ITHS Clinical Research Education Series Innovations in Informed Consent June 20, 2017
Institute of Translational Health Sciences CLINICAL RESEARCH EDUCATION SERIES Mandy Morneault Manager for Regulatory Knowledge and Training, ITHS We love to hear from you! vicka@uw.edu Please connect anytime. 206-616-6339
Our Focus • Speeding science to the clinic for the benefit of patients and communities throughout WWAMI • We promote the translation of scientific discovery to practice by: Fostering innovative research Cultivating transdisciplinary research partnerships Ensuring a pipeline of next-generation researchers through robust education and career development programs Laboratory Clinic Community
WORKSHOP AGENDA Data on Informed Consent (Seema Shah) 8:30-9:40 Dissolving the Monolith of Informed Consent (Adrienne Meyer) Group New Directions for Informed Consent (Bran LeFae) 9:40-9:50 Transition to Breakout • Restrooms are down the hall, to the right Break Comprehension (Lyceum) 9:50-11:20 Plain Language (145) Breakouts UW Consent Template (238) 11:20-11:30 Transition to Closing Remarks • Restrooms are down the hall, to the right Break 11:30-11:50 Closing Remarks (Lyceum) Group
PLEASE COMPLETE THE EVENT SURVEY AT THE CONCLUSION OF THE WORKSHOP. THANK YOU!
Data on In Informed Consent Seema K. Shah, J.D. Associate Professor, UW Department of Pediatrics Faculty, Treuman Katz Center Seattle Children’s Research Institute 20 June 2017
Case Study You are a research coordinator obtaining consent for a randomized controlled trial of a new breast cancer treatment vs. placebo (on top of standard of care) During consent process, one woman is impatient and doesn’t want to hear all the information When you ask why not, she says she thinks the experimental treatment will work
Case Study How can you tell if this potential What can you do to subject understands improve her enough to give valid understanding? informed consent?
Learning Objectives I. Where have we been? Review the historical, ethical and legal importance of informed consent II. How are we doing? Discuss the data on informed consent III. How can we improve? Data on improving consent, needs for future research on informed consent
I. I. W Where have we been? The historical, ethical and legal importance of informed consent
Historical basis of informed consent Slater v. Baker & Stapleton ( 1767): Exp xperim imental l su surgery ry on an im improperly ly heale led broken bone “improper Seeking to disu isunit ite consent was the callo llous “the custom with ithout and usage of consent” surgeons” Failing to obtain consent before surgery was “contrary to the rule of the profession”
Legal basis for informed consent “ Every ry human bein ing of f adult years and sound min ind has a ri right to determine what will be done wit ith his is body….” Justice Cardozo, Schloendorff v. Society of New York Hospital (1914)
Why is informed consent important? Functions of consent Respect for or au autonomy/persons Allo Allowing people le to o protect th their ir in interests
Why is informed consent important? Functions of consent Respect for or au autonomy/persons Allo Allowing people le to o protect th their ir in interests Allo Allowing people le to o con ontrol l what hap appens to th them Transparency/build ldin ing tru trust
How im important is is in informed consent? A legal and ethical requirement in medicine and in (most) research with human subjects • Requirement for medical research in 84 countries • Can be waived in some cases A process — not a form or an episode
1. Collaborative partnership 2. Social value 3. Scientific validity 4. Fair Subject Selection 5. Favorable risk-benefit ratio 6. Independent review 7. Informed consent 8. Respect for enrolled subjects What makes clinical research ethical? Emanuel et al. JAMA 2000; JID 2004.
1. Collaborative partnership 2. Social value 3. Scientific validity 4. Fair Subject Selection 5. Favorable risk-benefit ratio 6. Independent review 7. Informed consent 8. Respect for enrolled subjects What makes clinical research ethical? Emanuel et al. JAMA 2000; JID 2004.
How im important is is in informed consent? Widely subscribed to, but imperfectly realized!
II. II. H How are we doing? Discuss the data on informed consent
Elements of f informed consent Decision-maker with capacity to consent Disclosure of information Understanding Voluntariness Consent authorization
Data on ele lements of f in informed consent Decision-maker with capacity to consent Disclosure of information Understanding Voluntariness Consent authorization
Data on ele lements of f in informed consent Disclosure of information Understanding Voluntariness
Dis isclo losure of f In Information: : Is Issues and Challenges What How should information the should be information disclosed? be presented?
Dis isclosure of In Information: OHRP 45CFR46.116 and FDA 21CFR50.25 Statement of research Disclosure-required elements Purpose and procedures Foreseeable risks and discomforts Any benefits to subjects or others Appropriate alternatives Extent of confidentiality Treatment or compensation for injury Who to contact for answers to questions Participation is voluntary
Data on Disclosure • Content Consent documents • Readability and Length • Content Discussion • Quality of interaction
Dis isclo losure: : Content of f Consent Form rms Only 3/16 consent forms had all required elements Silverman et al. Critical Care Medicine 2001 Most Phase I oncology consent forms (n=267) were found to include the required elements • Purpose (92%) • Right to withdraw (99%) • Risk of death (67%) • Unknown risks (84%) • Cure as a possible benefit (5%) Horng et al. NEJM 2002
Review of f IC IC form content for 27 tr trials across 4 hospitals (a (abbreviated) Table 1. Information Frequently Missing From PICFs PICFs Missing Information Type of Information (%) Basic information Specific cancer being studied 12 Reason for research 12 Notice of voluntary participation 6 Options and further discussion Other treatment options available 12 Suggestion to discuss all options with 24 doctor Risks Potential for sterility 29 Irreversibility of risks 26 Beardsley et al. JCO 2007
Readability and Le Length Reading level is too high LoVerde et al, 1989, Grossman et al 1994, Paasche-Orlow et al., 2003, Sharp 2004 • Recommendations to write form at 8 th grade level • Consent forms and templates usually written at 11 th grade level or higher Consent forms getting longer over time Baker and Taub, 1983; LoVerde et al 1989; Tarnowski et al 1990; Beardsley et al 2007, Albala et al. 2010
Readability and Le Length Reading level is too high Consent forms getting longer over time
Huge variation in in quality of f in interaction
Dis isclo losure: : In Interaction Videotaped Survey of investigators of oncologists 12 multi-center RCTs N=12 N=60 • 58% gave full information • 92% described study purpose & reviewed • 12% did not inform patients prior to treatment, tests, randomization procedures • 38% did not always tell the patient • 82% reviewed about randomization alternatives • 5% did not seek consent at all Albrecht et al. 1999 Williams & Zwitter 1994
Dis isclo losure: : In Interaction Survey of investigators (n=117) of multinational HIV trial • 99% gave copy of IC document to read • 97% gave opportunity to read before clinic • 75% provided “a great deal” of information about risks & purpose • <56% emphasized randomization • 8.6% did formal assessment of understanding Sabik et al. IRB 2005
Summary ry of f Data on Dis isclo losure Limited Data Consent documents generally include relevant information, but not always, and long, complex and written at a high level Disclosure by investigators variable, more research needed
Data on ele lements of f in informed consent Disclosure of information Understanding Voluntariness
Overv rview of f data on understanding Data show that Most subjects Data are limited, understanding is know they are in hard to compare variable research Randomization is Age & education poorly sometimes affect understood understanding
Understanding of f research purpose 100% 90% 80% 70% 60% 50% Purpose 40% 30% 20% 10% 0% Mali pediatric U.S. oncology Thai HIV tx Swedish gyn U.S. rheumatoid study arthirtis Krosin et al. 2006 Joffe et al. 2001 Pace et al. 2005 Lynoe et al 1991 Criscione et al. 2003
Randomization 100% 90% 80% 70% 60% 50% Understanding of 40% randomization 30% 20% 10% 0% Uganda US IDUs, HIV Finnish women, Thai HIV tx U.S. men heart pediatric vaccine breast cancer attack malaria tx Pace et al. 2005 Hietanen 2000 Howard 1981 Harrison et al. 1995 Pace et al. 2005
Meta-analysis of f data on understanding 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Nguyen TT et al. Bull WHO 2015: Participants’ understanding of informed consent in clinical trials over three decades: system atic review and meta-analysis
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