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Terms and Condi-ons for Trust in Learning Health Systems
CBSSM Seminar Jodyn Pla2, MPH, PhD
October 8, 2015
A New Wardrobe for Informed Consent: Proposed Changes to the Common Rule
and the Learning Health System
CBSSM Seminar Jodyn Pla2, MPH, PhD
October 8, 2015
Overview
• What is informed consent? The Common Rule? • Why change informed consent? • What are the goals of changing consent requirements? • What are the key proposed changes to informed consent?
• Will they achieve the goals? What are the challenges? • How might a learning health system create a more robust system for informed consent? (And vice versa)
What is informed consent?
Fundamental social contract between researcher and parQcipant designed to
communicate the nature of the research and assure the parQcipant is voluntarily parQcipaQng
Types of informed consent
• Specific consent to individual research projects • Broad / Blanket consent to future studies • Tiered consent -‐ parQcipant specifies uses • Presumed consent -‐ parQcipants may opt-‐out but are included by default
• Dynamic consent – “ParQcipant Centric”, interacQve, asynchronous, virtual, flexible opQons
• And more!
The Common Rule
Federal Policy for the ProtecQon of Human Subjects (1991)
= Ground rules for informed consent
1979
Why change informed consent?
1. Lots of research indica-ng consent doesn’t meet its stated goals in “tradi-onal” system
Why change informed consent?
Public
Public health
Health care
Research
PopulaQon science
Public health surveillance TranslaQonal
research 2. The health system is changing. And consent isn’t going to meet its stated goals
TradiQonal challenges in informed consent
• “Informing” is hard to do; o^en deficient • Consent is confusing • Right Qming? • TherapeuQc misconcepQon
New(er) challenges to informed consent
• Open-‐ended nature of agreements – Unknown future uses – Unknown future risks, benefits – Use in perpetuity à people may forget what they’ve agreed to
• De-‐idenQficaQon less certain – Greater value of idenQfiable data
• Defining research v. pracQce (e.g., QA) less clear
• Posted to Federal Register September 8, 2015 • Proposes changes to informed consent, IRB review, exempQon
• Goal Some of the major changes being proposed that will be6er protect research subjects and help build public trust are the rules rela8ng to informed consent…The rules would be significantly 8ghtened to make sure that the process becomes more meaningful.
NoQce of Proposed Rule Making
h2p://www.hhs.gov/ohrp/humansubjects/regulaQons/nprm2015summary.html
What are the key proposed changes to informed consent?
1. Shorten forms to include details “most relevant to a person’s decision to parQcipate”
2. PosQng consent documents publically (clinical trials)
3. Broad consent for secondary use of biospecimens (incl. de-‐idenQfied)
Linking Community Engagement Research to
Public Health Biobank PracQce (R01 HD067264, NICHD)
Informed Consent and Data Access Issues
in State-‐based Biobanks (1 RC1 HG005439-‐01, NHGRI)
Source: Adapted from Mi Neonatal Biobank
NBS Dried Blood Spots
Live Births Records Infant Deaths Birth Defects Registry
Hospital Discharge
Cancer Registry
CSHCS Program
Study Specific InformaQon
Examples of data linkages
Empirical studies • Community meeQngs1
– 2009-‐2010 (10 meeQngs) – N= 393
• Michigan – young adults2 – 2012 (20 campuses) – N= 2,010
• DeliberaQve Juries3 – 2013 – N=67
• Dynamic consent simulaQon4 – 2011 – N=187
• Facebook (2 campaigns)4 – N= >1,800,000
• State of the State Survey3 – 2011-‐2013 (3 cohorts) – N= 2,618
• GfK Online survey (Michigan) – 2015 – N=506
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8768
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76 80
108 111
214
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212
Phase One: spring 2012N=989
Phase Two: fall 2012N=1,112
Total Campus Outreach N=2,101
Enga
ged
Part
icip
ants
Phase One: SpringPhase Two: Fall[1] Thiel,Pla2 et al, 2014;[2] Pla2 et al, 2014;[3] Pla2 et al, 2015;[4] Pla2 et al, 2013;[5]Thiel, Pla2 et al, 2015
Issues the public cares about 1. Trust 2. Public awareness 3. Consent/ permission 4. Interpersonal / cultural relaQonship 5. Costs and Benefits 6. Governance and privacy 7. Research uses 8. Non-‐research uses 9. Return of research results 10. Advocacy/ support
Pla2 et al. 2015; Thiel, Pla2, et al. 2013
“Can I truly trust you? African American people are always last to know. I want involvement and informa8on.” (Community mee8ng, Flint) “What other lab specimens are being taken without the knowledge of the person being tested? This will end as a trust issue….” (Community mee8ng, Petoskey)
Pla2 et al. 2015; Thiel, Pla2, et al. 2013
“Can I truly trust you? African American people are always last to know. I want involvement and informa8on.” (Community mee8ng, Flint) “What other lab specimens are being taken without the knowledge of the person being tested? This will end as a trust issue….” (Community mee8ng, Petoskey)
Pla2 et al. 2015; Thiel, Pla2, et al. 2013
“Cool” & “Creepy”1
1 Pla2 et al. 2014
Never heard of this unQl my son was born, although I did not like the process in which the nurse took his blood and didn’t understand what is was for, I know it has a purpose and if it can help save lives and it didn’t hurt my son I see no harm in it… people have too many conspiracy theories… I highly doubt the government is going to clone my son or whatever else you people are thinking will happen… and so what if they do, my son is awesome LOL. (Facebook comment, April 6, 2015)
Summary of QualitaQve Findings • People care • Low cost ways, large numbers of people (Facebook)
• People quickly (intuiQvely) relate to big issues • Desire for increased transparency • Trust / confidence related to personal and community experience
Sources: Thiel, Pla2 et al, 2014; Pla2 et al, 2014; Pla2 et al, 2015; Thiel, Pla2 et al 2015; Pla2 et al, 2013
YES: DBS should be used for research on... NO: DBS should not be used for research on...
ΎĞĨŽƌĞǁƌŝƟŶŐŝŶǀŽƚĞƐ ƉĂƌƟĐŝƉĂŶƚƐƌĞƐƉŽŶĚĞĚƚŽĂǁŽƌŬƐŚĞĞƚƉƌŽŵƉƚƚŚĂƚůŝƐƚĞĚĞdžĂŵƉůĞƐŽĨƉŽƚĞŶƟĂůƌĞƐĞĂƌĐŚƵƐĞƐ;ďŽůĚĞĚͿandĂƐŬĞĚƉĂƌƟĐŝƉĂŶƚƐƚŽƚŚŝŶŬŽĨŽƚŚĞƌĐŽŶĚŝƟŽŶƐ;ŶŽƚďŽůĚĞĚͿΎΎdŚŝƐŐƌĂƉŚƐŚŽǁƐŽŶůLJƌĞƐƉŽŶƐĞƐǁŝƚŚхϮϱLJĞƐŽƌŶŽǀŽƚĞƐ
“Do you think that the blood spots should be usedfor research on the following...?*
List your top three YES votes; List your top three NO votes”**
Obesity
Alcoholism/drug addiction
Hepatitis
Learning Disabilities (11 specify autism/Aspberger’s)
Viruses
Asthma
Genetic studies
Heart disease
Cancer
Environmental toxins
Intelligence
Depression
Mental Illness
Blood pressure
Childhood diabetes
Second-hand-smoke susceptibility
1
266 13
147
7396
5467
2060
1840
13539
32
9
31 122
36
30
28
28
12
11
7
19
73
32
25
335
Diabetes (10 specify Type 2)
Key Findings: People want to know how their data is used Responsive systems that can inform, listen to quesQons and concerns, and respond (i.e., learn) may improve acceptability of broad consent. Short forms, increased accessibility of forms, and consent for biorepositories are likely to help build trust
BUT Consent gathered
…as a single encounter …in a one-‐size fits-‐all (one-‐form)
is likely to be insufficient to meet NPRM’s goals of building trust and implemen8ng a more meaningful process.
How might a learning health system help/ hinder mee-ng the added goals of (a) building trust; and (b) making consent
meaningful?
Source: Adapted from T. Pletcher, MiHIN
Learning Cycles
Learning Scales
Learning Pla^orms
The Learning Health System
SOURCE: Adapted from C.P. Friedman
Learning scales Learning is a continuous process of study, reflection, and change leading to improvement. This learning can happen at multiple levels, by: • Individuals • Teams • Organizations • Regional, national, and international
systems.
Adapted from: CP Friedman
Learning Platforms? (v. Learning “Islands”) • Organizations that have become
Learning Health Systems at their level of scale.
• But don’t routinely connect with other islands.
Source: CP Friedman
Learning Health Systems Require Plasorms to Support Learning Cycles
Different Problems
Rapid Cycle
Slower Cycle
SUPPORTING PLATFORM
People
Process Technology
Policy
Source: CP Friedman
LHS may provide opportuniQes to balance the cycle
Consent and Data sharing (DURSA, Common Rule)
De-‐iden-fica-on (HIPAA, Common Rule)
Privacy (HIPAA)
Consent 2.0
Personalized feedback
Communica-on of benefit/ risk
Return of research results
Community feedback
à Supplementary Personalized Consent Short Form (S-‐PCSF) (R21, submi6ed, June 2015)
Consent and Data sharing preferences
De-‐idenQficaQon
Privacy
Consent 2.0
Personalized feedback
CommunicaQon of benefit
Return of research results
Common plasorm
Community feedback
Consent
Informed Consent in/ for a Learning Health System
Building trust and making consent meaningful by… Learning Cycles EvaluaQng alternaQve consent models and creaQng
paQent-‐centered systems
Learning Scales Trust-‐building at individual, organizaQonal, system levels
Learning Pla^orms
FacilitaQng ongoing, two-‐way, tailored communicaQon
Thank you
Sharon Kardia, PhD Chuck Friedman, PhD Daniel Thiel, MA Tevah Pla2, MA
Ann Mongoven, PhD, MPH Sung Won Choi, MD, MS
Kathleen Omollo, MPP, MSI
Community Partners: Community Based OrganizaQon Partners (Flint) The Asian Center (Grand Rapids) Arab Community Center for Economic and Social Services (Dearborn) Friends of Parkside
(Detroit) Alliance Health (Jackson) Student parQcipants from UM, Ann Arbor