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

Why change informed consent? 3. More data, more research, higher stakes

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)

Will these changes meet the goals to: (a) build trust

(b) implement a more meaningful process ?

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)

~4.5 million bloodspots in a biobank available for research

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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Phase One: spring 2012N=989

Phase Two: fall 2012N=1,112

Total Campus Outreach N=2,101

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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

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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

What is a Learning Health System?

Learning Cycles

Learning Scales

Learning Pla^orms

The Learning Health System

SOURCE: Adapted from C.P. Friedman

Learning Cycles

SOURCE: Friedman, 2014; Flynn, Pa2on, Pla2 2015

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

Broad, one-­‐Qme, consent is the current model…

… is not sustainable

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