This document summarizes a presentation on proposed changes to the informed consent process. The key proposed changes include shortening consent forms to only include the most relevant details, publicly posting consent documents for clinical trials, and allowing for broad consent for secondary use of biospecimens including de-identified samples. The goals of the proposed changes are to build more trust in the consent process and make it more meaningful. However, it is unclear if the changes will fully achieve these goals given challenges such as the open-ended nature of consent agreements. The presentation also discusses empirical studies conducted on community perspectives and issues regarding public health biobanks and consent.

1. Terms
and
Condi-ons
for
Trust
in
Learning
Health
Systems
CBSSM
Seminar
Jodyn
Pla2,
MPH,
PhD
October
8,
2015

2. 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

3. 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)

4. 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

5. 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!

6. The
Common
Rule
Federal
Policy
for
the
ProtecQon
of
Human
Subjects
(1991)
=
Ground
rules
for
informed
consent
1979

7. Why
change
informed
consent?
1.
Lots
of
research
indica-ng
consent
doesn’t
meet
its
stated
goals
in
“tradi-onal”
system

8. 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

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

10. TradiQonal
challenges
in
informed
consent
• “Informing”
is
hard
to
do;
o^en
deficient
• Consent
is
confusing
• Right
Qming?
• TherapeuQc
misconcepQon

11. 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

12. • 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

13. 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)

14. Will
these
changes
meet
the
goals
to:
(a)
build
trust
(b)
implement
a
more
meaningful
process
?

15.
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)

16. ~4.5
million
bloodspots
in
a
biobank
available
for
research

18. 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

19. 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
200
250
cipants
Phase One: Spring
[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

20. 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

21. “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

22. “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

23. “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)

24. 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

25. YES: DBS should be used for research on... NO: DBS should not be used for research on...
and
“Do you think that the blood spots should be used
for 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)

30. 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

31. 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.

32. 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

33. What
is
a
Learning
Health
System?

34. Learning
Cycles
Learning
Scales
Learning
Pla^orms
The
Learning
Health
System
SOURCE:
Adapted
from
C.P.
Friedman

35. Learning
Cycles
SOURCE:
Friedman,
2014;
Flynn,
Pa2on,
Pla2
2015

36. 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

37. 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

38. Learning
Health
Systems
Require
Plasorms
to
Support
Learning
Cycles
Different
Problems
Rapid
Cycle
Slower
Cycle
SUPPORTING
PLATFORM
People
Process
Technology
Policy
Source:
CP
Friedman

39. Broad,
one-­‐Qme,
consent
is
the
current
model…
…
is
not
sustainable

40. 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)

41. 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

42. 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

44. 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