Jane Kaye's presentation

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4 Οκτ 2013 (πριν από 4 χρόνια και 2 μήνες)

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A Significant Sea Change?

Dr Jane Kaye

University of Oxford

Using Participant
-
centric Initiatives
in
Biobanking



ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Outline of this Talk

1.
What is PCI?

2.
Why do we need PCI in
Biobanking
?

3.
Dynamic Consent

4.
Examples
from other
areas

5.
What are the challenges of
implementation?



ABN Conference

Hobart, Australia

3
-
4
th

December 2012






1. What is PCI?


Individuals at the centre of
decision
-
making


Communication and
i
nteractions
over time


Empowerment
o
f individuals


Partnerships


Kaye J et al. 2012
Nature Review Genetics

What is a PCI Approach?


ABN Conference

Hobart, Australia

3
-
4
th

December 2012



2. Why do we need PCI in
B
iobanking
?



New phase of
b
iobanking


Building of national infrastructure


Need for strategic vision


Raises complex issues


Need to address societal concerns
and be aware of interests and values


Understand that your
biobank

is part
of
of

an international
r
esearch
network


Develop governance mechanisms that
are designed for the fluctuations and
dynamism of global networks


Requires responsiveness and
reflexivity


This requires understanding the
interests of all stakeholders




International Research Networks


This raises new unpredictable questions
about how to manage the
biobank


These will change over time




International Research Networks


This raises new unpredictable questions
about how to manage the
biobank


These will change over time




Need to have a
biobank

that is:


Used


Relevant for researchers


Nimble and responsive


Has willing participants


Moving from project grants to more
long
-
term sustainable funding


Embedded in healthcare delivery


Engagement with the personalised
medicine agenda


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Talking Law and Ethics



HeLEX jane.kaye@law.ox.ac.uk









ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Talking Law and Ethics



HeLEX jane.kaye@law.ox.ac.uk








Are we collecting the right type of
samples?

Will they be wanted by researchers?

Are our consents future proof?

Do we have consent for re
-
contact?


ABN Conference

Hobart, Australia

3
-
4
th

December 2012



3. The Dynamic Consent Model


ABN Conference

Hobart, Australia

3
-
4
th

December 2012



How do these trends test
the basic principles of
medical research?






ABN Conference

Hobart, Australia

3
-
4
th

December 2012



How do these trends test
the basic principles of
medical research?






Online patient interface


Enables
peoples preferences to be
recorded and acted upon in real time


Sticky policies


Allows many different kinds of
consents to be selected


Vacation breaks


Use of clips and cascade of information


Tailored to individuals


Communication interface

What is Dynamic Consent?


do
the
basic principles of
medical research?






Places participants at the centre of
decision
-
making about their samples
and information


Enables ongoing communication
and interaction for clinical care as
well as research


Record of all consents and
interactions in one place


Engagement of individuals as part of
a personalised medicine approach

What does Dynamic Consent do?


Research
Projects

Clinical

Trials

Clinics

Public & Patient
Engagement

Public & Patient
Engagement

Research
Projects

Patient
Groups

Clinics

Public & Patient
Engagement

Public & Patient
Engagement

Oxford
Bioresource

Public & Patient
Engagement

Public & Patient
Engagement

Personalised

Communications
Settings

Variable
Participation
Levels

Research
Projects

Clinical

Trials

Clinics

Research

Findings

Academics

Clinicians

Industry

Public & Patient
Engagement

Public & Patient
Engagement

Personalised

Communications
Settings

Variable
Participation
Levels

Research
Projects

Clinical

Trials

Clinics

Research

Findings

Academics

Clinicians

Industry

Public & Patient
Engagement

Public & Patient
Engagement

Clinical eRecords

Tissue Collections

DC

Research Data

DC

Clinical

Trials

Research
Projects

Clinics

Research

Findings

DC

Tissue & Data

Self

Reporting

Academics

Clinicians

Industry

Public & Patient
Engagement

Public & Patient
Engagement

Data

Surplus Samples

Knowhow

Tissue Collections

DC

Research Data

DC

Clinical

Trials

Research
Projects

Clinics

Research

Findings

Personalised

Medicine

Academics

Clinicians

Industry

DC


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Parliament



ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Parliament



Ensures conformity with legal and ethical
requirements nationally and globally


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Parliament



Ensures conformity with legal and ethical
requirements nationally and globally


Can be used to streamline:
-


Recruitment


Consent and re
-
consent processes


Feeding back research findings


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Parliament



Ensures conformity with legal and ethical
requirements nationally and globally


Can be used to streamline:
-


Recruitment


Consent and re
-
consent processes


Feeding back research findings


Recruitment costs lower


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Parliament



Ensures conformity with legal and ethical
requirements nationally and globally


Can be used to streamline:
-


Recruitment


Consent and re
-
consent processes


Feeding back research findings


Recruitment costs lower


Greater accountability leading to better science


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Parliament



Ensures conformity with legal and ethical
requirements nationally and globally


Can be used to streamline:
-


Recruitment


Consent and re
-
consent processes


Feeding back research findings


Recruitment costs lower


Greater accountability leading to better science


Accreditation can lead to fast tracking of
decisions
by
research ethics committees


ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



Opportunity for people to have greater
control over the use of their information if
they so desire over time


They can become active partners in the
research process with online surveys


On
-
going
interaction and communication
in real
time


Needs to be used with other participatory
democracy governance tools


Potential to enhance confidence and trust


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


4. What are examples of PCI from
other fields?


ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012



ABN Conference

Hobart, Australia

3
-
4
th

December 2012


5. What are the challenges of


implementation?

5. What are the challenges of


implementation?



Requires a cultural change



Move to partnerships



Understanding and valuing of


role that patients play in research



Development of policies and


practice to accompany it



Investment of resources


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


In Conclusion

In conclusion……


ABN Conference

Hobart, Australia

3
-
4
th

December 2012


Acknowledgements


Making Connections and ELSI 2.0 collaborators


EnCoRe

Project members and Team at HeLEX

http://www.publichealth.ox.ac.uk/helex/


Wellcome Trust; ESPRC; ESRC