From patients to
partners: participant- centric initiatives in biomedical research
楊沛東 李承翰 楊應甲 吳瑀涵 黃子豪 何亮融 林婷涵
楊沛東 Medical research is
increasingly analyzed by computing technology, so it generated a lot of
biobanks.
楊沛東 1. Big data.
2. Data sharing initiatives.
3. Concern about the use of personal data.
PCI
Medical research is
increasingly analyzed by computing technology, so it generated a lot of
biobanks.
楊沛東 Participant-Centric
Initiatives (PCI)
the tools to help build the long-term public trust that is needed for the new ways of carrying out medical research based on global networks of shared data and samples
楊沛東 Protecting individual
interests
In medical research domain
allow
beneficial research to proceed
protect the interests of research
participants
楊沛東 Protecting individual
interests
Participant's consent:
Traditional:
1. Reinforced by lots
procedures, policies and legal requirements.
(ex:IRB)
2. One-time consent.
楊沛東 Protecting individual
interests
Participant's consent:
PCI:
1. Build the long term public trust.
2. global networks of shared data.
3. More efficient on research.
New trends in research demand new consent models.
Why?
1.No uniform standards of consent.
2.The requirements differ
between jurisdictions at the regional or national level.
李承翰
New trends in research demand new consent models.
Why?
3.difficult to guarantee that individuals can remain
anonymous.
4.More data applies to the current studies but also to participation in a biobank or
a longitudinal study.Board consent? 李承翰
New trends in research demand new consent models.
李承翰 Broad consent
ref:
http://www.genome.gov/Pages/PolicyEthics/InformedConsent/ConsentFormEx ample4.pdf
New trends in research demand new consent models.
Problems in broad consent:
1.For researchers: difficult to make consent forms
future-proof.
2.For participants: Cannot express their preferences or protect their interests over
time. 李承翰
New trends in research demand new consent models.
Problems in broad consent:
3.Secondary research may reduce the levels of trust between participants and researchers
4."One size fits all" approach also risks losing segments of
the population. 李承翰
Giving research
participants a greater choice.
李承翰 From an ethical
perspective: necessary for
participants to give consent of new research possibilities on the same datasets.
The major challenge :
develop ways to engage and to communicate with diverse groups over long periods of time.one way is through the use of social media
technologies.
Giving research
participants a greater choice.
李承翰 1. Provide the basis to reshape
the current relationships with participants and patients.
2. Less passive and more interactive.
3. Enormous benefits for
biomedical research and clinical practice.
Aims:
楊應甲
What is PCI?
楊應甲
Participant-Centric Initiatives
Tools, programs and projects that empower participants to engage in the research
process.
ParticipantsParticipants
ParticipantsClinicians/Resea rchers
What is PCI?
楊應甲
Participant-Centric Initiatives
Patients and research
participants are located at the centre of decision making as equal partners in the research process.
Distinguish from PEI (Public Engagement Initiatives)
楊應甲 Key Functions of PCI
What is PCI?
楊應甲 PCI Used for Research Purposes
* The first 4 of 10 PCIs in the table are shown.
Features of PCI
吳瑀涵 1. Placing participants in
control.
• Need to place the
individual at the center of decision making is
embedded in the design of the IT interface for PCIs.
• Purely voluntary
• Empowering participants.
Features of PCI
吳瑀涵 2. Using social media
technology
• Use social media technology and approaches
• Allows participants to
record all of their research activity.
Features of PCI
吳瑀涵 3. Promoting active
participation
• ongoing active interaction between participants and researchers
• transparency and veracity in all interactions
• Participants must commit
themselves to research and to acting altruistically
for others
Features of PCI
吳瑀涵 3. Promoting active
participation
Features of PCI
吳瑀涵 4. Facilitating communication
• Individual participant interfaces.
• Blogs/Online
experts/Webcasts
• PCIs can inform
participants and keep in regular contact.
吳瑀涵
吳瑀涵
Features of PCI
吳瑀涵 5. Facilitating communication
• Through various social media tools, such as individual participant
interfaces, blogs, online
experts and webcasts, PCIs can inform participants and keep in regular contact.
Benefits of adopting a PCI approach
黃子豪
1. Streamlining the consent process.
2. Removing the need for anonymized data.
3. Facilitating participant recruitment.
4. Facilitating participant retention.
Benefits of adopting a PCI approach
黃子豪
5.Promoting the delivery of better quality and more cost- effective health care.
6.Sustaining public confidence in research.
7.Improving the quality of research.
黃子豪
黃子豪
黃子豪
黃子豪
黃子豪
黃子豪
客戶提供訊息
得到醫療數據
幫助病患 進行分析
獲得客戶 信任
招攬更多 使用者
P C I
效益
研究 客戶
Challenges to the wide- scale adoption
何亮融
1. Requires a shift in current attitudes and approaches
towards patients and research participants
respect research
participants as partners in the research rather than to see
them as patients or passive providers of information and sample
Challenges to the wide- scale adoption
何亮融
2. Bulk of consent efforts are still paper-based, but transition to effective
electronic consent models is difficult to managed online
need considerable support from institutional leadership and the investment of
resources.
Challenges to the wide- scale adoption
何亮融
3. broader implementation in research will be hampered by the lack of a common
reference ontology
Challenges to the wide- scale adoption
何亮融
4.Implementation of PCIs also requires a change for
research participants ,care needs to be taken to ensure that the use of PCIs does not prohibit or discourage certain groups from involvement in research,
applications for mobile phones and the use of
interactive screens using videos — instead of text — located in waiting rooms and public areas may help
Challenges to the wide- scale adoption
何亮融
5. greater use of PCIs may
lead to greater empowerment of participants, certain lines of research may not be
possible if many participants opt out
research is needed to determine how best to
introduce PCI approaches
while still allowing expedited research to continue.
23andMe Partnering with Patients
林婷涵
http://blog.23andme.com/news/inside-23andme /23andme-partnering-with-patients/
/
Not only do PCI return data to research participants, but they play an active role in the
research process. .
“it is fascinating to learn about myself, my own
biology. This is me, my
chromosomes, my DNA, and it helps me to make better choices for myself.”said
Cheryl-Anne.
Discovering Unknown Jewish Ancestry with 23andMe
林婷涵
By CeCe Moore
She joined 23andMe's
Ancestry Finder in 2010, and noticed a cluster on her
7th chromosome that appeared to contain a
significant number of matches with
self-declared Ashkenazi
ancestry.
Usually been mistaken for a Jewish person despite
having no known Jewish ancestors.
http://blog.23andme.com/23andme-customer-st ories/ashkenazi-and-me-discovering-unknown- jewish-ancestry-with-23andme/
The Genetic Tests for Drug Response
林婷涵
By Renae http://blog.23andme.com/23andme-customer-stor ies/the-genetic-tests-for-drug-response/
she and her doctors were
unaware of her sensitivity to the drugs used to temporarily relax a patient's muscles
before anesthesia is administered.
she noticed that her tests showed she had the variants that are associated with
pseudocholinesterase deficiency in
23andMe’s drug
response report, now she wears medical ID bracelet.
How does PCI make money?
林婷涵 PatientsLikeMe: share
about your experience with the disease and sell it to
their partners
23andMe: offer consumers the ability to get their
genes sequenced for $99.
“for a consumer it still seems to have such marginal utility, especially at that price.”as science policy wonk Jonathan Gitlin wrote on
Twitter.
Conclusion
林婷涵 PCI requires a cultural shift
in current research.
Some systems have demonstrated that
individuals are sufficiently motivated to engage in novel ways.
Conclusion
林婷涵 more Intuitive and Dynamic
Conclusion
林婷涵
From patients to active partners
obstacles of research?
PCI:
1. facilitate innovative research
2. safeguard public trust.
THANKS FOR ATTENTION
林婷涵
