From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015. This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University. For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy

1. From Patient to Participant:
The Evolving Role of
Consumers in Research
Natasha F. Bonhomme

2. Genetic Alliance Network
• Disease Advocacy Orgs
• General Support Orgs
• Universities
• Government
• Companies
• Labs
• Hospitals
• Health Centers
• Professional Societies
• Think tanks/policy
groups

3. Network of Resources

4. Maturing Patient Advocacy
• 1950s-1960s – Medical Models
‣ Voluntary Health Agencies
• 1970s – Nascent Patient Movement – Missing Services
‣ Self-organized Disease Specific Organizations
• 1980s – Maturing Patient Movement – IS & IT Technology
‣ New Alliances and New Strategies Emerge
• 1990s – Powerful Momentum “Patient Power” – Websites & Email
‣ Institutionalized Advocacy Coalitions
‣ Patient Organized Networked Research Organizations
‣ Effecting Broad Change of Public Policy
• 2000s – Successful Models “ResearchAdvocacy” – BioBanks
‣ Active Engagement in the Research Enterprise
‣ Breaking Conventional Boundaries of the Medical Model
‣ Demand for Quality, Services, Choice, & Personalized Delivery
‣ Patient Rights Public Policy – Changing the Status-Quo
• 2010s – Networks in the Commons – Translation & Delivery

5. What Do Groups Do in Research?
• Set research initiatives
• Raise funds for investigators
– Becoming investigators
• Sponsor projects
– Academic and Biotech
• IRB
• Collect data (registries and biobanks)
• Recruit
• Communicate out messages
• Disseminate findings

6. What do personal data collection tools look like in 2015?
iPhone App
iPhone App
Wireless Scale
Twitter
Facebook

7. What does it mean?
• Self aggregation
• Label =/= experience
• Data and experience even more intertwine
• Can’t have the specimen without the other
“Stuff”

8. Educate  Communicate
Because people seek out what they want
to know…

9. In other industries:
• Co-design
• Consumer testing
• Consumer preference
analysis
• Responsiveness

11. • Self-reported clinical data
“Enables individuals to set their own
sharing, privacy and data access
preferences, in a granular and dynamic
manner.”
• Community-based guides
• “White label” version

12. (“Open Consent”)
(similarto Portable LegalConsent)
(similarto HIPAA/CommonRule)
(“Dynamic Consent” model)
(Effectively an Opt-out)
Platformfor EngagingEveryoneResponsibly
(PEER)
...Adjustdynamicandgranularsettingsasvalues
and prioritieschangeover time

13. PEER Deployed
• PCORnet PPRN
– 11 Disease Advocacy Organizations
• Robert Wood Johnson Foundation Project
– 30 Communities/collectives (employers, churches, gyms)
• Campaigns
– Free the Data: https://www.free-the-data.org
– Patient Focused Drug Development (Sickle cell, IBD, IPF)
– Patient Preference Study (CDHR – Obesity)
• Advocacy Initiated
– United Mitochondrial Disease Foundation
– Pancreatic Cancer Action Network
– …
• General Public
– Registries for All: https://www.reg4all.org
– TrialsFinder: https://www.trialsfinder.org

14. Mosaic: crowd-sourced research
• Bullet
14

15. Advocacy owned and managed data
repositoryand samples
Clinical Information Medical Records
DNA/RNA Self-reported Data
Cell Lines Tissue / Organs
30,000 samples + 20,000 clinicalrecords
BioBank.org

16. Components of a network-based Learning
Health System*
1. Focus on outcome
2. Build community
3. Effective use of technology
4. Learning system
– System science, QI, qualitative
research, clinical research
*Collective creativity (Swarm Creativity; Peter Gloor)
Lead User innovation (Democratizing Innovation; Eric von Hippel)
New economic models (The Wealth of Networks; Yochai Benkler)
Actor-oriented organizational architecture (Configuring value for competitive advantage;
Charles Stabell and Oystein Fjelstad
Courtesy of Peter Margolis, ImproveCareNow PPRN, PCORnet

17. Biggest Ah-ha(s)!
• Not research “subjects” and are often not
just “patients”
• This is about relationships, not
transactions
• Relationships are messy
• This will be challengingAND fun

18. It’s about trust
(more so than privacy)
But privacy is a surrogate marker for trust
…it reflects a level of care and if these are not present, people
feel it …which undermines trust

19. Resources
• Community Campus Partnership for Health:
https://ccph.memberclicks.net/
• PCORI Patient and Family Engagement Rubric:
http://www.pcori.org/sites/default/files/PCORI-
Patient-and-Family-Engagement-Rubric.pdf
• The Center for Information and Study on Clinical
Research Participation: https://www.ciscrp.org/
• Research On Medical Practices (ROMP):
https://rompethics.iths.org/
• Clinical Trials Transformation Inititiative:
http://www.ctti-clinicaltrials.org/
• Community Engagement Studio:
https://www.aamc.org/initiatives/rocc/363090/vand
erbiltuniversityprojectdescription.html

20. Thanks!
20
Natasha F, Bonhomme, Sharon F. Terry, MA
nbonhomme@geneticalliance.org
peerplatform.org
geneticalliance.org/PEER
mosaic.ucsf.edu
@geneticalliance

21. • How do we create a culture of openness and
sharing?
• Where can we take friction out of our systems (or
lack thereof)?
• How do we animate the American public to get in
the game?
• How do we know what is working and what is
not?
• How to get complete data on individuals and
respect their desire to participate?
• How to get oversight that is flexible enough to
deal with these sorts of
engagements/development?