This document summarizes a Delphi panel discussion on the logistical and ethical considerations of patient engagement in research. The panelists, who represent the first generation of researchers formally trained in patient engagement, discussed multiple topics. They agreed that it is permissible for patients to switch roles after study participation ends, but debated what defines the end of participation. The panel also discussed challenges around tokenism in patient engagement and a lack of preparedness to submit ethics applications involving patients. Overall, the panel saw value in patient engagement despite the difficulties, but recognized the need to address issues around roles, power sharing, education and vulnerability.

1. PATIENTS IN MULTIPLE
ROLES: DOES IT LEAD TO
IMPROVED ENGAGEMENT?
Jean-Christophe Bélisle-Pipon, PhD
Visiting Researcher @ Petrie-Flom Center
CIHR Postdoctoral Fellow

2. MY (CANADIAN) PERSPECTIVE …
 Is (in part) informed by:
Highlights:
 Delphi to study the logistical and ethical considerations
of Patient Engagement in Research (PER)
 Panelists represent the very first generation of
researchers (in)formally trained to conduct PER
 They are the future of PER
31%
13%
13%
13%
6%
6%
6%
6%6%
Medicine Pharmacology
Public Health Health sciences
Nursing Clinical Research
Chemistry Epidemiology

3. ONE STEP BACK…
TAXONOMY
 STUDY PERSONNEL: […]
when they interact with
research subjects in a
study-related capacity
and/or have access to
identifiable data. Includes
patient co-investigators as
well as patients in other
roles
 ADVISOR
 RESEARCH SUBJECT
CO-INVESTIGATORS
AND PATIENT LEADERS
Patient-partners in research (PPRs):
 Are integral members of the research
team: M=5.33
 Have an Advisory role (voice their
opinions and participate in certain
decisions made throughout the
research process): M=5.00
 Are Co-researchers (contributing to
all decisions): M=4.66
 Not considered as staff (valuing
horizontal relationships rather than
vertical hierarchy)

4. SO… MULTIPLE ROLES AND SWITCHING
Research
Subject
Advisor
Study
Personnel
Permissible to switch,
when study
participation is over
(REC.8)
Ok, but when should
we consider study
participation to be
over?

5. GOOD “PER” MUST HAPPEN AS EARLY
AS POSSIBLE,THEY SAY
1
2
3
4
5
6
7
Start End
Study
participation?
A third possible
behavior may be
swinging.
WHICH RESEARCH
ACTIVITIES ARE MORE
APPROPRIATE FOR PPR
INVOLVEMENT?

6.  Switching may be permissible (if
really necessary)
 for priority-setting, research need
assessment to Participant
 Participant to KT advisor
 Swinging should be prohibited.
 Since there is no endpoint to
participation (research team will
continue to have special
consideration for participating
PPRs)
DRAWINGTHE LINE
Patients as CONSULTANTS /
SOUNDING BOARDS (HELICOPTER PPRS)
 Should not be allowed to be
research participants.
 For them, switching and
swinging should not be
permissible.
Patients as CO-INVESTIGATORS or
ADVISORS WITH SHARED LEADERSHIP
 Should not be allowed to
participate (no switching, no
swinging)
 No different from other RAs
Patients as STAFF
Partnership
Minima
Partnership
Maxima

7. ONE STEP FORWARD
LET’S ADD PRAGMATIC CONSIDERATIONS INTOTHE MIX…
TOKENISM LOOMS LARGE OVER PER
Instrumentalizing funding
While our panelists consider PPRs
experiential knowledge as being very
important and informative, they deem
adequate integration of PPRs and their
perspectives into a research project to
be very difficult to achieve and
recognized that this may lead to
tokenistic practices
Instrumentalizing patients
Panelists acknowledged that they may
potentially “modify a research protocol
to make it admissible to competitions
reserved for PER projects” without
necessarily carrying out PER thereafter,
citing the career opportunities doing so
affords
Only 1 of the 16 panelists disagreed
that they might do so.
Our panelists did not felt equipped to prepare
and submit an application for an ethics
certificate for a project engaging PPRs.
Pragmatic considerations are of great
import for IRBs, funders, institutions
and patient communities

8. OTHER ETHICAL/LOGISTICAL CONSIDERATIONS
STEMMING FROM OUR STUDY
Rank Ethical issues
1
Emergence of a class of professional patients
(a reduced pool of patients with specific profiles which PER projects
continually draw upon)
2 Patient remuneration
3
Fair recognition and appreciation of patient
expertise
Tokenism
(using PER for the financial opportunities it presents to researchers
without actually applying it once funding has been secured)
5
Power sharing between researchers and patients
Confidentiality
Exploitation of vulnerable persons
8 Paternalism and its off-shoots
9 Educating patients about the world of research
(structure, protocol format, validity criteria, etc.)
10 Educating patients about research integrity
1 2 3 4 5 6 7
Demonstrates willingness to get involved
Demonstrates curiosity
Demonstrates an interest for POR
Has no conflict of interest
Demonstrates an ability to interact with…
Is sufficiently available
Demonstrates altruism
Has good communication skills
Has significant experience with healthcare
Demonstrates leadership qualities
Suffers from (or lives with) the health…
Demonstrates advanced analytic abilities
Demonstrates a high level of literacy
Recognized by peers as eligible
Has privileged access to potential participants
Has significant experience with the research…
Has privileged access to data useful for the…
Demonstrates advanced writing abilities
Has relevant professional experiences
Has already participated in a study
Has already participated in a POR study
Has obtained a graduate diploma
Is a healthcare professional
Expected characteristics

9. LAST WORDTO OUR PANELISTS
Is feasible?
Yes
Is difficult?
Yes
Is harder than
traditional
research?
Yes
Is ethically
compelling?
Yes
Does worth it?
Yes
Engaging Patients in Research

10. THANK YOU
jbelislepipon@law.harvard.edu
@BelislePipon