Clarifying Roles and
Responsibilities
Patients and Other Stakeholders as Study Team
Advisors and Members
This project is funded by a Patient-Centered Outcomes Research Institute (PCORI) Eugene
Washington Engagement Award Program (EAIN-2299, PI: Bevans)
Thank you for joining!
This is the second of a 3-part webinar series on the
protection of human subjects in patient-centered
outcomes research (PCOR)
Overview of site functionality
 This session is being recorded
 Attendees’ lines are muted. Please
ask questions by:
• Using the CHAT box
• Note who you would like to
answer your question
Purpose of the Webinar Series
1. Develop and evaluate a process for
sharing actionable strategies for
addressing human subjects protection
challenges in PCOR;
2. Establish a community of stakeholders
who seek to advance the ethical conduct
of PCOR;
3. Identify high priority challenges to the
ethical conduct of PCOR.
We need your input!
 Help us improve our approach and identify speakers for our
remaining webinar (February 29, 2016, 3:00 – 5:00 EST)
 Webinar satisfaction survey
 Help us generate a stakeholder-informed, prioritized list of
challenges
 Brief (<10 minute) open-ended questionnaire or telephonebased interview to identify additional challenges
 Survey is closing Friday 2/12/16
 Online activity to generate, refine, and prioritize challenges
Guidance may be developed for the most highly prioritized
challenges.
Elicitation Survey Results:
A few examples (to date)
 Need for guidance on the protection of patient
contributors to research (not human subjects)
 How to protect contributor confidentiality, address conflicts of
interest, etc.
 Ways of communicating protections (and their limits) to research
contributors
 Need for trainings that are appropriate for
patient/other stakeholder contributors to research
 Human subjects protection
 Importance of following research protocol
 Patient/other stakeholder contributors’ intellectual
property rights
Today’s Webinar: Purpose
To illustrate ways of addressing challenges to
the protection of human subjects and research
contributors that commonly emerge in
research that involves patients and other
stakeholders as advisors and/or study team
members.
Patients & Families
Clinicians
Researchers
Policy Makers
Educators
Community
Leaders
Webinar #2 Contributors
Panelists
Facilitators
Patient/Other Stakeholder
Partners
Amy Kratchman
Family Consultant
CHOP
Darlene Barkman
Stephanie Solomon Cargill
Katherine Bevans
Assistant Professor
St Louis University
Assistant Professor
CHOP
Presenters
Family Consultant
CHOP
IRB Leaders
Amy Schwartzoff
Director, Human Subjects Research
CHOP
Megan Kasimatis Singleton
Associate Director, Human Research
Protections,
University of Pennsylvania
Megan Morash
Anna de la Motte
Emily Anderson
Project Manager
CHOP
Assistant Professor
Professor
Loyola University Chicago CHOP
Steve Leff
IRB Chair
Partners Healthcare
Levels of Patient
Engagement in Research
Full
Continuum
of Engagement
Happell & Roper, 2007
Oliver et al., 2008
Hall, 2009
Seid, 2014
Kratchman et al., 2015
Passive
Investigators
Research Team Members
Advisors
Human Subject/
Research Participants
Bevans et al., 2014
Defining Roles:
Level 1: Human Subject
Patient or other stakeholder
Roles
Consents to /
participate in
research as a
human subject
Principal Investigator
Responsibilities
Responsibilities
• Offers data (through an
intervention or
interaction) or provides
identifiable information
• Ensures participants provide
informed consent and are
protected in accordance with
IRB regulations
• Assumes risks and
responsibilities of
research participation
• Ensures that all research
staff who have contact with
human subjects or their data
are fully prepared to uphold
the ethical principles of
research
Defining Roles:
Level 2: Advisor
Patient or other stakeholder
Roles
Responds
(reactively) to
questions posed
by the research
team
No access to
human subject
data
May not need
training
Responsibilities
Principal Investigator
Responsibilities
• Represents the
perspectives of a
stakeholder group
• Determines whether advisors
are acting as research
participants
• Advises the research
team, but does not
make decisions that
directly impact research
activities
• Selects advisors who
authentically represent
stakeholder perspectives
• Minimizes advisors’
involvement to that which is
appropriate given their level
of training
• Ensures advisors are fairly
compensated
Defining Roles:
Level 3: Study Team Member
Patient or other stakeholder
Roles
Responsibilities
Principal Investigator
Responsibilities
• Proactivity
• Contributes to
• Ensures that research team
contributes to
research operations
members are adequately
development/cond
trained and supervised in the
uct of a research
• May contribute to
protection of human subjects
study
scientific aspects
of the study
• Supports a team structure
• Empowered
and culture that values the
member of the
expertise and decisionresearch team
making authority of all
with equal power
research team members
Probably has access
to human subject
data
Training needed
Defining Roles:
Level 4: Investigator
Patient or other stakeholder
Roles
Responsibilities
Principal Investigator
Responsibilities
• Provides leadership
in the scientific
development &
execution of the
study
• Leads one of more
operational and/or
scientific aspect(s)
of the study
• Ensures that team members
are adequately trained and
supervised in the
protection of human
subjects
• Significant
decision-making
authority
• Establishes a team
structure and
governance that
values and respects
the expertise of
patients and other
stakeholders
• Ensures that team members
are afforded adequate time
and resources to lead
assigned research activities
Has access to human
subject data
Training needed
Levels of Patient
Engagement in Research
Full
Continuum
of Engagement
Happell & Roper, 2007
Oliver et al., 2008
Hall, 2009
Seid, 2014
Kratchman et al., 2015
Passive
Investigators
Research Team Members
Advisors
Human Subject/
Research Participants
Patients and Other Stakeholders
as Advisors to Study Teams
Research Advisors:
Case Study 1: Developing a
Pediatric Sleep Health Measure
Purpose: A multi-stakeholder partnership developed and
validated child- and parent-report measures of children’s
sleep quality, wakefulness, and sleep practices.
Methods:
 Systematic literature review
 Parent and child interviews
 Semi-structured interviews
 Cognitive interviews
 Large field test (general population)
 Validation studies (clinical populations)
Presented by: Anna de la Motte
Sleep Study Contributors
The Sleep Health Partnership (Study Team) is comprised
of representatives of 5 stakeholder groups:
Researchers:
Clinicians:
Team member (1)
Advisors (3)
Team member (1)
Advisors (3)
Expertise on how
to develop
psychometrically
robust surveys
Knowledge of
information
needed about
children’s sleep
health to inform
clinical care
Parents:
Youth:
Sleep Advocates:
Team member (1)
Advisors (3)
Team member (1)
Advisors (3)
Team member (1)
Advisors (3)
Understanding of how children
manifest and experience sleep
health
Awareness of words and phrases
that children and parents use
to describe their sleep
experiences
Expertise in
translating
research findings
into practice
recommendations
and policies
Stakeholder Advisors
vs. Team Members
Patients & Other Stakeholders
Project Phase
Partnership development
and maintenance
Advisors
 Advise team on partnership’s
operational policies and procedures
 Participate in partnership
evaluations
Study Team Members




Study planning
 Review sleep items identified
through literature review and
expert interviews
 Suggest item revisions, additions
and deletions
Identify stakeholder
advisors
Lead stakeholder advisory
teams
Draft partnership policies
and procedures
Participate in partnership
evaluations
 Identify original sleep items
through literature review,
expert interviews, etc.
 Make final decisions
regarding item revisions,
additions and deletions
Stakeholder Team
Members vs. Advisors
Patients & Other Stakeholders
Project Phase
Advisors
Study Team Members
Study Implementation
 Review protocols and study
procedures
 Review and interpret de-identified
data from interviews
 Write protocols for study
activities involving human
subjects
 Recruit study participants
 Conduct interviews
 Review and interpret data
Study Dissemination
 Participate in workgroups to:
 Plan dissemination strategy
 Plan dissemination materials
 Present study findings to
advisors
 Create dissemination
workgroups
 Disseminate final materials
through various channels
Policies & Procedures to Protect
Human Subjects
Example: Child and Parent Cognitive Interviews
Activity
Advisor
Team
Member
Review and suggestion revisions to interview
protocol (e.g., recruitment material,
interview form)
YES
YES
Recruit study participants (human subjects)
NO
YES
Conduct interviews (human subjects)
NO
YES
Review and interpret de-identified interview
data
YES
YES
Training
 Cognitive
interview
procedures
 Cognitive
interview
procedures
 Human
subjects
protection
Policies & Procedures to Protect
and Empower Advisors
1.
Partnership Charter: Project Values &
Rules of Engagement
 Respect and trust
 No jargon
 Confidentiality
2.
Contributor Profiles
3.
Learning Sessions: Led by multiple
stakeholder groups
4.
Partnership evaluation and continual
improvement
 “I felt comfortable asking questions or sharing my
thoughts during research meetings.”
 “The team members and project advisors trust
each others”
5.
Sharing results of advisor contributions:
Progress reports
Issues Regarding the Protection of
Advisors
Role of contributor profiles:
Acknowledging and valuing contributor expertise
 For researchers, advocates and clinicians, this expertise is
professional
 For parents and youth, expertise is personal
Activities should be structured to protect advisors (responding to
materials, not providing research data):
Review study and recruitment procedures and provide feedback
Review sleep items and provide feedback
In reviewing procedures and materials, however, it is common for
advisors to speak from their experiences (their expertise)
Need: further guidance on how to protect the personal information of
advisors (when there is no designated consenting process)
Discussion Point (1):
Deciding
How and why do you decide to involve advisors in
research?
 Ethical considerations regarding advisors’ roles and
role limitations
 What are advisors’ most important contributions to research?
(vs. those of human subjects and study team members)
 What are some reasons to limit advisors’ responsibilities or
contributions to research?
 Selecting advisors
 How many advisors?
 Representation of stakeholder groups?
Discussion point (2):
Communicating
What are the best ways to communicate about
advisors’ roles and responsibilities in research?
 Communication with advisors and study team members
that:
 Empowers advisors to contribute to research, and
 Ensures that advisors have appropriate expectations
for their potential to impact the research
 Communication with IRBs that:
 Specifies advisors’ qualifications
 Clarifies advisors’ roles and responsibilities
Discussion points (3):
Preparing
How do you best prepare advisors to contribute
ethically to the research?
 Under what circumstances do advisors need training
in:
 Human subject protection?
 Research methods?
 Other topics?
 Are there disadvantages to training advisors?
 How can we best limit the burden of training to the
most essential skills while still providing (optional)
training that is desirable or useful?
Other questions or
comments?
Patients and Other Stakeholders
as Study Team Members
Study Team Members:
Case Study 1
Philadelphia Collaborative Violence
Prevention Center (PCVPC) PARTNERS
Project
PARTNER Goals:
Develop a youth aggression prevention
program that is:
 community-responsive
 culturally-sensitive
 generalizable to other urban settings
 sustainable and community-run
Presented by: Steve Leff
PARTNERS Program Features
 Intervention components
Social Cognitive Problem-Solving and Leadership
Parent and Family-Based Support
 Intervention sites/venues
After School Programs
Schools, Recreation Centers, YMCA, Faith-Based Centers
 Outcomes measured
Aggressive behaviors
Social problem solving
Youth leadership
Youth involvement in their community
PARTNERS Study Team
Philadelphia
Collaborative
Violence
Prevention
Center
PARTNERS
Leadership
Youth
Intervention
Parent
Intervention
Community
Mobilization
Integrity
Research
Coordination
Challenges of
partnership-based
research:
 Hiring/compensatio
n
 Trainings
 Supervision
Community Mobilization Specialist
Roles & Responsibilities
 Helped identified targeted program outcomes
Violence prevention AND leadership development
 Informed program content and procedures
 Assisted with organizational assessments to identify
appropriate intervention sites/venues
 Helped “re-design” study to better meet community needs
 Recruited study participants
 Assisted with PARTNERS implementation and data
collection
 Helped interpret and disseminate study results
Challenges Related to Human
Subjects Protection
 Deviation from participant recruitment,
consenting, and data collection protocol.
 Protection of collected data, and ensuring
that protocol is fully followed
 Need for human subjects protection
training that is appropriate for nonresearcher contributors.
Challenges of Conducting
Research in Partnership with
Community Stakeholders
 Need to continually strengthen the
partnership/study team by:
 Recognizing each team member’s varied
expertise, skills, motivation, goals, needs,
and challenges.
 Institutional barriers to hiring and
adequately compensating community
stakeholders
Study Team Members:
Case Study 2*
Study Purpose:
Establish baseline prevalence of childhood asthma
Education regarding prevention of attacks
Measure impact of community intervention
Methods:
Door-to-door household survey
Community-level intervention
Repeat surveys to assess impact
*This case is an amalgam based on my own experience, anecdotes from
other project teams, and information collected in focus groups from
community and academic researchers
Presented by: Emily Anderson
Case Study 2
Study Team and Roles:
Academic PI and Co-Is, project director
Community-based Co-I (director of community-based org
(CBO))
CBO staff – data collection and intervention delivery
History/Development
CBO identified/selected through systematic process
Working in community with limited resources, organizations
dedicated to health improvement
Health not part of CBO’s original mission
Case Study 2
Hiring and Compensation
Subcontract?
Consultants?
Employees of university?
Training
CITI online training in human research protections
Protocol specific training
Challenges (and Solutions)
 Compensation – Institutional Barriers
 Satisfactory solution would require institutional changes
 Protocol adherence/data integrity issues
 Training (can the problem OR the solution…)




Tailor HSP training to make it project- and role-specific
Provide better orientation re: all aspects of the project
Provide opportunities for practicing recruitment/IC
PROVIDE ONGOING SUPPORT
 Team Structure and Culture that Values Stakeholder
Expertise and Experience?
Discussion Point (1):
Deciding
How and why do you decide to involve patients
and other stakeholders as study team members?
 Under what circumstances should study teams include
patient and other stakeholder members?
 Advantages and challenges of patient/other stakeholder
engagement as study team members (vs. advisors)?
Discussion point(2):
Communicating
What are the best ways to communicate about
study team members’ roles and responsibilities in
research?
 Communicating about:
 Expectations for team members’ contributions to the
project
 Decision making authority
 Approaches to resolving conflicts about team members’
roles/responsibilities and authority
Discussion point (3):
Preparing
How do you best prepare study team members
(with varied expertise) to uphold the principles of
human subjects protection?
 Ways of respecting and utilizing team members’
expertise and prior training to enhance human
subjects protection
 Determining what level of training is most
appropriate for team members with varied expertise
and roles/responsibilities
Discussion point (4):
Other Issues
 Institutional and operational challenges
 What are some institutional and operational challenges to
engaging patients and other stakeholders as study team
members?
 Examples of how these challenges have been resolved
 Challenges associated with dual roles
 Under what circumstances do patient/other stakeholder
roles overlap? How should this be addressed?
 Research roles (e.g., an advisor and a human subject)
 Other roles (e.g., a study team member and a community
member)
Other questions or
comments?
Next Steps: We need your input!
 Webinar satisfaction survey
 Brief (<10 minute) open-ended questionnaire or
telephone-based interview to identify additional
challenges
 Online activity to generate, refine, and prioritize
challenges
 NEXT (and final) Webinar:
February 29, 2016, 3:00-5:00pm EST
Preparing Patients and Other Stakeholders to Uphold Ethical
Research Principles
Thank you!
Contact us at:
Katherine Bevans (Project Leader)
[email protected]
Anna de la Motte (Project Manager)
[email protected]