360 Degrees of Human
Subjects Protections (HSP) in
Community Engagement
Research (CEnR)
Lainie Friedman Ross, MD, PhD
University of Chicago
© Ross, 2010
Funding/Acknowledgements
 FUNDING: This project has been funded in whole
with Federal funds from the National Center for
Research Resources (NCRR), National Institutes of
Health (NIH), through the Clinical and Translational
Science Awards Program (CTSA), part of the
Roadmap Initiative, Re-Engineering the Clinical
Research Enterprise, UL1RR024999. The 3
manuscripts were approved by the CTSA
Consortium Publications Committee.
 CO-AUTHORS: Lainie Friedman Ross, MD, PhD,
Allan Loup, Robert M. Nelson, MD, PhD, Jeffrey R.
Botkin, MD, MPH, Rhonda Kost, MD, George R
Smith, Jr, MPH, Sarah Gehlert, PhD
© Ross, 2010
DISCLOSURES
I have no relevant financial relationships with
the manufacturer(s) of any commercial
product(s) and/or provider(s) of commercial
services discussed in this CME activity.
I do not intend to discuss an
unapproved/investigative use of a commercial
product/device in my presentation.
© Ross, 2010
Methodology
 A seven-member writing team to develop a framework for HSP
in CEnR
 One academic researcher who does community-based participatory
research (CBPR)
 One community research partner;
 Four with specialization in human subjects protections (HSP)
 3 who self identify as ethicists
 1 research subject advocate (RSA);
 One research associate with interest in HSP.
 Two stakeholder meetings were held with numerous academic
researchers, community research partners, community activists
and other HSP program personnel.
 At the first meeting, the stakeholders were asked to give presentations about the
process, challenges and benefits of CEnR from their various perspectives.
There were both large group and small group break-out sessions to give all
 Over the next 4 months, through iterative collaboration, the writing group
developed a taxonomy and framework for the risks presented by CEnR.
 At the second stakeholder meeting, some changes in stakeholder participants to
increase the diversity of viewpoints. All stakeholders were asked to comment on
written drafts and most were asked to give oral presentations regarding
strengths and weaknesses of the framework.
© Ross, 2010
Traditional Conception of
Human Subjects Protection (HSP)
 Code of Federal Regulations (CFR) Title 45 Part 46 (1981, rev.
1991, 2001) outlines federal policy for the protection of human
subjects in research
 Based on The Belmont Report (written by National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research)
 Three Principles
 Respect for persons
 Beneficence
 Justice
 Application
 Informed Consent
 Assessment of Risks and Benefits
 Selection of Subjects
 Establishes mandate for Institutional Review Boards (IRBs)
 Discusses additional protections for vulnerable populations
(pregnant women, human fetuses, neonates, prisoners, and
children)
© Ross, 2010
The Limits of the Fed Regs
 The Federal Regulations were designed for clinical
trials…
 Do not consider risks for communities
 The regulations also state that “The IRB should not
consider possible long-range effects of applying
knowledge gained in the research (for example, the
possible effects of the research on public policy) as
among those research risks that fall within the
purview of its responsibility.” §46.111 a2
 BUT there are other mechanisms to promote
HUMAN SUBJECTS PROTECTIONS
© Ross, 2010
Seven distinct entities may be
involved in an HSP program*
1.
2.
3.
4.
5.
6.
The individual investigators*
The institutional review board (IRB)*
Research ethics consultation (REC)
Research subject advocate (RSA)
Conflict of Interest Committee
Data safety monitoring plan (DSMP)*
 Data safety monitoring committee (DSMC)
7. Community Advisory Board
*These are federally regulated
© Ross, 2010
Greg Koski will discuss these
The Nine Key Functions
1. The risks of the research are minimized;
2. The risks to subjects are reasonable in relation to anticipated
benefits;
3. The selection of subjects is fair;
4. Each participant gives a voluntary and informed consent;
5. When appropriate, the research plan makes adequate provisions
for monitoring the data collected to ensure the safety of subjects;
6. There are adequate provisions to protect the privacy of subjects
and to maintain the confidentiality of data;
7. Conflicts of interest are transparent and appropriately managed;
8. Consideration is given to what additional protections, if any, are
needed for vulnerable populations; and
9. Proper training in human subjects protections is provided for
research personnel.
Again, Greg Koski will discuss these
© Ross, 2010
In CEnR, the same 7 entities
and the same 9 key functions
must be addressed by a HSP
program.
What changes is the greater need to
consider the risks to the community that
is both research partner and research
participant.
© Ross, 2010
What other HSP issues need to
be addressed in CEnR?
Risks not only of individuals, but also of
groups and communities
Potential risks to non-participant members of the
group
What is the significance of the role of the
group (community) as both research partner
and research subject?
© Ross, 2010
What is Community?
 Group versus Community
 Both have shared trait (for example, based on
geography, but also culture, ethnicity, education,
disease)
 Community = Structured groups
 Has its own internal structure and leadership
 Unstructured groups
 Internal: Can be empowered to create structure
 External: By a CBO
 Legitimacy of the structure may depend on the extent to
which the leadership is inclusive and responsive.
© Ross, 2010
A Taxonomy of Risks
LEVEL OF
RISK
Individual
[A]
Individual
by group
association
[B]
Process Risks to
Well-Being
Outcomes Risks
to Well-Being
Risks to Agency
Clinical and
Clinical and
psychosocial risks of
psychosocial risks of
the research interaction research findings
Risk of undermining
personal autonomy/
authority
Clinical and
psychosocial identity
risks of the research
interaction
Risk of group decisions
undermining personal
autonomy/authority. Risk of
individual decisions
undermining group
autonomy/authority
Community Risks to group
cohesion or structure
[C]
because of
engagement in
research
© Ross, 2010
Clinical and
psychosocial identity
risks of research
findings
Risks to group
Risk of undermining the
cohesion or structure group’s moral and
because of research sociopolitical authority
findings
A-Level (Individual Risks)
 Box A-1 : In a research interaction there are physical and psychosocial
risks to participating individuals.
 Blood is drawn for a sample; there is a risk of bruising.
 A drug is administered; there is a risk of adverse effects.
 A survey is performed; there is a risk of emotional distress.
 Box A-2: When the findings of research conducted on individuals are
reported, there are clinical and psychosocial risks to those individuals.
 A patient experiences adverse clinical effects from a trial and her condition is
worsened. There is the risk that she will no longer be able to take a particular
alternative treatment.
 A participant is informed she has tested positive for a genetic predisposition.
There is the risk that she will incur psychological difficulty or damage to her
social relationships.
 Box A-3: When an individual participates in research, there are risks to the
individual’s moral agency.
 Blood samples are taken as data for a cholesterol study to which the participant
has agreed; but the samples are then used as controls for a genetic study on
aggression without her knowledge—an area of genetic study that she does not
support.
© Ross, 2010
A Taxonomy of Risks
LEVEL OF
RISK
Individual
[A]
Individual
by group
association
[B]
Process Risks to
Well-Being
Outcomes Risks
to Well-Being
Risks to Agency
Clinical and
Clinical and
psychosocial risks of
psychosocial risks of
the research interaction research findings
Risk of undermining
personal autonomy/
authority
Clinical and
psychosocial identity
risks of the research
interaction
Risk of group decisions
undermining personal
autonomy/authority. Risk of
individual decisions
undermining group
autonomy/authority
Community Risks to group
cohesion or structure
[C]
because of
engagement in
research
© Ross, 2010
Clinical and
psychosocial identity
risks of research
findings
Risks to group
Risk of undermining the
cohesion or structure group’s moral and
because of research sociopolitical authority
findings
C-Level (Community Risks)



Box C-1: When a community engages in the research process, there are risks to the group’s
cohesiveness and structure.
 A community engages in research. Conflict arises within the community’s leadership regarding the
direction and extent of the group’s participation. One leader loses respect within the group or is
ousted.
Box C-2: When the findings of research are reported, there are risks to the engaged group itself.
 Havasupai traditionally believed their origin as a people to be the Grand Canyon. Genetics
revealed their origins in Asia with migration across the Bering Straight to what is now Arizona.
Threat to identity.
 Research found evidence of elder abuse among one Navajo community. The most prevalent form
of abuse cited was neglect. The findings spurred self-critique and discord within the community
because of its potential adverse impact on group solidarity and social traditions.
 A study of an isolated genetic community in Greece identified community members who were
heterozygote carriers for Sickle Cell Disease. The traditional social operation of the community
was disrupted.
Box C-3: When an established community (structured group) engages in research, there are risks to
the group’s moral agency.
 The Havasupai tribe grew concerned about diabetes in their community and sought to participate in
a research study to address the issue. Unbeknownst to the tribe, the researchers used these blood
samples to study evolutionary biology and schizophrenia. The data may also have been shared
with researchers at other institutions. The group’s agency was harmed because they had not given
consent for these additional uses of its samples.
 The Sephardic Jewish Congregation Mikvé Israel-Emanuel (Curaçao) is the oldest synagogue in
continuous use in the Western Hemisphere with a few hundred individual members. In the 1960s,
the synagogue’s Board of Directors commissioned Dr. Isaac Emmanuel to write a comprehensive
history of the congregation, but retained the right to prevent publication of unfavorable descriptions
to protect the community as a whole and its individual members.
© Ross, 2010
A Taxonomy of Risks
LEVEL OF
RISK
Individual
[A]
Individual
by group
association
[B]
Process Risks to
Well-Being
Outcomes Risks
to Well-Being
Risks to Agency
Clinical and
Clinical and
psychosocial risks of
psychosocial risks of
the research interaction research findings
Risk of undermining
personal autonomy/
authority
Clinical and
psychosocial identity
risks of the research
interaction
Risk of group decisions
undermining personal
autonomy/authority. Risk of
individual decisions
undermining group
autonomy/authority
Community Risks to group
cohesion or structure
[C]
because of
engagement in
research
© Ross, 2010
Clinical and
psychosocial identity
risks of research
findings
Risks to group
Risk of undermining the
cohesion or structure group’s moral and
because of research sociopolitical authority
findings
B-Level (Individual [participant and nonparticipant] by Group Association Risks)
 Box B-1: When an individual or group participates in research, there may be risks to an individual
who can be associated with a group—both participating and non-participating individuals.
 In Native Hawaiian culture, blood is correlated with power. If blood samples are taken for a research study,
participants may be at risk for being stigmatized by their cultural community.
 A study is underway exploring the high occurrence of Sexually Transmitted Infections in North St. Louis. The
individual resident of North St. Louis might be associated with the STI-likelihood trait to his detriment,
whether or not he participates.
 Box B-2: When the findings of research are reported and traits are ascribed to a group, there are
risks to individuals who can be associated with the group whether or not they participate.
 Studies showed a prevalence of the BRCA1 and BRCA2 genes, genes linked to breast cancer, in persons of
Ashkenazi Jewish heritage. The increased risk is ascribed to any woman who self-describes as Ashekanazi
Jewish, whether or not she participated in the research, and this may result in higher insurance premiums.
 Expatriate Native Americans maintain group association by their biological heritage. Any study of genetic
factors that enrolls these individuals can produce findings that, once ascribed to the genetic group, are
ascribed to all associated individuals of that group, both on- and off-reservation and in- and out-of-study.
 Box B-3: When a group chooses to engage or not to engage in research, there are risks of the
associated individual’s moral agency being undermined.
 The leader of an established community has established ongoing relationships with a research institution. He
hears about a project and thinks it would be great if his community participated. Members hear about the
project and are not interested as they believe that there are more important health priorities. However, they
feel pressured to participate given that the leader has promised the cooperation of the community.
 The leader of a disease group has a bad personal experience with a researcher. The researcher now
proposes a research project that may be of significant benefit to the group. The leader claims it is too
dangerous and refuses to provide access. The other members of the disease group are unaware of the
opportunity.
© Ross, 2010
A Taxonomy of Risks
LEVEL OF
RISK
Individual
[A]
Individual
by group
association
[B]
Process Risks to
Well-Being
Outcomes Risks
to Well-Being
Risks to Agency
Clinical and
Clinical and
psychosocial risks of
psychosocial risks of
the research interaction research findings
Risk of undermining
personal autonomy/
authority
Clinical and
psychosocial identity
risks of the research
interaction
Risk of group decisions
undermining personal
autonomy/authority. Risk of
individual decisions
undermining group
autonomy/authority
Community Risks to group
cohesion or structure
[C]
because of
engagement in
research
© Ross, 2010
Clinical and
psychosocial identity
risks of research
findings
Risks to group
Risk of undermining the
cohesion or structure group’s moral and
because of research sociopolitical authority
findings
Interpreting Risk & Agency in CBPR
 RISK
 Incommensurability of Risks (esp. between A-level and C-level)
 Benefit: Risk Ratio
 Non-Participant Third Parties (B-type harms)
 AGENCY
 The Complexity of Relationships and Agency in CBPR
A-level process concerns are addressed by informed consent
and respect privacy/confidentiality
Agency tension between individual and group
 Structured versus Unstructured Groups
Structure is a necessary but not sufficient condition for group
agency
Only structured groups can have C-level risks
 PARTNERSHIPS
 Memorandum of understanding
© Ross, 2010
In CEnR, the 9 functions of Human
Subjects Protections (HSP) must still
be fulfilled, but a HSP program must
take into account group and individual
risks [process and outcome risks];
…and the additional risks that occur
when the Community is both research
partner and research subject (threats
to individual and group agency).
© Ross, 2010
Who provides the HSP?
 In traditional research, HSP emanated from the
Academic Medical Center (AMC)
 In CEnR, 360 degrees of Human Subjects Protections
emanates from both the AMC (IRB*, REC, COIC) and
from the community (CAB)
 Other HSP may be joint efforts of AMC and community (role
of individual investigators, the establishment of a DSMP, and
possibly the RSA functions)
 Human subjects protection training must be developed
that is culturally sensitive and linguistically appropriate
for non-health care professionals.
*community members are encouraged to serve on IRBs.
© Ross, 2010
Concluding Remarks
Community Engagement Research (CEnR)
requires a broader conception of human
subjects protections.
We need to train those who provide HSP
about how CEnR is different from traditional
research.
In CEnR, HSP, like the research itself, ought
to use a collaborative methodology.
© Ross, 2010