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Ethical Goals of Community Consultation in Research

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Abstract

In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval. Community consultation is a particularly common method of involving communities. However, the fundamental ethical goals of community consultation have not been delineated, which makes it difficult for investigators, sponsors, and institutional review boards to design and evaluate consultation efforts. Community consultation must be tailored to the communities in which it is conducted, but the purposes of consultation-the ethical goals it is designed to achieve-should be universal. We propose 4 ethical goals that give investigators, sponsors, institutional review boards, and communities a framework for evaluating community consultation processes.
American Journal of Public Health | July 2005, Vol 95, No. 714 | Health Policy and Ethics | Peer Reviewed | Dickert and Sugarman
HEALTH POLICY AND ETHICS
Ethical Goals of Community Consultation in Research
| Neal Dickert, BA, and Jeremy Sugarman, MD, MPH, MA
In response to the traditional
emphasis on the rights, inter-
ests, and well-being of individ-
ual research subjects, there has
been growing attention focused
on the importance of involving
communities in research de-
velopment and approval.
Community consultation is a
particularly common method of
involving communities. How-
ever, the fundamental ethical
goals of community consulta-
tion have not been delineated,
which makes it difficult for
investigators, sponsors, and
institutional review boards to
design and evaluate consulta-
tion efforts.
Community consultation must
be tailored to the communities
in which it is conducted, but the
purposes of consultation—the
ethical goals it is designed to
achieve—should be universal.
We propose 4 ethical goals that
give investigators, sponsors, in-
stitutional review boards, and
communities a framework for
evaluating community consul-
tation processes. (Am J Public
Health. 2005;95:XXX–XXX. doi:
10.2105/AJPH.2004.058933.)
ALTHOUGH ETHICAL
considerations of human sub-
jects research have historically
focused on protecting the rights,
interests, and well-being of
individual subjects, growing at-
tention has been given to the im-
portance of involving communi-
ties in research development and
approval. Activists who represent
disease communities,” particu-
larly AIDS and breast cancer
communities, during the 1980s
lobbied for access to experimen-
tal treatments and for a larger
role in the development of re-
search agendas, study designs,
and drug approval processes.
1–4
Research in population genetics
raised awareness about the risks
for stigmatization and discrimi-
nation,
5–7
and studies of indige-
nous communities raised con-
cerns about threats to communal
identity and social structure.
7–10
International collaborative re-
search includes working with so-
cieties that have radically differ-
ent structures and norms,
11–14
and researchers in emergency
settings, where obtaining partici-
pant or surrogate consent is im-
practical, must conduct commu-
nity consultation during project
development and approval.
15 , 16
Finally, forms of community-
based research, such as partici-
patory action research, include
communities throughout the re-
search process.
17–20
Despite an
increasing sense of need for
community input, difficult ques-
tions persist about how best to
involve communities as partners
in research.
Efforts to expand attention to
community perspectives, beyond
representation on institutional
review boards,
21–23
have ranged
from advocating a principle of
respect for community to estab-
lishing guidelines that require
community disclosure, consulta-
tion, and consent.
12 , 2 4–30
Addi-
tionally, general principles have
been developed for guiding dif-
ferent types of community-based
research.
10 , 2 0 , 3 0
Among the
methods for involving the com-
munity in research, community
consultation is particularly com-
mon. Formal community consul-
tation is required by Food and
Drug Administration regulations
before research is allowed to be
conducted without informed
consent in emergency settings.
31
Similarly, proposed and actual
guidelines for research that in-
volves aboriginal communi-
ties,
27,28,30
population genetics
and epidemiologic research,
29,32
international research,
12 , 2 9
and
HIV-related research
25,26,33
rec-
ommend consulting communities
when planning and implement-
ing research.
8
Despite such endorsements,
the general ethical goals of com-
munity consultation remain un-
clear, which makes designing and
evaluating consultation efforts a
challenge for investigators, spon-
sors, and institutional review
boards. Because of the heteroge-
neity of communities and re-
search projects, the methods of
community consultation must be
context specific. However, the
purposes of community consulta-
tion—the fundamental ethical
goals that consultation is de-
signed to achieve—should be uni-
versal. We propose a set of gen-
eral goals for community
consultation that will provide a
framework for investigators,
sponsors, institutional review
boards, and communities to eval-
uate community consultation
processes. We in no way intend
to detract from the need to con-
sider the particularities of any
given research project and com-
munity; careful understanding of
particular contexts is indispensa-
ble for understanding and achiev-
ing the goals we recommend.
Distinguishing Community
Consultation and Consent
Community consultation should
not be mistaken for community
consent, although the 2 are not
mutually exclusive. To consult
is “to seek advice or informa-
tion.”
34
Consulting with a com-
munity includes eliciting feed-
back, criticism, and suggestions;
it does not include asking for ap-
proval or permission. Community
consultation is designed to recog-
nize and accommodate the rele-
vant particularities of a given
community for a specific project.
For example, community consul-
tation for HIV-related trials may
include consulting with HIV ad-
vocacy groups, people who are
HIV-infected, and potential par-
ticipants.
1,35
Conducting genetics
research in an aboriginal com-
munity may necessitate dis-
cussing studies with existing po-
litical authorities and community
members.
9,30
Rather than soliciting input,
community consent involves so-
Published Ahead of Print on June 2, 2005, as 10.2105/AJPH.2004.058933
July 2005, Vol 95, No. 7 | American Journal of Public Health Dickert and Sugarman | Peer Reviewed | Health Policy and Ethics | 15
HEALTH POLICY AND ETHICS
liciting approval or permission
to conduct a study within a
community. Community consent
may occur after community con-
sultation and does not obviate
the need for individual con-
sent.
36,37
Rather, the community
decides whether to permit inves-
tigators to solicit participation
from community members. For
community consent to be valid,
there must be a legitimate politi-
cal system in place, with repre-
sentatives properly empowered
to make such decisions on be-
half of the community.
37,38
In
many aboriginal communities,
such legitimate systems exist.
However, disease-based commu-
nities and many social groups
typically lack a political struc-
ture, which makes community
consent inappropriate.
37,38
Although conceptually distinct,
the line between community con-
sultation and community consent
is inevitably blurred in practice.
It would be disingenuous to
enter into a consulting arrange-
ment where the consulting party
does not intend, ex ante, to take
the consultants’ advice. If rele-
vant consultants have strong neg-
ative reactions or endorse partic-
ular modifications, those
reactions or modifications have
significant moral force and war-
rant respect and careful consider-
ation, even though investigators
may sometimes justifiably act
contrary to such opinions. Other-
wise, community consultation is
merely symbolic.
39
Despite the
clear conceptual distinction be-
tween consent and consultation,
the degree to which consultants
support is necessary represents a
persistent challenge.
15 , 16 , 2 9
Challenges of Community
Consultation
Potential difficulties exist at
each stage of community consul-
tation. At the outset, it can be
hard to identify communities and
stakeholders that have legitimate
and relevant interests. Common
elements exist among concep-
tions of community,
40
but delin-
eating and identifying particular
communities for consultation can
be challenging. Identifying the
community at risk for HIV, for
example, can be problematic,
because at-risk individuals may
not believe they are a part of
any such community.
41
Identify-
ing representatives also can be
difficult. Helpful procedures for
identifying representatives have
been suggested by The National
Institute for General Medical Sci-
ence,
32
but important conceptual
and practical challenges remain.
For example, no clear representa-
tive exists for persons who may
suffer from traumatic brain in-
jury or cardiac arrest.
42,43
Closely related to the chal-
lenge of identifying communities
is deciding when communities
should be consulted (assuming
they can be identified). In cer-
tain cases, there are regulatory
requirements for community
consultation.
31
Similarly, when
research poses real risks for so-
cial stigma to well-defined com-
munities, such as certain genet-
ics studies in native
communities, the need for com-
munity consultation is evident.
44
Yet, requiring community con-
sultation in all research projects
is unwarranted. Relevant factors
to consider when deciding
whether to conduct community
consultation include the particu-
lar community under considera-
tion, the nature of the research,
and the likely impact of the re-
search on that community. Fur-
ther analysis is needed; how-
ever, we hope that articulating
the goals of community consul-
tation will at least be a helpful
step in determining when con-
sultation is warranted.
The type of community being
considered for consultation is an
important factor when determin-
ing the way in which community
input is solicited. Common solici-
tation methods include open
public forums, meetings with
community advisory board mem-
bers, presentations at meetings of
religious or civic organizations,
and radio and television call-in
shows.
1,17,44–49
Devising success-
ful methods for generating public
input can be challenging, particu-
larly in communities that lack a
well-defined structure or are geo-
graphically disparate.
37,50
In many
cases, multiple modalities of in-
teraction must be employed,
44
it
can also be difficult to determine
when consultation efforts have
been sufficient. Although insuffi-
cient consultation can be ineffec-
tive, requiring overly extensive
consultation may hamper impor-
tant work.
Finally, incorporating consult-
ants’ input into research plans
can be challenging. Although it
is undesirable to override or dis-
miss community objections or
concerns, failure to conduct im-
portant research on the basis of
objections by groups who are
nonrepresentative or who have
not carefully considered the is-
sues at hand is also problematic.
Ethical Goals for Community
Consultation
A clear set of ethical goals will
help investigators, sponsors, insti-
tutional review boards, and regu-
lators plan and assess community
consultation methods. Addition-
ally, such a framework will pro-
vide endpoints for measuring the
adequacy of consultation meth-
ods. We propose four ethical
goals of community consultation:
(1) enhanced protection, (2) en-
hanced benefits, (3) legitimacy,
and (4) shared responsibility
(Table 1).
Enhanced protection. Enhancing
the protection of research partici-
pants’ interests and welfare is
grounded in the researchers’ duty
to minimize risks for research
subjects. Consultation efforts
should be designed and con-
ducted to help identify risks or
hazards for individuals and com-
munities and to help identify ad-
ditional protections to ensure the
safety of research participants.
Some risks, particularly social
risks, may not be apparent at the
outset to investigators, sponsors,
and institutional review boards.
Members of cancer advocacy
groups, for example, may serve
as important consultants when
designing informational materials
or calling attention to concerns
about adverse treatment effects
that may not be obvious to re-
searchers conducting a cancer
trial.
51
When research is con-
ducted in emergency settings,
community consultation may
generate discussion that helps to
identify groups who are likely to
want to opt out of specific studies
and that suggests strategies to fa-
cilitate the identification of those
American Journal of Public Health | July 2005, Vol 95, No. 716 | Health Policy and Ethics | Peer Reviewed | Dickert and Sugarman
HEALTH POLICY AND ETHICS
TABLE 1—Ethical Goals of Community Consultation
Ethical Goal Definition
Enhanced protection Enhance protections for subjects and communities by
identifying risks or hazards that were not previously
appreciated and by suggesting or identifying potential
protections
Enhanced benefits Enhance benefits to participants in the study, the population
for which the research is designed, or the community in
which the study is conducted
Legitimacy Confer ethical/political legitimacy by giving relevant parties
the opportunity to express their views and concerns at a
time when changes can be made to the research
protocol
Shared responsibility Consulted communities may bear some degree of moral
responsibility for the research project and may take on
some responsibilities for conducting the study
groups during the study. In this
sense, community consultation
may be a particularly effective
way for investigators to identify
individuals or subgroups with
particular needs or vulnerabili-
ties that individuals outside the
community may not recognize.
Community consultation also
may enhance nonparticipant pro-
tections by identifying risks for
community members who are
not enrolled in the study. For ex-
ample, studies of cancer suscepti-
bility that were conducted
among Ashkenazi Jews were op-
posed by some community mem-
bers who were concerned that
research findings might be used
for eugenics or might jeopardize
health coverage.
5
Although all
risks are not preventable, making
them explicit and minimizing
them are essential goals.
Enhanced benefits. Enhancing
benefits through community
consultation is consistent with
researchers’ general duty of
beneficence toward research
subjects.
52
Early HIV research
illustrates how community con-
sultation enhances benefits to in-
dividual subjects. For example,
1 community advisory board
recommended that a clinical trial
incorporate referral programs for
participants to gain access to
available ancillary services.
35
Based on this recommendation,
investigators chose to incorpo-
rate such programs into their
studies.
Community consultation may
also enhance benefits to the
community of individuals who
have the condition being studied
or to the larger communities to
which study subjects belong. In
the international setting, a com-
mon benefit of research involve-
ment is the improvement of the
research or health care delivery
infrastructure. By consulting with
host country researchers and
others in the host community,
the areas of infrastructure that
need improvement can be identi-
fied.
14
Similarly, a central notion
in community-based participa-
tory research is that communi-
ties should be involved in identi-
fying research questions and
planning studies in order to con-
duct studies that benefit the par-
ticular communities involved.
20
In short, community consultation
may enhance direct, indirect,
and aspirational benefits.
53
In-
vestigators are by no means re-
quired to provide all benefits
that could conceivably be of-
fered to participants or commu-
nities, but enhancing benefits to
ensure that research efforts are
mutually beneficial is an impor-
tant goal.
Legitimacy. Community con-
sultation can help to confer ethi-
cal and political legitimacy on a
research project by engaging in a
process in which _____________
may express their views and
concerns. Giving _____________
the opportunity to speak has sig-
nificant justificatory power for
imposing research risks, espe-
cially when individuals are un-
able to provide consent and sur-
rogate decision makers are
unavailable. In such cases, com-
munity consultation may be the
only chance investigators have to
assess the likely preferences of
the study population. Similarly,
when a study poses significant
risks for a community, such as
genetics research that could
have potentially negative impli-
cations on the insurability of an
entire population, community
consultation seems essential for
legitimacy.
The challenges to achieving
this goal are well-known. What
counts as a community? Who
counts as a representative? What
level of community support is
needed to legitimize a particular
study? These are deep, concep-
tual questions for which we do
not have well-developed an-
swers; however, it is important
to note that the goal of legiti-
macy refers to the process of
community consultation and
not the political legitimacy of
consulted bodies.
37
Suggestions
or concerns that are expressed
during community consultations
are significant, even when con-
sultants lack the authority to
provide consent on behalf of
the community.
Shared responsibility. As part-
ners in the research process,
community members may share
responsibility in 2 ways. First,
community consultants may as-
sume active roles in conducting
research. Community advisory
board members, for example,
may become involved in recruit-
ing subjects for studies
40,48,54
and
thus bear some responsibility for
the success of research efforts.
Second, by acknowledging the
stake that relevant community
members have in the conduct of
research, and by soliciting their
assistance and input through a
legitimate process, community
consultation confers on commu-
nities a degree of moral responsi-
bility for the research.
26
Shared responsibility is partic-
ularly evident with cases involv-
ing HIV advocacy groups, where
the advocacy groups have taken
on the role of actually conduct-
ing studies,
1
and with cases in-
volving participatory-action re-
search or community-based
participatory research, where
communities are involved at
July 2005, Vol 95, No. 7 | American Journal of Public Health Dickert and Sugarman | Peer Reviewed | Health Policy and Ethics | 17
HEALTH POLICY AND ETHICS
every stage.
17–19
It is important
to clarify that sharing responsibil-
ity does not constitute a shifting
of blame or removal of responsi-
bility from investigators, spon-
sors, and institutional review
boards. On the contrary, commu-
nity consultation places addi-
tional responsibility on investiga-
tors to attend to important
community concerns. The degree
to which responsibility can be
shared is limited by the degree to
which investigators and sponsors
are sensitive to and accommo-
date those concerns.
CONCLUSION
As the need for identifying
and incorporating community
input into the design, planning,
and conduct of research has be-
come clearer, it is critical to iden-
tify the ethical goals of commu-
nity consultation. Enhancing
protection, enhancing benefits,
creating legitimacy, and sharing
responsibility should allow for
more effective assessment by
communities, investigators, insti-
tutional review boards, and spon-
sors of particular consultation ef-
forts. We also hope that these
goals can be developed into met-
rics by which methods of com-
munity consultation may be sys-
tematically assessed. For
example, enhanced protections
can be measured by observing
whether a particular consultation
effort identifies additional risks
previously unknown to investiga-
tors or whether it proposes new
solutions for minimizing risk.
There are currently few empiri-
cal data on the effectiveness of
consultation strategies.
54
By iden-
tifying the goals of the process,
this framework should facilitate
attempts to assess different types
of consultation efforts in different
settings and enhance understand-
ing of which research methods
are appropriate in varying types
of communities and consulta-
tion methods.
Finally, this framework draws
attention to 2 important linger-
ing issues that are beyond the
scope of this article. First, an ac-
count is needed for determining
when investigators may justifi-
ably override or dismiss commu-
nity concerns. Such an account
must be particularly sensitive to
the nature of disagreements.
55
Second, further research is
needed to determine what
types of studies require commu-
nity consultation and what types
of consultation are needed for
particular research projects. In
the meantime, careful attention
to the 4 ethical goals we have
identified should facilitate the
proper incorporation of commu-
nity views into research and its
oversight.
About the Authors
The authors are with the Phoebe R. Berman
Bioethics Institute, Johns Hopkins Univer-
sity, Baltimore, Md. Jeremy Sugarman also
is with the Department of Medicine, Johns
Hopkins University.
Request for reprints should be sent to
Jeremy Sugarman, MD, MPH, MA,
Phoebe R. Berman Bioethics Institute,
Johns Hopkins University, Hampton
House 351, 624 N Broadway, Baltimore,
MD 21205 (e-mail: jsugarm1@jhmi.edu).
This article was accepted February 15,
2005.
Contributors
J. Sugarman originated the idea for this
article; both authors developed ideas
and reviewed each draft of the article.
Acknowledgments
We are extremely grateful for the
helpful comments we received while
developing this article. In particular,
we would like to thank Ezekiel
Emanuel, Christine Grady, Kate Mac-
Queen, Holly Taylor, and Myron Weis-
feldt. We also thank the reviewers for
their very thoughtful and instructive
suggestions.
Human Participant Protection
No protocol approval was needed for
this project.
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... The importance of engaging with local, regional and national health authorities (8) and gaining the necessary legitimacy via the permission and approval of local actors (22,23,25) was evident in the literature. ...
... Avoiding exploiting people (9,11,23), ensuring the protection of participants (25) and making sure that communities are not overburdened (22) all feature in the literature. Overburdening communities, in terms of going back to the same community rather than reaching out to other communities, was an issue that emerged from the workshop. ...
... Ensuring that research benefits the community is an often cited goal of CPE (7,10,25). Echoing the work of Pratt (27), workshop participants queried what or whose goals were the priority; the goals of the relatively short term research or the longer term goals of the community. ...
Article
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Community and public engagement (CPE) is increasingly becoming a key component in global health research. The National Institute for Health Research (NIHR) is one of the leading funders in the UK of global health research and requires a robust CPE element in the research it funds, along with CPE monitoring and evaluation. But what does "good" CPE look like? And what factors facilitate or inhibit good CPE? Addressing these questions would help ensure clarity of expectations of award holders, and inform effective monitoring frameworks and the development of guidance. The work reported upon here builds on existing guidance and is a first step in trying to identify the key components of what "good" CPE looks like, which can be used for all approaches to global health research and in a range of different settings and contexts. This article draws on data collected as part of an evaluation of CPE by 53 NIHR-funded award holders to provide insights on CPE practice in global health research. This data was then debated, developed and refined by a group of researchers, CPE specialists and public contributors to explore what "good" CPE looks like, and the barriers and facilitators to good CPE. Hickey et al. What Is "Good" CPE? A key finding was the importance, for some research, of investing in and developing long term relationships with communities, perhaps beyond the life cycle of a project; this was regarded as crucial to the development of trust, addressing power differentials and ensuring the legacy of the research was of benefit to the community.
... 24 Nevertheless, in low-income contexts in particular, economic, educational and power inequalities between the research team and the host community, could serve as barriers Open access and build distrust in the communities leading to study refusals and withdrawals [25][26][27][28] ; premature study closures; and inadequate sample sizes which cumulatively compromise the ability to generate high-quality evidence. [29][30][31] In community research, researchers are sometimes obliged-prompted by demands from communities-to address the burden of disease that is unrelated to the area of research, which potentially diverts resources away from achieving study aims. For example, factors such as poverty, malnutrition, lack of healthcare infrastructure and high disease burden bring additional challenges which may be unrelated to the research but demanding attention during the research process. 2 25 Involving communities from the designing phase of the research will thus enable them to present their disease burdens and other important issues for consideration. ...
... In reality, decision-making is much more complicated, with many women subtly influencing the outcome. 29 With the goal of having gender-inclusive CE in research, this study will examine current trends of gender considerations in involving communities. The findings of this study will also be useful because of the scarcity of literature on gender dynamics in engaging communities in research. ...
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Introduction: Meaningful community engagement (CE) is increasingly being considered the major determinant of successful research, innovation and intervention uptake. Community leaders, policy makers and funders have expressed the need to engage communities in research. CE in research empowers the host community to participate in addressing its own health needs and health disparities while ensuring that researchers understand community priorities. Thus, appropriate CE opens a unique way to promote coproduction, coimplementation and coevaluation, which may strengthen both the sense of inclusion, ownership and the effectiveness of the research life-cycle. The aim of this review is to synthesise available evidence on how to engage communities in research in a gender-sensitive, ethical, culture-appropriate and sustainable way in sub-Saharan Africa (SSA). This protocol has been developed following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and follows the guidance provided by the Cochrane Handbook for Systematic Reviews. Methods and analysis: A combination of key text words and medical subject headings such as ‘Community Engagement’ or ‘Community Involvement’ will be used to search 009 databases for all literature published between 1 January 2000 and 31 July 2021. Citations retrieved from database searches will be exported into EndNote X9 to remove duplicate citations and imported into Rayyan QCRI for screening. Two independent reviewers will conduct the screening and data extraction process. Disagreements between review authors will be resolved through discussions, consensus a third reviewer serving as a tiebreaker. The risk of bias will be assessed using the 10-item Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research. The three-staged process described by Thomas and Harden will be used for the thematic and narrative synthesis of findings. Ethics and dissemination: This is a systematic review which uses already collected data thus ethical approval not required. Findings will be published in an open access peer-reviewed journal and presented in relevant conferences and workshops.
... Data collection focused on three main areas which were used to code data: the goals of CE, the means and processes of CE, and the evaluation of CE. One of the important topics in CE is the question of what its goals are, or ought to be, and whether these can be generalized across settings and specific studies [1,5,35,[41][42][43][44]. Even though there was no agreement on a standard set of goals, we inferred from our respondents' views four key themes which stood out, and could be regarded as universal goals of CE. ...
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Background Community engagement (CE) in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering the emerging trend towards mandating CE in many research studies, this study aimed at documenting how CE is conceptualized and implemented, and then providing context-specific guidance on how researchers and research regulators in Uganda could think about and manage CE in research. Methods We conducted qualitative interviews and focus group discussions involving forty-one respondents who were experienced in HIV/AIDS biomedical research involving CE. Thirty-eight of these were directly or indirectly associated with Uganda’s leading research institution in the field of HIV/AIDS. They included Principal Investigators, Community Liaisons Officers, Research Ethics Committee members and Community Advisory Board Members. Three respondents were from Uganda National Council for Science and Technology. Data were collected between August 2019 and August 2020, using audio-taped focus group discussions and key informant interviews, transcribed and analyzed manually to generate themes and subthemes. Results Three major themes emerged: goals or value of CE; the means of CE, and, the evaluation of CE. Goals or value of CE generated four subthemes representing the overarching goals of CE: (1) Promote communities’ agency; (2) Generate and sustain trust; (3) Protect and promote communities’ rights and interests; and, (4) Help studies optimize participation in the form of enrolment and retention of participants. What usually comes under the nomenclatures of methods, strategies, and approaches of CE, such as town-hall meetings, sports events, drama, and the like, should simply be understood as the means of CE, and it is not desirable to hold pre-conceived and fixed ideas about the best means to conduct CE in research since a lot depend on the context. Finally, the study found that despite CE’s critical importance, which suggests the need to track and evaluate it, CE is currently intermittently evaluated, and for inadequate motivations. Conclusions Existing guidance on how to conduct robust CE in research is no substitute for creativity, flexibility, and reflexivity on the part of both researchers and research regulators.
... Health care workers (HCWs) represent another group that has been significantly harmed by the pandemic and should be included in CSC development. [65][66][67][68][69] Some physicians and other healthcare professionals have been put in the untenable ethical position of needing to ration resources or provide substandard care to patients during the pandemic. Current research on the impact of the COVID-19 pandemic on HCWs has revealed increased stress and mental distress within this cohort. ...
Article
The COVID-19 (SARS-CoV-2) Pandemic has revealed multiple structural inequities within the United States (US), with high social vulnerability index communities shouldering the brunt of death and disability of this pandemic. BIPOC/Latinx people have undergone hospitalizations and death at magnitudes greater than White people in the US. The untold second casualties are health care workers that are suffering from increased risk of infection, death, and mental health crisis. Many health care workers are abandoning the profession all together. Although Crisis Standards of Care (CSC) mean to guide the ethical allocation of scare resources, they frequently use scoring systems that are inherently biased. This raises concern for the application of equity in CSC. Data examining the impact of these protocols on health equity is scarce. Structural maltreatment in healthcare and inequities have led to cumulative harms, physiologic weathering and structural adversities for residents of the US. We propose the use of Restorative Justice (RJ) practices to develop CSC rooted in inclusion and equity. The RJ framework utilizes capacity building, circle process, and conferences to convene groups in a respectful environment for dialogue, healing, accountability, and action plan creation. A phased, non-faith-based facilitated RJ approach for CSC development (or revision) that fosters ethically equitable resource distribution, authentic community engagement, and accountability is shared. This opportunity for local, inclusive decision making and problem solving will both reflect the needs and give agency to community members while supporting the dismantling of structural racism and oppressive, exclusive policies. The authors are asking legislative and health system policy makers to adopt Restorative Justice practices for Crisis Standards of Care development. The US cannot afford to have additional reductions in inhabitant lifespan or the talent pool within healthcare.
... For example, raising community awareness of the risks associated with research participation may be at odds with a goal of supporting recruitment (1). Third, challenges emerge in defining indicators to explore the extent to which engagement addresses intrinsic goals, such as trust, respect, and relationship building (20)(21)(22). Recruitment rates are argued to be inadequate indicators of the success of community engagement without a thorough understanding of participant's degree of voluntariness and understanding of the proposed research (1,23). Lastly, the embeddedness of community engagement within health research institutes, with their dominant culture of experimental approaches (24,25), is likely to influence the consideration of randomized control trials (RTC) for evaluation of engagement. ...
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Background The growing ethical requirement to engage communities with health research has yielded diversification in approaches and targeted audiences. Conventional approaches like community “town-hall meetings,” laboratory open-days and focus group discussions, have evolved into new methods and audiences such as community drama and school engagement with health research (SEHR) involving learning interactions between researchers and school students. While engagement practices are diversifying, evaluations of these initiatives are rare in Low- and Middle-Income Countries (LMIC). This article focuses on the use of Participatory Video (PV) to explore the influence of the KEMRI-Wellcome Trust Research Programme's (KWTRP) School Engagement Programme (SEP) on the views and understandings of science and research among Kenyan state secondary school students. Methods Twelve male and twelve female students from four coeducational schools were provided with film-making kits (1 per school), and a one-day PV training workshop. They prepared 22 short films over 8 weeks depicting their experiences and views of research and engagement and conveying their career aspirations. Schools were selected based on prior SEP participation; two schools having experienced different engagement approaches, and the others with no prior school engagement. Study data comprised footage and participant observation notes. Results PV provided an opportunity to simultaneously engage and evaluate to inform practice. Through student-led filmmaking, PV stimulated conversations with students about research and engagement, enabling them to share their views in a way they felt was appropriate. These interactions offered an understanding of student gains from engagement, the depth of interaction required to address perceptions held about research and the potential unintended consequences of engagement. PV also provided insights into the context and complexity of life in which engagement is situated. Understanding this context is important because of its potential influence on participation in engagement activities. We draw on these insights to make two recommendations for school engagement practice. First is that PV can provide an enjoyable and insightful means of combining engagement with evaluation. Second, given that time for SEHR is competed for against other important curricular and extracurricular activities, SEHR practitioners must ensure that activities are as beneficial and enjoyable as possible to students.
... Fins and colleagues describe an approach of "consensus consent" when considering enrolling persons with DoC in clinical trials, which requires involvement and agreement among four parties-the participant's "legally authorized representative, the subject's physician, the clinical investigator, and a lay subject advocate" [101][102][103]. Others contend that a model of interactive community consultation or public deliberation, whereby salient values and preferences of recovered patients and other key stakeholder groups are ascertained in advance of a planned study, could potentially supplant or supplement the traditional informed consent process in select circumstances [81,[104][105][106][107]. Despite the proliferation of alternative models to informed consent, ethical debate still exists regarding the optimal form these approaches should take. ...
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As the clinical trial landscape for patients with disorders of consciousness (DoC) expands, consideration of associated ethical challenges and opportunities is of ever-increasing importance. Responsible conduct of research in the vulnerable population of persons with DoC, including those with coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), minimally conscious state (MCS), covert cortical processing (CCP), and cognitive motor dissociation (CMD), demands proactive deliberation of unique ethical issues that may arise and the adoption of robust protections to safeguard patients, surrogates, and other key stakeholders. Here we identify and critically evaluate four central categories of ethical considerations in clinical trials involving participants with DoC: (1) autonomy, respect for persons and informed consent of individuals with liminal consciousness; (2) balancing unknown benefits and risks, especially considering the epistemological gap between behavior and consciousness that complicates ordinary ascription of subjective states; (3) disclosure to surrogates and clinical teams of investigational results pertaining to consciousness; and (4) justice considerations, including equitable access to clinical trial enrollment across communities and geographies. We outline guiding principles and research opportunities for clinicians, neuroethicists, and researchers engaged in DoC clinical trials to advance ethical study design and deployment in this complex yet crucial area of investigation.
Article
The majority of emerging and re-emerging infectious diseases in people are zoonotic. Despite substantial research in communities adjacent to protected areas with high levels of biodiversity, limited data exist on people's knowledge, attitudes, and practices to avoid exposure to infections from domestic and wild animals. We used a modified grounded-theory framework in QS NVivo to develop a Knowledge, Attitude, and Practices (KAP) survey administered at two time points, KAPT1 (April-July 2016) and KAPT2 (February-May 2018) to participants living at the edge of Kibale National Park, Uganda. We measured the difference in willingness to engage in protective behaviors around zoonotic exposure between an Intervention group (n = 61) and a Comparison group (n = 125). Prior to KAPT1, the Intervention group engaged in a human-centered design (HCD) activity identifying behaviors that reduce zoonotic exposure (March-May 2016). Using a difference-in-difference approach, we compared the Intervention and Comparison groups to assess sustained willingness and use of protective behaviors against domestic and wild animal exposures. At KAPT1, Comparison group participants had a significantly lower (p < 0.05) level of willingness to engage in behaviors that increase exposure to zoonoses from domestic animals; Intervention group participants had a significantly higher (p < 0.01) level of willingness to engage in behaviors that increase exposure to zoonoses from wild animals. At KAPT2, the treatment effect was significant (p < 0.01) for sustained willingness to engage in protective behaviors for domestic animal exposure in the Intervention group. There were no significant differences in practices to avoid domestic and wild animal zoonotic exposure between the Intervention and Comparison groups.
Article
Background: Involvement of communities in health research has been at the forefront of ethical conduct of research Worldwide. Many scholars put forward different ways of engaging communities in health research, debates on the levels of engagement, who should be engaged in the community and how, still persist. At the Ifakara Health Research Institute (IHI) in Bagamoyo, Tanzania. Different approaches to engaging with the community in health research have been used over the last decade. The present research was aimed to describe the nature of community structures, that could be engaged in health research at the Ifakara Health Institute. Methods: Data collection was undertaken in between February 2019 and December 2019.A total of 25 interviews in which 19 were In-Depth Interviews, and 6 were Focus Group Discussions were carried out. Respondents were those previously participated in IHI research. Interviews were audiotaped, transcribed, and analyzed using framework analysis. Results: Different community structures including; village executive officers, community health workers, hamlet leaders, and community advisory board were involved in engagement activities. Approaches used as per the findings; community-level public meetings, information giving at household level/health facilities, the outpatient attendance at hospital/dispensary, Health District Coordinators, village leaders/representatives and routine health care campaigns; such as Tuberculosis day (TB day), Malaria day and HIV day. Reported weaknesses were inconsistence research feedback, insufficient engagement with participants about specific research projects are recruited into and false promises by researchers to community stakeholders. Conclusion: The results emerged the need to strengthen community engagement system at IHI, which require coordination of engagement at the institute and across different research activities. The current approach, seems inadequate but also is very challenging due to minimal opportunities for interactions and for deeper levels of engagement. Recommendations to use other methods such as mass media to reach larger populations is more appropriate than ever.
Chapter
Psychiatric genetics is a relatively new field that has changed rapidly over the past few decades due to technological advancement and scientific breakthrough. This chapter reflects on the origins of psychiatry, its history, and the history of psychiatric genomics.
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Groundwater pumping can cause reductions in streamflow (“streamflow depletion”) that must be quantified for conjunctive management of groundwater and surface water resources. However, streamflow depletion cannot be measured directly and is challenging to estimate because pumping impacts are masked by streamflow variability due to other factors. Here, we conduct a management‐focused review of analytical, numerical, and statistical models for estimating streamflow depletion and highlight promising emerging approaches. Analytical models are easy to implement, but include many assumptions about the stream and aquifer. Numerical models are widely used for streamflow depletion assessment and can represent many processes affecting streamflow, but have high data, expertise, and computational needs. Statistical approaches are a historically underutilized tool due to difficulty in attributing causality, but emerging causal inference techniques merit future research and development. We propose that streamflow depletion‐related management questions can be divided into three broad categories (attribution, impacts, and mitigation) that influence which methodology is most appropriate. We then develop decision criteria for method selection based on suitability for local conditions and the management goal, actionability with current or obtainable data and resources, transparency with respect to process and uncertainties, and reproducibility.
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Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research.
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The issue of the protection of communities in clinical research first arose 10 years ago in studies conducted in technologically developing countries by scientists from technologically developed nations. The question was, which ethical standards ought to apply, those of the Western investigators or local standards?
Article
Background This article describes how one Institutional Review Board (IRB) chose to implement the issue of waiver of consent for a research study involving brain trauma victims brought to an emergency department. Methods Presentations were conducted in the state of Mississippi among cultural and ethnic groups representative of Mississippi9s demographic composition. Individuals from the neurotrauma research team, including neurosurgeons and nurse study coordinators, conducted all of the presentations. One IRB member served as an objective “community liaison” and attended all presentations. This individual administered evaluation forms to attendees that measured their levels of comprehension and acceptance for the use of waiver of consent in the brain trauma study. Results All of the 137 attendees in 7 community consultation meetings gave their approval for the use of “waiver of consent.” Continued community consultations are planned for the duration of the brain trauma study. Conclusion Based on our experience, we conclude that in collaborating with local IRBs, research teams can successfully develop strategies for obtaining “acceptable community consultations” as required by regulatory mandates. We suggest that standardized community consultation guidelines be developed for obtaining waivers of informed consent in emergency research. Such criteria should form the basis for local IRBs to obtain their respective community consultations.
Article
In November 1996, regulations developed by the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) went into effect to allow certain emergency and resuscitation human subjects research to proceed without prospective informed consent. These new regulations brought harmonization to the requirements of the 2 federal agencies charged with research oversight and ended a moratorium that had essentially shut down resuscitation research for almost 4 years. However, the FDA's emergency exception from informed consent and the HHS's waiver of informed consent have been used infrequently. Many perceived obstacles to implementation of the regulations have been described, including the additional regulatory burden for investigators and institutional review boards, the extra expense and time. required to adequately fulfill the regulatory requirements, and the reluctance of institutional review boards to allow these studies to move forward because of concerns about potential legal ramifications. Regardless of the arguments advanced, these regulations are essentially the only current regulatory options that have been provided for research without consent. This article presents a brief history of the development of the FDA's Final Rule, a summary of its requirements and its use so far, and suggestions for its implementation. Some strategies to allow the resuscitation research community to suggest fine tuning of the regulations are suggested in hopes that research requiring an exception from informed consent is allowed to proceed in a manner acceptable to regulators, is stringent in patient protection, and yet is sensitive to the practical aspects of performing resuscitation research.
Article
The knowledge, expertise, and resources of the involved community are often key to successful research. Three primary features of participatory research include collaboration, mutual education, and acting on results developed from research questions that are relevant to the community. Participatory research is based on a mutually respectful partnership between researchers and communities. Partnerships are strengthened by joint development of research agreements for the design, implementation, analysis and dissemination of results. Results of participatory research both have local applicability and are transferable to other communities.
Article
The current practice of requiring the informed consent of research subjects is relatively new. The emphasis on a person's right to accept or refuse participation in biomedical research stems directly from the atrocities committed by Nazi "scientists" — an extreme instance of ignoring the value of individual human beings allegedly in the pursuit of knowledge.1 2 3 Similar but less dramatic disrespect for the subjects of medical research was common just after the Second World War and reflected the paternalistic atmosphere that pervaded medical practice at that time.1 , 4 More recent examples of unethical research, which stimulated the development of the current theory . . .