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Ethical Goals of Community Consultation in Research

August 2005
American Journal of Public Health 95(7):1123-7

DOI:10.2105/AJPH.2004.058933

Source
PubMed

Authors:

Emory University

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.

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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.

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.

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.”

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

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HEALTH POLICY AND ETHICS

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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

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.

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,

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.

Identify-

ing representatives also can be

difficult. Helpful procedures for

identifying representatives have

been suggested by The National

Institute for General Medical Sci-

ence,

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.

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.

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,

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.

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

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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.

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.

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.

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.

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.

In short, community consultation

may enhance direct, indirect,

and aspirational benefits.

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.

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.

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,

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

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HEALTH POLICY AND ETHICS

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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.

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.

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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Role of Social Science in Infectious Disease Research: A Case Study of Partnering with Communities in Vector Control in a Kenyan Village

Chapter

Full-text available

Dec 2024

Partnering with communities is a vital component of public health research. Terms such as community participation, community engagement, and citizen participation have been used to denote community partnerships that aim to re-distribute power through negotiation between citizens and researchers and enable co-creative processes that bring non-researchers in as core partners. These citizen-researcher partnerships go beyond informed consent, voluntary participation, and intervention adherence but instead constitute a means by which shared planning, design, implementation, dissemination, and decision-making take place. In this case study, we describe our intervention study in coastal Kenya that included homeowners, schools, schoolchildren, and other stakeholders to increase people’s awareness of vectors and vector-borne diseases and catalyze their participation in vector control. The partners for this work included researchers from local and international universities, social scientists, non-governmental organizations, officials from the ministries of health and education, and the community members themselves. We trialed new strategies to deeply engage adult and child community members to promote vector control activities at home and in the community. Strengthening community involvement and establishing prolonged interaction of community representatives with control services, municipalities, and other public actors were shown to be time-consuming and costly at the beginning but rewarding during the process and with excellent potential for sustainability. In this case study, we also investigate the concepts of gender norms and patriarchy and underscore how they interact with other forms of culture to impact decision-making processes, power imbalance and dominance, and vulnerability to ill health at our study site in Kenya. We highlight social science’s contribution to enhancing a deeper understanding of the social constructs that underlie power structures and concepts of disease and health in the Kenyan village, thus fostering successful partnerships with the community and enhancing research outcomes. The key tenets from this case study are relevant to community-based research conducted in similar contexts.

8 Building Biomedical Research Capacity in Low- and Middle-Income Countries: Why It Matters and Some of the Barriers to Success

Chapter

Full-text available

Aug 2024

This chapter elaborates on the importance of preexisting research capacity in low- and middle-income countries (LMICs) for strengthening resilience against emerging and re-emerging infectious disease (EID) threats. In a broad sense, resilience is the ability of societies to maintain their core functions while responding to infectious disease outbreaks and other threats to the well-being of the population in order to minimize their health impact and other socioeconomic consequences. As the COVID-19 pandemic has demonstrated, broadly available research capacity can contribute to resilience by helping the global research community refine the research questions that should be asked, elucidate essential scientific information about emerging pathogens more quickly and effectively, and develop and assess medical countermeasures (MCMs) such as vaccines and treatments for the disease. Strong research capacity in LMICs would help identify, characterize, and then slow or contain the spread of a new or unfamiliar pathogen, especially when it first appears in a geographically confined outbreak in one or a few contiguous LMICs. This may give research scientists more time to understand and counteract it. LMIC research capacity also contributes to more equitable governance of research during outbreaks, with at least the potential for broader distribution of MCMs than was seen during the COVID-19 pandemic. Building biomedical research capacity is not a simple matter as it requires educational and healthcare systems that can support it by producing the necessary personnel, and, through health system functions like biosurveillance, access to patient data and the capacity to conduct clinical trials to assess MCMs. Such capacity building will require sustained investment by countries and international partners, but that investment would be more than justified even on solely economic terms by one averted pandemic. Additionally, the value of progress toward universal healthcare that comes with comprehensive capacity building is incalculable.

The Bidirectional Engagement and Equity (BEE) Research Framework to Guide Community–Academic Partnerships: Developed From a Narrative Review and Diverse Stakeholder Perspectives

Article

Full-text available

Aug 2024
HEALTH EXPECT

Background The engagement of community partners in equitable partnerships with academic teams is necessary to achieve health equity. However, there is no standardized approach to support bidirectional engagement among research stakeholders in the context of partnership equity at each phase of the research process. Objective We describe the development of a systematic framework along with competencies and tools promoting bidirectional engagement and equity within community–academic partnerships at each phase of the research process. Design We conducted a four‐step research process between November 2020 and December 2023 for framework development: (1) a narrative literature review; (2) expansion of existing bidirectional, equitable framework; (3) a scientific review with two groups of cognitive interviews (five community engagement researchers and five community leaders and members); and (4) three community‐based organization leader focus groups. Thematic analysis was used to analyse focus group data. Results Using results of each step, the framework was iteratively developed, yielding four phases of the bidirectional engagement and equity (BEE) research framework: Relationship building and assessment of goals and resources (Phase I); form a community–academic partnership based on shared research interests (may include multilevel stakeholders) (Phase II); develop a research team comprising members from each partnering organization (Phase III); and implement the six‐step equitable research process (Phase IV). Bidirectional learning and partnership principles are at the core of the partnership, particularly in Phases II–IV. Competencies and tools for conducting an equitable, engaged research process were provided. Discussion This conceptual framework offers a novel, stepwise approach and competencies for community–academic partners to successfully partner and conduct the research process equitably. Conclusion The BEE research framework can be implemented to standardize the conduct of an equitable, engaged research process within a community–academic partnership, while improving knowledge and trust across partners and, ultimately, an increased return on investment and sustainability to benefit both partners in the area of health outcomes and ultimately health equity. Patient or Public Contribution The development of this framework was co‐led with a community organization in which two leaders in the organization were equitably involved in each phase of the research process, including grant development, study design, participant recruitment, protocol development for focus groups and community and researcher review, framework design and content and dissemination of this manuscript as a co‐author. For grant development, the community leader completed the give‐get grid components for them as a partner. They also wrote up their lived experience in the research process for the progress report. For the focus groups, one community leader co‐led the focus group with the academic partner. For the narrative review, the community leaders did not actively conduct the narrative review but observed the process through the academic partners. One community leader wrote the section ‘relationship building’ and ‘bidirectional learning’ sections with the assistance of the academic partner, while they both equally provided input on other sections of the manuscript alongside academic partners. The community leaders have extensive experience in leading programmes, along with partnering with researchers to address health equity issues and improve health outcomes.

Démarche participative d’élaboration d’un programme générique de préparation au mariage à l’Église maronite au LibanA Participatory Process to Developing a Generic Marriage Preparatory Program for the Maronite Church in LebanonProceso participativo para desarrollar un programa genérico de preparación al matrimonio en la Iglesia maronita en el Líbano

Article

Feb 2025

Cadre de la recherche : Cet article s’appuie sur une thèse de doctorat portant sur l’élaboration d’un programme générique de préparation au mariage à l’Église maronite au Liban. Dans ce contexte, la préparation au mariage est confrontée à des défis majeurs tels que la réticence et le désintérêt des couples, résultant notamment d’une adaptation insuffisante aux attentes contemporaines. Objectifs : Développer un programme générique de préparation au mariage répondant aux besoins et aspirations des couples, tout en favorisant leur participation active. Les objectifs de ce processus visent à impliquer les parties prenantes dans l’analyse des programmes de préparation au mariage existants, l’étude des besoins des couples, et la conception du programme. Méthodologie : L’étude s’appuie sur l’analyse des besoins comme outil de planification de programme. Les résultats obtenus de la première phase de collecte des données ont servi de base à l’élaboration initiale d’un programme générique de préparation au mariage. La deuxième phase a porté sur un forum communautaire interactif visant à finaliser la version définitive du programme. Conclusion : La recherche souligne l’importance de la préparation au mariage pour les couples contemporains tout en insistant sur l’importance de répondre à leurs besoins et préoccupations. Contributions : Proposer un programme de préparation au mariage adapté aux besoins des couples contemporains et intégrant des stratégies de motivation pour encourager leur engagement actif, et ainsi renforcer leur responsabilité dans la réussite de leur mariage.

Vaccines for The Prevention and Treatment of HIV Infection

Chapter

May 2017

Psychiatric factors play a significant role in the ongoing human immunodeficiency virus (HIV) pandemic. In less than four decades, advances in HIV medical care and research have transformed acquired immune deficiency syndrome (AIDS) from a rapidly fatal illness of unknown cause into a chronic, manageable illness. Vast strides have been made in clinical care and pathogenesis research in the fields of HIV prevention and psychiatric care, including pre- (PreP) and and post-exposure (PEP) prophylaxis. Although AIDS is an entirely preventable infectious illness, HIV transmission continues throughout the world. Transmission of HIV continues to be fueled by many factors, including stigma of HIV and mental illness as well as discrimination, criminalization, and risky behaviors. A comprehensive biopsychosocial approach to sexual health and mental health and diminution of stigma are key to both HIV prevention and HIV care. Integration of psychiatric care into HIV prevention and treatment entails use of a biopsychosocial approach that maintains a view of each individual with HIV as a member of a family, community, and society who deserves to be treated with dignity and compassion. This textbook provides an update on HIV medicine and psychiatry; introduces the concept of HIV/AIDS as “the great magnifier of maladies”; explores the paradoxes and disparities of HIV care; explains how HIV psychiatry is a paradigm for the psychiatric care of the medically ill (psychosomatic medicine); and sets the stage for an understanding of how integrated care can prevent transmission of HIV and reduce morbidity and mortality in persons with HIV.

Conceptualizing Community Engagement for Mental and Brain Health Research in Low- and Middle-Income Countries: A Case of Kilifi County, Kenya

Article

Aug 2024

Community engagement (CE) has increasingly been recognized as a critical element for successful health promotion and intervention programs. However, the term CE has been used to mean different things in different settings. In this article, we explore how CE has been conceptualized in the field of mental and brain health in Kilifi County, Kenya. We used ethnographic methods encompassing focused group discussions, key informant interviews, and observations with 65 participants, purposively recruited from Kilifi County. Data were transcribed verbatim and thematically analyzed. Our findings show that community members and stakeholders had diverse perceptions of and experiences with CE. Factors such as trust between researchers and community members, sensitization, and awareness creation were key for acceptance of research projects. Partial involvement in research, lack of access to information, poverty and socio-economic challenges, and financial expectations from researchers hindered CE and led to resistance to participation in research projects. For effective CE, there is a need to work closely with community gatekeepers, create awareness of the research projects, use local languages, and ensure continuous engagement that promotes equitable research participation. Our findings suggest that tacit knowledge, context, and mechanisms for research are all critical features of CE and should be considered to enhance acceptance and sustainability of mental and brain health interventions in Kenya.

Ethical Issues in Implementation Science: A Qualitative Interview Study of Participating Clinicians

Article

Aug 2024

Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma

Article

Jul 2024

Importance Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive. Objective To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests. Design, Setting, and Participants This survey study analyzed the CC and PD campaigns conducted for the TAP trial (Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival), an EFIC trial of the early administration of prothrombin complex concentrate in patients with trauma. The CC and PD campaigns consisted of social media advertisements, linked websites, community surveys, and online community forums. These activities were coordinated from a central site and approved by a central institutional review board. This study focused on the first 52 of 91 TAP trial sites (level I trauma centers) in the US to have completed their CC and PD campaigns. Community members in the catchment areas of the participating trauma centers were targeted. Data analysis was conducted between October 2023 and February 2024. Exposure Social media advertisements, surveys, and online community meetings conducted as part of the CC and PD campaign for the TAP trial. Main Outcomes and Measures Social media campaign reach and engagement, web page views, survey results, online community forum attendance, and opt-out requests. Results Fifty-two trial sites were approved for participant enrollment. Social media advertisements were displayed 92 million times, reaching 11.8 million individuals. The median (IQR) number of people reached in each location was 210 317 (172 068-276 968). Site-specific websites were viewed 144 197 times (median [IQR] viewings per site, 2984 [1267-4038]). A total of 17 206 fully or partly completed surveys were received, and survey respondents had a median (IQR) age of 40.1 (15-65) years and included 10 444 females (60.7%). Overall, 60.6% survey respondents said they would want to be entered into the trial even if they could not give consent, 87.7% agreed that emergency care research was necessary, and 88.0% agreed that the TAP trial should be conducted in their community. Online community forums were attended by a median (IQR) number of 38 (20-63) people. Four opt-out requests were received. Conclusions and Relevance The interactive media-based approach to CC and PD for the ongoing TAP trial showed the feasibility and benefits of executing an efficient, coordinated, centrally run series of locally branded and geographically targeted CC and PD campaigns for a large EFIC study.

A youth advisory group on health and health research in rural Cambodia

Article

Jun 2024

Engaging young people in health research has been promoted globally. We explored the outcomes of youth advisory group on health and research engagement (YAGHRE) in rural Cambodia. In May 2021, the Mahidol Oxford Tropical Medicine Research Unit (MORU) partnered with a local health centre and a secondary school to establish a youth engagement group. Ten students underwent training and led health engagement activities in schools and communities. Activities were documented as field notes and audio-visual materials which underwent content analysis using theory of change supplemented by iterative discussions with YAGHRE members and stakeholders. Five major outcomes were identified: 1. Increased respect. Engagement activities developed based on input from students and stakeholders may have fostered greater respect. 2. Built trust and relationships. Frequent visits to MORU's laboratory and interactions with researchers appeared to contribute to the building of trust and relationship. 3. Improved health and research literacy. Learning new health and research topics, through participatory activities may have improved literacy; 4. Improved uptake of health and research interventions. Health promotional activities and communication with research participants potentially increased the uptake of interventions; 5. Improved community health. YAGHRE's health promotional interventions may have contributed in enhancing community's health.

Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic

Article

Apr 2024
CLIN TRIALS

Introduction Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research. Methods The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings. Results During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public. Conclusion The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

Protecting Communities in Biomedical Research

Article

Full-text available

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.

When Science Offers Salvation: Patient Advocacy And Research Ethics

Book

Sep 2023

Rebecca S Dresser

Biomedical research today has a high public profile, largely because of patient advocacy. Following in the footsteps of HIV/AIDS activists, advocates representing an array of patient groups are now vocal partners in the research enterprise. This book shows how advocates have transformed health research, often - but not always - for the better. Dresser is the first to examine patient advocacy through the lens of research ethics. She exposes the bright and dark sides of patients’ expanded opportunities to enroll in clinical trials and join researchers in planning and evaluating studies. She considers the virtues and drawbacks of giving patients more influence over how the government invests its research dollars. She argues that advocates should do more to promote ethical human studies and responsible media reporting about research. Patient advocates can help make research more ethical, but advocacy raises ethical issues of its own. This book clearly and vividly recounts the advocacy contribution to research and explores the thorny ethical issues facing research advocates.

Implementation of Community Consultation for Waiver of Informed Consent in Emergency Research: One Institutional Review Board's Experience

Article

Mar 2004

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.

Research without consent: Current status, 2003

Article

Oct 2003
ANN EMERG MED

Michelle Biros

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.

ETHICS: Fair Benefits for Research in Developing Countries

Article

Dec 2002

Participants in the Conference on Ethical Aspects of Research in Developing Countries

Task force 3. Special aspects of research conduct in the emergency setting: Waiver of informed consent

Conference Paper

Mar 2000
J AM COLL CARDIOL

Ethics in Public Health Research

Article

Jun 2004

Sandra Crouse Quinn

Increasingly, researchers grapple with meaningful efforts to involve communities in research, recognizing that communities are distinct from individuals. We also struggle to ensure that individual participants in research are fully protected. Community advisory boards (CABs) offer an opportunity to adopt a relationships paradigm that enables researchers to anticipate and address the context in which communities understand risks and benefits, and individuals give consent. CABs provide a mechanism for community consultation that contributes to protecting communities and fostering meaningful research. Furthermore, CABs can help us to re-create informed consent as a process. It is critical that we conduct research to understand the role of CABs in the informed consent process.

Working Through the Public Disclosure Process Mandated by Use of 21 CFR 50.24 (Exception to Informed Consent)

Article

Nov 1998
J Trauma Inj Infect Crit Care

New Food and Drug Administration guidelines allow research to be done under an "exception to informed consent." These guidelines mandate advance public disclosure (PD) but provide no specifics for how to accomplish this task. This report outlines the history of informed consent in emergency care situations, highlights the Food and Drug Administration regulations for an exception to informed consent, and describes a stepwise approach with specific details of a PD program for a study using a blood substitute. This descriptive report can serve as a guideline for subsequent emergency care investigators in the development of a strategic plan for PD.

Research without consent

Article

Oct 2003
ANN EMERG MED

Michelle Biros

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.

Participatory Research Maximises Community and Lay Involvement

Article

Sep 1999

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.

Ethical Goals of Community Consultation in Research

Abstract

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