Ethical Issues in International

Clinical Research: Understanding,

Respecting and Addressing Local

Cultural Patterns

Béatrice Godard University of Montreal

Public Health School

Outline

• International clinical research trends

• Rationale for understanding, Respecting and Addressing

Local Cultural Patterns

• Guidelines

• Challenges

• Definitions

• Types of involvement

• Advantages and limits

• What has been done for improvement?

• What could be done better?

• Conclusion

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Clinical research: Types of Registered

Studies

Study and Intervention Type

(as of November 04, 2014)

Number of Registered Studies and

Percentage of Total

Total 178,077 (187 countries)

Interventional 143,799 (80%)

Drug or biologic 92,866

Behavioral, other 38,118

Surgical procedure 15,679

Device 14,102

Observational 33,461 (18%)

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Map of all studies

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5

Country

Community

Participation

Community

Involvement

Community

Engagement

Community-

Based

Participatory

Research

USA 319 185 159 47

Canada 49 39 16 2

Mexico 1 4 0 0

Central America 11 3 5 1

South America 10 10 1 2

Europe 50 47 7 2

Africa 30 27 18 0

Middle East 7 8 2 0

North Asia 4 4 2 0

East Asia 20 15 7 5

Southeast Asia 3 12 1 2

South Asia 9 9 2 0

Japan 0 3 0 0

Pacifica 4 8 0 1

TOTAL 498 330 224 66

Rationale for addressing cultural

patterns (1)

• Due to the number and scale of clinical research, the risk of group harm gives greater urgency: • To ensure that communities understand the

investigations

• To seek their input regarding how the investigations and the groups are described

• NIH: « may help to identify pitfalls in the design or study plan which may improve the project’s aims to address issues of importance to the community and to yield meaningful data while working within distinct social and cultural contexts” (2002)

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Rationale for addressing cultural

patterns (2)

• To take into account a number of social, cultural and ethical issues relevant to research results communication since scientific knowledge is susceptible of being interpreted according to different mental schemes and framed according to different values and cultures

Ex: Cholera Haïti

Genetic stigmatisation Canada

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International Guidelines: Minimal

requirements

• Helsinki (1964-2013)

• Individual informed consent > community consent

• CIOMS International Ethical guidelines for biomedical research

involving human research (2002, in revision)

• Universally ethical principles > pluralist view

• Ethical review in the sponsoring country limited to comply with ethical

standards of the host country

• Respect of cultural customs: Individual consent only after obtaining

permission from a community leader

• UNESCO Universal Declaration on Bioethics and Human

Rights (2005)

• Respect for cultural diversity and pluralism vs respect for human dignity

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National Guidelines: US

• Indigenous Peoples Council on Biocolonialism, Indigenous

Research Protection Act (2000)

• Establish research review mechanism to prevent the continued

abuses, to protect the people’s traditional knowledge and

properties

• Fully informed consent after full consultation and full disclosure

or the research

• Respect of the integrity, morality, and spirituality of the culture,

traditions, and relationships of tribal members with the world

• Cultural sensitivity training

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National Guidelines: Australia

• National Health and Medical Research Council, Values and Ethics:

Guidelines for Ethical Matters in Aboriginal and Torres Strait

Islander Health Research (2003)

• Consultation and other strategies that facilitate aboriginal

participation in all phases of the research process

• Community engagement

• Aboriginal Research Ethics Committees

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National Guidelines: Canada

• CIHR Guidelines for Health Research Involving Aboriginal People

(2007)

• TCPS-2, Chapter 9, Research Involving the First Nations, Inuit and

Métis Peoples of Canada (2010)

• Requirement of community engagement in aboriginal research

• Recognizing diverse interests within communities

(ex: individuals and subgroups who may not have a voice in the

formal leadership)

• Respect for community customs and codes of practice

(ex: oral cultures and knowledge that can be publicly disclosed)

• Recognition of the role of elders and other knowledge holders

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Challenge 1: Community Definition

« Collectivity with shared identity or interests that has the

capacity to act or express itself as a collective » (TCPS2 2010)

• May include members from multiple cultural groups

• May be territorial, organizational or a community of interest

•An individual may belong to multiple communities

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Challenge 2: Culture Definition

• Culture: Full range of learned human behavior patterns

« That complex whole which includes knowledge, belief, art, law,

morals, custom, and any other capabilities and habits acquired by

man as a member of society » (Taylor 1871)

• Large and fragile concept: It exists only in our minds…

• ≠ layers of culture:

• Geographical: Shared language, tradition, beliefs that set

peoples apart from others (ex: American culture)

• Subculture: when peoples retain much of their original cultural

traditions (ex: Mexican Americans)

• Cultural universals: learned behavior patterns that are shared by

all of humanity collectively (ex: incest taboo)

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Challenge 3: Community Involvement (1)

• Community Participation (Heller et al 2014)

– clinicaltrials.gov: Process ≠ outcome

– Nelson & Wright (1995): Means ≠ empowerment

• Community Involvement: Political symbol of community

participation (Morgan 2001)

– Kahssay & Oakley (1999): « Project-level commitment to

community participation, while important, is insufficient to ensure

the sustainability of the concept; (…) In order for participation to be

sustainable, it must extend beyond the local (or project) level ».

• Community Engagement: The terms “CP” and “CP” both

connote manifestations of CE and have been influential in

CE approaches. (Tindana et al 2007) (Participants 2013)

– « The process of working collaboratively with relevant partners

who share common goals and interests » 14

Challenge 3: Community Involvement (2)

• Community-based participatory research (Mikesell et al

2013, Seifer et al 2010)

• « A collaborative approach to research that equitably

involves all partners in the research process and

recognizes the unique strengths that each brings. CBPR

begins with a research topic of importance to the

community, has the aim of combining knowledge with

action and achieving social change to improve health

outcomes and eliminate health disparities ». (WK Kellogg

Foundation Community Health Scholars Program)

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Challenge 3: Community Involvement (3)

• Not legally required, not a required part of the REC approval process

• No agreement on which methods of consultation are best for addressing particular goals

• No agreement on which ethics and policy goals consultation can address

• Little agreement as to what should trigger consultations, or the standards by which oversight bodies should evaluate them

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Advantages of involving communities

• An ongoing dialogue facilitates greater

comprehension and responds to the potential

concerns of the community

• To elicit feedback regarding potential participants’

values, preferences, concerns

• Community involvement makes the individual

consent process more strong: an informed

decision-making process

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Limits of involving communities

• Conducting community consultations for clinical

research is delicate:

• Issues of representativeness, social identity, internal

politics and cross-cultural differences abound (Juengst

2000)

• Protections for communities are asymmetric: • If the community consents to research participation,

individuals may still refuse to participate

• Even with the willingness to respect cultural

patterns, there is still a risk that the public mistrust

researchers and simply not participate in sufficient

numbers

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What has been done for improvement?

• Having local ethical review to ensure local cultural

norms are taken into account (Ravinetto et al 2011) (Ibia

et al 2010)

• Partnership: include participants and communities as

key-actors (ex: PARTAKE, Burt et al 2013)

• New strategies to improve communication (Kuthning et

al 2013)

• Benefit sharing (Lairumbi et al 2012) (Pratt et al 2012)

(Caplan 2010)

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What could be done better?

• Replacing a ‘tick-box’ culture by a culture of ethicovigilance: over-

regulation can lead to a lack of ethical vigilance (Shaw et al 2012, Pratt

et al 2012)

• Proactive communication between IRB, where the research takes

place and in the country of the funding agency for mutual learning

process (Ravinetto et al 2011)

• Education of participants regarding fundamental ethical principles

(Cornejo et al 2012)

• Participants’ responsibilities: duties related to promise-keeping,

avoiding harm to one's self or others, beneficence and reciprocity

(Resnik et al 2012)

• Improving transparency in the clinical trial system to ensure fulfillment

of the “social contract” between researchers, participants, and the

community (Djulbegovic)

• Mechanisms for turning transnational clinical research into a more

cooperation and fairer enterprise (Garrafa et al 2010)

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Conclusion

• Require specialized and targeted communications, with an

appropriate proportioning of information and

communication

• Consider the "values and personal interests" of individuals

depending on the reference group

• Ongoing dialogue: As partners in, rather than simply as

subjects of the research activity, participation increases the

likelihood that community members will feel empowered

rather than exploited

• Build bridges with many stakeholders and institutions in

various environments

Thank you!

beatrice.godard@umontreal.ca

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