Research in Resource-Poor Settings

Navigating Ethical Challenges

Anita Ho, PhD, MPH

Associate Professor, Centre for Applied Ethics, University of British Columbia
Affiliate Faculty, UCSF Bioethics
 Dr. Carol Pavlish

With Rose and Lawrence from ARC in Yei, South Sudan

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3 Presentation Title and/or Sub Brand Name Here 7/6/17
 Photo source: http://a.abcnews.com/images/International/AP_South_Sudan_Targeted_Rapes_MEM_160804_16x9_992.jpg

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 Ethical Concerns
§Outside of the IRB protocol
§ Original protocol: Key informant interviews with officials and service
providers; focus groups with community residents
§Was voluntary and informed consent possible?
§ The woman wanted to tell her story
§ But can someone under police protective custody feel free to
decline UNPOL’s request even if she didn’t want to?
§ Even we – the researchers from “rich” foreign institutions – didn’t
feel comfortable saying no to the UNPOL!

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 “Vulnerable” Participants

§Potential targets for manipulation

and coercion, or exploitation for
the sake of researchers’ benefits
due to their disadvantaged
positions

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Belmont Report (1979): Ethical Principles for Human Research
§ Three ethical principles: Respect for persons,
beneficence, justice
§ Respect for persons requires treating individuals as
“autonomous agents” and protecting those “with
diminished autonomy.”
§ Researchers need to take extra care when recruiting
“vulnerable subjects,” whose legal or sociocultural status
reduces their relative power or ability to promote their
own vital interests.
§ People’s presumed “dependent status” may “compromise
[their] capacity for free consent.” (Part 3.3, para 5)

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 Council for the International Organizations of Medical Sciences

§ CIOMS: “Special justification” and strict

application of rights/welfare protection when
recruiting prospective participants who are
relatively incapable of protecting their own
interests.
§ Particular focus on the vast socioeconomic and
political disparities in the global community
(CIOMS, 2002, 2016)

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 Respect for Persons Revisited
§ Community-based research involves more than the research
participants
§ Respect for the woman/family, for the organizational partner, for the
police who were facilitating contact
§ Given the nature of community-based collaborative research, would a
blanket protective approach to restrict participation based on
presumptions of vulnerability be the most effective means to promote
or respect the woman/family’s autonomy?
§ What would respect for the collaborating organization require in a
community-based research setting?

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 Other Practical Questions
§ Expect unexpected situations
§ Implications for relationships of trust: with the participant, with the
community partners
§ Reflexivity and fluidity in unfamiliar settings
§ Would a protective approach to restrict participation of “vulnerable”
persons promote or further deny the woman’s agency?
§ What about respect and trust of the community partners, who offered
the most community-relevant way to contribute?

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 Cautions
§ Unexpected situations in community-based research do not negate
IRB and research ethics guidelines.
§ If the recruitment criteria were sound, the burden of proof is on the
researcher to justify deviation.
§ Clinical trials: inclusion criteria are often standardized for
generalization purposes. Exceptions can be made at the level of
considering different contextual factors or processes in judging the
protocol, such as conducting clinical trials during an outbreak or
emergency disaster.
§ WHO: training manual on possible variations to standard procedures of
ethics review that apply to research in emergencies.

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 Take-Home Lessons
§ Researchers need to attend to what would benefit the community (as defined
by the community) and design and conduct the study accordingly.
§ Ethical guidelines for human participant protection continue to apply, but local
contexts and realities need to be considered in determining the best ways to
uphold participants’ rights and respect for their communities.
§ Close collaboration with local organizations from research inception can help
to promote respectful research design and recruitment.
§ Input from community representatives about ethical and culturally respectful
conduct can help researchers prepare for unusual circumstances.
§ Deviation from protocol: researchers should seek guidance and re-approval
before using the data collected.

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