Henry Silverman, MD, MA Professor of Medicine University of Maryland

1. Recruiting Marginalized Vulnerable Populations into Health Research: Issues in International Research Henry Silverman, MD, MA Professor of Medicine University of Maryland

2. How to define vulnerability • A definition of vulnerability is as follows: “To be vulnerable means to be exposed to a significant probability of incurring an identifiable harm or wrong while substantially lacking ability/means to protect oneself.” • Some individuals in the research are substantially more likely than others to incur identifiable wrongs/harms in the research • Individuals are more prone than others to incur identifiable wrong/harms Adapted from Samia Hurst

3. Defining vulnerability • Vulnerability of participants is usually more related to the context and environment of the research rather than the socio-demographic characteristics of the population. • Categorizing whole populations as vulnerable lacks sensitivity to context and fails to consider what a person might be vulnerable to.

4. Distinct types of vulnerability • Consent-based vulnerability • Barriers to obtaining meaningfully informed and voluntary consent • Risk-based vulnerability • Enhanced level of research-related risk of harms and wrongs (dignity) • Exploitation-based vulnerability • Neither the individual participant nor the society of which they are members receive a fair share of the transaction (research).

5. Case #1 • Ethical issues involved with research in conflict situations: • Case Study from Lebanon • Cindy A. Sousa, Kristy Clark, KavehKhoshnood

6. Tensions in research relationships in conflict settings

7. Consent-based vulnerability • Autonomous decision-making may be compromised, as participants may be motivated by • Fear • Desperation • Unrealistic expectations of assistance • Perceived coercion • Restriction of human rights • Dependent on external agencies • Informed consent process • Community, family, and then the individual

8. Risk-based vulnerability • “how you conduct research, to whom you talk and what you talk about” is essential to avoiding putting communities at risk • Tension • scientific rigour vs. advocacy • Ethical propriety of turning research into direct social activism

9. Risk-based vulnerability • Unrealized Benefit • Neutral quest for knowledge and overly concern for scholarship (researcher’s career) risks failure to obtain any meaningful data • If research is too subjective and clouded by too much subjectivity (lens of advocacy) = less credibility and unable to inform policy appropriately • Failure to intervene in the name of scholarly objectivity

10. Risk-based vulnerability • Psychological • Opening old wounds: “re-traumatization if sensitive issues are not handled appropriately and adequate supports are not made available.

11. Risk-based vulnerability • Confidentiality: stigma/discrimination • Difficult to maintain confidentiality in small communities • Reliance on local interpreters who might not be trusted • Recruitment efforts • Lack of access to courses of redress in cases of grievance

12. Exploitation-based vulnerability • Community does not realize the expected benefits of the research • False expectations of assistance from researchers • “They asked us to lead them to women who had been raped so they could record their stories…We never heard form them [the researchers] again…They stole our stories” • Ownership of stories?

13. Safeguards • Consent-based vulnerability • Enhance consent process • Harm-based vulnerability • Minimize breaches of confidentiality • Avoid invasion of privacy

14. Safeguards: “do some good” • Research into the suffering of others can only be justified if alleviating their suffering is an explicit objective. • Correct balancing of advocacy vs. scientific objectivity • Provide some immediate benefits or feedback while they are with the community. • Some of the ways in which researchers do seek to return benefit may be discouraged by IRBs • Offering skills as health or community workers • Acting as advocates to assist participants with legal or health problems identified during the research • Too advocacy-oriented?

15. Safeguards: Exploitation • Community Participatory Research • Ethical only when done in collaboration and partnership with members of the cultural communities being studied • Avoids exploitation as it ensures benefit • Help generate the evidence for better policy and practice that is relevant to the community. • Has the potential to empower refugees and IDPs and build capacity, resilience and agency

16. Dignity-based harms • “Stop stealing our stories?” • Treating human participants as data (objects) rather than as moral agents (subjects) • Capacity of refugees and IDPs in conflict to take an active role in the research process is seldom acknowledged • Constant focus on vulnerabilities and the failure to recognize strengths and resilience can further disempower already exploited groups

17. What is Vulnerability? • “Understanding that vulnerability results from the circumstances in which they find themselves – rather than locating it within the person – helps to remind us that such groups consists of ‘ordinary people’ buffeted by extraordinary – albeit disturbingly common- events” Karen Block, et.al, “Values and Vulnerabilities”

18. Thank you!