With the fragile ceasefire in Syria barely holding, Lebanon continues to host more than 1 million Syrian refugees. An estimated 190 000 refugees live in informal settlements and another 120 000 in non-residential structures such as garages and shops. Sanitary conditions are poor. More than 71% of refugee households live below the poverty line with one-third affected by food insecurity. Depending on age group, between 48% and 84% of refugee children are out of school.1

The purpose of regulating human subject research is to protect participants from unconscionable past practices and safeguard them from emergent risks, but it is impossible to develop regulations that provide sufficient protections in all conceivable situations. Such is the variety and complexity of human subject research that gaps in regulation and ethical oversight leave some participants open to exploitation and harm. How serious this problem is depends on the risks involved. In general, medical research involving experimental drugs, invasive procedures, or new devices has higher risks than public health or other social and behavioral research. Similar regulations in Western jurisdictions require investigators to conform to principles for recruiting and consenting patients, protecting privacy, and maintaining confidentiality. The oversight required has produced a research ethics industry that sometimes frustrates public health specialists, qualitative researchers, and others who conduct research on health and healthcare systems from a social science perspective. Common criticisms are that the approval process is too long, irrelevant to social and behavioral science research, which is inherently benign, and inhibits potentially beneficial research. Consequently, some investigators have suggested that alternatives to formal research ethics are needed.2 Whereas, there are sometimes grounds for such criticisms, they neglect the internal dynamics of the knowledge production industry and the self-interested global community of investigators who build reputations on uncovering new facts about human behavior and health or the same facts in unique circumstances.

International nongovernmental organizations (NGOs), overwhelmed by the refugee crises in the Levant, are funding studies to quantify the nutritional, reproductive, and mental health needs of refugees living in informal communities, and to a lesser extent the response of host communities to the influx of refugees and displaced persons. Concurrently, some of the world's most prestigious medical schools are attracting funds to develop research programs aimed at bringing the best expertise to the problems of the most disadvantaged refugees. The urgency of the refugee crisis and the depth of suffering of those forced by war to live in informal settlements is a magnet for investigators eager to establish their humanitarian credentials and socio-political relevance. The result is a proliferation of studies in the countries of the Levant; some initiated by NGOs, some by investigators in the region, and others by researchers living overseas who want to collaborate with those nearer the action.

Regulators of human subject research recognize the vulnerability of prisoners for obvious reasons. Prisoners are vulnerable to exploitation because they are invisible to the wider community, stigmatized as criminals, and dependent on prison staff for protection from intimidation and violence. Informed consent means nothing in a prison unless the consent process is free from coercion, undue influence, and misleading information about benefits and risks. Accordingly, US Federal regulation 45 CFR 46, Subpart C,3 provides special protections for prisoner research funded by the Department of Health and Human Services (DHHS), conducted by the National Institutes of Health, by an institution that has committed to compliance with Subpart C, or funded or conducted by the Central Intelligence Agency. A US institutional review board (IRB) reviewing a proposal for prisoner research must include a prisoner or prisoner representative. For research supported by the DHHS, the IRB must provide details to the Office of Human Research Protections (OHRP). The research cannot proceed until it has been reviewed by the OHRP, which consults with a panel of experts in medicine, penology and ethics on behalf of the DHHS.

Compare the situation of prisoners in the United States with that of Syrian refugees living in informal settlements in the Levant.1 Notice that an informal settlement is just that, a collection of tents pitched in the open far from services, sanitation, medical assistance, and health services. Occupants are prey to the best and worst of human intentions from self-appointed leaders, fellow refugees, landowners, predators looking for under-age brides, consanguineous marriage, and employers of child labor. Perhaps there is no need to worry. If regulation of human subject research is effective, refugees will be protected from undue influence to participate in research studies from the NGOs that need the information. Privacy will be possible when they discuss the physical, psychological, and sexual trauma they have suffered. They will know that everything they reveal about the worst experiences anyone could imagine will remain confidential, and that audio recordings of interviews and focus group discussions will be destroyed as soon as they have been transcribed. When relevant, they will understand that only de-identified information will be sent to collaborators in universities overseas. But recruitment to research studies cannot be free of undue influence when refugees are dependent on United Nations agencies and NGOs for subsistence. Privacy cannot be protected and confidentiality cannot be maintained when everyone can hear everything that is said. An unnecessary research burden cannot be avoided when refugees are asked to reveal yet again the degradation that life has become, the humiliation of not being able to feed their children, the despair that remains after hope is abandoned.

Except for some epidemiological studies, 45 CFR 46, Subpart C permits prisoner research only if it involves no more than minimum risk and inconvenience [(a)(2)(i)(ii)]3 or has a reasonable probability of improving prisoner health or welfare [(a)(2)(iii)(iv)]. Refugees in informal settlements should have the same protections. Only research necessary to assess needs or that has a high probability of improving refugee health or welfare should be permitted.

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