All posts by Lilian V Cruz

Whose Consent? Vulnerable Populations and Ethical Standards

In the expansive organism of research regimes, a.k.a contract research organizations (CROs), there seems to be a baseline standard for which all research is considered “ethical”. As Petryna notes in Ethical Variability: Drug Development and the Globalization of Clinical Trials, “the ethical universe in which researchers operate [is] an essentially procedural one” with the basic but critical concerns of obtaining informed consent from subjects and assuring investigator responsibility in case of adverse reaction or death.  Especially in the context of globalized drug development, I believe it’s incredibly important to explore the ways in which these procedural ethical standards are warped according to and “across distinct political and economic contexts”.

Still, I get a nagging feeling that at the core of the research regime’s baseline ethical standard lies a more subtle danger: it seems to me  that the definition of “informed consent” is built in to whatever subjective understanding the Independent Review Boards (IRBs) and CROs may have of it. Seeing as “informed consent” acts as foundational language for an entire ethical standard, a subjective or shaky definition of the phrase is problematic in a way Petryna does not explore at length. When taken across differential political and economic contexts, the ambiguous language of “informed consent” is further destabilized.

In the U.S., informing subjects can be relatively simple if the population is english-speaking and if they have already been exposed to the culture of research, whether through ads  for subjects or through lived experience. When in a place in which research is not the norm or is in the process of becoming a norm, language barriers, stigmatization, and local knowledges seem to lead subjects to create their own understanding of the research purpose.  In Fairhead’s article, which focuses on the MRC project in The Gambia, many parents seemed to believe that the taking of blood samples was for insidious purposes.  Although MRC fieldworkers attempted to inform subjects by “explaining the immune system as the body’s soldiers” and framing their research in an attempt to understand such a system, local knowledges still prevented people from fully accepting the idea. In the end, participants were primarily concerned about the health care that they and their infants were receiving that was unavailable through the government.

If informing subjects according to time and place can be tricky, then obtaining  valid consent might prove to be exceptionally difficult.  Although most CROs would agree that the patients in the MRC study have consented despite being limitedly informed, they fail to take into consideration the structural elements involved in these people’s lives that lead them to agree to a study despite limited understanding or informed hesitancy. It begs the question: can true consent exist in structurally violent circumstances? Even if the subject is informed, outside forces such as political instability, governmental inadequacy, and economic constraints may push people in impoverished conditions towards “consenting” to a study. In this way, consent becomes antithetical to a person’s true desires.  In that case, can it even be called consent?  CROs have no  interest or responsibility in addressing  “how true” consent may be, therein perpetuating inequality while creating ethical variability across specific populations that exploits in a way that is distinct from the crises that Petryna explores. In the article by Fairhead, some people that were not able to get the care they needed from the government consented to the  MRC study because of the benefits to them and their family.

A recent October article presents a case which is not entirely analogous but still relevant to the exploitation of vulnerable populations through research.  In their WashingtonPost article, Gowen and Lakshmi discuss the “Rent-a-Womb” industry  in India that allows foreign couples to find surrogate mothers.  If the nick-name of service and commodification of the womb is not concerning, these surrogate mothers are “often poor and illiterate women from rural areas who are paid little.” It is a largely unregulated business supported by fertility clinics and produces a whopping $400 million dollar a year. Although the “Rent-a-Womb” industry is not necessarily a research study, it is again a moment in which biological bodies are used in a manner that is exploitative, in which monetary gains drive poor women to “consent” to the use of their wombs.

In this way, the shaky foundational language of ethical standards is a powerful means to exploit vulnerable populations in quite subtle ways. Informed or not, consent hinges on the socioeconomic status of subjects in a way that perpetuates inequalities between privileged and impoverished bodies. Consent is not given by subjects, but rather created by CROs to benefit their own goal of cost-effective and rapid research.

 

Sources:

Leach, Melissa and James Fairhead. 2011. “Being ‘with the Medical Research Council’: Infant Care and the Social Meanings of Cohort Membership in Gambia’s Plural Therapeutic Landscapes.” In Evidence, Ethos and Experiment: The Anthropology and History of Medical Research in Africa. P. Wenzel Geissler and Catherine Molyneux, eds. New York: Berghahn Books.

Gowen, Annie, and Rama Lakshmi. “India’s ‘rent-a-womb’ Industry Could Close Doors to Foreigners.” Washington Post. The Washington Post, 28 Oct. 2015. Web. 8 Nov. 2015. <https://www.washingtonpost.com/news/worldviews/wp/2015/10/28/indias-rent-a-womb-industry-could-close-doors-to-foreigners/>

Petryna, Adriana. 2005. “Ethical Variability: Drug Development and the Globalization of Clinical Trials.” American Ethnologist 32(2): 183-197.

Questions:

Can the consent of people in such impoverished communities ever be taken as true, regardless of whether they have been informed?  How does allowing these people to have bodily autonomy complicate the issue?

How can IRBs or other bodies claiming to uphold ethical standards prevent exploitation of vulnerable communities given that structural violence often drives such individuals to use their biology in order to benefit themselves and their families?