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?

28 thoughts on “Whose Consent? Vulnerable Populations and Ethical Standards”

  1. Hi Lilian,

    Thanks for your insightful post – I thought your exploration of consent among vulnerable populations was very valuable. It reminded me of our discussions of noncompliance – often the reasons for “noncompliance” are not factors that are easily changed by the individuals labeled noncompliant, and in some cases, the noncompliance is a result of structural differences (like policies mandating MDRTB patients finish the same initial drug, even if the patients have proven they have a strain resistant to this drug; or varying policies due to stereotypes or discrimination). Similarly, I thought your post brought up interesting ideas of how structural factors affect the concept of consent.

    I agree that consent when in a vulnerable situation is different from consent in a more privileged situation. However, I also believe that all individuals should have autonomy over their body, which includes accepting or denying drugs and other interventions. I am inclined to say that the consent given can be true, but that this consent is produced under a very different set of circumstances that should always be taken into account. This is definitely a tough question to consider and I am really interested to hear what others think.

    1. I think you’re definitely right to say that we have to take into account the different sets of circumstances in which “consent” is produced. But if, like you said, we should give everyone bodily autonomy and the right to make their own decisions, then what difference will cataloguing their situation do? What are we going to do to help them once we understand their situation, if we’re still going to let them do something that they wouldn’t have done had they been in a position of privilege? Although I don’t really have an answer, it’s a very frustrating dilemma.

      1. I don’t think cataloguing the situation, as you say, will generally make a difference in the outcome. However, I believe it is important to think of these distinctions and teach those in the medical sphere and in policy to be thinking of these when prescribing, treating, and coming up with policy.

  2. Hi Lilian,

    Thank you for your thoughtful post. The issue of informed consent is an interesting, but very complicated one, for the reasons you mentioned. In answer to your question about whether true consent is possible, I would say no, agreeing with you that consent is often a definition manipulated by CROs. It’s easy to say that consent means permission by a subject who has been informed about the harms and benefits of the drug. This is limiting consent to a purely “technical” consideration. But almost always, especially in unstable situations, consent involves biosocial factors and the negative influence of structural violence. Besides, the ability of subjects to understand and the way in which they understand what they are being “informed” about depends largely on the local context.

    When I read your post, I was reminded of the discussion about the placebo trials presented by Petryna’s article. It’s interesting to think of the placebo effect in terms of informed consent, because subjects, in order of having any chance of receiving treatment, “consent” to participating in a trial in which they might NOT receive the treatments. The subjects, informed about the nature of the trial, assume risk to have a chance at experiencing the benefits. In this case, the argument is utilitarian, but a little different than the cost-effective approach of the CROs. The “good” affected by a clear trial of a drug, which will end up being used by many people in the future, outweighs the loss of human life now due to the administration of placebos.

    I don’t have many answers to the questions you posed; they are extremely difficult. But, as in this placebo example, I think it is informative to look at how not only does cost-effectiveness and structural violence influence consent in trials, but also our (sometimes flimsy) constructions of what is good. This is something that subjects in a trial never have a say in.

    1. Thanks for bringing up the example of the Placebo trials–it made me think back to the Belmont Report, which is supposed to guide ethical procedure in research involving human test subjects in the US. If there is any chance of real harm being done the to the subject, it is generally considered unethical. At the moment,the IRB is doing a questionable job of protecting human subjects in research. Do you think it would be possible to re-structure the system in a way that takes into account structural violence and cost-effectiveness? Even more so, would it feasible to implement effectively?

  3. Hello Lillian,

    The stance you take in this post is very powerful. To me, the manner in which CROs are able to take advantage of populations is similar to our discussions of corporate power from September; we discussed in The Cigarette Century how tobacco companies are able to target groups who lack the knowledge and agency to make informed decisions about cigarette usage. Without equating something as pernicious as cigarettes with potentially useful experimental therapies, one should note that both the industries for tobacco and pharmaceuticals take advantage of relaxed regulations.

    I don’t believe that the consent of people living in vulnerable communities can ever be perfectly informed. In order for consent to be truly valid, both the researcher and the study participant should be on equal footing (as is often the case with domestic clinical trials in the US). In such circumstances, the study participant is equipped with a baseline understanding of what the research seeks to achieve, what the potential risks are, and how much agency one has. These all seem to be lacking when study participants are from underdeveloped communities. As you discussed, individuals who lack the means to provide for themselves and for their families often make desperate decisions that places their needs over their own safety. As such, even in situations when participants are aware of the potential consequences of participation, they may still submit to a clinical trial.

    I think the criteria for qualified consent as articulated by IRBs and similar authorities are extremely superficial. As such, they are not equipped to prevent the manipulation of vulnerable groups and are far removed from ideas such as structural violence. Furthermore, in order for these hidden factors to be addressed and for ethical standards to be upheld, there needs to be unified agreement about how the research community is complicit in the exploitation of underserved communities, something that I believe is currently lacking.

    1. I totally agree with the last point you made–the IRB and similar authorities need to address the structural violence rampant in communities that have lax regulations and create ethical standards to abate manipulation of such communities. The real question, I believe, is how? What issues are the ones they need to focus on? Meeting a certain level of income? Have enough food? There are so many levels to poverty that it seems difficult to come to a consensus. Do you think, perhaps, it could be the role of the WHO to create those ethical standards necessary to protect the health of underprivileged populations entered into a subject pool? They certainly have no teeth, but it seems they do have some form of uniting power.

      1. Hi, Lillian!

        Let me reiterate—I agree with you in that there are many difficulties associated with tackling structural violence (and I am not entirely sure how to go about solving them), but before the IRB can even begin to address this issue, it must first recognize its historic oversight (or even neglect) of it. Also, while it would be ideal for the WHO to create the types of standards you described, historically, we’ve seen the WHO fail to actually act to enforce real change. Alternatively, perhaps a more knowledgeable world audience can exercise some power in changing in the current operations of CROs.

  4. Hi Lillian,

    Thank you for your post, the issue of informed consent is something I was really struggling with in this reading, and you conveyed a lot of the same frustrations I have been having. I agree with Sachit, that in some regards the idea of targeting and recruiting a uninformed population into a research study has a very similar feeling as the tobacco companies we read about in September. I think CROs are walking a very dangerous line by accepting consent that may not be entirely informed. For these organizations, it is easier to accept this uninformed consent than to take the time and effort to make sure that developing communities understand the risk and choice they are making.

    I do not think that the consent of people in these impoverished communities can ever be taken as true. When presented with the opportunity to be involved in a study in exchange for access to healthcare better than any care they have the opportunity to receive in their life, the pressure to consent is high. People living in these developing countries deal with many hardships, and to offer to provide services they would not normally have access to in exchange for a “research body” almost seems coercive. In order for this consent to be informed and valid, the researcher and the subject must be on equal footing. When the researcher is from a developed country, working in an impoverished community, with much more health education, there is inherently not equal footing.

    In order for IRBs or other regulatory bodies to prevent the exploitation of vulnerable communities in research settings, I think an consensus needs to be made about what is to be considered informed consent in developing countries. Without a strong and comprehensive definition of informed consent, regulation on CRO’s can never be strict enough. Until structural violence in these developing countries is irradiated, and health infrastructure is developed, I think it will be challenging to avoid individuals joining research studies to give themselves access to healthcare. Until such a definition arises, the responsibility is on CRO’s and IRB’s to make sure that a person can truly give informed consent, which is not an ideal situation.

    1. The last paragraph of your response really hit home. I think what we need is for the IRB and other governing powers to step up and create ethical standards that take into account the unequal footing of researchers and the communities where they pull subjects from. At the same time, I wonder how feasible it would be to enforce, especially in countries where regulations may be extremely lax. Are there any ways of scaling up the IRBs and their strength as enforcing and protecting powers?

      1. Hi Lilian,
        Your last question is something I have really been struggling with all semester. It is so important to help people in developing countries get access to health care, but how do we enforce that it happens, and that it is done the correct way. I understand now that a regulatory body is needed, but I don’t know who that should be, and perhaps it does not exist yet. Since the IRBs are often specific to a single research “experiment” or drug trial, I think it is difficult to strengthen them across the board, but perhaps that is an option.

  5. Hi Lillian,

    Thank you for your post. I really appreciate how thoughtful it was. I thought your argument on the destabilization of the term “informed consent” across different political and economic contexts was very powerful.

    In response to your first question, I don’t believe that consent of impoverished people can every be completely true. It is very tricky in this situation because the care these people are being offered is probably much better than any care they would receive within their community. Obviously if the care is seen as better, there are going to be more people who give consent then there would be if the researcher and patient standings were equal. You mentioned that people who suffer to provide for themselves often make desperate decision to better their needs. Giving consent to a clinical trial to better their health despite the possible risks can be seen as an example of one of these desperate decisions.

    Your second question is more difficult for me to answer. I think that ultimately the fact that I don’t believe consent to be true for those living in impoverished settings makes it hard for me to think of a way to prevent this exploitation. I guess one way could be to reevaluate what consent means in this type of situation. Again though, creating this definition is extremely difficult because each community is different and the factors playing into their poverty are not always the same. I am sorry I cannot give more of a definitive answer but I think that variability of these impoverished communities makes it hard

    1. Thanks for bringing up the idea of variability of impoverished communities, as that wasn’t something that I had previously thought about! Thinking on it now, it definitely seems to be an issue that would come up if the IRB and similar authorities were to re-define consent and related ethical standards. Although it always difficult to think of solid solutions to these kinds of questions, I wonder if having a stronger involvement with governments could help address this issue? They could be a source of information that helps us gauge the common problems of communities in that country. Of course, this may run into problems if those governments are weak

  6. Hi Lillian ,

    I appreciate your argument that in regions where structural violence is a factor “consent” from populations may illustrate the exact opposite as the instability they face force people into treatments. If the populations do “consent” to clinical trials, even if we aware that this might not even be a true form of consent, I would imagine that the factors that fuel unstable environment could affect the drug trial itself.

    The issues that you pose, political instability, governmental inadequacy, and economic constraints, may create decreased mobility of the populations (in order to physically get the drug) and limited access to food or water to take with the medication (as we learned with HIV/AIDS treatments there are nutrient requirements). Both of these could decrease the efficacy and results of the trials and treatment. It might be worthwhile for CROs to invest in finding solutions for these issues that generate structurally violent circumstances. Although it would be a challenge for CROs to address all factors, I suggest they put aside resources to help regions and governments where they want to have clinical trials. This should be done for obvious humanitarian reasons while simultaneously strengthening the results of their research study.

    1. Your suggestion that CROs invest in abating the structural circumstances that may lead to “consent” is really interesting. On the one hand, I think that it’s a great way for such organizations to responsibly engage in their work. It could be a source of money and aid that these populations would not get otherwise. At the same time, I wonder if providing such aid (which really sounds akin to humanitarian aid) would create a dangerous co-dependecy, especially when the aid is coming from an organization that would probably be most interested in providing quick, vertical, technological or pharmaceutical fixes. Once the CROs end their research, these communities will once again be at the same position as before the research began and their “benefits” will have been in the past.

  7. Hi Lilian,

    This is a great post! You raise some really difficult questions–I am not sure I have answers to them…

    Your discussion of consent was incredibly interesting. Oftentimes, I think people just think of language barriers when discussing issues with consent, but you did a great job in evaluating the other challenges that can create consent that isn’t really genuine such as economic constraints, political instability, and government inadequacy. Although it is kind of cynical, I don’t think that you can ever take consent of people in impoverished countries to be completely true. As you mentioned in your post, there are so many other variables that factor into decisions on and push people towards consent. This can become really complicated when people are granted bodily autonomy and are making choices because of economic and political circumstances. It can have a hugely negative effect on health of a population–as you mentioned with the example of the surrogate mothers in India.

    I’m really unsure of how to come up with a solution to the second question you posed. Perhaps IRBs need more/stricter regulations, but I also think it is highly difficult to create a general set of standards for all health issues. Situational circumstances vary so much in terms of how they influence consent in global health, so I’m not sure there is really a practical answer for this question…

    Thank you so much for this post, and your thoughts!

    -Rebecca

    1. Hi! I definitely agree that situational circumstances play a big role in terms of what affects health issues. The burden of every community is different, and perhaps a universal set of ethical procedures regarding use of human subjects cannot do the job of effectively protecting impoverished communities. And so, I wonder what you think of the idea the IRB continue create a universal code of ethics, but that another authority (like the WHO ) work with the local government in each research area in order to gauge what kinds of issues those communities face and reasons that might lead to false consent. At the same time, is it fair to potentially remove the possibility for better health or care that those communities would be receiving, if only for a limited amount of time?

      1. Hi Lilian,

        I think the idea you propose to have the IRB continue create a universal code of ethics, but have another authority (like the WHO ) work with the local government in each research area in order to gauge what kinds of issues those communities face and reasons that might lead to false consent. I am not sure what to do about your second question. I think you bring up a really important point that unintended consequences could occur that could make this sort of intervention worse for people’s health despite good intentions and goals to improve health. I think before actually going through this process, you would have to do quite a bit of research and you would need to project negative (short-term) impacts to health, and positive impacts to health and see if the ends justify the means.

        Thanks,
        Rebecca

  8. Hi Lillian –

    I totally agree with you in that informed consent is a tricky issue. Given the frequent scarcity of medical care in regions where medical trials are often conducted, people may see a medical trial as their only source of medical access. This context can’t be seen as one where the individual is making decisions based solely on whether they want to be involved in the the trial, as the trial is inextricably linked to their overall health. In such a context, I think it is essential that we consider the ethics of testing unknown drugs in RCTs. Participation in a trial isn’t given as one of the treatment options, but rather the only potential course of treatment. Regardless of how highly we value informed consent and bodily autonomy, the choices we are presenting in these contexts are inherently different that those presented to someone in a more developed country. The choice they make for the body is in large part dictated by the health infrastructure (or lack thereof) that surrounds them, and to ignore such contexts in research studies I believe is unethical.

    1. I’m really interested in your suggestion to investigate the ethics of testing unknown drugs within these countries. In the Belmont Report (which is a summary of the agreements that the US has of ethical procedures for research involving human subjects), one of the tenets was that there must be some expectation that the intended treatment will be good rather than harmful. If the risk is too much, the trial would be considered unethical. I wonder if banning the testing of such potentially harmful drugs, or even exchanging the use of placebos with proven equivalents, would help abate the negative consequences of people who end up participating in trials because they have to, in the hope of better health. As most people have agreed, it is extremely difficult to obtain true consent. But, perhaps there are ways of making trials more safe and beneficial for participants. I believe your suggestion is one such way.

  9. Hi Lilian,
    I really enjoyed reading your post. I really like how you challenge the use of informed consent—it’s not enough just to use the term; researchers have to really mean it.
    Your example about surrogacy in India is fascinating. What an interesting example of how economic, political, and cultural factors can impact women’s bodies. I think surrogacy and clinical drug trials have one main parallel—they are both very important. Without clinical trials, we wouldn’t be able to prove drug safety and efficacy; and without surrogacy, many couples would not be able to get pregnant. However, as the Washington Post article points out, regulation is critical, so that both processes can exist in the safest, most consensual way possible.
    The questions that you pose are really tough, and they seem to get to the heart of the issue. Even if people have been informed of the potential benefits or unknown harms of an experimental treatment, a general need for money or any form of healthcare may drive them to enroll in the study. But if researchers don’t take that consent at face value, how will they ever find anyone to enroll in the study? Again, I think regulation (and clarification of the meaning of the term “informed consent” across languages and cultures) is key, so that enrollees can be sure they are receiving the best possible care, and are not taken advantage of.

    1. I was able incredibly interested in the article about surrogate mothers in India. You mention that increased regulation is necessary in order to ensure the safety and “informed consent” of enrollees. In the case of the women in India, how much do you think one can regulate such an activity without infringing on the bodily rights of women? Although most people agree that it is almost entirely impossible to obtain true consent considering the demographics, does obtaining true consent matter more than giving women power over their own bodies?

  10. Thank you, Lilian and everyone else, for your comments on the tricky topic of informed consent.

    As you noted, Lilian, the definition of informed consent is heavily influenced and shaped by IRBs and CROs, which doesn’t get to the heart of whether or not this definition is altered from place to place. This brings into question the difference between informed consent and true consent because, clearly, informed consent varies. Like many of previous commenters, I agree that it is extremely difficult to obtain this kind of “true consent” wherein research participants understand the intricacies of the purpose and methods of the proposed research. Sarah brought up the point that incentives, such as access to health care, add pressure to consent. Since we cannot place participants on the “equal footing” that researchers are on as Sachit suggests, we must consider what we can do for vulnerable populations facing the dilemma of deciding whether or not to participate in a research study. Thus, the real question is not whether or not the consent is true among vulnerable populations, but rather how researchers can ensure that all consent is appropriately informed and true. A secondary, but also important question then arises: how do the researchers measure the potential participants’ knowledge of the study?

    In thinking about your second question, I wonder whether a basic understanding of a community health needs assessment would give IRBs the agency to prevent the exploitation of vulnerable populations. Ideally, researchers have gained extensive knowledge on the place and peoples they are going to work with before deciding that this is the place and these are the people they want in their study. Consequently, it may be necessary for IRBs, CROs, and other comparable bodies to also understand the beliefs and needs of the communities where the research is going to be conducted to prevent these communities from being exploited. International bodies, such as the WHO, could potentially set these kinds of standards for understanding the power dynamics of international research (if they had the power). So, I’ll leave you all with a question I always seem to come back to: How do we give international bodies, such as the WHO and the UN, the ability to enforce and sustain international research regulations?

    1. Hi Natalie! Thanks for your insightful response. I definitely agree that the question is not so much about whether participants consent is true, but how can CROs and the IRB ensure that it is. But of course, even if CROs and IRBs had developed a set of ethical standards that were appropriate for each community, how to enforce such procedures? The WHO, historically, is all talk and no teeth. I wonder, then, if giving a the government a bigger role in research could be a potential strategy for enforcement. Though that role seems ambiguous to me at the moment, perhaps it would entail governments having workers that review the ethical standards that are being practiced in research sites in the country and assuring they are minimizing false consent and benefitting participants as much as possible.

  11. Hi Lilian!
    I thought your post was extremely relevant to Dr. Reynolds presentation in class.
    I think that the consent in these situations refers to the term “engineered consent,” meaning that it is consent without real consent. I do not think this is ethically the right thing to do as it tricks people and takes advantage of individuals that have less knowledge about the dangers and risks associated with the trials. I think that everyone should have complete autonomy of their body, which can make this question difficult to answer. I think that it is the state and government’s responsibility to fully explain the risks and dangers in a way that can be fully comprehended by individuals in these countries. I don’t think there should be any incentives for people because this can promote bodily harm in order to obtain goods or money, which is not right. The benefit should be the results of the experiment (if there are any). I’m not entirely sure though, this is a hard question to answer.

    1. I agree, it is definitely a difficult question. Although the government and the state should definitely have a huge role in explaining the risks and dangers of research, I think that would still not do anything for the abating the structural violence that leads participants to give consent in the first place. At the same time, I agree that incentives are not good: they may create dependency and/or promote bodily harm. Perhaps the only way to make some progress in this quandary of consent is ensure that all participants get the best possible care for engaging in studies. CROs and IRBs must be responsible for minimizing the risk of harm to the utmost extent possible. Even if they were to create methods of doing this, though, the question always returns to, as Natalie notes above: who will enforce it?

  12. Hey Lilian,
    I think your post incited a wonderful, thought-provoking discussion about informed consent. As I was reading the comment thread above, I found myself agreeing that achieving and even more so defining “true” consent is difficult. However, I think that it is also important to consider that, even though clinical research is inherently a goal-driven, data-producing endeavor, unequal footing tends to be the nature of global health work in general. For instance, consider Paul Farmer’s work with TB in Haiti. PIH used food packages and transportation to incentivize the population, just as MRC used privileges to better health care as an incentive for parents to allow blood testing of their infants. To some extent. leveraging structural violence is a gateway for NGOs and research firms alike to implement their health endeavors within a population. Moreover, I find it hard to believe that the intentions of research conglomerates such as the MRC are always necessarily malicious. So what differentiates a NGO and medical research? Moral imperative? Humanitarianism? Profits? The absolute lining between these two global health works is hard to differentiate but I think important to consider when we question the ethical grounds of health work.

  13. Lillian, thanks for you powerful post. One moment in particular stuck with me strongly: “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.”
    I am struggling to contribute further to the way you articulate this, because I could not agree more that there is a great risk in how underdeveloped and potentially varied ideas of consent are in rhetorics around the world – on top of that, what types of ethical guidelines are there that govern a sense of “implied consent” during medical emergency? And what constitutes emergency? I keep returning to anthropological reflexivity and emphasis on personal subject narrative as a way of quelling the huge risks organizations conducting research take when they seek “informed consent” from a subject population of historically disadvantaged and violated regions of the world, but your post has forced me to think of the insufficiency of reflexivity and storytellling for developing a truly equitable protocol that can join research and intervention without dissonance.

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