THE ETHICALITY OF CLINICAL TRIALS IN DEVELOPING COUNTRIES:FROM HIV TO CANCER

Jason BalesDr. Woolfrey

Bioethics4 May 2017

THE ETHICALITY OF CLINICAL TRIALS IN DEVELOPING COUNTRIES: FROM HIV TO CANCER

Based on concerns regarding lenient research restrictions, cultural and linguistic

misunderstanding, disadvantageous research potentiality, coercion, and exploitation, I

argue that the ethicality of clinical trials in developing countries is dependent upon a

global organization committed to creating an environment which fosters the protection of

vulnerable populations, enforces stringent research regulation and review, and ensures

complete diversity among its members. A few predictable objections are then carefully

considered.

AZT and the New England Journal of Medicine: The Debate Begins

In 1997, Dr. Marcia Angell published “The Ethics of Clinical Research in the Third

World,” an editorial in the New England Journal of Medicine, which sparked an

onslaught of debate regarding the ethicality of the then ongoing clinical trials in Third

World countries.1 These clinical trials attempted to validate an economically efficient

treatment for the vertical transmission of human immunodeficiency virus (HIV) infection.

The discrepancy involves whether or not a placebo control group is ethically justifiable

in short-course zidovudine (AZT) treatment, as the participants are dealing with a life-

threatening disease and prior research in 1994 revealed that the administration of long-

course AZT reduces the risk of HIV transmission by 67.5 percent.2 Angell argues, “Only

when there is no known effective treatment is it ethical to compare a potential new

treatment with a placebo. When effective treatment exists, a placebo may not be used.

Instead, subjects in the control group of the study must receive the best known

1Angell, Marcia. "The Ethics of Clinical Research in the Third World." New England Journal of Medicine 337, no. 12 (1997): 847-49. doi:10.1056/nejm199709183371209.2"Zidovudine for the Prevention of HIV Transmission from Mother to Infant." Centers for Disease Control and Prevention. April 29, 1994. Accessed April 11, 2017. https://www.cdc.gov/mmwr/preview/mmwrhtml/00030635.htm.

treatment.”3 In the case of the short-course AZT participants, that best known treatment

would be long-course AZT.

Backlash ensued regarding Angell’s argument in opposition to the short-course

AZT clinical trials in Uganda, South Africa, Tanzania, Cote d’Ivoire, Burkina Faso, and

Thailand. Harold Varmus and David Satcher responded to Angell’s argument in “Ethical

Complexities of Conducting Research in Developing Countries,” which was also

published in 1997 via the New England Journal of Medicine. Varmus and Satcher argue

that

An obvious response to the ethical objection to placebo-controlled trials in countries where there is no current intervention is that the assignment to a

placebo group does not carry a risk beyond that associated with standard practice, but this response is too simple. An additional response is that a placebo-controlled study usually provides a faster answer with fewer subjects, but the same result might be achieved with more sites or more aggressive enrollment. The most compelling reason to use a placebo-controlled study is that it provides definitive answers to questions about the safety and value of an intervention in the setting in which the study is performed, and these answers are the point of the research.4

Varmus and Satcher’s favorable approach to placebo-controlled experimentation in

developing countries is not without company. An abundance of literature exists to

support both Angell and Varmus and Satcher.

The AZT clinical trials during the 1990s shed light on the ethical complexities

involved in research and experimentation in developing countries, thrusting potential

Third World malevolence into the public eye. Ethical frameworks specific to research in

developing countries are essential, as these cases must have an extended ethical

3Angell, Marcia. "The Ethics of Clinical Research in the Third World." New England Journal of Medicine 337, no. 12 (1997): 847-49. doi:10.1056/nejm199709183371209.4Varmus, Harold, and David Satcher. "Ethical Complexities of Conducting Research in Developing Countries." New England Journal of Medicine 337, no. 14 (October 2, 1997): 1003-005.

evaluation due to the extreme risk of coercion, exploitation, misunderstanding, and

disadvantageous research potentiality.

Roche and Norvartis in Egypt: The Debate Continues

Despite vigorous debate beginning in the 1990s regarding the ethicality of certain

clinical trials in developing countries, questionable behavior remains. This issue is still

relevant, as can be seen by the recent and ongoing clinical trials in Egypt. According to

a recent study, through the combined efforts of Public Eye, Centre for Research on

Multinational Corporations (SOMO), Wemos Foundation, Egyptian Initiative for Personal

Rights, and Shamseya for Innovative Community Healthcare Solutions, it was found

that 57 active international drug trials existed in Egypt as of February of 2016.5 A

majority of these active international drug trials are testing medication for Hepatitis C

and cancer, which is abundant in the host communities. Cancer treatment tends to

benefit high-income patients, which leads to questions about the validity of the trials in

Egypt. According to the prior-mentioned report, one in five medicines involved in the

trials costs twenty times more than the monthly minimum wage in the host community.6

According to the Declaration of Helsinki, which provides international guidelines

regarding international ethical standards for human research, “Medicine research with a

vulnerable group is only justified if the research is responsive to the health needs or

priorities of this group and the research cannot be carried out in a non-vulnerable group.

In addition, this group should stand to benefit from the knowledge, practices, or

interventions that result from the research.”7 Roche and Novartis, two multinational

5Industry-sponsored clinical drug trials in Egypt: ETHICAL QUESTIONS IN A CHALLENGING CONTEXT. Report. Public Eye, SOMO, Wemos Foundation, Egyptian Initiative for Personal Rights, and Shamseya for Innovative Community Healthcare Solutions. 3-57.6 Ibid.7 "World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects." Accessed April 11, 2017.

pharmaceutical companies that were involved in 28 of the 57 clinical trials in February of

2016, along with various other pharmaceutical and biotech companies, are taking

advantage of the political unrest, lack of clear-cut laws regarding clinical trials, and

patients inability to afford adequate treatment for life-threatening diseases in Egypt. This

violation of human autonomy and dignity shows that without proper supervision and an

adequate ethical framework specific to research in developing countries, even today,

hideous forms of injustice, coercion, and exploitation are viable to happen.

Special Considerations for Developing Countries: Five Areas of Concern

Clinical trials in developing countries are not intrinsically unethical, but special

considerations need to be addressed when dealing with a vulnerable population or

community. In order to ensure ethicality when conducting clinical trials in developing

countries, lenient research restrictions, the potential for misunderstandings, an

inclination for disadvantageous research, coercion, and exploitation must all be

adequately addressed.

Lenient Research Restrictions

In certain developing countries, a complete lack of clinical oversight or lenient

research restrictions allow for an environment in which misunderstandings regarding

important clinical trial information, disadvantageous research in favor of pharmaceutical

companies, and coercion and exploitation of local, poverty-stricken communities are

permitted. Foreign authorities are pressured into allowing for this kind of unethical

conduct, as pharmaceutical and biotech companies decide where to invest millions of

dollars in research infrastructure, training of healthcare workers, and healthcare

facilities. This can be seen in the recent developments in India. According to Peter

Mansell,

The Indian authorities have been under pressure both politically and publicly to clamp down on clinical trials, amid allegations that industry has exploited

impoverished patients for research without proper consent or oversight. Recent developments have included a new regime of trial-site inspections; reported barriers to clinical-study approvals; a temporary freeze imposed by the Supreme Court on clinical trials of some 157 new chemical entities; disputed financial- compensation arrangements for study participants; and draft guidelines requiring audio-visual recording of all informed-consent procedures.8

These are all valid considerations in an effort toward a fairer and more just safeguard

against unethical behavior. In response to these new safeguards, John Lewis, the

president of the Association of Clinical Research Organizations (ACRO), responded

with animus, stating that research “can be relocated to more hospitable countries to

mitigate the direct economic damage.”9 This creates a very challenging situation for

foreign authorities, as pressures from the rest of the world, local communities, and

industry combat against one another.

Misunderstandings

When attempting to communicate multilaterally across language and culture,

misunderstandings are highly probabilistic. This miscommunication, when deliberate, is

a form of coercion and exploitation that needs to be confronted. Misunderstanding can

occur as the result of ineffective or nonexistent communication between physician and

patient, language barriers, cultural barriers, or illiteracy. For example, Nigeria Pfizer

8 Mansell, Peter. "ACRO Warns on Indian Clinical-Trial Regulations." PharmaTimes. February 20, 2014. Accessed April 12, 2017. http://www.pharmatimes.com/news/acro_warns_on_indian_clinical-trial_regulations_1001558.9 Ibid.

tested trovafloxacin on children from Kano infected with meningitis in 1996.10 The

children’s parents were not informed, and five children died as a result of the treatment.

This is an example of nonexistent communication, but the water tends to be much

murkier. In 2012, BBC reported on clinical trials happening at Maharaja Yeshwantrao

Hospital in India.11 According to Dr. Anand Rai, “[The drug companies] chose poor,

illiterate people who [did] not understand the meaning of clinical drug trials.”12 This is an

issue of illiteracy and a clear language barrier, but cultural barriers must also be

considered. Nitu Sodey, the mother-in-law of one of the patients, recalls, “We were

surprised. We are low-caste people and normally when we go to the hospital we are

given a five-rupee voucher, but the doctor said he would give us a foreign drug costing

125,000 rupees.”13 These people hit the jackpot, and questioning members of the

medical field is not culturally acceptable for patients in India. It is not surprising that the

clinical trials went unquestioned by the participants. Without a proper understanding and

careful consideration of these miscommunications, injustice is free to run rampant.

Disadvantageous Research Potentiality

Host communities, or local communities that partake in clinical trials, deserve

adequate compensation for participating in research that has the potential to generate

immense profits. This right to adequate compensation should be respected regardless

of any ignorance toward financial negotiation, and thus, this transaction should be

mitigated by an adequately informed person representing the ignorant or incapable (due

10 Kelly, Stephanie. "Testing Drugs on the Developing World." The Atlantic. February 27, 2013. Accessed April 12, 2017. https://www.theatlantic.com/health/archive/2013/02/testing-drugs-on-the-developing-world/273329/.11 Lloyd-Roberts, Sue. "Have India's Poor Become Human Guinea Pigs?" BBC News. November 01, 2012. Accessed April 12, 2017. http://www.bbc.com/news/magazine-20136654.12 Ibid.13 Ibid.

to cultural or health factors) potential participant. Unfortunately, this kind of

representation is unavailable. As Paddy Rawlinson comments, “As the demand grows

for newer and better drugs for an expanding range of conditions, so too does the need

for clinical testing. Health as a commodity repositions ethics within an economic

framework, and human experimentation is no exception. Profits, rather than people,

become the prime consideration.”14 The poverty-stricken nature of developing countries,

along with life-threatening diseases with no adequate healthcare options, creates for an

unequal relationship between the industry and potential clinical trial participants, which

leads to the potential for disadvantageous research.

Coercion

Coercion is always a primary concern when dealing with ethical considerations

involving vulnerable populations. In Honorarium or Coercion: Use of Incentives for

Participants in Clinical Research, Susan W. Groth writes, “Vulnerable populations may

be at particular risk because they can be enticed by the financial reward and thus may

be more willing to accept any study risks.”15 This risk only increases when dealing with

poverty-stricken foreign populations dealing with serious medical conditions without

available adequate treatment. The industry has obligations to shareholders, which puts

pressure on pharmaceutical and biotech companies to develop new drugs as quickly

and cost-effectively as possible. Lenient research restrictions, as previously mentioned,

14 Paddy Rawlinson Associate Professor of Criminology , Western Sydney University. "Ethics vs Economics: The Cost of Outsourcing Clinical Trials to Developing Countries." The Conversation. February 28, 2017. Accessed April 12, 2017. http://theconversation.com/ethics-vs-economics-the-cost-of-outsourcing-clinical-trials-to-developing-countries-43246.15 Groth SW. “Honorarium or Coercion: Use of Incentives for Participants in Clinical Research.” The Journal of the New York State Nurses’ Association. 2010;41(1):11-22.

allow for coercion to take place, especially in the form of intentional miscommunication.

Incentivizing clinical trials is important, but offering a potential cure to a life-threatening

illness or financial considerations to families that struggle to feed their children has the

ability to turn into a coercive relationship and must be monitored. As Stephanie Kelly

questions in “Testing Drugs on the Developing World,” “To what extent do you have a

choice about participating when you see an opportunity to feed your starving family, or

assist your extended family, or get treatment for a terminal disease you could never

hope to pay for by conventional means? … With these kinds of life or death pressures,

the idea that it is a choice gets fuzzy.”16

Exploitation

Exploitation is a serious area of concern for clinical trials in developing countries.

Ezekiel J. Emanuel, David Wendler, Jack Killen, and Christine Grady adequately

explain this concern, stating,

Research in developing countries creates a greater risk of exploitation: individuals or communities in developing countries assume the risks of

research, but most of the benefits may accrue to people in developed countries. Although poverty, limited health-care services, illiteracy, cultural and linguistic differences, and limited understanding of the nature of scientific research neither cause nor are necessary for exploitation, they increase the possibility of such exploitation. Furthermore, the regulatory infrastructures and independent oversight processes that might minimize the risk of exploitation may be less well established, less supported financially, and less effective in developing countries.17

The prior-mentioned concerns all make exploitation that much easier for the industry.

Understanding these concerns and working in order to minimize or prevent them

16 Kelly, Stephanie. "Testing Drugs on the Developing World." The Atlantic. February 27, 2013. Accessed April 12, 2017. https://www.theatlantic.com/health/archive/2013/02/testing-drugs-on-the-developing-world/273329/.17 Manuel, Ezekiel J., David Wendler, Jack Killen, and Christine Grady. "What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research." The Journal of Infectious Diseases 189 (February 17, 2004): 930-37.

altogether is an important first step toward producing an environment in which clinical

trials in developed countries can be ethically acceptable, but implementation can only

be adequately enacted with a global effort.

Combating Unethical Treatment in Developing Countries: A Global Effort

Over the last three decades, the bioethics community has provided quite a bit of

literature regarding the ethicality of clinical trials in developing countries. For example,

Emanuel identifies eight ethical principles involved in assuring ethicality in multinational

clinical research - collaborative partnership, social value, scientific validity, fair selection

of study population, favorable risk-benefit ratio, independent review, informed consent,

and respect for recruited participants and study communities.18 Each of these eight

ethical principles is accompanied by various benchmarks, which, although opaque at

times, are meant to provide a framework for reviewing specific clinical trials. These

ethical principles and benchmarks, however, are not implemented without the

assistance of international health authorities and governments. Unfortunately, as

Premnath Shenoy points out in Multi-regional Clinical Trials and Global Drug

Development, “International health authorities and government-sponsored efforts have

provided some guidance but there is a lack of harmonized guidance from health

authorities.”19

Albeit advancement in pharmaceutical and biotech company responsibility over

the last few years, a global effort to end the unethical treatment of vulnerable

communities from developing countries is needed. This can not be done without

universal, established regulations and review boards. The current political landscape 18 Ibid. 19 Shenoy, Premnath. "Multi-regional clinical trials and global drug development." Perspectives in Clinical Research. April 1, 2016. Accessed April 17, 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4840793/.

allows for massive injustices to occur and does little to pressure the industry to develop

ethical, cost effective, and medically beneficial clinical trial procedures. Instead, the

industry openly threatens to revoke highly beneficial foreign investment if reasonable

regulations are pursued. This creates a bidding war between poverty-stricken

developing countries, which is evidenced by the prior-mentioned reaction between John

Lewis (Vice President of Public Affairs for ACRO) and the effort to increase clinical trial

regulations in India. Economically speaking, without proper global regulation and review

boards, it is currently beneficial to exploit, manipulate, and coerce local communities

and foreign authorities into unfair, unjust, and unethical clinical research. Shenoy is

absolutely correct in asserting that “The minimum acceptable criterion for running a

clinical trial anywhere in the world needs to be [emphasis added] established.”20

In One World Now, Peter Singer eloquently argues in favor of a world

government, and this argument, if slightly adjusted, parallels almost perfectly with the

argument for global regulation with regards to clinical trials in developing countries.

Singer states,

Just as parents are expected to provide for the interests of their children rather than for the interests of strangers, so too anyone accepting the office of president of the United States takes on a specific role that makes it his or her duty to protect and further the interests of Americans. Other countries have their leaders, with similar roles in respect of the interests of their fellow citizens. There is no world government, and as long as that situation prevails, we must have sovereign states, and the leaders of those states must give preference to the interests of their citizens. Otherwise, unless electors were suddenly to turn into altruists of a kind never before seen on a large scale, democracy could not function.21

In Singer’s example, the president of the United States can be seen as the CEO or

owner of a large pharmaceutical or biotech company. The citizens can be seen as the

20 Ibid. 21 Singer, Peter. One World Now: The Ethics of Globalization. New Haven: Yale University Press, 2016.

shareholders of the prior-mentioned company. Democracy can be seen as business.

Currently, there exists an environment in which coercion and exploitation are rational,

beneficial decisions for business with regards to increasing profits and gains for

shareholders and the company. While all people should be held accountable for

unethical decision-making, it becomes difficult to push all the blame onto these

pharmaceutical and biotech companies. At least partial blame needs to be placed on

the environment in which the world has created. Until this is changed and a global

regulatory body is adopted, expect coercion and exploitation to continue.

More Harm Than Good: A Complete Ban

Outrage and frustration are warranted reactions to the unethical clinical testing

that has been happening in developing countries for the last few decades. However,

advocating for a complete ban on clinical testing in developing countries is the wrong

way to express that outrage and frustration, as it would do more harm than good for

impoverished communities. The bioethics community should refer to arguments in favor

of a market for organ transplantation, as the literature involved in that discussion can be

beneficial toward advancing forward with an ethically-acceptable environment in which

to pursue clinical trials in developing countries. For example, in The Case for Allowing

Kidney Sales, Janet Radcliffe-Richards et al. argue that “Trying to end exploitation by

prohibition is rather like ending slump dwelling by bulldozing slums: it ends the evil in

that form, but only by making things worse for the victims. If we want to protect the

exploited, we can do it only by removing the poverty that makes them vulnerable, or,

failing that, by controlling the trade.”22 The trade in the prior-mentioned argument is

22 Radcliffe-Richards, J., As Daar, Rd Guttmann, R. Hoffenberg, I. Kennedy, M. Lock, Ra Sells, and N. Tilney. "The Case for Allowing Kidney Sales." The Lancet 351, no. 9120 (1998): 1950-952. doi:10.1016/s0140-6736(97)08211-1.

organ transplantation, but that statement is just as applicable to clinical trials. Clinical

trials in developing countries are not inherently unethical, but the current political

landscape and lack of regulation allows for unethical practices to occur. Unfortunately, a

universal ban on clinical trials outside of developed countries harms developing

countries by removing foreign aid and investment, much-needed healthcare products

and services, and ethically-permissible clinical trials in search of economically-efficient

solutions to Third World health problems. A global regulatory body will help to push

toward a borderless effort toward healthcare, benefitting the lives of all, rather than a

nationalistic effort toward healthcare, benefitting the lives of the already well-off.

Recognizing the Vulnerable: Feminist Standpoint Theory

If a global organization dedicated to producing ethically-justifiable clinical

research guidelines is essential to reshaping the current political landscape in order to

prohibit coercion and exploitation of vulnerable populations (this theoretical organization

will from here on out be referred to as the Global Organization on Clinical Research, or

GOCR), the minimum requirements in order to produce such an organization must be

spelled out. In other words, how does the GOCR differ from the World Medical

Association, Council for International Organizations of Medical Sciences, World Health

Organization, National Bioethics Advisory Commission, Nuffield Council on Bioethics,

and so on? There are two major differences - the GOCR is a global regulatory body that

would have complete control of global policy, research restrictions, and review boards,

and the GOCR insists on diversity among the board members. Carol Quinn’s “What Can

Survivors of Nazi Experiments Teach Us All?,” in Globalizing Feminist Bioethics:

Crosscultural Perspectives, is exceptionally helpful in understanding this distinction.

Philosophers, scientists, and policy makers can generally only imagine, if possible, the

situations that vulnerable populations face. Feminist standpoint theory recognizes this

consideration and pushes for an appreciation of the subjugated perspective. Quinn

states, “Marginalized people’s experiences, experiences of those cast into epistemic

limbo, have been disvalued and ignored as legitimate sources of knowledge, yet

feminist standpoint theorists claim that an epistemically better account is one that

begins from the standpoint (the perspective) of subjugated lives.”23 She continues, “The

dominant group’s inability to critically ‘interrogate their advantaged social situation and

the effects of such advantages on their beliefs’ leaves them epistemically

impoverished.”24 Quinn is making the argument that data obtained through Nazi

experimentation belongs to the survivors and their loved ones, but this kind of

argumentation will help to develop a GOCR that is not infiltrated with unquestioned

dominant values and beliefs.

Diversity is key to the successful implementation of a GOCR that combats

unethical treatment of vulnerable populations. The richest and most powerful countries

tend to dominate global efforts to thwart questionable ethical behavior worldwide. This

should be rather obvious. The countries with the most leisure time and resources write

the global guidelines, but these countries are not without a power bias. For example, In

Missing Persons: Minorities in the Health Professions, The Sullivan Commission

reports,

The U.S. health care delivery system was conceived within a Eurocentric model that originally excluded non-white patients or providers. Moreover, the

nation’s early history of medicine is replete with unscientific principles

23 Tong, Rosemarie, Gwen Anderson, and Aida F. Santos. Globalizing Feminist Bioethics: Crosscultural Perspectives. Boulder, CO: Westview Press, 2001.24 Ibid.

espousing the racial inferiority of non-white people. These doctrines entered the American medical school curricula by the early 19th century, became widely disseminated in medical textbooks and prestigious peer-reviewed medical journals, and ultimately gave rise and section to the medical mistreatment, abuse, and neglect of early non-white populations, particularly Native Americans and African Americans.25

This report speaks to the injustice that can occur if vulnerable populations are not

represented accordingly, even in the most altruistic of professions. Without diversity,

any effort at fairness fails. The GOCR must include members of various nationalities,

ethnicities, genders, and classes, and no nationality, ethnicity, gender, or class should

significantly outweigh another. A global organization as diverse as the one

recommended, while perhaps less efficient in the beginning, will raise awareness with

regards to important cultural differences, as well as ask questions that could have been

overlooked. This is absolutely essential to promoting ethicality in clinical trials in

developing countries.

Hold On, Wait One Second: Possible Objections

There are bound to be various objections regarding this view, as is the case with

most arguments. All of these objections are not foreseeable, nor would it be feasible to

respond to them all adequately. Below, there are three predicable arguments against a

diverse, global regulatory organization for clinical research - the efficiency argument, the

complete autonomy argument, and the privileged perspective argument.

This Is Taking Forever: The Efficiency Argument

Some will argue that employing a global regulatory organization, especially one

as diverse and complex as the one recommended in this argument, will severely limit

the industry’s ability to develop and test drugs in an efficient and effective manner. Not

25 Missing Persons: Minorities in the Health Professions. Report. The Sullivan Commission. 32.

only that, but the costs of developing and testing these drugs will increase. In this view,

people are treated as means to an end, a moral dilemma commented upon by

Immanuel Kant hundreds of years ago. It should be clear by now that human beings

have intrinsic worth by virtue of being human and to diminish that worth is unethical. If

the potential clinical trial is halted because of a serious disagreement between

competing cultures, it is likely that the potential clinical trial needs significant review. An

abundantly obvious ethically-permissible clinical trial proposal should slide through the

review process fairly quickly. Actions with serious potential consequences require

serious scrutiny and review. As Ruth Macklin comments in Ethics in Global Health:

Research, Policy, and Practice, “If some resolution of these controversies in

international research comes down to the age-old battle between economics and

efficiency on the one side, and ethics on the other, then let ethics win out.”26

Freedom and Free Will: The Complete Autonomy Argument

A second argument against the global perspective is that limiting a person’s

ability to choose whether or not to participate in a clinical trial is to limit a person’s

autonomy. According to University of California, San Francisco’s School of Medicine,

“Autonomy is the personal rule of the self that is free from both controlling interferences

by others and from personal limitations that prevent meaningful choice.”27 Assuming that

autonomy is of value and should not be limited, this argument still does not hinder the

validity of creating a global organization for clinical trial regulation and review. Certain

local communities and populations are vulnerable due to health and financial concerns.

These vulnerabilities create an environment in which uninfluenced meaningful choice is 26 Macklin, Ruth. Ethics in Global Health: Research, Policy, and Practice. New York: Oxford University Press, 2012.27 Pantilat, Steve. "Autonomy vs. Beneficence." UCSF School of Medicine. Accessed April 19, 2017. http://missinglink.ucsf.edu/lm/ethics/content%20pages/fast_fact_auton_bene.htm.

impossible to pursue. Situations in which suffering and potential death are involved

rarely involves choice or free will. This is not to say that vulnerable populations are

voiceless due to their unfortunate circumstances, and that people better equipped to

understand and react to these situations should make decisions of their behalf. Instead,

vulnerable populations should be removed from these vulnerabilities, if possible, and

make uncoerced decisions regarding their lives. The GOCR would foster an

environment in which vulnerable populations would be a part of the conversation, rather

than the topic of conversation, effectively generating uninhibited choice - the very

definition of autonomy.

Textbooks and University Degrees: The Privileged Perspective Argument

Finally, some will argue that certain foreign communities are incapable of

understanding various parts of clinical research, and thus, they should not be involved

in any form of policy or decision making regarding that subject. This is likely due to the

lack of a formalized educational system in these foreign communities. An argument of

this nature depends on a universal valuing of “dominant group values,” such as,

rationality, objectivity, clarity, precision, and the capacity to be verified or falsified.28

Sandra Harding argues, “The social group that gets the chance to define the important

problematics, concepts, assumptions, and hypotheses in a field will end up leaving its

social fingerprints on the picture of the world that emerges from the results of that field’s

research processes.”29 To further her point, that value defining social group is generally

blinded by its sureness. All knowledge is socially and historically situated, which makes

diversity not only the key to creating an ethically-justifiable landscape for clinical 28 Tong, Rosemarie, Gwen Anderson, and Aida F. Santos. Globalizing Feminist Bioethics: Crosscultural Perspectives. Boulder, CO: Westview Press, 2001.29 Harding, Sandra G. Whose Science? Whose Knowledge?: Thinking from Women's Lives. Ithaca, NY: Cornell Univ. Press, 1991.

research, but for true knowledge acquisition, as well. Feminist standpoint theory asserts

that it is “fundamentally a moral and political act of commitment to understand the world

from the perspective of the socially subjugated.”30 This socially subjugated viewpoint is

no further from the truth than the dominant viewpoint. If anything, it is closer. As a result,

diversity with regards to nationality, ethnicity, gender, and class is still an absolute

necessity in the creation of a global organization committed to fostering an environment

in which clinical research can be justified from an ethical standpoint.

One Final Word: The Conclusion

Within the current political landscape, misunderstandings, non-beneficial

research for the participants, coercion, and exploitation are all commonplace, as lenient

regulations allow the industry to cut corners with regard to ethicality in clinical research

and trials. Outrage and frustration are directed at pharmaceutical and biotech

companies, foreign authorities, and government bodies, but changing this harmful

environment starts with us. This is now a global problem. Stricter regulation in India will

not solve this problem. Clinical trial review boards in Europe will not solve this problem.

A stronger developed world presence in developing worlds will not solve this problem.

Third World countries do not need saving. A collaborative effort toward understanding

differences in culture and way-of-life, an environment in which differing opinions are

carefully considered and resolutions are reached, and a platform for the voiceless to

become a part of the conversation will help to sort out these ethical quandaries. The

Global Organization on Clinical Research is a great start toward ethicality in clinical

research and trials, but we must continue to remain vigilant to potential coercion and

30 Ibid.

exploitation. At least in the area of clinical research in developing countries, we are one.

In fact, we must be one.

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