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Abstract

What are the principles and values that should govern research with human beings, and what are the rights that should be respected when humans participate in research? This is the core question addressed in this entry. In the ﬁrst part the difference between clinical research and other forms of research and the difference between clinical practice and clinical research are brieﬂy discussed, followed by an analysis of the changes and modiﬁcations scientiﬁc and ethical standards in clinical research have undergone, in particular since the 1990s. Emphasis is put on the impact on international biomedical research of the global expansion of the neoliberal market model: the globalization of biomedical research and the weakening of international normative ethical frameworks. Finally, the attention is turned to the standard of care debate in international clinical research and the controversy between proponents of accepting the use of local standards and defenders of a universal ethical standard. It is argued that respect for human dignity and social justice must be at the core of such debates and that differences in cultural, social, and political conditions cannot be taken as facts outside the scope of ethical consideration when research is planned and conducted. On the contrary, it is argued that research in low income countries has to satisfy the local health conditions, the priorities and human needs, since only in this way it will be possible to research fairly in an unjust world.

Introduction

The never-ending desire to gain new knowledge enabling us to understand the causes of disease, to restore health, promote well-being, and diminish human suffering has given way to new and more complex initiatives in the methods used to acquire that information in medicine.

However, ethical questions emerge regarding the principles and values that should govern research and the rights that should be respected. This is clearly evident in the tension between the objectives of science and the ethical limits that should model the methods used to achieve them.

The difference between clinical practice and clinical research is also a very important distinction to take in account. Clinical research can be deﬁned as an intervention on human beings aimed at generating generalizable knowledge that can improve the health and well-being and/or increase the understanding of disease. It is carried out in order to validate a new product or a diagnostic or therapeutic procedure. Clinical practice, on the other hand, is the act done on the body of a patient in order to diagnose and treat his/her illnesses. Doing this, professionals perform an already validated intervention for a patient with a diagnostic or therapeutic target. Clinical research is the activity oriented to achieve this validation through a methodology that has certain primary requisites. This methodology rests on some pillars: the question or issue raised should be relevant, it should be stated accurately and operatively, it should be addressed or answered by the best means available in every circumstance, and one should avoid redundancies or repetitions of issues that have already been reviewed by other researchers. But the rigor of the method by itself does not respond to some questions of great signiﬁcance related to the value of research for the population on which the research is carried out or also if it will have any added value to other drugs already in use. Several other ethical questions have been raised in the last years, to not “use” the participants only for proﬁt objectives, particularly in relation to the increase of clinical research in poor and low-income countries. There, some drugs will not be available for the study populations after the research has been conducted, or it is not at all a priority in relation with their health needs.

Background

The history of clinical research ethics is a narrative about the answers that have been given with regard to the violation of dignity and rights of individuals and communities, justiﬁed by the value of new knowledge and of ﬁnding out what in general is in the best interest of society or the humankind. These answers were set out in codes, guidelines, and declarations with norms and ethical principles that doctors and researchers should respect as part of their oath to act accordingly and as a responsible obligation to the social order in which they were carrying out their practices.

Auschwitz and Dachau were two of the most blood-curdling examples of what medicine was capable of, without an ethical guide for medical practice, but other examples have also shown that even with more and more updated ethical structures, the guidelines proposed were still ignored. This, in turn, led to the need to develop more sophisticated control systems and regulations.

Recent history is rich with examples. In this respect, it is difﬁcult to introduce the background of clinical research without taking into account the political and economic systems within which medical practices have been carried out. Scientiﬁc development, the rights of patients, questions pertaining to health justice, and the right to health have taken place within certain regimes and historical contexts where human rights are speciﬁcally protected or violated, precisely because the system makes it possible. This is the frightening framework of the twentieth century of which medicine was a part and which led to the building of an ethical body of norms including principles, values, and rights that should be taken into consideration by doctors, in particular those involved in research with human beings. In the last years of the twentieth century and the beginning of the twenty-ﬁrst century, some additional conditions have been inﬂuencing the way in which clinical research is developed and the ethical principles that are meant to guide these practices.

Among the issues that have been paradigmatic in the ethical review of clinical research are methodological as well as ethical assessment of protocol design, informed consent, assessment of the relationship between risks and beneﬁts, equitable selection of participants, conﬁdentiality of data, and evaluation by an independent ethics committee. However, there is one particular ethical issue that cuts across all others, that is justice. It was evident in the events that took place in the 1990s. It was in this time period that a new normative order emerged in international clinical research, i.e., the application of different standards of research (both methodological and ethical standards) according to different socioeconomic and cultural contexts. This is clearly expressed in the case of the use of placebo but is applicable to almost all other ethical issues related to clinical research.

Central Concepts Undergoing Change: Scientific And Ethical Standards

If anything characterized the period that arose at the beginning of the 1990s, it was a deep and systematic revision of concepts and terms that could also modify the way in which they were used in different normative frameworks, i.e., ethical codes, declarations, and recommendations. It was precisely because of this fact that an intense debate related to the so-called standards emerged, in both clinical practice and in clinical research. The standard of care debate not only concerned the ethical aspects of clinical practice and research but also their epistemological dimensions.

Scientific Standards Of Care In Clinical Research

In the ﬁeld of medicine, standard of care is a diagnostic or therapeutic procedure that a doctor should follow for a certain type of patient, illness, or clinical circumstance. Legally speaking, it is the level at which an average prudent physician in a given community would perform certain practice.

From a technical and methodological perspective, a scientiﬁc standard is a provisional truth which has been validated through a methodologically regulated procedure. Through these procedures we obtain recommendations that are referred to as standard treatment or care.

When a standard shows greater evidence (in terms of probabilities) in achieving effectiveness and safety in the treatment of a certain sickness, it receives the name of “gold standard.” The method par excellence used in clinical medicine to achieve this kind of evidence is through the use of the controlled clinical trial (CCT) design, especially with the use of placebo in the control group. The introduction of this methodology has, however, not been without controversy, and notably for epistemological as well as ethical reasons, in particular when confronting doctors’ duties to help patients and protect their rights with the medical researchers’ duties to abide by and uphold a strict and straightforward methodology.

In the rush to resolve this potential conﬂict, many clinicians and ethicists agree that a controlled clinical trial (CCT) is not technically or ethically acceptable unless it complies with the required “principle of uncertainty,” which means that when research begins and after a review of the literature regarding what treatments can beneﬁt a certain group, on an impartial basis, then, informed, reasonable people, in good faith, agree that for comparable interventions there exists sufﬁcient proof to show that the level of therapeutic merit is acceptably high, while none of the alternative treatment options show to be either of a better or worse quality. The technical label for this kind of uncertainty is clinical equipoise, which refers to “a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial… Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment.. .” (Freedman 1987, p. 141).

This leads to the assumption that the use of placebo in a control group is epistemologically and ethically acceptable, when a proven treatment does not exist for the situation at hand, with relatively very few exceptions. When a proven therapy exists, it requires comparing the new intervention with the already proven treatment (gold standard) due to the fact that the research is not only to prove effectiveness but also to show superiority over an already existing treatment. It would not be scientiﬁcally correct to give placebo to a group when there is already an existing treatment that has shown effectiveness and safety. Doing so would violate the principle of clinical equipoise.

Ethical Standards Of Care In Clinical Research

Clinical research has relied on rules and ethical principles meant, at ﬁrst, to guide the good deed of researchers and more recently in addition on external obligations related to law and social rules aimed at protecting the rights, well-being, and safety of participants involved in research. The historical basis of this normative structure relates to three normative documents, two of them which clearly reﬂect the reaction western civilization had when faced with the unethical and criminal experiments that had been conducted during World War II (the Universal Declaration of Human Rights UDHR and the Nuremberg Code) and a third normative document, later on, reﬂecting the consensus of the World Medical Association with respect to the ethical standards that should be abided by in medical research practices (Declaration of Helsinki). These three normative documents are all rooted in the conviction that human rights should be the normative baseline for the protection of human beings participating in biomedical research. Other conventions and declarations have followed, as, for example, the Oviedo Convention approved by the Council of Europe in 1997 and the Declarations approved by UNESCO (the United Nations Educational, Scientiﬁc and Cultural Organization). Of particular relevance for medical research is the most recent one, i.e., the Universal Declaration on Bioethics and Human Rights, UDBHR (UNESCO 2005).

Common for the UDHR and the Nuremberg Code as well as the Declaration of Helsinki (DoH) is the commitment to a universal ethical standard, which strives for equal treatment of all human beings based on respect for their dignity. As stated in Article 1 of the UDHR: “All human beings are born free and equal in dignity and rights.. ..” Most of the articles of the Nuremberg Code were inspired by this core commitment. Likewise, the World Medical Association adhered to this commitment as the normative basis for its Declaration. The original version of Article 5 of this Declaration states: “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society,” thus placing respect of humans above any other consideration. The common ground is the idea of dignity which assumes that all human beings possess a condition that makes them deserving to be treated with equal respect and consideration.

At the end of the 1970s, a new normative model arose with the Belmont Report which was the ﬁnal report of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research in the USA. It was anchored in the liberal, Anglo-American tradition and introduced three ethical principles that should be respected in all biomedical research. The document suggests the use of these principles as a method of evaluation in research and considers existing declarations as ineffective: “The codes consist of rules, some general, others speciﬁc, that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conﬂict, and they are frequently difﬁcult to interpret or apply. Broader ethical principles will provide a basis on which speciﬁc rules may be formulated, criticized and interpreted” (The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, 1979).

The Belmont Report gave rise to a new line of normative development which normative basis, principlism, clearly moves the focus away from universal ethical standards to make room for a strong predominance of the autonomous individual.

In the UNESCO UDBHR, approved in 2005, a strong commitment to respecting and protecting the interest and welfare of research participants is given from a triple justiﬁcation: (1) as a recognition of the dignity, human rights, and fundamental freedom of research subjects (Article 3.1); (2) as an institution for protecting the integrity and interests of individuals and groups of special vulnerability against the interests held by the majority or by those in power (Articles 6.3 and 8); and (3) by linking the search for knowledge in clinical research to the principles of harm and beneﬁt (Article 4) (Solbakk and Vidal 2012, pp. 775–785).

Returning to the controlled clinical trial (CCT) case, the main ethical conﬂict relates precisely to the use of placebo in a control group when a proven treatment is not available for the population because they are members of poor or low-income countries. When administration of an already approved drug is unfairly denied in a particular clinical context because the best proven standard is not accessible for the population, it takes us back to the subject of uncertainty and clinical equipoise but raises also serious ethical problems. Using a placebo in the control group when the existence of a proven treatment is known is not only unethical but also scientiﬁcally questionable. The defenders of the use of placebo in such situations argue that a local standard should be applied if the population doesn’t have access to any treatment and that standard of care for them, in this case “no treatment,” which is the same as receiving placebo.

This consideration concerning the use of placebo is at odds with the principle of equal treatment for all human beings and respect for human dignity, as expressed in the DoH and in the UDBHR. What this means is that in research it is never, ever, ethically justiﬁable to deny an individual or group of individuals of a proven treatment (in the control group), by giving them placebo or a less effective treatment, although locally they don’t have access to this treatment because of economical reasons.

To this two other requirements should be added, without which, research cannot be considered ethical, i.e., equitable selection of participants, informed consent, beneﬁt-risk relationship, etc. It is, however, worth mentioning, that these last requirements, although necessary, are not sufﬁcient if the ﬁrst rule of respect for dignity is not adhered to, as well as the obligation to cause no harm. Lastly, there are numerous other ethical considerations necessary to attend to as well, for example, the value of a study related to the health needs of the population in which the study is carried out, the necessary review by an independent ethics committee, and considerations pertaining to vulnerable groups to avoid exploitation.

New Times, New Standards In The Global Sphere

The 1990s was marked by the global extension of the neoliberal market model as the only viable option, both for high-income countries and for countries with lower incomes. Accompanying this movement was a new world strategy for the markets, and a new economic policy was founded by the international ﬁnancial organizations for the world. Hand in hand with this, corporations linked to the health ﬁeld, in particular, the pharmaceutical industry, developed their global market strategy based on these recommendations. This new, international economic approach substantially impacted the international biomedical research scene.

A New Biomedical Research Model Emerged

Before the 1990s clinical research was carried out by the most prestigious universities which received private funds or donations to develop independent research projects, and then academic researchers were given incentives for their activities. In the new model that could be called the “privatized model,” the ﬁnancial backing began to be provided by international companies which made contracts directly with principal researchers or with intermediate organizations, generating a long list of conﬂicts of interest. In 1991, 80 % of the investment by the pharmaceutical industry was allocated for clinical research and went to researchers in academic medical centers, while in 1998 only 40 % went toward the same, while most of the rest were direct contracts through researchers or intermediary companies like contract research organizations (CROs), (Klein and Alan 2002). In this way, the goals of research most deﬁnitely came into play, in particular with regard to multinational studies.

Most of ﬁnancial investment in research does not recognize human health necessities, in particular, the prevalent illnesses in poorer countries that are largely responsible for worldwide mortality (i.e., malaria, dengue, yellow fever, Chagas disease, etc.), what has been called by WHO the 90/10 gap (WHO 1996). It establishes that 90 % of the funds invested for biomedical research are directed to study diseases which affect 10 % of the world’s population. In this sense, we notice an obvious widening in the gap that exists between the health needs of communities that participate in the multinational market research and the objectives that these projects have.

Globalization Of Biomedical Research

Ever since the 1990s, there has been an increase in research performed by international companies in poor and low-income countries. In this context, of the 50,000 ongoing clinical trials in the world, more than 40 % are now being conducted in areas of “nontraditional” research (Petryna 2007). Each time, more and more studies in phase II and III are being directed to places like India, sub-Saharan Africa, and Latin America, among other new “markets.” There are different explanations regarding the development behind the continued increase in research in poor and low-income countries. First, there has been an increased development of stricter regulations, and at the same time bureaucracy slows down and complicates matters in many of developed countries (Glickman et al. 2009).

Second, the normative standards and the regulations in poor and low-income countries tend to be more ﬂexible (if there exists any control system at all), allowing researchers to use ethical, as well as scientiﬁc, standards that are different with respect to the ones required in the host countries (e.g., the use of different versions of the same protocol for different countries, using placebo in the control group when studies are conducted in poor and low-income countries and the best proven treatment when conducted in high-income countries where the use of placebo is forbidden). Third, ethical evaluation by research ethics committees in these countries is less strict, in part due to less training of members of the committees and the pressures the members are exposed to when they do not have decision-making powers. Another point worth mentioning here concerns the ease of recruitment in these countries, which is due to the fact that large sectors of the population are considered to be illiterate and often sign without fully understanding the informed consent forms they are signing (Lorenzo et al. 2010). Fifth, there is a very strong paternalist model of inﬂuence, so that in many cases it is unclear to the patient the distinction between the clinical doctor and the researcher whereby participation in the project (even with the signed forms) can really be more of a proposal by the doctor rather than a conscious decision by the patient to be enrolled in the research. Sixth, conducting research in poor and low-income countries is less costly, as researchers and a nurses charge ten times less for participation in research (Glickman et al. 2009). Furthermore, there is less risk of law suits, and insurance companies (not always completely valid legally in the host country) charge lower fees in poor or low-income countries than in those with higher incomes. Last, but not least, there is a need for companies taking part in the large-scale, globalized, research model to ﬁnd untreated populations to lead them to new markets.

Weakening The International Normative Ethical Framework

The third impact on international biomedical research following the global expansion of the neoliberal market model is the systematic attempt to make international ethical norms more lenient, especially those that have had greater normative power and “stricter” rules as is the case with the DoH and the UNESCO UDBHR. The attempts to modify the DoH have especially been focused on making more ﬂexible the prohibition to use placebo in the control group when a proven treatment exists. This began with the inclusion in 2002 of an explanatory note to Article 29 related to the use of placebo. With the revisions of the DoH in Seoul in 2008 and in Recife 2013, this note was given the status of a separate article (Article 33). Other examples are related to the post-research responsibilities of researchers and sponsors with regard to participants and communities. By the same token, UNESCO’s UDBHR, shortly after being approved, received harsh criticism. This critique seems blind to the fact that this declaration was unanimously adopted by all the 192 member states of the UN in 2005.

The tendency goes in the direction of more lenient and less restrictive international guidelines into clinical research, thereby weakening the rights of research participants, in particular vulnerable groups from poor and low-income countries involved in such studies.

Ethical Fractures Of The Globalized Model

The nonethical use of placebo in vulnerable groups has become one of the most controversial issues in clinical research ethics. In 1997 Lurie and Wolfe published a report (Lurie and Wolf 1997) arguing that unethical trials were performed in Africa and other low-income countries. The trials referred to the vertical transmission of HIV in pregnant women (in total 18 trials, including 17,000 women in Uganda, Haiti, Dominican Republic, Thailand, Africa, and the USA). Two of these trials were performed in the USA, comparing the new drug with zidovudine in the control arm, which was considered the gold standard treatment (after proving its effectiveness in the prevention of vertical transmission of HIV in the AIDS Clinical Trials Group 076, performed in 1994). A third trial was conducted in Thailand comparing the new intervention with a short form of the proven treatment. The remaining 15 studies were conducted comparing the new drug against placebo in low-income countries. The study was sponsored by the US Department of Health and Human Services (DHHS), the 550

National Institute of Health (NIH) USA, the Center for Disease Control (CDC) in Atlanta, and Harvard University. In the same publication, the editor of NEJM, Marcia Angell, denounced the research as being unethical, and she pointed to the use of a double ethical standard since the 15 trials conducted in low-income populations were using placebo for the control group, while the two trials conducted in the USA made use of the best proven treatment, i.e., standard of care, as a control (Angell 1997). Angell argued for the need of one universal standard in international biomedical research. The counterargument which later was made public by the sponsoring institutions, in this case, the NIH, was that the ethical standard with regard to the use of placebo which had been administered was “the local standard,” which in poor countries signiﬁes no treatment.

This gave rise to the hot debate over the criterion for the use of placebo, while as mentioned earlier discussions also started about the need to modify the strictest articles of the DoH, especially with respect to banning the use of placebo when a proven treatment exists, and it emphasized the fact that “the decision should rest with the patients,” defending the use of a new scientiﬁc standard referred to as “the highest standard of affordable treatment.”

Another example that later marked the center of the debate was a study supposed to have been developed in 2001, in Latin American countries, by the Discovery Laboratories from the USA. The lab presented a proposal to be evaluated by the FDA for the study of a new surfactant, Surfaxin, used in the treatment of premature neonatal infants with respiratory distress syndrome. The outline of the study foresaw three comparative branches with 325 children in each group. The ﬁrst group would receive the new experimental drug, a new surfactant; the second group would receive an already proven and established surfactant, while the third group would receive placebo. The study was supposed to take place in four Latin American countries (Mexico, Peru, Ecuador, and Bolivia). While the study was waiting for approval, the directors of an NGO, the Public Citizen’s (PC) Health Research Group, objected to the study and presented a scathing letter to the Department of Health and Human Services (Lurie et al. 2001), espousing that the study was unethical, as it could not be performed in the USA, due to the fact that the USA already had a proven treatment; therefore, the use of placebo would not be authorized. Meanwhile, in these poorer populations, researchers were trying to authorize the use of placebo, knowing full well that the participants and their communities did not have the economic resources; therefore, they would not have access to treatment, if, in fact, it did prove to be effective. The laboratory argued that they could use placebo since the children in the countries included in the study did not have access to an effective, proven treatment; therefore, the subject’s arm that would receive placebo would neither be worse off nor would it be harmed and would react as if no test had ever been performed. Furthermore, the study was backed up by the fact that it satisﬁed the ethical principles of the Belmont Report, while at the same time, the laboratory stated that it would offer training and equipment for the neonatal units and Surfaxin (if this proved to be effective) with a “discount” in the price for 10 years. Robert Temple, Director of the FDA’s Ofﬁce of Medical Policy defended the study, stating that, “If they did the trial, half of the people would get surfactant and better perinatal care, and the other half would get better perinatal care. It seems to me that all the people in the trial would have been better off” (quoted by London 2005, 27). In the end, the study design was not approved and was performed instead in the USA with a new design comparing Surfaxin against the standard of care treatment.

The Local Standard And The Liberal Minimalistic Ethics Model

The so-called local standard states that the contextual conditions or, in other words, the status quo of the host community is the one which establishes the normative baseline by which we should evaluate the initiatives of research proposals, which means that this status quo is seen as the reference point for individual moral rights in this particular realm (London 2005).

The conditions, in which the community lives, establish the minimum basis of justice (understood as fair) from which it may or may not conduct a clinical research. The model puts great value on the autonomous decision of the participants, regardless of how those conditions affect the exercise of autonomy or expose them to greater risks (Lorenzo et al. 2010). This produces a split between the socioeconomic and health conditions of the community, their health needs, and the research in which members of that community participate, since research is proposed as an isolated fact in relation to the contextual conditions of individuals and communities, but even more, this way of life is used as an ethical standard to evaluate the methodological correction, as well as the ethical aspects of the protocol. To make this possible, it would require a very ﬂexible model of ethical evaluation such as is the case with the model proposed in the Belmont Report (London 2005).

The conception of justice included in this approach is based in some new standards like the “fair beneﬁts standard” or “justice as mutual advantage standards” (London 2005) or ﬁnally something like “consensual exploitation” proposed by different authors. In this way the local standards (and therefore the double standard) are applied not only to justify the use of placebo in populations without economic means for access to health but rather also to evaluate:

– The possibilities that the population could beneﬁt from the results of the research – to have access to the best preventative diagnostic, or therapeutic, methods, resulting from the study

– The provision of treatment during the study (the same one they have in the local health services)

– The treatment of adverse events

Health Conditions, Human Needs, And Local Standard

The reports that have been made in recent years regarding the health conditions in the third world are a good source of information with regard to what has been called “local standard.” PAHO, in its Health Report of the Americas, in 2007, stated that “The greatest share of health problems is attributable to broad social determinants – the “causes behind the causes” of ill-health: poverty, malnutrition, unemployment, lack of access to education and health services, the social exclusion of certain population groups, among others” (PAHO 2007, 2). At the same time, a clear reference has been made to the “unﬁnished agenda” of Latin America, which means that countries in Latin America continue to be faced with issues that have already been resolved in other places, thus becoming priorities. They are, among others, extreme poverty and hunger, higher death rate in children under the age of 5 years old, lack of improvement in health in mothers, prevention and inadequate control of infection from HIV, tuberculosis and malaria, limited access to essential medicine, insufﬁcient access to water supply and sanitation, obstacles in improving health in indigenous populations, and illnesses not attended to in neglected populations. This is not different related with the situation in other low-income regions in the world. Nevertheless, it is not possible to understand health conditions without having a comprehensive view of what is referred to as social determinants of health (WHO 2003). What this means is that most health problems are related to the social, economic, and political conditions in which people live and die.

The report of the Millennium Development Goals in 2015 describes this situation thus: “Big gaps exist between the poorest and richest households, and between rural and urban areas” (.. .) “millions of poor people still live in poverty and hunger, without access to basic services: Despite enormous progress, even today, about 800 million people still live in extreme poverty and suffer from hunger. Over 160 million children under age ﬁve have inadequate height for their age due to insufﬁcient food. Currently, 57 million children of primary school age are not in school. Almost half of global workers are still working in vulnerable conditions, rarely enjoying the beneﬁts associated with decent work. About 16,000 children die each day before celebrating their ﬁfth birthday, mostly from preventable causes. The maternal mortality ratio in the developing regions is 14 times higher than in the developed regions. Just half of pregnant women in the developing regions receive the recommended minimum of four antenatal care visits. Only an estimated 36 % of the 31.5 million people living with HIV in the developing regions were receiving ART in 2013. In 2015, one in three people (2.4 billion) still use unimproved sanitation facilities, including 946 million people who still practice open defecation. Today over 880 million people are estimated to be living in slum-like conditions in the developing world’s cities” (UN 2015, 8–9).

When taking this kind of information into account, it is easy to understand what “local standard” means for clinical research and why it is justiﬁed to talk about double ethical standards not only with regard to the use of placebo, but rather for most research interventions made in the third world.

Conclusion

It is imperative to identify the role that research takes on in health and biomedicine, in particular, in impoverished and marginalized contexts. A universal standard of justice seems to be the only way to measure the needs of human beings from an equal rights’ point of view.

Clinical research should contribute to narrowing the 90/10 gap and improve and radically modify the conditions determining the illnesses and the deaths in these communities, as well as to promote human development. Research should be part of a process to raise human capabilities that promote a truly human development and should also be geared toward improving life conditions, health, and human well-being where they are performed.

The liberal, minimalistic model with its local standard, nevertheless, tries to avoid the existent relationship between globalized biomedical research and global justice, the world distribution of poverty and wealth and its repercussions in each context, the social determinants of health and disease, the health needs, the human development conditions, and the social and economic structures of communities.

If the founding principle of ethics is justice, it is not possible to continue discussing different types of justice for the ethical evaluation of clinical research in different countries. Only one ethical standard could then be accepted, implying considering human beings in their dignity and taking into account cultural differences and contexts. Clinical research is not a different ﬁeld in this regard.

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