Human Subjects Research Ethics Research Paper

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Abstract

This research paper describes the development of global research ethics guidelines and emphasizes the importance of the conceptual distinction between research and other activities in the health ﬁeld. It also presents the main principles of human subject research and provides some examples of the ethics challenges in global research.

Introduction

The ethics of human subject research can be characterized by several distinctive features. First, its twentieth century history has been marked by widely publicized cases of unethical or ethically problematic research, which had a signiﬁcant impact on the development of relevant international normative documents and research ethics as a ﬁeld. Second, research ethics can be regarded as the most institutionalized branch of bioethics – research ethics committees (RECs) and institutional review boards (IRBs), as they are called in the USA, represent universally accepted institutions authorizing the conduct of studies on humans all over the world. Third, in many countries research ethics regulations are based on the same set of internationally accepted principles and guidelines and, therefore, the ﬁeld of research ethics can be seen as the area of bioethics in which broad consensus on the procedural and substantive ethical principles has been achieved. Finally, however, despite this almost globally accepted normative and institutional ethical framework, there are still complex and controversial research ethics issues emerging in the ﬁeld of biomedicine. This research paper brieﬂy explores the issues mentioned above.

History And Development Of Global Research Ethics Guidelines

The history of human subject research represents a very diverse picture of different types of experiments involving humans. On one hand, there have been many examples of what may be seen as altruistic self-experimentation, such as James Sympson’s search for an anesthesia superior to ether in 1847 when he found himself lying ﬂat on the ﬂoor after inhaling chloroform. Similarly, in 1929 a pioneer in cardiology and the joint 1956 Nobel Prize winner, Werner Forssmann, passed a catheter, guided by radiography, into the right ventricle of his heart, demonstrating the feasibility and safety of the procedure (Rothman 2004).

However, the historical picture of human experimentation also contains examples of unethical or, in some cases, even horrifying stories of experimentation on humans. A dramatic phase in the history of human subject research took place during World War II when Nazi doctors conducted their infamous experiments on prisoners in the concentration camps. These activities were investigated by the war crimes tribunal in Nuremberg, in particular during the so-called “Doctors’ Trial,” which resulted in seven Nazi experiment instigators being sentenced to death. The judgment by the war crimes tribunal at Nuremberg in 1947 laid down ten principles to which physicians must conform when carrying out experiments on human subjects. These sets of principles have been called the Nuremberg Code, the document that can be regarded as the ﬁrst international instrument in the ﬁeld of human subject research ethics, giving a top position in the list of its ten standards to the principle of “voluntary consent of the research participant who should also have a legal capacity to give consent” (The Nuremberg Code 1947).

The problem was that straightforward application of the ﬁrst principle of the Nuremberg Code would had stopped all research studies on incapable adults and children. Therefore, the initiative to draft a more nuanced research ethics guidelines was taken by the WMA in 1964. The Declaration of Helsinki (DoH) – research ethics guidelines adopted by the WMA during its world assembly in Helsinki – marked the beginning of another very important global document in the ﬁeld of ethics of human subject research (WMA Declaration of Helsinki 2013). The DoH introduced the possibility of consent being given by the “legal guardian” in cases of a participant’s legal incapacity. However, it should be noted that this provision had a limited scope of application: it was only justiﬁed in so-called “clinical research combined with professional care” (i.e., research with direct beneﬁt to the participants), while the term “non-therapeutic clinical research” was still used to deﬁne studies where persons unable to give consent were not supposed to be involved.

Since its adoption in 1964, the DoH has undergone multiple revisions introducing some notable additions to the document. For example, the 1975 Tokyo revision introduced the requirement that independent committees, also called RECs or IRBs (the title more prevalent in the USA), must review research protocols before they are started. The text of the document also included a signiﬁcant elaboration of the requirements for informed consent.

The most important feature of the South African (1996) revision was that for the ﬁrst time the DoH made a reference to a speciﬁc type of research methodology: placebo-controlled trials. It was stated in the section pertaining to “Medical Research Combined with Clinical Care (Clinical Research)” that in any medical study, every patient should be assured of the best proven diagnostic and therapeutic method and the inert placebo can only be used in studies where no proven diagnostic or therapeutic method exists. This revision sparked a larger international debate a couple of years later when HIV transmission placebo-controlled trials were carried on in some developing countries.

The Edinburgh (2000) revision of the DoH introduced two key provisions that also have a global signiﬁcance to the ﬁeld: the so-called responsiveness to the health needs of populations in which the research is carried out as well as posttrial access to the prophylactic, diagnostic and therapeutic methods identiﬁed by the study. These topics are addressed in more detail in the later sections of this research paper. At this point, it should be noted that these particular additions expanded the scope of the DoH beyond the analysis of risks and burdens to also encompass a broader perspective of fair access to the products and results of research (Carlson et al. 2004). The latest revision of the DoH in 2013 also introduced a requirement of research registration, publication, and dissemination of its results.

Today, the DoH remains a code incorporating 37 aspirational principles of medical research ethics grouped in 12 sections. There have been two common criticisms raised regarding this document: ﬁrst, that the DoH lacks details and speciﬁcity regarding its principles to guide researchers while carrying out their research projects and, second, that the scope of the document addresses primarily physicians and only encourages other professionals to adopt its principles.

The mentioned points of criticism have been addressed by the third globally relevant document, the CIOMS (Council for International Organizations of Clinical Sciences) International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS Guidelines 2002). This document, which is currently under revision, was adopted in 1993 and revised in 2002. In contrast to the DoH, the CIOMS Guidelines are addressed to all professionals working in the ﬁeld of biomedical research and, no less important, contain not only 21 general guidelines but are also supplemented by detailed commentaries.

The last global document to be mentioned in this section is the UNESCO Declaration on Bioethics and Human Rights, which was adopted in 2006 (UNESCO DBHR 2006). Although this document is not speciﬁc in respect to research ethics, it includes a set of principles applicable to the ﬁeld of human subject research, in particular those related to informed consent and beneﬁt sharing.

Conceptual Clarifications

When exploring the ethical issues relating to human subject research, it is also important to analyze the research/non-research distinction because, as a rule, activities deﬁned as human subject research should only be carried out after their approval by the relevant REC. In addition, the activity called research, particularly biomedical research, requires not only independent ethical review but is also subject to other regulatory requirements, such as express and written consent, arrangements to compensate research participants in the case of damage, etc., which are not required for some other health-related activities. The problem is that in some cases the research/non-research distinction is not a simple one. For example, some non-research activities such as clinical practice, auditing of healthcare institutions, or various types of health monitoring can overlap or be confused with research. Therefore, the mentioned distinctions are not only interesting from a theoretical perspective but also have important practical implications.

The Belmont Report by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report 1979) was one of the earliest research ethics guidelines to emphasize the importance of conceptual clariﬁcations between biomedical research and clinical practice, such as the aims of the researcher, deviation from the standard practice, and uncertainty about the consequences of the interventions involved. According to the report, clinical practice can be characterized as aiming to beneﬁt the individual patient, diagnose or apply preventive measures, and cure diseases by using standard interventions with reasonably foreseeable consequences. At the same time, “research” designates an activity designed to test a hypothesis and to develop or contribute to generalizable knowledge and thereby beneﬁt future patients. Research activities usually also deviate from the standard practice by including additional procedures such as randomization of research subjects into different study groups, which leads to uncertainty about the consequences for the individual research participants. The general features of activities designated as research also help to distinguish research from clinical audit or health monitoring, which do not involve deviation from standard clinical practice and aim, for example, to assess the standard healthcare procedures in order to ﬁnd out whether the activity is carried out as planned (or carried out properly) or to monitor the health status of a certain population.

Although consideration of what counts as a research activity is an important issue for the scope of ethical review by RECs, it should be noted that in many countries even some clear types of human research are not subject to ethical review. For example, while biomedical research (especially clinical drug trials) almost always falls within the remit of RECs all over the world, some other types of human research such as psychological or sociological studies do not. In many European countries the stringency of ethical review of different types of human research is rather diverse and some types of studies are not reviewed by independent bodies for their ethical acceptability at all. For example, in many European countries ethical review of non-biomedical research that employs methods of social sciences (e.g., different surveys and questionnaires) is not legally binding and is of a rather advisory nature (e.g., examine the Eurecnet (European Network of Research Ethics Committees) webpage (http:// www.eurecnet.org) for the types of research reviewed by RECs in different European countries). The “asymmetry” of ethical review between different types of human research is particularly evident and striking in some of the Central and Eastern European countries and other transition societies where the systems of ethical review have been established relatively recently (Gefenas et al. 2010). This does not seem to be the case in the USA, where regulations employ a rather broad deﬁnition of the term “human subject research” and differentiate the stringency of ethical review according to the risks related to the studies to be reviewed by IRBs.

Basic Principles Of Human Subject Research

As has been discussed, national research ethics regulations in many countries are based on the internationally accepted principles and guidelines. The most general normative principles that shape the content of these guidelines and the ethical review of research projects are:

Respect for persons;
Minimization of risks and a favorable beneﬁt–risk ratio; and
Fair distributions of risks, burdens, and beneﬁts to research participants.

Respect For Persons

The fundamental principle of respect for persons is operationalized in the requirements of informed consent, privacy, and conﬁdentiality. According to the international research ethics guidelines, the procedure of consent to participate in biomedical research should be express, speciﬁc, and documented, preferably in a written form. For example, it is generally already well-accepted practice that all potential research participants should be provided an information sheet describing in lay language all of the important aspects of the proposed participation in the research project. This information should cover the following items: the nature, extent, and duration of the procedures involved, particularly details of any burdens and risks imposed by these procedures as well as any available alternatives to participation in the research project; arrangements for responding to adverse events; measures to ensure privacy and conﬁdentiality of personal data; arrangements for fair compensation in the case of damage; and the source of funding of the research project. In addition, the persons being asked to participate in a research project should be speciﬁcally informed of their right to withdraw consent at any time without being subject to any form of discrimination, particularly regarding the right to medical care. It is also assumed to be good practice to allow sufﬁcient time for potential research participants to consider participation and consult others, such as family members, about it. Finally, it should be stressed that the consent is valid only when a participant has understood all of the relevant information and there has been no undue inducement or coercion to enroll him or her into the research project.

Minimization Of Risks And A Favorable Benefit–Risk Ratio

On the one hand, the principle of minimization of risks and a favorable beneﬁt– risk ratio is rather straightforward as the requirement to assure the social value of the research and minimize risks to research participants sounds like common sense. However, even if the risks are minimized, many human subject research projects still expose research participants to a certain level of remaining risk. Balancing these remaining risks with the research beneﬁts is rather complex due to ambiguity of the term “beneﬁt,” as this raises a fundamental dilemma of trading off between the beneﬁts to an individual patient and social beneﬁts, which are the beneﬁts to future patients.

Another complex issue is the relationship between capacity to consent and the level of risk that is justiﬁable for particular types of research. For example, all of the major contemporary research ethics guidelines introduced in this research paper only allow incapable research participants, including minors, to be exposed to minimal risk (usually deﬁned as the risk of everyday life) in cases where research does not have the potential to provide direct beneﬁts. The level of risk is much more ﬂexible when research participants are capable of giving informed consent. In these cases, the guidelines refer to “acceptable” risk, which is usually deﬁned by RECs on a case-by-case basis. For example, phase I studies, or the so-called human challenge studies, in which participants are deliberately infected with microorganisms or viruses to test the efﬁciency and safety of new vaccines are examples of high-risk research that may still be considered as acceptable by the relevant REC.

Just Distribution Of Benefits And Burdens: Protection Of Vulnerable Individuals, Groups, And Populations

The main idea behind the third fundamental principle of research ethics is to apply additional safeguards to those groups of research participants who are not able to protect their own interests due to decisional incapacity, institutional dependency, or social and economic deprivation. To follow the wording of the DoH 2013, these persons have an “additional likelihood of being wronged or of incurring additional harm.” According to this and other international guidelines, research with vulnerable groups is only justiﬁed if:

Such research cannot be carried out in non-vulnerable individuals and groups;
It is responsive to the health needs and priorities of this group; and
Vulnerable research participants will beneﬁt from the knowledge, practices, or interventions that result from the research, e.g., post-trial access for all participants who still need an intervention identiﬁed as beneﬁcial in the study.

Such special protection is to be applied to institutionalized persons and also those in a hierarchical relationship, e.g., prisoners, students, or military personnel. The mentioned safeguards are also particularly important for populations in resource-poor countries or communities which are vulnerable due to social and economic deprivation. In addition, as has already been mentioned in the previous section, the requirement of a minimal risk threshold should be applied in research involving persons unable to consent.

Global Research Ethics Challenges

This section of the chapter concentrates on a few ethical challenges that could be seen as having a global dimension: ﬁrst, because they have arisen in very different societal and economic contexts; and, second, due to the fact that they involve interactions between developed and developing parts of the world.

Understanding Research-Related Information And Therapeutic Misconception

As has been demonstrated by different studies, understanding of the main aims and methodological features of biomedical research, including clinical drug trials, remains far from satisfactory in different regions of the world (Mandava et al. 2012). For example, features such as placebo control or randomization are in some cases only understood by less than half of the research participants. This may be due to very long and complex text in information sheets (information sheets for pharmaceutical trials are sometimes 20 or more pages) or because of a discrepancy between the complexity of the information sheet and the reading level of research participants. However, this may also reﬂect the so-called phenomenon of therapeutic misconception. The problem is that one of the most important information topics to be provided to a potential participant in a biomedical research project concerns the balance between the potential risks and beneﬁts related to their involvement in a research project. For example, a participant in a clinical drug trial should know the risks related to different interventions of the trial and, most importantly, be able to distinguish between potential beneﬁts to future patients and potential beneﬁts to the participants of the trial. Confusion regarding these beneﬁts leads to the mentioned therapeutic misconception when research subjects mistakenly believe non-therapeutic research interventions or projects will have direct beneﬁts for them. This phenomenon can be fostered by researchers who may have ﬁnancial or academic interests in performing biomedical research projects and are therefore attempting to recruit large numbers of research subjects.

Alternative Models Of Consent And “Research Exemption”

Development of large-scale genome projects and biobanks has challenged the very concept of speciﬁc informed consent developed in the postNuremberg period. The problem is that the model of speciﬁc consent relevant to currently developed research projects with clearly deﬁned aims, designs, and intervention plans is hardly applicable when describing the possible future use of biological samples and personal data stored in biobanks, which have become an increasingly important infrastructure for future research. Therefore, many countries have adopted models of broad or even presumed consent in their biobank-related regulations to meet the new scientiﬁc and technological opportunities provided by modern medicine. The move towards the mentioned consent alternatives has also been reﬂected in the international European and global research ethics guidelines. For example, the explanatory report to the Council of Europe, the Recommendation on Research on Biological Materials of Human Origin of 2006 [Rec(2006)4], has introduced a distinction between interventions that aim to remove materials for use in a speciﬁc research project and interventions in which the sample is removed for research storage. The latter option can be combined with alternative types of consent, such as broad or presumed consent (in the case of storage of residual biological materials for future research), which do not require the description of the speciﬁc aims of a research project for which the biological sample will be used in the future.

No less complex situations arise with regard to consent in the context of retrospective studies on health information (e.g., medical ﬁles) and biological material previously collected for other purposes (e.g., tissue samples taken for diagnostic purposes). These types of studies raise the so-called issue of “research exemption,” where waiving the requirement for informed consent is claimed to be a necessary condition to carry out the research project. In general, re-contacting the patient and obtaining a new speciﬁc consent to use previously collected materials for research (which had not been discussed at the time the data/tissue sample was obtained) is considered to be the best policy from an ethical standpoint. However, the problem is that, depending on the circumstances, such re-contacting may be impossible or would require disproportional efforts due to, for example, a large number of persons to be recontacted. The mentioned European Recommendation Rec(2006)4 states that biological material can be used in a research project without the consent of the person concerned when an independent evaluation certiﬁes that contacting the person concerned is not possible with reasonable efforts, and (1) the research addresses an important scientiﬁc interest; (2) the aims of the research could not reasonably be achieved using biological materials for which consent can be obtained; and (3) there is no evidence that the person concerned has expressly opposed such research use. However, it should be taken into account that the burden of responsibility of waiving consent in those cases is shifted to RECs, which are supposed to decide what “reasonable efforts” mean and how they should be balanced with the scientiﬁc importance of the research (Gefenas 2012).

Placebo

The use of placebo in clinical trials is one of those complex topics in which the issues of research methodology closely merge with ethical and socio-economic considerations. Thus, what at ﬁrst glance might seem to be just an ethically neutral issue of scientiﬁc design very often becomes the object of ﬁerce controversy and disagreements at both the academic and policymaking level.

It seems there are no ethical controversies related to placebo control when there are no options of established effective or safe therapies available or, to use the phrase from the DoH 2013, where “no proven intervention exists”, because in this case research participants do not risk losing an opportunity of beneﬁting from an established therapeutic or diagnostic method. Controversy arises, however, as soon as there is a certain treatment that has had its efﬁcacy and safety established in the past and for which attempts are being made to develop a better or cheaper therapeutic modality. In this situation, the preference to use placebo as a comparator is based on the viewpoint that a study design that includes a placebo arm is methodologically superior to an active control study design where the safety and efﬁciency of a new medication is compared with the medication for which use has been accepted in medical practice. There have been two types of inter-related ethical criticisms of placebo-controlled trials in these circumstances. First, it can be claimed that participants in the placebo arm receive suboptimal treatment and are therefore used as a means to serve the interests of future patients. Second, and the point that we explore in more detail below, it can be argued that placebo-controlled trials are often used to exploit participants from resource-poor countries when these trials are carried out in these locations. Such a situation arises where “the best proven intervention” (which is required as a comparator by the DoH) exists somewhere in the world but is not available in the poor country and, therefore, the drug that would normally be used as an active control in the wealthy country is replaced by a placebo.

This particular situation created a worldwide controversy in 1997 when placebo-controlled, mother-to-child HIV transmission trials were carried out in developing countries. The critics of these trials argued that those who designed, approved, and carried out studies on the maternal transmission of HIV to newborns involving placebo controls were violating the placebo rule of the DoH and were responsible for hundreds of preventable deaths because an effective zidovudine (AZT) regimen taken from AIDS Clinical Trials Group (ACTG) study 076 was available and routinely used in the USA and other developed countries. On the other hand, supporters of the mentioned AZT trials refuted the criticism and argued that the “best proven therapeutic method” does not mean the best therapy available in the developed countries of the world but rather the standard that de facto prevails in the country where the research is carried out. This interpretation of the phrase is much more permissive with regard to the use of placebo as a comparator, and in some cases it also allows the use of participants from poor countries as a cheaper and/or faster means to develop a new drug to be used elsewhere in the world.

The attempts to form a more balanced position should also be mentioned in this context. For example, the US Presidential Commission report supports the view that the optimal standard should lie between the extremes of the “global best proven” and “local de facto” standard. According to this moderate point of view, the optimal standard of care should be deﬁned by taking the level of available medical and logistical infrastructure, cultural practices, genetics, and the capacity to sustain a certain treatment into the future into account (Presidential Commission Report 2011).

Protection Of Vulnerable Populations And Post-Trial Access

The ﬁnal two global-scale issues to be mentioned in this research paper are protection of vulnerable populations and post-trial access to the interventions identiﬁed as beneﬁcial in the study. Although these two provisions marked a new paradigm in research ethics that brought the perspective of distributional justice into the scope of global research ethics guidelines, their implementation can be ethically rather problematic.

With regard to the ﬁrst issue, the latest version of the DoH only justiﬁes medical research involving vulnerable groups if this research is responsive to the health needs and priorities of this group and the research cannot be carried out in a non-vulnerable population. However, a straightforward interpretation of this requirement can be rather problematic. Imagine an HIV transmission prevention study with a direct beneﬁt to the research participants that is planned as a multicenter trial including resource-poor countries. According to the DoH, such a study could not be conducted on a vulnerable population unless it had already been carried out on a non-vulnerable population. However, this would disadvantage vulnerable populations as they would be blocked from accessing a research study with immediate health beneﬁts (Schroeder and Gefenas 2013).

The post-trial access requirement also meets some practical and ethical challenges, such as unrealistic timeframes and unfairness. This requirement states that before the start of a clinical trial, sponsors, researchers, and host country governments should make provisions for post-trial access for all participants who still need an intervention identiﬁed as beneﬁcial in the study. However, the problem is that the majority of medicinal products involved in early-stage clinical drug trials do not reach the registration stage and even in the case of a successful trial, it takes on average a decade to bring a drug to the market. Therefore, even if post-study access could be assured a decade after a study is completed, this would realistically only beneﬁt those research participants who were lucky enough to be part of the last phases, and not the participants of phase I or II trials – the most risky stages of drug development. These study participants are therefore contributing to medical progress without having a reasonable prospect of accessing a successfully tested intervention (Schroeder and Gefenas 2012).

Conclusion

The ethical challenges described in this research paper remain the principal focus of global bioethics considerations. However, the scope of the ethical issues faced on a global level will be supplemented by those related to new emerging technologies such as nanomedicine, “big data” projects, or neuroenhancement. The convergence of these technologies will open new opportunities for progress, particularly with regards to human health; however, at the same time, this can also bring interventions that may be more invasive and intrusive, and could possibly challenge a person’s autonomy, integrity, and privacy (van Est et al. 2014).

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