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Research policies, aimed at excellence in research, are designed and implemented to ensure that good research practices are pursued in balance with ethical considerations. As there is increasing overlap between good research practices and research ethics, and given that there are other chapters in this book that include detailed discussion of conﬂicts of interest, research misconduct and related topics, this chapter mainly focuses on the ethical aspects of research policies aimed at protecting human subjects in research. The history and development of the Declaration of Helsinki, International Conference on Harmonization: Good Clinical Practice (ICH-GCP) guidelines, and Council for International Organizations of Medical Sciences (CIOMS) guidelines, as well as ethical principles speciﬁed in these documents, were examined. Problems and challenges faced by different layers of research policies, for instance international guidelines, national laws/regulations, and institutional policies and procedures, are discussed. We conclude that lessons should be learnt from history and all stakeholders involved in human subject research bear the responsibility to develop new research policies. However, the diversity and uniqueness of a particular context should be considered seriously during the process of policy making, and once a research policy is developed, it still needs regular re-examination to ensure that any required updates are undertaken.
The past few centuries, especially since the eighteenth century, have seen a boom in scientiﬁc research. There is no doubt that scientiﬁc research is now a global affair. Take China as an example: investment in research and development amounted to 2.09 % of total gross domestic product (GDP) in the year 2014, which increased approximately 12.4 % from 2013. Such rapid growth can be seen everywhere in the world, both in afﬂuent and developing countries. As one of the indispensable impetuses of civilization, we are very excited to see how scientiﬁc research has dramatically changed the quality of human life, welfare, and even history. However, the commitment to scientiﬁc research comes with concerns about what these good research practices are that should be part of the very nature of performing research from the very beginning, as well as how ethical research should be conducted post-World War II as a result of the tragic experiences and lessons learned from the conduct of unethical research.
The basic nature of good research practices is their appropriateness to fulﬁll the research purposes. Originally, the main concerns concentrated on the feasibility, efﬁciency, and effectiveness of conducting the research. They related to whether research questions could be answered in an efﬁcient and cost-effective way from a much more practical and technical perspective. However, mixed with the vast development of technologies, research methodologies, and the changing research landscape since the middle of the twentieth century, good research practices are continuingly affected by problems raised such as conﬂicts of interest, research misconduct, malpractice, etc. On the other hand, the ethical problems of research, particularly research involving human subjects, were brought to the agenda during the Nuremburg Trials after World War II. Seventy years later, research ethics are now widely accepted throughout the world to protect the rights and welfare of research subjects (both human beings and animals).
Research policies, aimed at excellence in research, are systematically designed and implemented to ensure that good research practices are pursued in balance with ethical considerations. As there is increasing overlap between good research practices and research ethics, it is reasonable to claim that research ethics are necessary for good research practices, which are insufﬁcient by themselves. Given that there are other chapters in this book that include detailed discussion on conﬂicts of interest, research misconduct and related topics, in this chapter the discussion of research policies mainly focuses on the ethical aspects and concentrates on research policies aimed at protecting human subjects involved in research.
History And Development
Looking at the history of scientiﬁc research, not only the curiosity and/or research interests of investigators, but also external, practical needs contribute signiﬁcantly to the implementation of research. Ideally, the ultimate goal of scientiﬁc research is to discover or produce generalizable knowledge that helps further the understanding of the world, whether it is in the form of objects, phenomena, or relationships. Usually, new knowledge will aid people pursuing other research (if used reasonably) to develop further knowledge, which in turn helps advance social civilization. However, it is worth noting that, in the context of a much more modernized and technically developed society than ever before, it is imperative for us to set the boundary between what we can do and what we should do with more caution, especially regarding the conduct of research involving human subjects.
The increasing need for the use of human subjects in research began in the nineteenth century. Before World War II, two guidelines were issued in Germany in 1900 and 1931. The ﬁrst was the Berlin Code of Ethics, considered to be the ﬁrst ethical code related to human experiments. The later one was the Guidelines for New Therapy and Human Experimentation issued by the German Ministry of the Interior. However, these guidelines were quickly forgotten without making any substantial impact.
The Nuremburg Code was issued after World War II in 1947 and is now accepted worldwide as the ﬁrst set of ethical regulations on human subject protection. People were shocked by the atrocities and brutalities disclosed as having occurred during World War II; however, in the early days, some US scholars and doctors questioned this code. Firstly, they believed that these kinds of inhuman activities would not have been carried out by well-educated scientists in the civilized society of America. Secondly, the environment that allowed the conduct of these experiments was extremely unusual, as concentration camps were so different from prison, let alone normal hospitals and medical research institutions. Thirdly, in the USA, for example, the opponents claimed that there was a long history of “do no harm” dating back to Hippocratic Oath. Fourthly, they felt that the absolute requirement of informed consent was deﬁnitely not appropriate for children and other populations that could not give valid consent, and that these populations should not be excluded purely because of their consent capacity.
In June 1964, the World Medical Association (WMA) announced its best-known policy statement: Ethical Principles for Medical Research Involving Human Subjects, known as the Declaration of Helsinki. The latest version, after seven amendments, was adopted in October 2013. In addition to the ethical requirements speciﬁed in its previous versions, there are some new updates that need further discussion. In this document, it is conﬁrmed that while the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects, which can be reasonably considered an ethical gold standard for conducting research. Special concerns regarding vulnerable groups and individuals have also been added to the current version. All such groups and individuals should receive speciﬁcally considered protection to avoid being wronged or incurring additional harm. Placebo use, a long-disputed topic, must take into account the best-proven intervention(s).
During the 1960s and 1970s, most countries saw a rapid increase in laws, regulations, and guidelines for clinical research administration. At the same time, industries were becoming more international and seeking global markets. However, the divergence in technical requirements among different countries made the process of marketing new products time-consuming and costly. The European Community (now the European Union) has undertaken pioneering work on the harmonization of regulatory requirements since the 1980s. After several years of bilateral discussions between Europe, Japan, and the USA on possibilities for harmonization, the International Conference of Harmonization (ICH) was born in April 1990.
The ICH ﬁrst developed its tripartite ICH guidelines on safety, quality, and efﬁcacy. Over the next 10 years, attention was mainly paid to facilitating the implementation of such guidelines in ICH’s own regions, as well as focusing on communication and dissemination of information in the ICH guidelines to non-ICH regions. The development of ICH guidelines continued to keep pace with the development of science and technology throughout its second decade. Now, in its third decade, the ICH is paying more attention to extending the beneﬁts of harmonization beyond the ICH regions. Training and the active participation of non-ICH regions (e.g., China) in guideline development are seen as being key to this effort.
Among the ICH guidelines, the Good Clinical Practice (GCP) document, ﬁnalized in May 1996, describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors, and institutional review boards (IRBs). GCPs cover ICH-GCP principles, the reviewing, monitoring, reporting, and archiving of clinical trials by IRBs/ independent ethics committees (IECs), and incorporates addenda on essential documents and investigator’s brochure requirements. The ICH-GCP (E6) is now one of the most commonly used guidelines for facilitating international clinical trials.
The Council for International Organizations of Medical Sciences (CIOMS), established jointly by the WHO and UNESCO in 1949, updated the International Ethical Guidelines for Biomedical Research Involving Human Subjects (ﬁrst issued in 1993) in January 2002 and the International Ethical Guidelines for Epidemiological Studies (ﬁrst published in 1991) in 2008. The purpose of the biomedical research guideline (2002) is to indicate how fundamental ethical principles and the Declaration of Helsinki can be applied effectively in medical research conducted in different countries, especially low and middle-income countries, with various cultures, religions, traditions, and socioeconomic statuses. It has been widely used to date in developing countries. In 2012, taking into consideration the updates to the Declaration of Helsinki and other related documents, changes in the research ﬁeld and its landscape, the evolution of existing laws, regulations and ethical practices in various countries, as well as the development of research ethics worldwide, CIOMS initiated another revision of the CIOMS guidelines. According to internal discussion within the working group, the guidelines on risks and beneﬁts (Guideline 8), choice of control (Guideline 11), and women (Guideline 16) require major revision. Some guidelines, e.g., Guidelines 4 and 6, which are both on informed consent, could be merged. In addition, the Guidelines for Biomedical Research may be merged with the Guidelines for Epidemiological Research.
In addition to the most prominent guidelines mentioned above, there are also other signiﬁcant international documents. For instance, the Universal Declaration of Human Rights, adopted by the United Nations General Assembly in 1948, states that “No one shall be subjected.. .to cruel, inhuman or degrading treatment or punishment” (Article 5). The International Covenant on Civil and Political Rights, approved by the General Assembly in 1966 to give the declaration legal and moral force, illustrated that this prohibition means “In particular, no one shall be subjected without his free consent to medical or scientiﬁc experimentation” (Article 7). In 2000, the United Nations Program on HIV/AIDS (UNAIDS) published Ethical Considerations in HIV Preventive Vaccine Research; later, in 2007, UNAIDS and the WHO produced a revised version titled Ethical Considerations in Biomedical HIV Prevention Trials.
According to ICH-GCP (E6), a “clinical trial” is “any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamics effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product (s) with the object of ascertaining its safety and/or efﬁcacy” (Article 1.12).
According to US Common Rule (Title 45, Part 46, the Code of Federal Regulations), “research” means a systematic investigation designed to develop or contribute to generalizable knowledge. The term “systematic investigation” covers the whole process of research development, testing, and evaluation.
As also deﬁned in US Common Rule, “human subject” means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction; or (2) identiﬁable private information. An intervention can be carried out by physical procedures, and also by manipulations of the subject or his/her external environment for research purposes. Interaction includes communication or interpersonal contact between an investigator and subject. Private information here includes personal behaviors in a context that can be reasonably expected to be free of observation or recording and information provided for speciﬁc purposes that the individual can reasonably expect will not be made public.
To summarize, in this chapter the deﬁnition of research in US Common Rule is adopted. Research policy aimed at excellence in research means regulations and procedures that are systematically designed and implemented to make sure good research practices are pursued in balance with ethical considerations. Taking into rough consideration the applicable scope and policymaking agencies, there are at least three layers of research policies: ﬁrst, international guidelines; second, Federal regulations/state laws (e.g., in the USA) and national regulations (e.g., in China); and, third, institutional policies and procedures.
Ethical Dimensions Of Research Policy
Debra Rosenthal and Bruce Perlman proposed a framework to categorize the ethical dimensions of public policy in terms of the proper domain, scope, means, and goals or purposes of governmental power. Regarding analysis of the ethical dimension of current research policies from a global perspective, this chapter mainly focuses on (1) examining the various ethical principles and underlying values; and (2) reﬂecting on problems and challenges faced regarding these policies.
Ethical Principles And Underlying Values
One of the most inﬂuential policy statements, the Declaration of Helsinki speciﬁed general principles in 13 articles (Articles 3–15). These principles include putting the patient’s interest ﬁrst, respect for all human subjects, the responsibilities of physician investigators, compensation, and treatment for subjects, etc. The Declaration is essentially the combination of professional codes in medical and research ethics in the research ﬁeld. This can be attributed to the mandate of the WMA, which led to the Declaration being addressed primarily to physicians.
The ICH-GCP adopted 13 principles. First and foremost, it conﬁrmed that clinical trials should be conducted in accordance with the ethical principles originated in the Declaration of Helsinki, and should also comply with other applicable regulatory requirements. The rights, safety, and wellbeing of subjects should not be over-ridden by the interests of science and society. There must be a reasonable risk/beneﬁt ratio, pre-clinical data must be adequate to verify the scientiﬁc validity of the research protocol, and this protocol must be approved by an independent ethics committee before implementation. Investigators and caregivers involved in the research must be qualiﬁed and obtain voluntary informed consent from the subject before their participation. Trial information and records must be recorded, handled, and stored appropriately and conﬁdentially to protect privacy.
The CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects articulated 21 guidelines rather than specifying any principles. These guidelines concentrate on ethical review, informed consent, and vulnerable groups, as well as conﬁdentiality, compensation, and capacity building.
Besides the international guidelines mentioned above, the three ethical principles identiﬁed in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (known as the Belmont Report, it was published in 1979 by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research) are worth noting. Three basic principles particularly relevant to the ethics of research involving human subjects – those of respect of persons, beneﬁcence, and justice – were identiﬁed and articulated in this report.
Respect for persons requires that, ﬁrstly, competent individuals should be treated as autonomous agents and, secondly, persons with diminished autonomy are entitled to special or extra protection. The principle of beneﬁcence adopted by the Belmont Report as an obligation goes far beyond the normal acts of kindness or charity. There are two general rules that have been formulated: (1) do not harm; and (2) maximize the possible beneﬁts and minimize possible harms. Justice, as another ethical principle, concerns fair distribution of burdens and beneﬁt, or requires that equals ought to be treated equally. These three ethical principles were the basis of the ethical framework for research policies in the USA and have become widely accepted in China and other Asian countries in the last decade.
It is obvious that there are some shared values behind the ethical principles illustrated in the different policy documents, the most fundamental of which is respect for people. Each individual, no matter his or her sex, race, socioeconomic status, or educational background, deserves respect and protection. Respect is important, not only to uphold the dignity of an individual person, but also to adhere to the categorical imperative that people should act in a humane way, whether towards themself or another person, and not merely as a means to an end. Secondly, for those vulnerable individual and groups who may have an increased likelihood of being wronged or of incurring additional harm, particular protections should be tailored and provided. This is a commonly accepted value. Though there may be variety of speciﬁcations on how to protect human subjects in research in different circumstances and contexts, these principles and underlying values are widely accepted and keep evolving.
Problems And Challenges Of The Current Research Policy
As mentioned previously, there are at least three layers of research policies: international guidelines, Federal regulations/state laws or national regulations, and institutional policies and procedures. International guidelines are considered to be the most ethical guidelines and are encouraged to be followed. However, while it is praiseworthy to follow such high standards, it is not blameworthy if they are not followed. A lack of legal force is one of the biggest challenges facing international guidelines, no matter how well they are formulated. For instance, in the current version of the Declaration of Helsinki, the wording in many articles has been changed from “should” to “must”; however, whether these articles can be made compulsory requirements in the real world requires further veriﬁcation.
At a national level, the development of research policies varies from country to country. On one hand, most countries, especially low and middle-income countries, face the problem of inadequacy of research policies; on the other hand, even developed countries such as the USA, which is well-known for its well-developed research policies, have their own problems. For example, within a few decades the USA has developed systematic research policies that incorporate the Common Rule, FDA regulations on human subject protection, and privacy rules. However, problems have arisen since the 1990s. It is well-known that the USA adopts two main strategies to protect human subjects: ethical review by an independent committee and informed consent. The quality and efﬁciency of the ethical review has been questioned for a long time, and these questions continue. The mechanism of informed consent leads to long, complex, boring documents that are geared towards protecting investigators rather than the subject’s right to be informed. Furthermore, more systematic errors in US research policies have been identiﬁed, such as over-protection and pseudo protection. In one of the latest discussions, scholars pointed out that this error was rooted in a problematic distinction between research and treatment, which the USA has adopted from the very beginning for determining what research activities should have ethical oversight.
Institutional policies and procedures are the most practical and concrete items among all of the research policies. Both international guidelines and national regulations should be general enough to respect the diversity and heterogeneity of different contexts. Nevertheless, institutional policies must be designed to be speciﬁc and operable and need to comply with applicable laws and regulations, both international and domestic. In a country such as the USA, which has organized research policies, it is much easier for its institutions to formulate their institutional policies and procedures, but this is not easily duplicated. For instance, in China, the national regulations are too general to be implemented directly in real practice. The inadequacy of national research polices hamper a lot of the discretion and innovation of institutions in developing policies and procedures.
Take informed consent as an example. It is widely accepted that informed consent is one of the most signiﬁcant strategies that can help protect the rights and welfare of human subjects. Nearly all of the international and national guidelines and regulations have reached consensus and agreed to adopt this requirement. However, the social, economic, and cultural context of informed consent varies signiﬁcantly when applied in real-world situations. Informed consent, which is derived from the basic idea of individual rights and respect for people, may sometimes be overturned by local customs or other pitfalls that are unpredictable at ﬁrst glance. For instance, in China and many other Eastern cultures, people always identify themselves in families/groups/communities; in other words, with different interpersonal relationships, rather than as an individual. This tradition, which is deeply rooted in the culture, makes it particularly difﬁcult to seek individual voluntary informed consent. However, it should be noted that while informed consent is fundamental for engaging in human subject research, it is not everything. Other strategies such as minimized risk, an acceptable risk/beneﬁt ratio, sound scientiﬁcally valid design, equitable subject selection, and recruitment, etc., work together for better protection. Ideally, local laws/regulations should bear responsibility for identifying and managing such challenges and problems; however, even within a country or region, there is a lot of diversity. Thus, local institutions should play a more active role in the creation of tailored research policies and in the ongoing evolution of processes. Considering the particular problem of informed consent, more and more strategies are now being adopted as alternatives, such as community engagement, local consultant, etc.
After a brief overview of research policies globally, it is clear that, although many problems and challenges still exist, the ﬁeld of protecting human subjects has experienced signiﬁcant progress and evolution worldwide during the last 50 years.
Looking at the history of research policies, the dynamics of research ethics development are usually divided into three categories relating to what they arose in response to: (1) cases of research that generated controversy, particularly after disclosure of research scandals; (2) public or professional concerns about the research components of dramatic new technologies or about the use of that kind of research; and (3) broader social concerns that had implications for particular types of research. The latter two categories are now becoming more and more common as the impetus for new research policy making. However, the importance of the issues in question themselves may not be sufﬁcient to prompt the emergence of research policies. Thus, more information must be present to ensure that their importance is recognized; this is the responsibility of all stakeholders involved in human subject research.
It is unreasonable to expect a one-size-ﬁts-all solution to the development of research policies. Diversity based on the uniqueness of different circumstances, conditions, and contexts in different nations and regions should be taken into full consideration to reach a dynamic equilibrium in human subject protection research policies. The uniqueness of each nation or region is constructed over time by local cultures, traditions, social structures, economic status, religions, etc. Research policies must be tailored to satisfy and be responsive to the particular needs derived from such contexts. Good policies can be communicated and learned; however, it is also important to keep in mind that others’ experiences should never be simply copied or duplicated. Thus, different solutions should be created after careful examination.
What would the appropriate steps be to take when we would like to develop new research policies? Theoretically, the soundness of policies is decided by two main factors: ﬁrstly, the soundness of the methodology by which they were developed; and, secondly, the soundness of their content. In a modern pluralistic society, in order to develop applicable research policies, the targeted problems should be clearly identiﬁed, a variety of stakeholders should have their voices heard during the entire policy-making process, and different needs and concerns should be taken into consideration. It should also be remembered that even the best process does not guarantee the soundness of the result. Once a policy is developed, timely re-examination needs to take place to see whether further updates are needed.
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