Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Should Epidemiological Studies Be Subject to Ethics Review?

Should Epidemiological Studies Be Subject to Ethics Review? Abstract Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. Background An ethics review is widely recognized as an essential element of a research subject protection system. However, it can significantly impede epidemiological studies and increase costs. Recently, some commentators have argued in favor of evidence-based regulations (Sachs, 2010) and there are doubts whether the institutional research boards/research ethics committee (IRB/REC) system provides overall beneficial results (Whitney and Schneider, 2011). In this article we make an attempt to answer a question: Should epidemiological studies be subject to an ethics review? We offer a moderate defense of an ethics review arguing that it has already become an important part of social and political control over the research enterprise, and therefore, it should be maintained, at least until a better instrument of democratic control is devised. We focus on the arguments concerning the requirement of an ethics review and we do not discuss other aspects of ethics oversight system: how the system of ethics oversight should be organized in details and how it should be embedded in the law. We adopt a definition of epidemiology from A Dictionary of Epidemiology published by International Association of Epidemiology, defining an epidemiological study as: ‘the study of the occurrence and distribution of health-related events, states, and processes in specified populations, including the study of the determinants influencing such processes, and the application of this knowledge to the control of relevant health problems’ (Porta, 2014). Although we assume that the discussed arguments refer only to a limited subgroup of epidemiological studies, this subgroup excludes three types of studies: (i) studies that do not involve human beings, for instance, using only already existing anonymized medical records, (ii) public health studies, and (iii) studies that from a methodological point of view could be considered epidemiological, but at the same time are subject of clinical trials regulations. The burdensome character of the reviewing process for large, multicenter epidemiological and observational studies is well-known and well-described (Middle et al., 1995; Lux et al., 2000; Tully et al., 2000; Thornquist et al., 2002; Greene and Geiger, 2006; Green et al., 2006). IRBs/RECs, themselves, were sometimes unfamiliar with applicable regulations and imposed unnecessary requirements. At the same time, IRBs/RECs overlooked safeguards needed specifically for observational health services research (Burman et al., 2001; Janoff E et al., 2009). Recently, researchers conducting multicenter epidemiological studies also reported the burdensome character of the reviewing process (Gulmez et al., 2012; Abramovici et al., 2015). Research shows that IRBs/RECs’ internal policies and interpretations of national regulations differ from one committee to another, even in very specific, and relatively narrow issues like secondary use of biospecimens (Goldenberg et al., 2015). That might impede both large population research and cooperation between local IRBs/RECs. A system of review organized in an inappropriate way is burdensome and costly, even for observatory low-risk studies that utilize non-identifiable data (Vaughan et al., 2012). Moreover, the input of multiple IRBs/RECs is often limited to minor linguistic improvements (Abramovici et al., 2015). The existing empirical studies of the functioning of IRBs/RECs have chiefly qualitative character and focus on structure and timeliness of an ethics review. There is neither consensus on an appropriate set of criteria for assessing IRBs/RECs work or long-time outcomes studies (Nicholls et al., 2015). In the forthcoming sections we briefly examine what the existing ethical guidelines for epidemiological studies say about an ethics review and we discuss arguments against ethical reviewing of epidemiological studies. Finally we analyze the merits of the current IRB/REC system providing a moderate and conditional defense of an ethics review of epidemiological studies. Ethical Guidelines for Epidemiological Studies A short overview of ethical guidelines for epidemiological studies shows some reservations about an ethics review. On the one hand, the documents confirm the necessity of an ethics review of research involving human subjects. But on the other hand, epidemiologists and policy makers are aware of the fact that the ethics review sometimes impedes the launch of a study. In the epidemiological guidelines that we have analyzed in a systematic manner, three types of provisions are present: (i) a requirement of an ethics review for studies involving human subjects; (ii) pointing out that in some cases an ethics review is not necessary or should be done in an expedited way; (iii) IRBs/RECs should be aware of the burden that is posed by an ethics review (Piasecki et al., 2016). For instance, in good epidemiological practice—a document issued by International Epidemiological Association (IEA)—one finds examples of all three types of provisions: ‘The IEA fully respects the important role of ethics committees and all research should be based on accepted ethical standards and be of high quality’, but further it is added, ‘There must, however, be flexibility and an acknowledgement that different types of research will require different levels of ethical appraisal’. It means that some studies should be reviewed in expedited way or even be exempted from a review. Finally it states that some studies ‘can be threatened by time-consuming, over-exhaustive and costly ethical appraisal that may only be necessary for research that involves invasive and/or risky procedures’ (Table 1). Table 1. Ethical guidelines for epidemiological studies on an ethics review Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Table 1. Ethical guidelines for epidemiological studies on an ethics review Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Although epidemiological studies do not usually require invasive procedures and do not pose serious risks to their participants, there is a vast area of issues that can become a subject of an ethics review. IRBs/RECs could examine existence of a conflict of interests, as well as the plans of communication with the general public and the necessity of obtaining informed consent. IRBs/RECs could inspect the plans for ensuring confidentiality and manner of data storage. But still one can wonder, is an ethics review necessary in the case of epidemiological research? Perhaps, as stated by good epidemiological practice, in some cases the task of an IRB/REC is limited to overseeing data protection safeguards, and therefore it can be done by ‘experts in data protection’ (International Epidemiological Association, 2007). If this is true, it would be even possible to eliminate an ethics review in most of epidemiological studies, especially when they do not involve risky and invasive procedures. And if research was conducted by an institution certified in data protection, unnecessary procedural and bureaucratic burden would be minimized. Ethics Review Is an Unnecessary Burden Recently some researchers suggested a change in general attitude toward biomedical sciences (Pinker, 2015). There is a simple consequentialist argument supporting this suggestion: most moral concerns rest on unwise predictions about the future and they slow down the progress in medical science; slower progress means a higher death toll and larger health costs. Similar stance is taken by Whiney and Schneider, who discuss a method to estimate the cost in lives of an ethics review (Whitney and Schneider, 2011). Therefore, the first argument against an ethics review of epidemiological studies refers to cost-benefits analysis. It is stated that cost of an ethics review—a cost counted in future patients’ lives and quality of life—is higher than the benefits: the lives that are saved and health that is maintained by the protective approach of IRBs/RECs’ members. The suggestion to abandon the requirement of an ethics review in case of low-risk epidemiological studies comes with a demand to create only evidence-based policies (Sachs, 2010). A requirement to submit a research protocol to an ethics review is not an ethical principle as such; this is only a policy rule that is created by a government. Policy rules, in contrast to ethical principles, serve a certain purpose, namely to promote interests of some parties, for instance, interests of research subjects (Sachs, 2010). As Sachs states, in case of an ethical principle one does not ask, what is the purpose of that principle or is that principle effective. If two different moral principles conflict one with another, we have to decide, which one is more morally binding in a certain situation. For instance, in case of infectious disease outbreak we have to decide what is morally more important: privacy of citizens or protection of public health. But policy rules call for examination of their effectiveness (Sachs, 2010). Therefore, the question ‘Should epidemiological studies be subject to ethics review?’ is a question about the effectiveness of a certain policy. The opponents of the current IRB/REC system claim that this system neither promotes public health interests nor effectively protects research subjects’ interests. On the contrary, it delays useful research, and delaying denies patients the research benefits. Overprotection leads to underprotection (Kass et al., 2013). The opponents of the current IRB/REC system may also raise, especially in the US context, another argument. Namely, they could argue that it is very difficult to draw a line between practice of public health and epidemiological research. Both epidemiological research and public health practice involve systematic collection of data and generation of generalizable knowledge. In addition, these two pose similar risks to participants (Mckeown and Learner, 2009; Kass et al., 2013; Willison et al., 2014). Therefore, the argument follows: because epidemiological studies are more similar to public health practice, than to randomized clinical trials (RCTs), they should be regulated similarly to public health interventions rather than to RCTs, and the requirement of ethics review is unnecessary. Summing up, the argument against the existing IRB/REC system consists of three elements: (i) the requirement of an ethics review is not an ethical principle; this is only a policy and as such should be realized only if it is effective, only when it promotes patients’ benefit; (ii) policy in case of low-risk epidemiological studies does not fulfill its goal, and it causes more harm than good; and finally (iii) the policy was introduced to protect research subjects’ interests in different circumstances, when research was clearly different and more risky than practice. Now the circumstances are different: research, especially low-risk epidemiological research, is more beneficial to patients, and is not risker than medical or public health practice as such. Therefore, if one wants to defend the ethics review system one must demonstrate that this policy is either linked to important ethical principles or evidently promotes important interests of rightful stakeholders. The first case is a moderate defense—one could link ethics review with some ethical principle, but still have doubts about effectiveness of the policy. Here one could propose improvements in the existing policy or reshaping the policy. In the second case the defense is successful, when the policy effectively promotes rightful interests. The defense is fully successful only if there is no other way that promotes these interests to the same or to any greater extent. We defend ethics review in a moderate way, knowing that the existing system needs improvements or even a new, more creative approach. Argument in Favor of an Ethics Review In the ethical guidelines for epidemiological research we have analyzed, the most important functions of IRBs/RECs were protection of subjects’ well-being and safety along with assuring a proper balance between risk and benefits for subjects and the public (Piasecki et al., 2016). These are commonly recognized functions of IRBs/RECs, which are supposed to protect research subjects from being deceived, exposed to unnecessary risk and to protect their rights (Holm, 2011). In this context as well, the commentators often employ an important distinction between being harmed and being wronged (Holm, 2011). One does not have to be physically or psychologically harmed, to be wronged. Being wronged refers to our other than physical and psychological interests, to our world-view, religion, values we believe and realize in our lives. It seems that the opponents of the IRB/REC system and an ethics review of epidemiological studies usually either overlook the distinction between harm and wrong or do not give it sufficient significance. They overstress the beneficiary character of public health advances. Therefore, the first step in argumentation in favor of an ethics review of epidemiological studies would be to refer to the concept of being wronged. One can argue that although IRBs/RECs do not effectively protect from being harmed, since epidemiological research is sufficiently safe, they protect from being wronged. For instance, researchers may want to collect data and investigate the rate of schizophrenia and diabetes in a certain population. Because researchers could know that this particular community would not accept the research on schizophrenia prevalence in the population, they would like to abstain from including a complete list of the study purposes in the consent forms (Harmon, 2010; Klitzman, 2015). An IRB/REC could insist on explaining all goals of the study in the consent form and in doing so protect participants, who do not want to participate in a schizophrenia study, from being wronged. This argument links an ethics review with the respect for the autonomy principle. An IRB/REC system is a tool that effectively defends participants’ rights by a careful review of informed consent forms. An IRB/REC then fulfills its role, if it finds information that is relevant to participants, and that would not have been otherwise enclosed into an informed consent form by researchers (Dranseika et al., 2017). If the IRB/REC system of an ethics review is effective in this kind of protection, we have a successful defense. But of course this is a matter of facts, whether IRBs/RECs are really fulfilling this task. IRB/REC’s members could be insensitive to cultural diversity and beliefs of research participants. They could share a worldview of researchers and not discern information that could be relevant for research participants (Dranseika et al., 2017). Nevertheless, two different things should not be confused: an improper use of a correct tool and improperness of a tool. The second argument refers to the role of IRBs/RECs in democratic societies. In the 1960s IRBs/RECs were established as bodies composed of professional members, whose task was to monitor cases deviating from accepted medical practice, protect research subjects as well as professional integrity (Bowen, 2008; Levine, 2009). But since that time, RECs evolved and are recently inbuilt in the legal systems in most of the democratic societies. Thus, it can be said that IRBs/RECs are given legal authority over the research enterprise (Bowen, 2008; Mcguinness, 2008). Although members of IRBs/RECs are not usually elected in democratic way, IRBs/RECs are thought to be independent bodies, and as such they are part of the legal order that has democratic legitimacy. Moreover, IRBs/RECs mostly function in accordance with both democratically established laws and representatives of local communities. It seems then that IRBs/RECs are not merely professional institutions, but they are important instruments of democratic societies aimed at subject protection, assurance of research integrity and the social value of research. Therefore one can find a link between the IRBs/RECs system and an important ethical and political principle—which is democratic control over the research. The opponents of ethics review could of course still have doubts about the effectiveness of such control. Moreover, one can wonder whether the IRB/REC system is the best tool to exercise this control. It can be argued that in a democratic state a society always somehow exercises its control by voting for politicians, who support or oppose certain healthcare policies in research. In other words, the opponents of an ethics review can always wonder to what extent healthcare research should be subject to democratic control. How should democratic control be exercised and why research should be regulated differently than either traffic or gambling? The opponents of an ethics review can argue that a democratic society may decide not to impose a requirement of an ethics review on low-risk epidemiological studies. A society can have trust in epidemiologists and prefer faster development of science over a more cautious approach. In that situation, the opponents of an ethics review say, society still exercises its control over the research, but by loosening the formal requirements for researchers. That is true, it can happen, but the question is: Is that the case? This problem should probably be subject both to empirical research and to a public debate, not only a debate among researchers. The society may decide in a democratic debate not to control through an IRB/REC system and in this way increase the risk of being wronged. But this argument does not cut the link between an IRB/REC system and the democratic principle. Moreover, we also do not deny that it is possible to create a more efficient system that would allow more democratic control over the research enterprise. For instance, Largent et al. (2011) describe a multifaceted system of monitoring and control research within learning healthcare systems. In her example a key role is played by the research advisory committee, which is a body composed of democratically elected members of the institution. The main task of this body is oversight of the research portfolio. According to Largent, a research advisory committee has a function similar to the Citizen Council of UK National Institute for Health and Clinical Excellence (NICE). NICE involves patients and public in the process of deliberation over research and healthcare regulations (Barham, 2011). Nevertheless, to date an IRB/REC system is probably the best tool for efficiently controlling research and protecting the interests of research subjects that involves people with different backgrounds and representatives of local communities. Conclusion We arrive at a conditional conclusion: if there is no better means to protect the interests of participants, an ethics review should be maintained. But if a more efficient institutional tool is possible, we should not hesitate and embrace this new instrument. There is also the possibility that a society in a democratic debate would choose to loosen control over some kinds of research. In this case also another more flexible approach might be adopted. However, to date, it seems there is no better tool to protect all important interests of research participants than an IRB/REC system. Acknowledgments We thank Phyllis Zych Budka for edits. Funding This project was funded by the National Science Centre, Poland, DEC-2011/03/D/HS1/01695. References Abramovici A. , Salazar A. , Edvalson T. , Gallagher N. , Dorman K. , Tita A. ( 2015 ). Review of Multicenter Studies by Multiple Institutional Review Boards: Characteristics and Outcomes for Perinatal Studies Implemented by a Multicenter Network . American Journal of Obstetrics and Gynecology , 212 , 110 e1 – 116 . Google Scholar CrossRef Search ADS American College of Epidemiology ( 2000 ). American College of Epidemiology Ethics Guidelines . Annals of Epidemiology , 10 , 487 – 497 . CrossRef Search ADS PubMed Barham L. ( 2011 ). Public and Patient Involvement at the UK National Institute for Health and Clinical Excellence . Patient , 4 , 1 – 10 . Google Scholar CrossRef Search ADS PubMed Beauchamp T. L. , Cook R. R. , Fayerweather W. E. , Raabe G. K. , Thar W. E. , Cowles S. R. , Spivey G. H. ( 1991 ). Ethical Guidelines for Epidemiologists . Journal of Clinical Epidemiology , 44 (Suppl 1) , 151S – 169S . Google Scholar CrossRef Search ADS PubMed Bowen A. J. 2008 . Models of Institutional Review Board. In Emanuel E. J. , Grad C. , Crouch R. A. , Lie R. K. , Miller G. G. , Wendler D. (eds) The Oxford Textbook of Clinical Research Ethics . New York : Oxford University Press . Burman W. J. , Reves R. R. , Cohn D. L. , Schooley R. T. ( 2001 ). Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards . Annals of Internal Medicine , 134 , 152 – 157 . Google Scholar CrossRef Search ADS PubMed Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) 2009 . International Ethical Guidelines for Epidemiological Studies. Geneva. Dranseika V. , Piasecki J. , Waligora M. ( 2017 ). Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure . Science and Engineering Ethics , 23 , 215 – 225 . Google Scholar CrossRef Search ADS PubMed Goldenberg A. J. , Maschke K. J. , Joffe S. , Botkin J. R. , Rothwell E. , Murray T. H. , Anderson R. , Deming N. , Rosenthal B. F. , Rivera S. M. ( 2015 ). IRB Practices and Policies Regarding the Secondary Research Use of Biospecimens . BMC Medical Ethics , 16 , 32. Google Scholar CrossRef Search ADS PubMed Green L. A. , Lowery J. C. , Kowalski C. P. , Wyszewianski L. ( 2006 ). Impact of Institutional Review Board Practice Variation on Observational Health Services Research . Health Services Research , 41 , 214 – 230 . Google Scholar CrossRef Search ADS PubMed Greene S. M. , Geiger A. M. ( 2006 ). A Review Finds that Multicenter Studies Face Substantial Challenges but Strategies Exist to Achieve Institutional Review Board approval . Journal of Clinical Epidemiology , 59 , 784 – 790 . Google Scholar CrossRef Search ADS PubMed Gulmez S. E. , Lignot-maleyran S. , De Vries C. S. , Sturkenboom M. , Micon S. , Hamoud F. , Blin P. , Moore N. ( 2012 ). Administrative Complexities for a European Observational Study Despite Directives Harmonising Requirements . Pharmacoepidemiol Drug Saf , 21 , 851 – 856 . Google Scholar CrossRef Search ADS PubMed Harmon A. 2010 . Havasupai Case Highlights Risks in DNA Research . The New York Times . Holm S. ( 2011 ). Commentary: Systems, Rules and the Costs of Being Ethical–A Response to D. Chalmers and to S. Whitney and C. Schneider . Journal of Internal Medicine , 269 , 403 – 406 . Google Scholar CrossRef Search ADS PubMed International Epidemiological Association . 2007 . Good Epidemiological Practice: IEA Guidelines for Proper Conduct of Epidemiological Research. International Epidemiological Association. Available from: http://ieaweb.org/good-epidemiological-practice-gep/ [accessed 18 October 2017]. International Society for Environmental Epidemiology . 2012 . Ethics Guidelines for Environmental Epidemiologists. International Society for Environmental Epidemiology. International Society for Pharmacoepidemiology . ( 2016 ). Guidelines for good pharmacoepidemiology practice (GPP) . Pharmacoepidemiology and Drug Safety , 25 , 2 – 10 . CrossRef Search ADS PubMed Janoff E. , Bohjanen P. , Boucher H. , Burman W. , D'aquila R. , Eisenstein B. , Kauffman C. , Lane C. , Margolis D. , Marshall G. , Poutsiaka D. , Ratner A. , Reller B. , Rice L. , Ryan E. , Spearman P. , Thio C. , Natarajna P. ( 2009 ). Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts . Clinical Infectious Diseases , 49 , 328 – 335 . Google Scholar CrossRef Search ADS PubMed Kass N. E. , Faden R. R. , Goodman S. N. , Pronovost P. , Tunis S. , Beauchamp T. L. ( 2013 ). The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight . Hastings Center Report , 43 , S4 – S15 . Google Scholar CrossRef Search ADS Klitzman R. 2015 . The Ethics Police? The Struggle to Make Human Research Safe , Oxford University Press . Largent E. A. , Joffe S. , Miller F. G. ( 2011 ). Can Research and Care be Ethically Integrated? Hastings Center Report , 41 , 37 – 46 . Google Scholar CrossRef Search ADS PubMed Levine R. J. 2009 . The Institutional Review Board. In Coughlin S. S. , Beauchamp T. L. , Weed D. L. (eds) Ethics and Epidemiology , 2nd edn. New York : Oxford University Press . Lux A. L. , Edwards S. W. , Osborne J. P. ( 2000 ). Responses of Local Research Ethics Committees to a Study with Approval from a Multicentre Research Ethics Committee . BMJ , 320 , 1182 – 1183 . Google Scholar CrossRef Search ADS PubMed Mcguinness S. ( 2008 ). Research Ethics Committees: The Role of Ethics in a Regulatory Authority . Journal of Medical Ethics , 34 , 695 – 700 . Google Scholar CrossRef Search ADS PubMed Mckeown R. E. , Learner R. ( 2009 ). Ethics in Public Health Practice . Ethics and Epidemiology , 147 – 181 . Middle C. , Johnson A. , Petty T. , Sims L. , Macfarlane A. 1995 . Ethics Approval for A National Postal Survey: Recent Experience . British Medical Journal , 311 , 659 – 660 . Google Scholar CrossRef Search ADS PubMed Ministry of Education, Culture, Sports, Science and Technology and Ministry of Health, Labour and Welfare . 2008 . Ethical Guidelines for Epidemiological Research. National Ethics Advisory Committee . 2012 . Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities, Revised edn. Wellington : Ministry of Health . Nicholls S. G. , Hayes T. P. , Brehaut J. C. , McDonald M. , Weijer C. , Saginur R. , Fergusson D. , Bayer A. ( 2015 ). A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review . PLoS One , 10 , e0133639. Google Scholar CrossRef Search ADS PubMed Piasecki J. , Waligora M. , Dranseika V. ( 2016 ). What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review . Science and Engineering Ethics , 23 , 743 – 768 . Google Scholar CrossRef Search ADS PubMed Pinker S. 2015 . The Moral Imperative for Bioethics . Boston Globle . Porta M. 2014 . A Dictionary of Epidemiology . Oxford University Press . Google Scholar CrossRef Search ADS Sachs B. ( 2010 ). The Case for Evidence-Based Rulemaking in Human Subjects Research . The American Journal of Bioethics , 10 , 3 – 13 . Google Scholar CrossRef Search ADS PubMed Thornquist M. D. , Edelstein C. , Goodman G. E. , Omenn G. S. ( 2002 ). Streamlining IRB Review in Multisite Trials Through Single-Study IRB Cooperative Agreements: Experience of the Beta-Carotene and Retinol Efficacy Trial (CARET) . Controlled Clinical Trials , 23 , 80 – 86 . Google Scholar CrossRef Search ADS PubMed Tully J. , Ninis N. , Booy R. , Viner R. ( 2000 ). The New System of Review by Multicentre Research Ethics Committees: Prospective Study . British Medical Journal , 320 , 1179 – 1182 . Google Scholar CrossRef Search ADS PubMed Vaughan G. , Pollock W. , Peek M. J. , Knight M. , Ellwood D. , Homer C. S. , Pulver L. J. , Mclintock C. , Ho M. T. , Sullivan E. A. ( 2012 ). Ethical Issues: The Multi-Centre Low-Risk Ethics/Governance Review Process and AMOSS . The Australian and New Zealand Journal of Obstetrics and Gynaecology , 52 , 195 – 203 . Google Scholar CrossRef Search ADS PubMed Whitney S. N. , Schneider C. E. ( 2011 ). Viewpoint: A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research . Journal of Internal Medicine , 269 , 396 – 402 . Google Scholar CrossRef Search ADS PubMed Willison D. J. , Ondrusek N. , Dawson A. , Emerson C. , Ferris L. E. , Saginur R. , Sampson H. , Upshur R. ( 2014 ). What Makes Public Health Studies Ethical? Dissolving the Boundary between Research and Practice . BMC Medical Ethics , 15 , 1. Google Scholar CrossRef Search ADS PubMed © The Author 2017. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Public Health Ethics Oxford University Press

Should Epidemiological Studies Be Subject to Ethics Review?

Piasecki, Jan; Dranseika, Vilius; Waligora, Marcin
Public Health Ethics , Volume Advance Article (2) – Oct 31, 2017
Download PDF
8 pages

Loading next page...
 
/lp/oxford-university-press/should-epidemiological-studies-be-subject-to-ethics-review-eBBeE7xLDF

References (29)

Publisher
Oxford University Press
Copyright
© The Author 2017. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org
ISSN
1754-9973
eISSN
1754-9981
DOI
10.1093/phe/phx016
Publisher site
See Article on Publisher Site

Abstract

Abstract Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. Background An ethics review is widely recognized as an essential element of a research subject protection system. However, it can significantly impede epidemiological studies and increase costs. Recently, some commentators have argued in favor of evidence-based regulations (Sachs, 2010) and there are doubts whether the institutional research boards/research ethics committee (IRB/REC) system provides overall beneficial results (Whitney and Schneider, 2011). In this article we make an attempt to answer a question: Should epidemiological studies be subject to an ethics review? We offer a moderate defense of an ethics review arguing that it has already become an important part of social and political control over the research enterprise, and therefore, it should be maintained, at least until a better instrument of democratic control is devised. We focus on the arguments concerning the requirement of an ethics review and we do not discuss other aspects of ethics oversight system: how the system of ethics oversight should be organized in details and how it should be embedded in the law. We adopt a definition of epidemiology from A Dictionary of Epidemiology published by International Association of Epidemiology, defining an epidemiological study as: ‘the study of the occurrence and distribution of health-related events, states, and processes in specified populations, including the study of the determinants influencing such processes, and the application of this knowledge to the control of relevant health problems’ (Porta, 2014). Although we assume that the discussed arguments refer only to a limited subgroup of epidemiological studies, this subgroup excludes three types of studies: (i) studies that do not involve human beings, for instance, using only already existing anonymized medical records, (ii) public health studies, and (iii) studies that from a methodological point of view could be considered epidemiological, but at the same time are subject of clinical trials regulations. The burdensome character of the reviewing process for large, multicenter epidemiological and observational studies is well-known and well-described (Middle et al., 1995; Lux et al., 2000; Tully et al., 2000; Thornquist et al., 2002; Greene and Geiger, 2006; Green et al., 2006). IRBs/RECs, themselves, were sometimes unfamiliar with applicable regulations and imposed unnecessary requirements. At the same time, IRBs/RECs overlooked safeguards needed specifically for observational health services research (Burman et al., 2001; Janoff E et al., 2009). Recently, researchers conducting multicenter epidemiological studies also reported the burdensome character of the reviewing process (Gulmez et al., 2012; Abramovici et al., 2015). Research shows that IRBs/RECs’ internal policies and interpretations of national regulations differ from one committee to another, even in very specific, and relatively narrow issues like secondary use of biospecimens (Goldenberg et al., 2015). That might impede both large population research and cooperation between local IRBs/RECs. A system of review organized in an inappropriate way is burdensome and costly, even for observatory low-risk studies that utilize non-identifiable data (Vaughan et al., 2012). Moreover, the input of multiple IRBs/RECs is often limited to minor linguistic improvements (Abramovici et al., 2015). The existing empirical studies of the functioning of IRBs/RECs have chiefly qualitative character and focus on structure and timeliness of an ethics review. There is neither consensus on an appropriate set of criteria for assessing IRBs/RECs work or long-time outcomes studies (Nicholls et al., 2015). In the forthcoming sections we briefly examine what the existing ethical guidelines for epidemiological studies say about an ethics review and we discuss arguments against ethical reviewing of epidemiological studies. Finally we analyze the merits of the current IRB/REC system providing a moderate and conditional defense of an ethics review of epidemiological studies. Ethical Guidelines for Epidemiological Studies A short overview of ethical guidelines for epidemiological studies shows some reservations about an ethics review. On the one hand, the documents confirm the necessity of an ethics review of research involving human subjects. But on the other hand, epidemiologists and policy makers are aware of the fact that the ethics review sometimes impedes the launch of a study. In the epidemiological guidelines that we have analyzed in a systematic manner, three types of provisions are present: (i) a requirement of an ethics review for studies involving human subjects; (ii) pointing out that in some cases an ethics review is not necessary or should be done in an expedited way; (iii) IRBs/RECs should be aware of the burden that is posed by an ethics review (Piasecki et al., 2016). For instance, in good epidemiological practice—a document issued by International Epidemiological Association (IEA)—one finds examples of all three types of provisions: ‘The IEA fully respects the important role of ethics committees and all research should be based on accepted ethical standards and be of high quality’, but further it is added, ‘There must, however, be flexibility and an acknowledgement that different types of research will require different levels of ethical appraisal’. It means that some studies should be reviewed in expedited way or even be exempted from a review. Finally it states that some studies ‘can be threatened by time-consuming, over-exhaustive and costly ethical appraisal that may only be necessary for research that involves invasive and/or risky procedures’ (Table 1). Table 1. Ethical guidelines for epidemiological studies on an ethics review Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Table 1. Ethical guidelines for epidemiological studies on an ethics review Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Name of the guidelines A requirement of an ethics review A reservation toward an ethics review Ethical Guidelines for Epidemiologists (Beauchamp et al., 1991) All research involving human subjects should be reviewed by a proper review process, for both scientific design and for ethical adequacy. Some research conducted by epidemiologists may legitimately be exempt from ethical review or may be handled through an expedited review process. American College of Epidemiology Ethics Guidelines (American College of Epidemiology, 2000) Epidemiologists should submit research protocols for review by an independent ethics committee. An exception may be justified when epidemiologists investigate outbreaks of acute communicable diseases, evaluate programs and conduct routine disease surveillance as part of public health practice activities. Good Epidemiological Practice. IEA Guidelines for proper conduct in epidemiological research (International Epidemiological Association, 2007) The IEA fully respects the important role of ethics committees, and all research should be based on accepted ethical standards and be of high quality. Much epidemiological research requires simple observation of populations and study participants and does not involve risky or invasive procedures. Such research can be threatened by time-consuming, over-exhaustive and costly ethical appraisal. Ethical Guidelines for Epidemiological Research (Ministry of Education and Ministry of Health, 2008) The director of a research institution shall establish an ethics review committee to conduct reviews on necessary matters concerning epidemiological research, such as whether a research protocol conforms to these Guidelines. The director of a research institution may decide to give approval before hearing the opinion of the ethics review committee if he/she determines that the research needs to be conducted urgently to prevent a serious public health threat from occurring or spreading. International Guidelines for Epidemiological Studies [Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO), 2009] All proposals to conduct epidemiological research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. Some observational studies, such as those utilizing publicly available or anonymous data, may not be subject to prior review and approval by an ethical review committee under the regulations of the local jurisdiction. Ethical Guidelines for Environmental Epidemiologists (International Society for Environmental Epidemiology, 2012) It should be acknowledged by researchers that research involving people should include institutional oversight In certain circumstances, the IRB/REB may cause needless obstruction or delay for timely and important research and therefore there should be an institutional oversight mechanism to adequately handle such exceptional situations. Ethical Guidelines for Observational Studies: Observational research, audits and related activities. Revised edition (National Ethics Advisory Committee, 2012) Observational studies that may present more than minimal risk to participants and that require review by an ethics committee. Public health investigations, as defined above, do not require ethics committee review. This is because they are required for the protection of public health as a central part of public health practice, they are often of an immediate or urgent nature, and they are often required by legislation. Guidelines for Good Phamacoepidemiology (International Society for Pharmacoepidemiology, 2016) Approval by an institutional review board (IRB), independent ethics committee or other appropriate body, should be obtained for all research involving human subjects Studies using commercially or publicly available de-identified secondary data sources, or which meet certain other criteria, are not considered research involving human subjects in some countries and may be exempt from IRB review. Although epidemiological studies do not usually require invasive procedures and do not pose serious risks to their participants, there is a vast area of issues that can become a subject of an ethics review. IRBs/RECs could examine existence of a conflict of interests, as well as the plans of communication with the general public and the necessity of obtaining informed consent. IRBs/RECs could inspect the plans for ensuring confidentiality and manner of data storage. But still one can wonder, is an ethics review necessary in the case of epidemiological research? Perhaps, as stated by good epidemiological practice, in some cases the task of an IRB/REC is limited to overseeing data protection safeguards, and therefore it can be done by ‘experts in data protection’ (International Epidemiological Association, 2007). If this is true, it would be even possible to eliminate an ethics review in most of epidemiological studies, especially when they do not involve risky and invasive procedures. And if research was conducted by an institution certified in data protection, unnecessary procedural and bureaucratic burden would be minimized. Ethics Review Is an Unnecessary Burden Recently some researchers suggested a change in general attitude toward biomedical sciences (Pinker, 2015). There is a simple consequentialist argument supporting this suggestion: most moral concerns rest on unwise predictions about the future and they slow down the progress in medical science; slower progress means a higher death toll and larger health costs. Similar stance is taken by Whiney and Schneider, who discuss a method to estimate the cost in lives of an ethics review (Whitney and Schneider, 2011). Therefore, the first argument against an ethics review of epidemiological studies refers to cost-benefits analysis. It is stated that cost of an ethics review—a cost counted in future patients’ lives and quality of life—is higher than the benefits: the lives that are saved and health that is maintained by the protective approach of IRBs/RECs’ members. The suggestion to abandon the requirement of an ethics review in case of low-risk epidemiological studies comes with a demand to create only evidence-based policies (Sachs, 2010). A requirement to submit a research protocol to an ethics review is not an ethical principle as such; this is only a policy rule that is created by a government. Policy rules, in contrast to ethical principles, serve a certain purpose, namely to promote interests of some parties, for instance, interests of research subjects (Sachs, 2010). As Sachs states, in case of an ethical principle one does not ask, what is the purpose of that principle or is that principle effective. If two different moral principles conflict one with another, we have to decide, which one is more morally binding in a certain situation. For instance, in case of infectious disease outbreak we have to decide what is morally more important: privacy of citizens or protection of public health. But policy rules call for examination of their effectiveness (Sachs, 2010). Therefore, the question ‘Should epidemiological studies be subject to ethics review?’ is a question about the effectiveness of a certain policy. The opponents of the current IRB/REC system claim that this system neither promotes public health interests nor effectively protects research subjects’ interests. On the contrary, it delays useful research, and delaying denies patients the research benefits. Overprotection leads to underprotection (Kass et al., 2013). The opponents of the current IRB/REC system may also raise, especially in the US context, another argument. Namely, they could argue that it is very difficult to draw a line between practice of public health and epidemiological research. Both epidemiological research and public health practice involve systematic collection of data and generation of generalizable knowledge. In addition, these two pose similar risks to participants (Mckeown and Learner, 2009; Kass et al., 2013; Willison et al., 2014). Therefore, the argument follows: because epidemiological studies are more similar to public health practice, than to randomized clinical trials (RCTs), they should be regulated similarly to public health interventions rather than to RCTs, and the requirement of ethics review is unnecessary. Summing up, the argument against the existing IRB/REC system consists of three elements: (i) the requirement of an ethics review is not an ethical principle; this is only a policy and as such should be realized only if it is effective, only when it promotes patients’ benefit; (ii) policy in case of low-risk epidemiological studies does not fulfill its goal, and it causes more harm than good; and finally (iii) the policy was introduced to protect research subjects’ interests in different circumstances, when research was clearly different and more risky than practice. Now the circumstances are different: research, especially low-risk epidemiological research, is more beneficial to patients, and is not risker than medical or public health practice as such. Therefore, if one wants to defend the ethics review system one must demonstrate that this policy is either linked to important ethical principles or evidently promotes important interests of rightful stakeholders. The first case is a moderate defense—one could link ethics review with some ethical principle, but still have doubts about effectiveness of the policy. Here one could propose improvements in the existing policy or reshaping the policy. In the second case the defense is successful, when the policy effectively promotes rightful interests. The defense is fully successful only if there is no other way that promotes these interests to the same or to any greater extent. We defend ethics review in a moderate way, knowing that the existing system needs improvements or even a new, more creative approach. Argument in Favor of an Ethics Review In the ethical guidelines for epidemiological research we have analyzed, the most important functions of IRBs/RECs were protection of subjects’ well-being and safety along with assuring a proper balance between risk and benefits for subjects and the public (Piasecki et al., 2016). These are commonly recognized functions of IRBs/RECs, which are supposed to protect research subjects from being deceived, exposed to unnecessary risk and to protect their rights (Holm, 2011). In this context as well, the commentators often employ an important distinction between being harmed and being wronged (Holm, 2011). One does not have to be physically or psychologically harmed, to be wronged. Being wronged refers to our other than physical and psychological interests, to our world-view, religion, values we believe and realize in our lives. It seems that the opponents of the IRB/REC system and an ethics review of epidemiological studies usually either overlook the distinction between harm and wrong or do not give it sufficient significance. They overstress the beneficiary character of public health advances. Therefore, the first step in argumentation in favor of an ethics review of epidemiological studies would be to refer to the concept of being wronged. One can argue that although IRBs/RECs do not effectively protect from being harmed, since epidemiological research is sufficiently safe, they protect from being wronged. For instance, researchers may want to collect data and investigate the rate of schizophrenia and diabetes in a certain population. Because researchers could know that this particular community would not accept the research on schizophrenia prevalence in the population, they would like to abstain from including a complete list of the study purposes in the consent forms (Harmon, 2010; Klitzman, 2015). An IRB/REC could insist on explaining all goals of the study in the consent form and in doing so protect participants, who do not want to participate in a schizophrenia study, from being wronged. This argument links an ethics review with the respect for the autonomy principle. An IRB/REC system is a tool that effectively defends participants’ rights by a careful review of informed consent forms. An IRB/REC then fulfills its role, if it finds information that is relevant to participants, and that would not have been otherwise enclosed into an informed consent form by researchers (Dranseika et al., 2017). If the IRB/REC system of an ethics review is effective in this kind of protection, we have a successful defense. But of course this is a matter of facts, whether IRBs/RECs are really fulfilling this task. IRB/REC’s members could be insensitive to cultural diversity and beliefs of research participants. They could share a worldview of researchers and not discern information that could be relevant for research participants (Dranseika et al., 2017). Nevertheless, two different things should not be confused: an improper use of a correct tool and improperness of a tool. The second argument refers to the role of IRBs/RECs in democratic societies. In the 1960s IRBs/RECs were established as bodies composed of professional members, whose task was to monitor cases deviating from accepted medical practice, protect research subjects as well as professional integrity (Bowen, 2008; Levine, 2009). But since that time, RECs evolved and are recently inbuilt in the legal systems in most of the democratic societies. Thus, it can be said that IRBs/RECs are given legal authority over the research enterprise (Bowen, 2008; Mcguinness, 2008). Although members of IRBs/RECs are not usually elected in democratic way, IRBs/RECs are thought to be independent bodies, and as such they are part of the legal order that has democratic legitimacy. Moreover, IRBs/RECs mostly function in accordance with both democratically established laws and representatives of local communities. It seems then that IRBs/RECs are not merely professional institutions, but they are important instruments of democratic societies aimed at subject protection, assurance of research integrity and the social value of research. Therefore one can find a link between the IRBs/RECs system and an important ethical and political principle—which is democratic control over the research. The opponents of ethics review could of course still have doubts about the effectiveness of such control. Moreover, one can wonder whether the IRB/REC system is the best tool to exercise this control. It can be argued that in a democratic state a society always somehow exercises its control by voting for politicians, who support or oppose certain healthcare policies in research. In other words, the opponents of an ethics review can always wonder to what extent healthcare research should be subject to democratic control. How should democratic control be exercised and why research should be regulated differently than either traffic or gambling? The opponents of an ethics review can argue that a democratic society may decide not to impose a requirement of an ethics review on low-risk epidemiological studies. A society can have trust in epidemiologists and prefer faster development of science over a more cautious approach. In that situation, the opponents of an ethics review say, society still exercises its control over the research, but by loosening the formal requirements for researchers. That is true, it can happen, but the question is: Is that the case? This problem should probably be subject both to empirical research and to a public debate, not only a debate among researchers. The society may decide in a democratic debate not to control through an IRB/REC system and in this way increase the risk of being wronged. But this argument does not cut the link between an IRB/REC system and the democratic principle. Moreover, we also do not deny that it is possible to create a more efficient system that would allow more democratic control over the research enterprise. For instance, Largent et al. (2011) describe a multifaceted system of monitoring and control research within learning healthcare systems. In her example a key role is played by the research advisory committee, which is a body composed of democratically elected members of the institution. The main task of this body is oversight of the research portfolio. According to Largent, a research advisory committee has a function similar to the Citizen Council of UK National Institute for Health and Clinical Excellence (NICE). NICE involves patients and public in the process of deliberation over research and healthcare regulations (Barham, 2011). Nevertheless, to date an IRB/REC system is probably the best tool for efficiently controlling research and protecting the interests of research subjects that involves people with different backgrounds and representatives of local communities. Conclusion We arrive at a conditional conclusion: if there is no better means to protect the interests of participants, an ethics review should be maintained. But if a more efficient institutional tool is possible, we should not hesitate and embrace this new instrument. There is also the possibility that a society in a democratic debate would choose to loosen control over some kinds of research. In this case also another more flexible approach might be adopted. However, to date, it seems there is no better tool to protect all important interests of research participants than an IRB/REC system. Acknowledgments We thank Phyllis Zych Budka for edits. Funding This project was funded by the National Science Centre, Poland, DEC-2011/03/D/HS1/01695. References Abramovici A. , Salazar A. , Edvalson T. , Gallagher N. , Dorman K. , Tita A. ( 2015 ). Review of Multicenter Studies by Multiple Institutional Review Boards: Characteristics and Outcomes for Perinatal Studies Implemented by a Multicenter Network . American Journal of Obstetrics and Gynecology , 212 , 110 e1 – 116 . Google Scholar CrossRef Search ADS American College of Epidemiology ( 2000 ). American College of Epidemiology Ethics Guidelines . Annals of Epidemiology , 10 , 487 – 497 . CrossRef Search ADS PubMed Barham L. ( 2011 ). Public and Patient Involvement at the UK National Institute for Health and Clinical Excellence . Patient , 4 , 1 – 10 . Google Scholar CrossRef Search ADS PubMed Beauchamp T. L. , Cook R. R. , Fayerweather W. E. , Raabe G. K. , Thar W. E. , Cowles S. R. , Spivey G. H. ( 1991 ). Ethical Guidelines for Epidemiologists . Journal of Clinical Epidemiology , 44 (Suppl 1) , 151S – 169S . Google Scholar CrossRef Search ADS PubMed Bowen A. J. 2008 . Models of Institutional Review Board. In Emanuel E. J. , Grad C. , Crouch R. A. , Lie R. K. , Miller G. G. , Wendler D. (eds) The Oxford Textbook of Clinical Research Ethics . New York : Oxford University Press . Burman W. J. , Reves R. R. , Cohn D. L. , Schooley R. T. ( 2001 ). Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards . Annals of Internal Medicine , 134 , 152 – 157 . Google Scholar CrossRef Search ADS PubMed Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) 2009 . International Ethical Guidelines for Epidemiological Studies. Geneva. Dranseika V. , Piasecki J. , Waligora M. ( 2017 ). Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure . Science and Engineering Ethics , 23 , 215 – 225 . Google Scholar CrossRef Search ADS PubMed Goldenberg A. J. , Maschke K. J. , Joffe S. , Botkin J. R. , Rothwell E. , Murray T. H. , Anderson R. , Deming N. , Rosenthal B. F. , Rivera S. M. ( 2015 ). IRB Practices and Policies Regarding the Secondary Research Use of Biospecimens . BMC Medical Ethics , 16 , 32. Google Scholar CrossRef Search ADS PubMed Green L. A. , Lowery J. C. , Kowalski C. P. , Wyszewianski L. ( 2006 ). Impact of Institutional Review Board Practice Variation on Observational Health Services Research . Health Services Research , 41 , 214 – 230 . Google Scholar CrossRef Search ADS PubMed Greene S. M. , Geiger A. M. ( 2006 ). A Review Finds that Multicenter Studies Face Substantial Challenges but Strategies Exist to Achieve Institutional Review Board approval . Journal of Clinical Epidemiology , 59 , 784 – 790 . Google Scholar CrossRef Search ADS PubMed Gulmez S. E. , Lignot-maleyran S. , De Vries C. S. , Sturkenboom M. , Micon S. , Hamoud F. , Blin P. , Moore N. ( 2012 ). Administrative Complexities for a European Observational Study Despite Directives Harmonising Requirements . Pharmacoepidemiol Drug Saf , 21 , 851 – 856 . Google Scholar CrossRef Search ADS PubMed Harmon A. 2010 . Havasupai Case Highlights Risks in DNA Research . The New York Times . Holm S. ( 2011 ). Commentary: Systems, Rules and the Costs of Being Ethical–A Response to D. Chalmers and to S. Whitney and C. Schneider . Journal of Internal Medicine , 269 , 403 – 406 . Google Scholar CrossRef Search ADS PubMed International Epidemiological Association . 2007 . Good Epidemiological Practice: IEA Guidelines for Proper Conduct of Epidemiological Research. International Epidemiological Association. Available from: http://ieaweb.org/good-epidemiological-practice-gep/ [accessed 18 October 2017]. International Society for Environmental Epidemiology . 2012 . Ethics Guidelines for Environmental Epidemiologists. International Society for Environmental Epidemiology. International Society for Pharmacoepidemiology . ( 2016 ). Guidelines for good pharmacoepidemiology practice (GPP) . Pharmacoepidemiology and Drug Safety , 25 , 2 – 10 . CrossRef Search ADS PubMed Janoff E. , Bohjanen P. , Boucher H. , Burman W. , D'aquila R. , Eisenstein B. , Kauffman C. , Lane C. , Margolis D. , Marshall G. , Poutsiaka D. , Ratner A. , Reller B. , Rice L. , Ryan E. , Spearman P. , Thio C. , Natarajna P. ( 2009 ). Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts . Clinical Infectious Diseases , 49 , 328 – 335 . Google Scholar CrossRef Search ADS PubMed Kass N. E. , Faden R. R. , Goodman S. N. , Pronovost P. , Tunis S. , Beauchamp T. L. ( 2013 ). The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight . Hastings Center Report , 43 , S4 – S15 . Google Scholar CrossRef Search ADS Klitzman R. 2015 . The Ethics Police? The Struggle to Make Human Research Safe , Oxford University Press . Largent E. A. , Joffe S. , Miller F. G. ( 2011 ). Can Research and Care be Ethically Integrated? Hastings Center Report , 41 , 37 – 46 . Google Scholar CrossRef Search ADS PubMed Levine R. J. 2009 . The Institutional Review Board. In Coughlin S. S. , Beauchamp T. L. , Weed D. L. (eds) Ethics and Epidemiology , 2nd edn. New York : Oxford University Press . Lux A. L. , Edwards S. W. , Osborne J. P. ( 2000 ). Responses of Local Research Ethics Committees to a Study with Approval from a Multicentre Research Ethics Committee . BMJ , 320 , 1182 – 1183 . Google Scholar CrossRef Search ADS PubMed Mcguinness S. ( 2008 ). Research Ethics Committees: The Role of Ethics in a Regulatory Authority . Journal of Medical Ethics , 34 , 695 – 700 . Google Scholar CrossRef Search ADS PubMed Mckeown R. E. , Learner R. ( 2009 ). Ethics in Public Health Practice . Ethics and Epidemiology , 147 – 181 . Middle C. , Johnson A. , Petty T. , Sims L. , Macfarlane A. 1995 . Ethics Approval for A National Postal Survey: Recent Experience . British Medical Journal , 311 , 659 – 660 . Google Scholar CrossRef Search ADS PubMed Ministry of Education, Culture, Sports, Science and Technology and Ministry of Health, Labour and Welfare . 2008 . Ethical Guidelines for Epidemiological Research. National Ethics Advisory Committee . 2012 . Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities, Revised edn. Wellington : Ministry of Health . Nicholls S. G. , Hayes T. P. , Brehaut J. C. , McDonald M. , Weijer C. , Saginur R. , Fergusson D. , Bayer A. ( 2015 ). A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review . PLoS One , 10 , e0133639. Google Scholar CrossRef Search ADS PubMed Piasecki J. , Waligora M. , Dranseika V. ( 2016 ). What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review . Science and Engineering Ethics , 23 , 743 – 768 . Google Scholar CrossRef Search ADS PubMed Pinker S. 2015 . The Moral Imperative for Bioethics . Boston Globle . Porta M. 2014 . A Dictionary of Epidemiology . Oxford University Press . Google Scholar CrossRef Search ADS Sachs B. ( 2010 ). The Case for Evidence-Based Rulemaking in Human Subjects Research . The American Journal of Bioethics , 10 , 3 – 13 . Google Scholar CrossRef Search ADS PubMed Thornquist M. D. , Edelstein C. , Goodman G. E. , Omenn G. S. ( 2002 ). Streamlining IRB Review in Multisite Trials Through Single-Study IRB Cooperative Agreements: Experience of the Beta-Carotene and Retinol Efficacy Trial (CARET) . Controlled Clinical Trials , 23 , 80 – 86 . Google Scholar CrossRef Search ADS PubMed Tully J. , Ninis N. , Booy R. , Viner R. ( 2000 ). The New System of Review by Multicentre Research Ethics Committees: Prospective Study . British Medical Journal , 320 , 1179 – 1182 . Google Scholar CrossRef Search ADS PubMed Vaughan G. , Pollock W. , Peek M. J. , Knight M. , Ellwood D. , Homer C. S. , Pulver L. J. , Mclintock C. , Ho M. T. , Sullivan E. A. ( 2012 ). Ethical Issues: The Multi-Centre Low-Risk Ethics/Governance Review Process and AMOSS . The Australian and New Zealand Journal of Obstetrics and Gynaecology , 52 , 195 – 203 . Google Scholar CrossRef Search ADS PubMed Whitney S. N. , Schneider C. E. ( 2011 ). Viewpoint: A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research . Journal of Internal Medicine , 269 , 396 – 402 . Google Scholar CrossRef Search ADS PubMed Willison D. J. , Ondrusek N. , Dawson A. , Emerson C. , Ferris L. E. , Saginur R. , Sampson H. , Upshur R. ( 2014 ). What Makes Public Health Studies Ethical? Dissolving the Boundary between Research and Practice . BMC Medical Ethics , 15 , 1. Google Scholar CrossRef Search ADS PubMed © The Author 2017. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

Journal

Public Health Ethics – Oxford University Press

Published: Oct 31, 2017

There are no references for this article.