The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The role (...) of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

The role of ethics committees is to protect and safeguard the rights and welfare of participants, and promote good research by providing ethical guidance to researchers. In order for ethics committees to fulfil their role and obligations, they need to have adequate understanding of the science and scientific methods used in research. Genomics is a novel and rapidly evolving research field, and identifying the ethical issues raised by it is not straightforward. Limited understanding of, and expertise in, reviewing genomic research (...) may lead ethics committees to either hamper novel research, or overlook important ethical problems. Researchers are in the best position to assist ethics committees in their efforts to remain informed about scientific advancements. (shrink)

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a (...) panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB). (shrink)

Conducting large multi-site research within universities highlights inconsistencies between universities in approaches, requirements and responses of research ethics committees. Within the context of a social science research study, we attempted to obtain ethical approval from 101 universities across England to recruit students for a short online survey. We received varied responses from research ethics committees of different universities with the steps to obtaining ethics approval ranging from those that only required proof of approval from our home institution, to universities that (...) facilitated fast-track applications to those that required a full ethics review. Some universities also completely refused. After contacting all 101 universities in England, 60 universities gave clearance to our study. In this article, we present the different approaches universities adopted in response to our application to sample from students in their institution. We consider a number of conceptual and ethical issues pertinent to considering ethics approval for researchers from other universities in England and critically discuss three possible models of ethics governance that would cover all universities in England. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the (...) REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions, which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it (...) is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique. (shrink)

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

While it is acknowledged that there is a need for more qualitative research on suicide, it is also clear that the ethics of undertaking such research need to be addressed. This article uses the case study of the authors’ experience of gaining ethics approval for a research project that asks people what it is like to feel suicidal to (a) analyse the limits of confidentiality and anonymity and (b) consider the ways in which the process of ethics review can shape (...) and constrain suicide research. This leads to a discussion of the ways in which ethics committees assess and monitor qualitative research more generally and some preliminary suggestions for how this might be improved. (shrink)

In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical (...) research and that considerations of distributive fairness justify some paternalistic protections of research subjects. (shrink)

This is the first in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. The first considers the rationale for having ethics review by committee at all; seeking to explain why ethics committees, as we currently have them, are so important to the wider system of governing research.

This paper is concerned with how public health policy makers should respond to the public’s perception of risks. I suggest that we can think of this issue in terms of two different models of responding to the public’s view of such perceived risks. The first model I will call the public perception view (PP view) and the second the public good view (PG view). The PP view suggests that the public’s perception of any risks is so important that public health (...) policies should be formulated in direct response to knowledge about them. I will consider two possible ethical arguments that might be offered in support of such a view: the first argument is an autonomy argument and the second a consequences argument. I suggest there are serious problems with both arguments. I then outline an alternative model of public health policy formation that I call the public good or PG model. This model focuses on drawing distinctions between the clinical and the public health context, and argues that most of public health policy is primarily concerned with the creation and maintenance of various public goods. This latter fact means that the PP model is inappropriate for public health policy formation. (shrink)

BackgroundThe contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material information, comprehension of disclosed information and voluntary consent to research participation. There is thus an urgent need to test, and an ethical imperative, to test, modify or refine medications or healthcare plans that could reduce patient morbidity, lower healthcare costs or strengthen healthcare systems.MethodsConceptual review.DiscussionAlthough some allocation principles seem better than others, no single moral principle allocates interventions justly, necessitating combining the moral principles (...) into multiprinciple allocation systems. The urgency notwithstanding, navigating ethical challenges related to conducting corona virus disease (COVID-19) clinical trials is mandatory, in order to safeguard the safety and welfare of research participants, ensure autonomy of participants, reduce possibilities for exploitation and ensure opportunities for research participation. The ethical challenges to can be categorized as challenges in allocation of resources for research; challenges of clinical equipoise in relation to the research questions; challenges of understanding disclosed information in potential participants; and challenges in obtaining informed consent.ConclusionTo navigate these challenges, stakeholders need a delicate balance of moral principles during allocation of resources for research. Investigators need to apply information processing theories to aid decision-making about research participation or employ acceptable modifications to improve the informed consent process. Research and ethics committees should strengthen research review and oversight to ensure rigor, responsiveness and transparency. (shrink)

It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come (...) to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction; that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind. (shrink)

Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and (...) Allen make in the paper lack force, and why the ‘governance problem’ in research ethics that they allude to ought to be explained differently. (shrink)

Currently, research ethics committees in the UK meet behind closed doors—their workings and most of the content of their decisions are unavailable to the general public. There is a significant tension between this current practice and a broader societal presumption of openness. As a form of public institution, the REC system exists to oversee research from the perspective of society generally.An important part of this tension turns on the kind of justification that might be offered for the REC system. In (...) this paper I adapt Daniels and Sabin’s accountability for reasonableness model for just resource allocation to the research ethics context to provide some structural legitimacy and to enable progress on the question of openness. After considering the consequences of adopting this model for open REC meetings, I then examine some reasons that might be offered against open meetings. These arguments do not overwhelm the core intuitions behind the presumption of openness but they do, I suggest, give us reason to retreat from fully public meetings. I conclude that there should be important adjustments to the system towards public accountability and that there are grounds for stopping short of fully public meetings. (shrink)