The UK’s Medical Research Council (MRC) introduced a specific policy and procedure for inquiring into allegations of scientific misconduct in December 1997; previously cases had been considered under normal disciplinary procedures. The policy formally covers staff employed in MRC units, but those in receipt of MRC grants in universities and elsewhere are expected to operate under similar policies. The MRC’s approach is stepwise: preliminary action; assessment to establish prima facie evidence of misconduct; formal investigation; sanctions; and appeal. (...) Strict time limits apply at all stages. The procedure will be evaluated after two years. The indications so far are that the procedure is robust, and its clarity and transparency have been an asset to all parties. The MRC is also convinced that it is equally important to achieve a working culture that fosters integrity. Thus education and training in good research practices are fundamental to the prevention of research misconduct. (shrink)

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent (...) Research Ethics Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. (shrink)

The Medical Research Council National Survey of Health and Development (NSHD) is Britain’s longest-running birth cohort study. From their birth in 1946 until the present day, its research participants, or study members, have filled out questionnaires and completed cognitive or physical examinations every few years. Among other outcomes, the findings of these studies have framed how we understand health inequalities. Throughout the decades and multiple follow-up studies, each year the study members have received a birthday card (...) from the survey staff. Although the birthday cards were originally produced in 1962 as a method to record changes of address at a time when the adolescent study members were potentially leaving school and home, they have become more than that with time. The cards mark, and have helped create, an ongoing evolving relationship between the NSHD and the surveyed study members, eventually coming to represent a relationship between the study members themselves. This article uses the birthday cards alongside archival material from the NSHD and oral history interviews with survey staff to trace the history of the growing awareness of importance of emotion within British social science research communities over the course of the 20th and early 21st centuries. It documents changing attitudes to science’s dependence on research participants, their well-being, and the collaborative nature of scientific research. The article deploys an intertextual approach to reading these texts alongside an attention to emotional communities drawing on the work of Barbara Rosenwein. (shrink)

Aim: The aim of this paper is to present the development and evaluation of an art psychotherapy brief treatment method for complex depression for patients referred to mental health services.Background: Art Psychotherapy literature describes a range of processes of relational change through the use of arts focused and relationship focused interventions. Complex depression has a prevalence of 3% of the population in the West and it is recorded that in 2016 only 28% of that population were receiving psychological treatment. This (...) study was developed to test the hypothesis of whether an accessible and acceptable approach to the treatment of complex depression could be developed in relation to existing evidence-based practice within mental health services.Method: The United Kingdom Medical Research Council phased guidance for complex intervention development was used to develop the intervention. The process included producing a literature overview, systematic description of clinical practice, including a logic model and a clinical protocol. The art psychotherapy protocol described an arts-based dynamic interpersonal therapy approach, offered 1:1 over 24 sessions. Further to this the intervention was tested for referrer acceptability. The intervention is in the early stages of evaluation, using changes to the patient's depression and anxiety measured pre- and post-treatment with a follow-up measure at 3 months following completion of treatment.Results: Phase I of the study provided a good basis for developing a logic model and protocol. The authors found that there was good clinical consensus about the use of a structured clinical art psychotherapy method and the literature overview was used to support specific examples of good practice. The verification of clinical coherence was represented by a logic model and clinical protocol for delivering the intervention. The acceptability study demonstrated very high levels of acceptability for referrers reporting that ADIT was acceptable for patients with complex/major depression, that they were likely to refer to ADIT in the future that the use of arts was likely to improve accessibility the use of arts was likely to improve outcomes and that offering ADIT was an effective use of mental health resources.Discussion: Phase I of this intervention development study demonstrated theoretical and practice coherence resulting in a clinical protocol and logic model. Whilst Phase II of this study showed promising results, Phase II would need to be sufficiently scaled up to a full trial to further test the intervention and protocol. (shrink)

Medical research aims to achieve a better scientific understanding of health and disease. It is firstly undertaken for the improvement of medical care in general, not excluding a potential direct benefit for participants undergoing such research. There is a traditional conflict between the fundamental rights and the dignity of those participating individuals and the interests of science, researchers and even the society. The Convention of Human Rights and Biomedicine of the Council of Europe is a (...) new legally binding instrument for the solution of these conflicts. (shrink)

During the first half of the twentieth century, the mining industry in Britain was subject to recurrent disputes about the risk to miners’ lungs from coal dust, moderated by governmental, industrial, medical and mining bodies. In this environment, precise measurements offered a way to present uncontested objective knowledge. By accessing primary source material from the National Archives, the South Wales Miners Library and the University of Bristol's Special Collections, I demonstrate the importance that the British Medical Research (...) Council (MRC) attached to standardized instrumental measures as proof of objectivity, and explore the conflict between objective and subjective measures of health. Examination of the MRC's use of spirometry in their investigation of pneumoconiosis (miner's lung) from 1936 to 1945 will shed light on this conflict and illuminate the politics inherent in attempts to quantify disability and categorize standards of health. (shrink)

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the (...) guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India. (shrink)

Priorities in Medical Research was published in 1988 by a select committee of the House of Lords. The report ushered in an era of NHS research and development that lasted from 2001 to 2006. The inquiry's origins lay in concerns about academic medicine in the United Kingdom, yet PMR gave relatively little attention to this subject. Instead the report focused critically on the disconnect between the Department of Health and the NHS in R & D. This, the (...) committee argued, had led to the neglect of research into health services and public health. To sidestep the report's unwelcome proposal for a National Health Research Agency, the department eventually grafted R & D management onto structures created as part of wider NHS reforms. The Medical Research Council successfully pursued a strategy of keeping the committee's attention away from sensitive aspects of its own programme. The final focus of PMR was shaped by an alignment between committee members with an industrial view of research and champions of health services research. The actions of the various actors involved are interpreted using elite models of the state, and the applicability of these models is critically examined. (shrink)

Research ethics is a very exciting field at the moment. Important public debate is continuing at national and international levels, concerning the proposed revisions to the Declaration of Helsinki and the Council for the International Organisation of Medical Sciences (CIOMS) guidelines, the proposed European clinical trials directive and the recent Good Clinical Practice guidelines. There is also debate about obtaining, using and storing genetic, and tissue, samples. This ferment has resulted in a wealth of guidelines and learned (...) articles, but as yet there are few useful and up-to-date book-length discussions of the field. This is partly due to the increasing diversity of types of research (including research design), and the variety of the contexts of research (the hospital-based clinical trial is arguably no longer typical of medical research). However, it is also to do with what such a book is supposed to do. Recent works like Baruch Brody's Ethics of Biomedical Research (OUP, 1998) give, in effect, an …. (shrink)

The data produced by the scientific community impacts on academia, clinicians, and the general public; therefore, the scientific community and other regulatory bodies have been focussing on ethical codes of conduct. Despite the measures taken by several research councils, unethical research, publishing and/or reviewing behaviours still take place. This exploratory study considers some of the current unethical practices and the reasons behind them and explores the ways to discourage these within research and other professional disciplinary bodies. These (...) interviews/discussions with PhD students, technicians, and academics/principal investigators were conducted mostly in European higher education institutions including UK, Italy, Ireland, Portugal, Czech Republic and Netherlands.Through collegiate discussions, sharing experiences and by examining previously published/reported information, authors have identified several less reported behaviours. Some of these practices are mainly influenced either by the undue institutional expectations of research esteem or by changes in the journal review process. These malpractices can be divided in two categories relating to methodological malpractices including data management, and those that contravene publishing ethics. The former is mostly related to “committed bias”, by which the author selectively uses the data to suit their own hypothesis, methodological malpractice relates to selection of out-dated protocols that are not suited to the intended work. Although these are usually unintentional, incidences of intentional manipulations have been reported to authors of this study. For example, carrying out investigations without positive controls; but including these from a previous study. Other methodological malpractices include unfair repetitions to gain statistical significance, or retrospective ethical approvals. In contrast, the publication related malpractices such as authorship malpractices, ethical clearance irregularities have also been reported. The findings also suggest a globalised approach with clear punitive measures for offenders is needed to tackle this problem. (shrink)

Objectives: Recent legislative changes within the United Kingdom have stimulated professional debate about access to patient data within research. However, there is currently little awareness of public views about such research. The authors sought to explore attitudes of the public, and their lay representatives, towards the use of primary care medical record data for research when patient consent was not being sought.Methods: 49 members of the public and four non-medical members of local community health councils (...) in South Wales, UK gave their views on the value and acceptability of three current research scenarios, each describing access to data without patient consent.Results: Among focus group participants, awareness of research in primary care was low, and the appropriateness of general practitioners as researchers was questioned. There was general support for research but also concerns expressed about data collection without consent. These included lack of respect and patient control over the process. Unauthorised access to data by external agencies was a common fear. Current data collection practices, including population based disease registers elicited much anxiety. The key informants were equally critical of the scenarios and generally less accepting.Conclusions: This exploratory study has highlighted a number of areas of public concern when medical records are accessed for research without patient consent. Public acceptability regarding the use of medical records in research cannot simply be assumed. Further work is required to determine how widespread such views are and to inform those advising on confidentiality issues. (shrink)

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs, impact, and “quality of the research environment”. Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied ethics—unlike (...) in, for example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework. (shrink)

The National Academy of Science's 1956 study on the Biological Effects of Atomic Radiation was designed to provide an objective analysis to assess conflicting statements by leading geneticists and by officials in the Atomic Energy Commission. Largely because of its status as a detached, non-governmental evaluation by eminent scientists, no studies have had a broader impact on the development of biological thinking in regard to nuclear policies. This paper demonstrates that despite the first BEAR study's reputation as an objective and (...) independent study, it was the product of careful negotiation between Academy scientists, the Atomic Energy Commission, and Britain's Medical Research Council. This paper also reveals the fragility of the consensus that produced the Academy's report, the range of political uses of the report, and the subsequent disaffection of the scientists who took part in it. (shrink)

International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high-income countries have an obligation of justice to support health research in low and middle-income countries that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi-structured in-depth interviews were performed with 16 grants officers (...) working for 11 funders and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with five key features that advance health equity: being conducted with worst-off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength. It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities. (shrink)

The national ethical guidelines relevant to assisted reproductive technology have recently been reviewed by the National Health and Medical Research Council. The review process paid particular attention to the issue of non-medical sex selection, although ultimately, the updated ethical guidelines maintain the pre-consultation position of a prohibition on non-medical sex selection. Whilst this recent review process provided a public forum for debate and discussion of this ethically contentious issue, the Victorian case of JS and LS (...) v Patient Review Panel [2011] VCAT 856 provides a rare instance where the prohibition on non-medical sex selection has been explored by a court or tribunal in Australia. This paper analyses the reasoning in that decision, focusing specifically on how the Victorian Civil and Administrative Tribunal applied the statutory framework relevant to ART and its comparison to other uses of embryo selection technologies. The Tribunal relied heavily upon the welfare-of-the-child principle under the Assisted Reproductive Treatment Act 2008. The Tribunal also compared non-medical sex selection with saviour sibling selection. Our analysis leads us to conclude that the Tribunal’s reasoning fails to adequately justify the denial of the applicants’ request to utilize ART services to select the sex of their prospective child. (shrink)

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized by (...) the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

Although awareness of cultural differences that distinguish Indigenous peoples has increased worldwide following attention from international human rights bodies, Indigenous cultural values have had little influence in shaping research agendas or methods of inquiry. Self‐determination and reconciliation policies have been part of the decolonisation agenda of governments for several decades; however, these have not, until recently, been considered of relevance to research. Indigenous peoples feel that they are the most studied population in Australia, to the point where even (...) the word research arouses feelings of suspicion and defensive attitudes. Indigenous people are generally cynical about the benefits of research and cautious toward what many perceive to be the colonial mentality or ‘positional superiority’ ingrained in the psyche of western researchers. This article examines the characteristics and colonising effects of traditional research methods and describes an alternative, decolonising approach. Decolonising research methodology is congruent with Indigenous epistemology and is guided by the values and research agenda of Indigenous people. TheGuidelines for ethical conduct in Aboriginal and Torres Strait islander health research, developed by the National Aboriginal and Islander Health Organisation (NAIHO) with the National Health & Medical Research Council (NHMRC) in 2003 are examined, as they exemplify a decolonising paradigm for researchers. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators.It is (...) very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

Protecting confidentiality is an essential value in all human relationships, no less in medical practice and research.1 Doctor-patient and researcher-participant relationships are built on trust and on the understanding those patients' secrets will not be disclosed.2 However, this confidentiality can be breached in some situations where it is necessary to meet a strong conflicting duty.3Confidentiality, in a general sense, has received much interest in Islamic resources including the Qur'an, Sunnah and juristic writings. However, medical and research (...) confidentiality have not been explored deeply. There are few fatwas about the issue, despite an increased effort by both individuals and Islamic medical organizations to use these institutional fatwas in their research.Infringements on confidentiality make up a significant portion of institutional fatwas, yet they have never been thoroughly investigated. Moreover, the efforts of organizations and authors in this regard still require further exploration, especially on the issue of research confidentiality.In this article, we explore medical and research confidentiality and potential conflicts with this practice as a result of fatwas released by international, regional, and national Islamic Sunni juristic councils. We discuss how these fatwas affect research and publication by Muslim doctors, researchers, and Islamic medical organizations.We argue that more specialized fatwas are needed to clarify Islamic juristic views about medical and research confidentiality, especially the circumstances in which infringements on this confidentiality are justified. (shrink)

This paper is a personal account of the events associated with the author’s work at the University of Toronto’s Hospital for Sick Children on a drug, deferiprone, for the treatment of thalassaemia. Trials of the drug were sponsored by the Canadian Medical Research Council and a drug company which would have been able, had the trials been successful, to seek regulatory approval to market the drug. When evidence emerged that deferiprone might be inadequately effective in a substantial (...) proportion of patients, the drug company issued legal threats when the author proposed informing her patients and the scientific community. Until protests were made by international authorities in her field of research, the hospital and university did not adequately support the author’s academic freedom and responsibilities as a medical practitioner. It is argued that underlying cause of this, and of other similar cases, is the political philosophy which is driving the commercialisation of universities and bringing about the deregulation of drug approval procedures. Together these changes constitute a serious threat to the public good. (shrink)

Research Ethics, Volume 18, Issue 1, Page 51-63, January 2022. Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of (...) guidelines that govern research with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships. (shrink)

While there has been much discussion of how the scientific establishment’s culture can engender research misconduct and scientific irreproducibility, this has been discussed much less frequently with respect to the medical profession. Here the authors posit that a lack of self-criticism, an encouragement of novel scientific research generated by the recruitment policies of the UK Royal Training Colleges along with insufficient training in the sciences are core reasons as to why research misconduct and dishonesty prevail within (...) the medical community. Furthermore, the UK General Medical Council’s own data demonstrates a historic inattentiveness to the ease with which doctors can engage in research misconduct. Suggestions are made as to how these issues can be investigated and alternative incentives for career advancement are adumbrated. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators. It (...) is very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

The ability to improve diagnosis and refine prognosis in children with acute leukaemia is improving steadily. A growing number of tests can and are being performed on leukaemic cells. These include surface-marker analysis, DNA content, cytogenetics and studies of gene rearrangements. Increasingly large bone-marrow samples, now usually obtained under general anaesthesia, are required to make secure diagnoses. Ethical issues arise from three major areas. 1) Current research on leukaemia cells requested by the Medical Research Council is (...) considered by local research ethics committees, but parents are not regularly given detailed information about or asked specifically to consent to such research; 2) substantial quantities of excess cells are stored indefinitely. This archive of stored material is a valuable resource for research but there has been little consideration of the ethical issues which arise from this practice, and 3) there is a potential for pressure to obtain increasingly large samples. 'Creeping growth' in sample size is likely to continue unless ethics committees consider future research proposals in more detail. These issues deserve attention in order that worthwhile research and its publication are not impeded for want of ethical consideration. The implications extend beyond the field of childhood leukaemia. (shrink)

Ageing causes progressive decline in metabolic, behavioural, and physiological functions, leading to a reduced health span. The extracellular matrix (ECM) is the three‐dimensional network of macromolecules that provides our tissues with structure and biomechanical resilience. Imbalance between damage and repair/regeneration causes the ECM to undergo structural deterioration with age, contributing to age‐associated pathology. The ECM ‘Ageing Across the Life Course’ interdisciplinary research network (ECMage) was established to bring together researchers in the United Kingdom, and internationally, working on the emerging (...) field of ECM ageing. Here we report on a consultation at a joint meeting of ECMage and the Medical Research Council / Versus Arthritis Centre for Integrated Research into Musculoskeletal Ageing, held in January 2023, in which delegates analysed the key questions and research opportunities in the field of ECM ageing. We examine fundamental biological questions, enabling technologies, systems of study and emerging in vitro and in silico models, alongside consideration of the broader challenges facing the field. (shrink)

The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. Established by the Nuffield Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. Independence and quality are the underlining principles of the Council, and the way the Council works has been designed to ensure that its reports are thorough, authoritative and provide a novel, policy-oriented (...) approach to difficult ethical dilemmas. Recent reports have considered the issues raised by public health and critical care decisions in fetal and neonatal medicine. The Council is currently considering the ethical dilemmas surrounding dementia. (shrink)

The CQUniversity Australia Human Research Ethics Committee (HREC) is a human ethics research committee registered under the auspices of the National Health and Medical Research Council. In 2009 an external review of CQUniversity Australia’s HREC policies and procedures recommended that a low risk research process be available to the institution’s researchers. Subsequently, in 2010 the Human Research Ethics Committee Low Risk Application Procedure came into operation. This paper examines the applications made under the (...) Human Research Ethics Committee Low Risk Application Procedure during the course of 2010 and 2011. The paper contributes to the literature analyzing the decision-making processes of research review committees through an analysis of the quantitative data relating to the low risk research applications made and through discourse analysis of the qualitative data represented by the assessment comments of the members of the Committee. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must (...) also be considered and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

BackgroundClinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.FindingsIn Zimbabwe the parental informed consent document for children participating (...) in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.ConclusionThe challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. (shrink)

In this paper, we discuss and critically evaluate the National Health and Medical Research Council’s recently released document entitled ‘Draft Values and Ethics in Aboriginal and Torres Strait Islander Health Research’. We provide a brief account of its development, philosophy and contents, and then consider how the document could be used by HRECs. We recommend that three specially targeted documents be developed from this one document, to meet the particular needs of HRECs, Indigenous people and researchers. (...) We propose a system of Indigenous ethics advisers as a way to implement the central ideas of the new draft guidelines, without falling into the legalism and rule-following that these guidelines explicitly aim to avoid. (shrink)

The introduction of the National Health and Medical Research Council guidelines for the ethical conduct of Indigenous health research: Values and Ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (NHMRC, 2003), has prompted renewed debate about the ethical assessment of Indigenous health research in Australia. Concern has been expressed that these guidelines provide inadequate protection of Indigenous interests and that their introduction will result in a rolling back of important (...) Indigenous research reform gains of the past three decades. Another view is that the participatory focus of the Guidelines will help ensure that key Indigenous values are positioned as central to the development of research involving Indigenous interests. In this article we provide an overview of recent commentary on the Guidelines, and canvass practical proposals for their implementation into practice. In particular, we present a case for applying the Values and Ethics Guidelines as a foundation for establishing negotiated research agreements between Indigenous peoples and professional researchers at the local community level. The intention of this proposal is to give voice to the concerns and perspectives of Indigenous peoples through research, and to provide a framework for monitoring research after ethics approval has been granted. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When Should “Riskier” Subjects Be Excluded from Research Participation?*Dave Wendler** (bio)AbstractThe exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a specific account of a “condition on inclusion risks” (CIR), a condition (...) under which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.The exclusion of potential subjects on the basis of increased risks is a common and, in most instances, noncontroversial practice in human subjects research. Investigators routinely exclude potential subjects with reduced kidney function, bleeding disorders, and allergies to the drugs under investigation. Surprisingly, this use of exclusion criteria takes place in the absence of any explicit guidelines. In the present paper, I attempt to fill this gap in the literature and regulations by offering a specific account of the conditions under which potential subjects should be excluded from research on the basis of increased risk. This account serves two purposes.First, subjects who are excluded on the basis of increased risk are prevented from making their own enrollment decisions. Therefore, it is important to ensure, in spite of the broad range of potential subjects and the varied reasons for excluding them, that potential subjects are excluded in [End Page 307] a systematic and fair way. Second, certain instances of subject exclusion, most notably the exclusion of pregnant women and women of childbearing potential, raise more difficult issues. By providing a general framework for assessing the exclusion of potential subjects based on increased risks, the present analysis covers these cases as well and, thus, offers a solution to one of the thornier ethical dilemmas facing investigators and IRBs today.Briefly, I argue that standard exclusion practices suggest that whenever two groups of potential research subjects offer the same opportunity for scientific and individual benefit, but different levels of risk, the group that would introduce greater risks should be excluded. With this framework in place, I consider potential subjects, such as men and women of child-parenting potential, whose research participation introduces increased risks to third parties. I argue that the present approach is justified, not because it reduces harms to specific individuals, but because it reduces aggregate harms. Therefore, it should be applied to all riskier potential subjects regardless of who faces the risks in question. After defending this approach, I consider several objections.First, I argue that the present approach is not paternalistic; the exclusions it calls for are not justified by what is thought to be in the best interests of the individuals excluded. Rather, the argument is that these exclusions minimize the aggregate harm of human subjects research. In addition, the present approach does not violate the obligation of researchers to respect subject autonomy because it does not reduce the number of potential subjects who are given the opportunity to enroll in a particular protocol. Finally, the exclusions are consistent with reasonable side constraints on attaining the goals of research.“Riskier” SubjectsWhen it comes to evaluating risks, most guidelines on human subjects research stipulate simply that the risks entailed must be reasonable given the potential for benefit. The Australian National Health and Medical Research Council’s guidelines, for instance, require only that “the investigator... must be satisfied that the possible advantage to be gained from the work justifies any discomfort or risk involved” (ANMRC 1992, Clause 3). To determine whether the risks of a protocol are justified, one sums the risks of the various procedures in the protocol, whatever those procedures may be, and compares the result to the procedures’ potential for benefit. This evaluation of risks assumes that the aggregate risks of a [End Page 308] given protocol are fixed and thus will not help to determine whether and when the risks of particular protocols should be reduced by excluding riskier subjects. The United States Department of Health... (shrink)

In Australia, along with many other countries, limited guidance or other support strategies are currently available to researchers, institutional research ethics committees, and others responsible for making decisions about whether to return genomic findings with potential value to participants or their blood relatives. This lack of guidance results in onerous decision-making burdens—traversing technical, interpretative, and ethical dimensions—as well as uncertainty and inconsistencies for research participants. This article draws on a recent targeted consultation conducted by the Australian National Health (...) and Medical Research Council to put forward strategies for supporting return of finding decision-making. In particular, we propose a pyramid of decision-making support: decision-making guidelines, technical and interpretative assistance, and ethical assistance for intractable “tough” cases. Each step of the pyramid involves an increasing level of regulatory involvement and applies to a smaller subsection of genomic research findings. Implementation of such strategies would facilitate a growing evidence base for return of finding decisions, thereby easing the financial, time, and moral burdens currently placed on researchers and other relevant decision-makers while also improving the quality of such decisions and, consequently, participant outcomes. (shrink)

The Medical Research Council Laboratory of Molecular Biology (formerly the Medical Research Council Unit for the Study of Molecular Structure of Biological Systems) in Cambridge (England) played a key role in the postwar history of molecular biology. The paper, focussing on the early history of the institution, aims to show that the creation of the laboratory and the making of molecular biology were part of a new scientific culture set in place after World War (...) II. In five interlinked parts it deals with the institutional creation of the MRC unit dedicated to the crystallographic analysis of biological molecules; the attraction of postwar biophysics, the heading under which the work of the unit initially fell; the people who joined the laboratory and their appropriation of new technologies, in particular the electronic computer for protein crystal structure determination; the cultural appeal of postwar crystallography, as exemplified in the use of crystal structure diagrams for a wide series of consumer goods at the Festival of Britain in 1951 and the display of molecular models at the Brussels World's Fair in 1958, a key site for the presentation of science and its role in the postwar world. (shrink)

How could it happen that the very processes intended to assure ethical research in Australia might, themselves, undermine good research practice?This paper describes one PhD candidate’s recent experiences of multicentre review for a Human Research Ethics Committee approved, low/negligible risk, qualitative study, at the crossroad of health services research and organisational research.A retrospective review of international literature about multi-centre review processes revealed that many of these experiences were not unique and might have been expected, notwithstanding (...) Australian efforts at harmonisation of multi-centre review. This paper examines not only the burden of red-tape that was applied to a small doctoral study, but also the way in which the red-tape threatened the anonymity of potential study participants and risked exposing them to undue pressure and distress.These experiences support the view that harmonisation initiatives have not yet developed as the Australian National Health and Medical Research Council may have hoped and that further attention is needed to harmonise research governance processes. (shrink)

Background: Clinical trials involving children previously considered unethical are now considered a necessity because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.DiscussionThe Zimbabwean parental informed consent document for children (...) participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in interpreting and obtaining informed consent for orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation if the Zimbabwean courts had not legally appointed them. The situation contrasted with general clinical practice where legal papers where not required for providing consent for surgical procedures for example.SummaryExperiences gained from this clinical trial revealed that while there may be internationally established guidelines governing the process of obtaining informed consent for children participating in research, there may be need to be cognizant of the culture within which the research is taking place. This may call for the development of an ethico-legal framework that governs research-involving children in Zimbabwe that would facilitate their participation in clinical research, while ensuring that they are protected from exploitation. The Medical Research Council of Zimbabwe has since started developing that framework in a process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. (shrink)