Ethics and research governance in a multicentre study: add 150 days to your study protocol.
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ABSTRACT:
SUBMITTER: Elwyn G
PROVIDER: S-EPMC556088 | biostudies-literature | 2005 Apr
REPOSITORIES: biostudies-literature
Publications
Ethics and research governance in a multicentre study: add 150 days to your study protocol.
Elwyn Glyn G Seagrove Anne A Thorne Kym K Cheung Wai Yee WY
BMJ (Clinical research ed.) 20050401 7495
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Project description:The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an 'emergency' mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB's experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the 'optimal' ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.
| S-EPMC5444563 | biostudies-literature
Project description:BackgroundResearch has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.MethodsWe conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.
| S-EPMC8571668 | biostudies-literature
Project description:BackgroundSince the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research. Recently, a range of factors led to the development of more stringent bureaucratic procedures, governing the conduct of low-risk population-based health research in the United Kingdom.MethodsOur paper highlights a case study of the application process to medical research ethics committees in the United Kingdom for a study of the promotion of physical activity by health care providers. The case study presented here is an illustration of the challenges in conducting low-risk population-based health research.ResultsOur mixed-methods approach involved a questionnaire survey of and semi-structured interviews with health professionals (who were all healthy volunteers). Since our study does not involve the participation of either patients or the general population, one would expect the application to the relevant research ethics committees to be a formality. This proved not to be the case!ConclusionResearch ethics committees could be counter-productive, rather than protecting the vulnerable in the research process, they can stifle low-risk population-based health research. Research ethics in health services research is first and foremost the responsibility of the researcher(s), and we need to learn to trust health service researchers again. The burden of current research governance regulation to address the perceived ethical problems is neither appropriate nor adequate. Senior researchers/academics need to educate and train students and junior researchers in the area of research ethics, whilst at the same time reducing pressures on them that lead to unethical research, such as commercial funding, inappropriate government interference and the pressure to publish. We propose that non-invasive low-risk population-based health studies such as face-to-face interviews with health and social care professionals or postal questionnaire studies with patients on non-sensitive topics are given a waiver or a light touch review. We suggest that this can be achieved through a two-staged ethics application process. The first stage starts with a one or two-page outline application which ethics committees can use as the basis to grant a waiver or request a full application.
| S-EPMC2612000 | biostudies-literature
Project description: Not available
| S-EPMC131186 | biostudies-literature
Project description:Background Research ethics is intertwined with and depends on building robust and responsive research governance systems alongside researchers. Globally there has been substantial investment in agriculture, nutrition, and health (ANH) research motivated by the need to improve health outcomes, such as micronutrient deficiencies in Sub-Saharan Africa. Although there has been a notable focus on ethical issues inherent in ANH studies, there has been scanty research examining researchers’ attitudes related to ANH research. This study was conducted to explore the perspectives of researchers who conducted an agronomic biofortification study in Malawi. Methodology In-depth interviews were conducted with a purposive sample of ten ANH researchers. Interviews were conducted online via Zoom, audio-recorded, transcribed verbatim, and thematically analysed using the Leadership, Ethics, Governance and Systems Framework. Results Four core aspects emerged: Leadership: The relevance of building ethics leadership and ethical competence among researchers. Ethics: There is a need to develop a framework that operationalises core ethical values that can guide the implementation of ANH research. Governance: Research guidelines were perceived to be too generic to guide ANH research. Systems: Researchers’ recommended the establishment of a specialised ANH research ethics committee. Conclusions The findings highlight the significance of building ethics leadership and supporting ethical competency amongst researchers. Researchers recommended the development of tailored approaches rather than utilising generic governance systems and frameworks that are drawn from medical research and thus not fit for purpose in this field. In Malawi, specialised ethics review committees are needed to guide ANH research. Supplementary Information The online version contains supplementary material available at 10.1186/s12910-023-00940-x.
| S-EPMC10441702 | biostudies-literature
Project description: Not available
| S-EPMC4838154 | biostudies-literature
Project description:ObjectivesTo assess the use of NHMRC Indigenous research guidelines by Australian researchers and the degree of Aboriginal and Torres Strait Islander governance and participation in Indigenous health research.Design, setting, participantsCross-sectional survey of people engaged in Indigenous health research in Australia, comprising respondents to an open invitation (social media posts in general and Indigenous health research networks) and authors of primary Indigenous health research publications (2015-2019) directly invited by email.Main outcome measuresReported use of NHMRC guidelines for Indigenous research; reported Indigenous governance and participation in Indigenous health research.ResultsOf 329 people who commenced the survey, 247 people (75%) provided responses to all questions, including 61 Indigenous researchers (25%) and 195 women (79%). The NHMRC guidelines were used "all the time" by 206 respondents (83%). Most respondents (205 of 247, 83%) reported that their research teams included Indigenous people, 139 reported dedicated Indigenous advisory boards (56%), 91 reported designated seats for Indigenous representatives on ethics committees (37%), and 43 reported Indigenous health research ethics committees (17%); each proportion was larger for respondents working in Indigenous community-controlled organisations than for those working elsewhere. More than half the respondents reported meaningful Indigenous participation during five of six research phases; the exception was data analysis (reported as apparent "none" or "some of the time" by 143 participants, 58%).ConclusionsIndigenous health research in Australia is largely informed by non-Indigenous world views, led by non-Indigenous people, and undertaken in non-Indigenous organisations. Re-orientation and investment are needed to give control of the framing, design, and conduct of Indigenous health research to Indigenous people.
| S-EPMC10952733 | biostudies-literature
Project description:BackgroundGood governance and regulatory supervision are required to conduct research in an international public health emergency context and to ensure compliance with ethical standards. The "Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic" study is a regional effort in which research ethics stakeholders participated in addressing research ethics governance and preparedness response challenges to the COVID-19 pandemic in Central America and the Dominican Republic.MethodsA qualitative action research study was conducted following a participatory approach. Research ethics stakeholders in Central America and the Dominican Republic were mapped; a regional webinar and three virtual workshops were conducted discussing research ethics governance, ethics review and collaborative research practice during the pandemic. A roundtable session presented results and obtained feedback on a draft of a policy to strengthen regional research ethics governance.ResultsCountries across Central America and the Dominican Republic are at different stages in their development of research ethics systems. Countries with more established systems before COVID-19 were better organized and prepared to respond. This finding argues against improvisation and supports further work on strengthening governance of research ethics systems. Community engagement in research ethics public policy-making is practically absent in the region. Research and research ethics collaboration schemes are lacking amongst the countries; however, there are incipient initiatives in the region, such as the Central America and Caribbean Network of Research Ethics Committees. A policy brief with recommendations on how to advance towards strengthening the governance of research ethics systems was prepared and submitted to the Central American Integration System for analysis and possible approval.ConclusionNational research ethics systems in Central America and the Dominican Republic were unprepared to respond to the COVID-19 pandemic with respect to research oversight and effective collaboration. In most cases, national research ethics systems were found to be weak, and regional research collaboration was practically absent. To promote collaboration, a joint strategy needs to be developed with a regional vision towards sharing knowledge and best practices.
| S-EPMC9786418 | biostudies-literature
Project description:Current research ethics frameworks were developed on the footprint of biomedical, experimental research and present several pitfalls when applied to non-experimental social sciences. This work explores how the normative principles underpinning policy and regulatory frameworks of research ethics and the related operational processes work in practice in the context of collaborative health and social care research. The work was organised in three phases. First, UK research ethics policy documents were analysed thematically, with themes further organised under the categories of 'Principles' and 'Processes'. Next, we conducted a scoping review of articles about research ethics in the context of collaborative health and social care research, published in English between 2010 and 2022. We then held an exploratory focus group with ten academic researchers with relevant experience to gather their views on how the research ethics system works in practice in England (UK). The thematic framework developed in the first phase supported the analysis of the articles included in the scoping review and of focus group data. The analysis of policy documents identified twelve themes. All were associated to both a principle and a related operational process. The scoping review identified 31 articles. Across these, some themes were barely acknowledged (e.g., Compliance with legislation). Other themes were extensively covered (e.g., The working of Research Ethics Committees), often to discuss issues and limitations in how, in practice, the research ethics system and its processes deal with collaborative research and to suggest options for improvement. Focus group data were largely consistent with the findings of the scoping review. This work provides evidence of the poor alignment between how the research ethics system is normatively expected to work and how it works in practice and offers options that could make research ethics more fit for purpose when addressing collaborative research in health and social care.
| S-EPMC10745183 | biostudies-literature
Project description:Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013.
| S-EPMC5527717 | biostudies-other