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"ethical review"
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Preparing ethical review systems for emergencies: next steps
Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.
Journal Article
Streamlining ethical review of data intensive research
Unfounded concerns about local liability should not delay urgent reform
Journal Article
Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better
Background
The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change.
Main text
We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies.
Conclusion
Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.
Journal Article
Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa
The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC.
Journal Article
Beyond Bioethics: Reckoning With the Public Health Paradigm
In the wake of scandal over troubling research abuses, the 1970s witnessed the birth of a new system of ethical oversight. The bioethics framework, with its emphasis on autonomy, assumed a commanding role in debates regarding how to weigh the needs of society against the rights of individuals.
Yet the history of resistance to oversight underscores that some domains of science hewed to a different paradigm of accountability—one that elevated the common good over individual rights.
Federal officials have now proposed to dramatically limit the reach of ethical oversight. The Institute of Medicine has called for a rollback of the federal privacy rule. The changing emphasis makes it imperative to grapple with the history of the public interest paradigm.
Journal Article
Ethical aspects of registry-based research in the Nordic countries
National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.
Journal Article
Impact of the National Mutual Acceptance on Research Governance Practices in Victorian Public Healthcare Agencies
Abstract
In 2013, the National Mutual Acceptance (NMA) of single ethical review was introduced into the Australian public health sector to address the timeliness of multisite clinical trials. A clinical trial is usually designed to test the effects of an experimental therapeutic product. While all research involving humans must comply with ethical guidelines, clinical trials testing products in Australia are also subject to stringent regulatory controls making the need to meet trial milestones critically import. Commercial clinical trials offer participating research sites substantial financial and clinical advantages. Concerns that bureaucratic processes have impeded commercial investment have influenced countries, including Australia, to introduce single ethical review, where one ethics review is accepted at multiple sites participating in the same research project. Although a central tenet of the NMA is the standardization of the behaviors and procedures of research review, concerns of inconsistency remain. This raises the question of whether the NMA does lead public healthcare agencies to adopt similar research governance practices.
A questionnaire survey was undertaken to explore the current experiences (n = 149) of the NMA in Victorian public health agencies, and 21 semi-structured interviews were conducted to explore expectations of the future of the NMA. The findings indicated that, while there was conformity to many of the process requirements of the NMA, a persistent focus on the needs of each individual healthcare agency rather than on complying with the national system weakened pressure on agencies to adopt standardization.
The NMA has the capacity to be a powerful tool in delivering quality clinical trial outcomes, maximize research resources and create dependable performance metrics if consistent policies and governance are followed.
Book Chapter
Ethical review reporting of Chinese trials records in WHO primary registries
Objective To investigate the report rate of ethical review in registered Chinese trials records. Methods Chinese trials recorded in WHO primary registries and http://clinicaltrials.gov to 14 July 2009 were identified. The report rates of ethical review and each of the 20 items in WHO's Trial Registration Data Set were calculated. Correlation of the item's report rate with the ethical review report rate was assessed. PubMed, EMBASE, CNKI and CBM (from the establishment of each database to 14 July 2009) were also searched to collect the full texts of completed trials to calculate the report rate of ethical review in the result publications. Results A total of 1247 records were identified, and 687 (55.1%) reported ethical review. The records reporting secondary sponsor(s), contact for public queries and key secondary outcomes were more likely to report ethical review information (66.3% vs 44.3%, 38.1% vs 28.5%, 53.9% vs 51.8%). The ethical review report rate of trials sponsored by industry was lower than those sponsored by non-industry (40.9% vs 51.9%). The report rates of ethical review for self-supported trials (83.5%) and trials with unidentified sources of monetary or material support (66.7%) were lower than the average ethical review report rate for records in the Chinese Clinical Trial Registration Center (ChiCTR). The ethical review report rate was not high in the result publications (84.3% in http://clinicaltrials.gov, 50.0% in ChiCTR). Conclusion Registered Chinese trials records report ethical review inadequately. Incomplete registration is correlated with not reporting ethical review. Medical journals should inspect ethical review more critically.
Journal Article
Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study
Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain.
Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse-Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach.
Four main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites.
The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.
Journal Article