The increasing need for innovative research driven by rapid global changes gives doctoral supervisors of early-stage researchers a significant role in facilitating the ethical conduct of qualitative research. In the context of European Commission funding, the demands of research ethics and integrity place a tremendous responsibility on the supervisors of early-stage researchers involved in cross-national projects. This document study seeks to illuminate the role of the supervisors in facilitating research ethics in these projects. Specifically, we describe and discuss the supervisor (...) role associated with five approaches to doctoral supervision of qualitative research, namely those described as ‘Functional’, ‘Enculturation’, ‘Critical thinking’, ‘Emancipation’ and ‘Developing a quality relationship’. The main challenges for supervisors of cross-national research projects are the cultural and linguistic mobilisation of ethical principles in qualitative research processes and the management of the future use of open data. The results from this study have implications for planning and conducting cross-national studies within research involving human participants. These results can guide supervisors in the codification and mobilisation of ethical qualitative research in practice. (shrink)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states (...) various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

During the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries. Between 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock project, we asked national coordinators to complete a structured survey of research ethic committee approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified in 2017. Eighteen (...) countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight countries used a single centralised process for approval, seven required approval by an ethics committee in each participating hospital, and three required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 months; in nine approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright. The potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation. (shrink)

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 procedures and the electronic Integrated Research Application System. 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. 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. 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. 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. 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. (shrink)

There is an increasing need for quality in ethics consultations, though there have been significant achievements in the United States and Europe. However, fundamental concerns that place the profession in jeopardy are discussed from the perspective of the U.S. in a manner that will be helpful for other countries. The descriptive component of the essay (the first two points) explains the achievements in ethics quality (illustrated by the IntegratedEthics program of the Veterans Health Administration) and the progress on standards and (...) competencies for ethics consultations (represented by the Core Competencies of the American Society for Bioethics and Humanities). Based on these achievements, the analytical component of the essay (the final three points) identifies and seeks to resolve three fundamental concerns (with increasing levels of importance) that compromise quality in ethics consultations: standards of quality; professionalism; and credentialing. The analysis argues for clearer standards of quality in ethics consultation and urges further professionalism by explaining the need for the following: interpreting the ASBH core competencies in a normative manner, developing a Code of Ethics, and clarifying the meaning of best practices. However, the most serious concern that threatens quality in ethics consultations is the lack of a credentialing process. This concern can be resolved effectively by developing an independent Ethics Consultation Accreditation Council to accredit and standardize graduate degree programs, fellowship experiences, and qualifying examinations. This credentialing process is indispensable if we are to strategically enhance quality in ethics consultations. (shrink)