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BMC Med Ethics ; 20(1): 7, 2019 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-30678668


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.

Governança Clínica/ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Órgãos Governamentais/ética , Pesquisadores/legislação & jurisprudência , Comportamento Cooperativo , Inglaterra , Revisão Ética , Comitês de Ética em Pesquisa/legislação & jurisprudência , Humanos , Entrevistas como Assunto , Pesquisadores/ética , Pesquisadores/organização & administração , Inquéritos e Questionários
BMC Health Serv Res ; 19(1): 24, 2019 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-30630475


BACKGROUND: While the development and evaluation of clinical ethics services in Norway has been recognized internationally, the country's research ethics infrastructure at times may have been less well developed. In 2016, media interest in the controversial nature of some health services research and pilot studies highlighted gaps in the system with certain types of research having no clear mechanisms through which they may be given due independent consideration. It is not clear that new legislation, implemented in 2017, will address this problem. We explore relevant law, committee scope, and the function of the system. We show that 1) Norwegian law provides for ethics assessment for all forms of health research; 2) regional RECs in Norway might not have always enforced this provision, considering some interventional health services research to be outside their remit; and 3) Norwegian law does not explicity provide for local/university RECs, meaning that, in practice, there may be no readily accessible mechanisms for the assessment of research that is excluded by regional RECs. This may include health services research, pilot studies, and undergraduate research. New 2017 legislation has no effect on this specifically but focuses on institutions regulating researcher activity. This may place researchers in the difficult situation of on one hand, needing to hold to recognized ethical standards, while on the other, not readily having access to independent committee scrutiny to facilitate consistent operation with these standards. CONCLUSION: To support researchers in Norway and to protect the public, it may be necessary either to widen the regional RECs' remit or to make legislative alterations that permit and do not discourage the existence of local RECs.

Ética em Pesquisa , Pesquisa/legislação & jurisprudência , Adulto , Idoso , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , Assistência à Saúde/ética , Assistência à Saúde/legislação & jurisprudência , Assistência à Saúde/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega , Projetos Piloto , Pesquisa/normas , Pesquisadores/ética , Pesquisadores/legislação & jurisprudência , Pesquisadores/normas