Ethical principles for research Sample Clauses

Ethical principles for research. SmartCare is a real-life trial with characteristics (mixed qualitative and quantitative approach) of a non-conventional, “classical” research project. It is useful to consider the ethical principles in relation to the so-called Belmont Report (1979), which is considered here as a reference standard. For the first time, this made a distinction in the domain of medical ethics between ‘research’ and ‘practice’. For the most part, the term ‘practice’ refers to interventions that are designed solely to enhance the well being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioural practice is to provide diagnosis, preventive treatment or therapy to particular individuals. By contrast, the term ‘research' designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalisable knowledge (expressed, for example, in theories, principles, and statements of relationships). Being a pilot project cutting across established domain boundaries, a challenging issue for SmartCare concerns what is (or should be) considered to fall within or outside the ‘medical’ and ‘social’ domains, respectively, when it comes to ethics and data protection. This is important because ethical perspectives, regulations and practices vary considerably within these different domains. In general, historically there has tended to be a lot more visibility and regulation / codification in the medical field than the social field, even if the former has in practice been a lot more arbitrary and less consistent than might be expected. For instance, almost all European countries have by now put regulative procedures in place concerning ethics approval of clinical research involving human beings. But even within the ‘medical’ domain, there is blurring between what is a ‘clinical’ intervention as opposed to more collateral interventions linked to healthcare needs in a wider sense 3. Also, ethics approval practices concerning medical research vary widely across countries and regions, and especially in the interventions and practices in the social care domain, which is typically much more ‘loosely’ conceptualised and regulated.