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Tijdschrift voor Psychiatrie 56 (2014) 8, 533 - 538

Short report

Good clinical practice and the maintenance of ethical standards in medical research: advice for junior researchers working in mental health care

S. Castelein, S.J. de Kort, A.E.G.M. van der Moolen, W. Houtjes, P.F. Roodbol, B. van Meijel, H. Knegtering

background In mental health care, more and more research is being done, particularly in the field of educational programmes. Unfortunately, junior researchers are often not fully informed about the rules and regulations relating to research and about medical ethics. Therefore, they are not in a position to make considered judgements that conform to good clinical practice and acceptable medical ethics.
aim To give practical advice to trainees, stimulating them to think carefully about ethical standards in patient-related research in mental health care. methods The article provides a practice-based overview of practical advice and ethical considerations.
results We stress that before beginning their research, researchers should think very carefully about the ethics of medical research. Instructions and guidelines relating to medical and ethical standards are to be found in: directive for good clinical practice compiled by the central committee for human research (CCMO) with the accompanying e-learning module and in the basic course ‘rules and organisation for clinical researchers’ (BROK). Practical tips, illustrated with examples, provide a framework for stimulating thoughts on medical ethics. Finally, it is important to improve the ways in which research is embedded in the organisational structure of teaching programmes.
conclusion Basic information about GCP and the upholding of medical and ethical standards in patient-related research can be obtained from various sources. The main challenge is to ensure that GCP is firmly embedded in patient-related research undertaken by junior researchers.

keywords good clinical practice, medical ethical review, mental health care