[Good clinical practice and the maintenance of ethical standards in medical research: advice for junior researchers working in mental health care]. / Good clinical practice en medisch-ethische toetsing: handvatten voor (beginnend) onderzoekers in de ggz.

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.

Value judgements that matter to patients remain implicit in oncology guidelines: an observational study.

BACKGROUND: Clinical practice guidelines are often evidence-based. However, it is inevitable that there are value judgements in the practical recommendations contained in the guidelines. In order to see if patients are ultimately being supplied with sufficient information to help them make treatment decision, we determined 1) which value judgements influence the process of developing guidelines for palliative chemotherapy, and 2) whether these value judgements were made explicit in the final guideline report. METHODS: We studied the development process of six Dutch oncology guidelines in which palliative chemotherapy plays a substantial role. We observed the guideline development groups (GDGs), conducted semi-structured interviews with individual GDG members (including the chairs), and analysed the minutes of GDG meetings and subsequent versions of the guidelines. A value judgement was defined as a statement about the value of a patient outcome with regard to palliative chemotherapy. RESULTS: We identified the following value judgements in the process of guideline development: 1) consensus on what should be considered as valuable minimum patient outcomes, 2) preference for tailored treatment in situations where there is no evidence of treatment effect, 3) preference for 'doing something' even when there is sufficient evidence of no effect, and 4) the patient outcome of 'prolonging life'. These value judgements, however, were not reported in the final guideline. CONCLUSION: At least the last two value judgements mentioned are relevant for patients with incurable metastatic cancer in making decisions whether to undergo chemotherapy and what kind. Value judgements should be made explicit in guidelines, so that clinicians can transparently discuss treatment options with individual patients.