Ethics of Mental Health Research Stepping out of the boundaries

1. Ethics of Mental Health Research Stepping out of the boundaries Chairperson Dafina Feinholz Klip Presentor Prabha Chandra Twenty People with strong opinions

2. Prelude • Relevance of research in mental health • Should always be only for their benefit and not because they are an available population • Mental health is not only psychiatry • While vulnerability is a great problem, suffering is also a great problem

3. Definition of Mental Health • To know the grays and not look at mental health as black and white • Mental health and illness as spectrum and to prevent naming diseases • Is mental health objective or subjective? • There is a disqualification of mental suffering

4. Different types of research • Milder and spectrum disorders • More severe psychiatric disorders

5. Mental Health Research need not neccessarily be drug research but these also need ethics review • Mental Disease Research

6. Ethics of Placebo use • Should we use placebos in patients with psychiatric illness? • Removal of drugs for drug free periods • Use of placebos in serious situations such as suicide

7. As practitioners we are looking for a drug that is better than others. • Head to head trials are more important

8. Methodological Issues • Measurement of end points are very subjective • Relevant research questions are not asked • Suitable research methodology • Development of technologies

9. As we dont have adequate methodologies there is inadequate research and sometimes poor quality research • Harm is not very well defined and more difficult to measure • Need for evidence base and systematic research before we embark on new research

10. Informed Consent • When so called normal people find it difficult it is even more difficult in mental illness • Tailoring informed consent procedures to different levels of competency

11. Administrative aspects • When psychiatric hospitals are understaffed then getting legal help and advocacy is difficult and increases vulnerability

12. The Marketplace • Research findings are not necessarily translated correctly when marketing of the drugs • Labelling of psychiatric conditions to market new drugs like ADD

13. Settings of Research • Pharmaceuticals vs needs of society • We need to find other routes of research and define better research questions rather than be dictated by one force • The most vulnerable patients have no lobby • Hence we need to set the right priorities • Need to hear the user groups about their research priorities

14. ROLE OF REC • Justice and Social Worth evaluation is an important role • Social worth is particularly important to prevent Me Too drugs • When there is no access to research drugs what is the relevance of that research

15. We have an obligation to discuss the need for pharmaceutical research • What is the responsibility of bioethics groups like our forum to discuss societal aspects of research of which pharma industry is just a part ?

16. If we dont raise these questions , who will? From the group sans frontiers