At the SNSF’s request, the Swiss Federal Department of Home Affairs (DHA) resolved in January of this year to discontinue the NCCR SESAM (Swiss etiological study of adjustment and mental health) as per 30 September 2009 and approved a one-year wind-down phase. The 3,000 expectant mothers required for the core study could not be recruited as planned. Begun in 2005 at the University of Basel, the NCCR aimed to examine the complex factors leading to healthy psychological development in humans throughout their life span.
Reasons and lessons
The SNSF subsequently reappraised the reasons for and consequences of discontinuing the NCCR SESAM. A working party, composed of National Research Council members formed for this purpose, singled out the following reasons as being primarily responsible for the failure of the NCCR:
• Overly optimistic assumptions with regard to the participation of expectant mothers in the core study;
• Lack of clarity in respect of legal responsibilities and a complex ethics procedure in Basel and other cantons;
• Continued public criticism of the NCCR, especially by interest groups.
What are the lessons that can now be learned by the SNSF in discontinuing the NCCR SESAM? The working party investigated this key question. In its Lesson Learned report it makes the following specific recommendations which should be applied to a broad spectrum of comparable research projects in the future:
• Feasibility studies:
Regarding major research projects, especially those requiring test persons, a more extensive feasibility study should be required beforehand, not only in relation to the research topic itself, but also to the legal, ethical and institutional issues. Additionally, in the case of applications for major projects, external feasibility expertise should be also obtained. One of the goals of such an extensive feasibility study is to ensure that potential recruitment problems like those encountered by the NCCR SESAM are identified early on – even for more complex research projects. The recommendations on feasibility studies will be especially relevant to the SNSF this year in the selection of the 3rd NCCR series.
• Launching major research projects:
The individual stages – e.g. planning, exploration and the core phase – should be more clearly distinguished from one another. Final approval of overall resources may only be granted subject to proof of feasibility.
• Ethical assessment:
Although managing ethical assessment is not part of the SNSF’s competence, it is nevertheless directly involved and thus keen to find suitable, Swiss-wide solutions for areas lacking clarity which involve responsibilities and procedures. Particularly in the case of multi-centric studies, like the NCCR SESAM, a compulsory procedure should be established at national level. In doing so, the ethics commission should only deal with the operational aspects of projects (establishing contacts, creating information material, study progression, questionnaires) insofar as these are relevant to the ethical assessment, while at the same time observing standards subject to disciplines. Special attention must be paid to balancing legally protected interests when recruiting particularly vulnerable groups such as, for example, patients and school children. Finally, preliminary studies required for assessing the feasibility of a major project should be evaluated in respect of the ethical aspects independently of and prior to the core study.
• Addressing public criticism:
Criticism must be taken seriously at the executive level. Those responsible for the project and the SNSF should respond to such criticism by taking appropriate, prompt and relevant communication measures.