HELSINKI CONSENSUS STATEMENT ON PhD TRAINING IN CLINICAL RESEARCH
Convened in Helsinki on September 6 – 8, 2007
Following the tradition of the First and Second European Conferences on Harmonisation of PhD Programmes in Biomedicine and Health Sciences, the orpheus 2007 Conference was held in Helsinki 6-8 September 2007 with 78 registered participants coming from 43 medical schools from 26 European countries. The participants agreed upon the need to encourage clinical research, and the measures which could be recommended to improve the possibilities for PhD candidates to do this.
Clinical research has several characteristics which makes it different from other types of medical research. In particular, clinical research is performed for and with patients, often involving new procedures and drugs. Moreover, clinical research must be consistent with the highest possible ethical standards. It is therefore essential that persons with a medical background are involved in such research, bearing in mind that this can only be performed under the supervision and responsibility of experienced clinicians. However, the education and training of clinicians, among others medical graduates (medical doctors; MDs), is longer than for other professions. For a medical graduate this involves six years of medical school, one-two years of internship, and usually more than four years of specialist training.†Thus, in medicine we in fact have two, very different prolongations of high education (PhD and specialization). This long period, as well as the need for a certain level of clinical expertise, implies that it is advantageous for the additional 3-4 years of a PhD program to be coordinated with clinical education and training. Nevertheless, according to our survey, in many European countries PhD programmes in a clinical setting are not sufficiently developed. In this document we describe the consensus of the ORPHEUS group at their meeting in Helsinki, as regards the manner in which one best can foster the training of medical graduate and other clinical professionals through their participation in a PhD programme in a clinical setting.
Clinical research at the highest level is important for the advancement of prevention, diagnosis, therapy and clinical sciences in general, and for the benefit of patients, doctors and the community at large. Furthermore, scientifically qualified clinicians are needed to supervise, educate and train medical students. Accordingly, we recommend that PhD training associated with medical schools should include programmes in clinical research.
The criteria for a PhD in clinical research should be the same as those in other sciences. ORPHEUS re-affirms the principles set out in the ‘Zagreb declaration’ concerning the earning of, and standard for, the PhD degree. In particular, the award of the PhD should require original high quality research that has been, or can be, published in international peer-reviewed journals.
PhD programmes in clinical settings integrate clinical, preclinical and public health research, since methodological approaches are becoming more similar. However, the importance of clinical research comes from the fact that clinical research forms the basis for the evidence-based medical approach. Furthermore, medical doctors and other clinical professionals with a research training are expected to have an enhanced ability to provide rational diagnosis, therapy and rehabilitation to patients and to be critical regarding the development and possible introduction of new therapies.
ORPHEUS recommends organisation of PhD programmes in clinical settings to be in accordance with the Guidelines for organisation of PhD programmes in Biomedicine and Health Sciences accepted at the Second Conference in 2005. ORPHEUS recommends flexibility in the structure of the programmes. Institutions should develop PhD and, where legal requirements allow this, medical graduate/PhD (MD/PhD) programmes that are attractive to students and candidates of all clinical disciplines. These programmes should accommodate individuals with different needs and different institutional requirements, different backgrounds and scientific development. We are aware that current models of PhD studies vary in structure, but flexibility in the integration of research training with undergraduate and postgraduate programmes is important.
An important element in raising the quality of PhD programmes should be the promotion of PhD student mobility. The exchange of good information and data are essential. Therefore, high quality, standardised information should be available for potential PhD candidates on websites and elsewhere. This should include information concerning the PhD programmes available for clinical research, as well as the information about how these can be funded.
PhD candidates in clinical research should receive a salary (stipend) that does not place him or her at a disadvantage with peers who have not entered a PhD programme.
Scientific research in a clinical setting should be based on cooperation and competitive collaboration. In such settings, the prestige of clinical institutions will be enhanced by active participation in the creation of new knowledge and technological advances and in clinical verification of these.Accordingly, the ORPHEUS 2007 Conference recommends policy makers and clinical institutions in Europe to consider the adoption and development of useful and ethically acceptable PhD programmes in clinical research.
The ´Helsinki Consensus Statementª was adopted at orpheus 2007 †Third European Conferences on Harmonisation of PhD Programmes in Biomedicine and Health Sciences in Helsinki †on Sept. 8th, 2007 and after additional corrections it was made public on Oct. 10th, 2007