From Exclusion to Inclusion: Improving Clinical Research in Vulnerable Populations. Memorandum by a Research Group of the Berlin-Brandenburg Academy of Sciences and Humanities and the EA European Academy of Technology and Innovation Assessment GmbH
Thursday, 24 July 2014
Bad Neuenahr-Ahrweiler, 24 July 2014. – In a recent publication an international group of scientists portrays the state-of-the-art in clinical research on vulnerable populations – such as minors, mentally ill, and critically ill – while also assessing the strengths and weaknesses of contemporary ethical and medical perspectives related to it. Based on interdisciplinary expertise, the researchers analyze the state of clinical research in vulnerable populations and develop suggestions for improving future research.
The memorandum is the result of a co-operative effort between the Berlin-Brandenburg Academy of Sciences and Humanities (Berlin, Germany) and the EA European Academy of Technology and Innovation Assessment (Bad Neuenahr-Ahrweiler, Germany). It is primarily oriented towards those in the relevant scientific disciplines who can benefit from obtaining an informed consensus regarding the current state of the discussions taking place.
Though proper protection of vulnerable populations is without question mandatory, it appears that the strong focus on preventing harm has been realized mainly by setting high standards for the enrolment of such populations in clinical research projects. However, compared to results for the non-vulnerable majority, the therapeutic situation for vulnerable populations is considerably less satisfactory.
The researchers hope that through a careful and responsible evolution of existing frameworks of clinical research, the current tendency to protect vulnerable populations by excluding them from clinical research might eventually shift towards offering better protection to these patients by including them in research projects, thereby letting vulnerable populations benefit from medical progress more than has been the case so far.
Overall, the group identified a variety of obstacles that seem to impede clinical research in vulnerable populations such as:
Underdeveloped assessment tools for determining the capacity to consent of prospective test persons.
Insufficient knowledge on the motivating factors for legal representatives to enrol their protectees in clinical research projects.
Furthermore, the researchers recommend certain measures that may help to increase morally and medically sound research in vulnerable populations. Examples are:
Initiating a debate on morally and legally justified incentives for stimulating research participation.
A critical assessment of likely benefits of research proposals in comparison to existing therapies.
H. Helmchen, K. Hoppu, G. Stock, F. Thiele, B. Vitiello, A. Weimann: From Exclusion to Inclusion. Improving Clinical Research in Vulnerable Populations, Berlin-Brandenburg Academy of Sciences and Humanities, 2014 (ISBN: 978-3-939818-45-8).
Professor Dr. phil. Dr. phil. h.c. Carl Friedrich Gethmann, Siegen (Speaker)
Kalle Hoppu, M.D., Ph.D., Helsinki/Finland
Professor Dr. med. Annette Grüters-Kieslich, Berlin
Professor Dr. rer. nat. Ursula-Friederike Habenicht, Berlin
Professor Dr. med. Hanfried Helmchen, Berlin
Professor Dr. med. Dr. h.c. Günter Stock, Berlin
PD Dr. med. Felix Thiele, M.Sc., Bad Neuenahr-Ahrweiler
Benedetto Vitiello, M.D., Bethesda/USA
A. Weimann, B. R. Kern, M. Löffler, A. Sablotzki, F. Thiele, F. M. Brunkhorst: “Der Einschluss von Intensivpatienten in klinische Studien”, in: Medizinische Klinik – Intensivmedizin und Notfallmedizin, 5/2013; 108(4):303–310. DOI:10.1007/s00063-012-0153-7
F. Thiele, J. M. Fegert, G. Stock: Clinical research in minors and the mentally ill, 11/2008, Graue Reihe No 46, EA European Academy, Bad Neuenahr-Ahrweiler
F. Thiele: “Is there a duty to tolerate research for members of vulnerable populations?”, in: Newsletter No 106, 4/2011, EA European Academy, Bad Neuenahr-Ahrweiler
The project was partly funded with the support of the “Stiftung Rheinland-Pfalz für Innovation” and the Berlin-Brandenburg Academy of Sciences and Humanities.
- PR_VulnerablePopulations_24072014.pdf (258 KB)