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  • Original Article
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Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study

International Journal of Obesity volume 32, pages S12–S18 (2008)Cite this article

Abstract

Rationale:

Research involving humans is regulated by regulatory authorities through their specific requirements and controls. The Healthy Life Style in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) is a multicenter biomedical research study of adolescents in several representative European cities, which requires satisfying medico-regulatory requirements including Independent Ethics Committee (IEC) approval and agreement by the national or local regulatory authorities. To achieve a high level of quality assurance relating to ethical issues, we followed the good clinical practices (GCP) described at the International Conference on Harmonisation (ICH), which we adapted to the national and local situations of each of the 11 participating cities in 10 European countries.

Objective:

The main objective of the HELENA-CSS is to evaluate reliable and comparable data of nutritional habits and lifestyle in a representative sample of European adolescents. The aim of this paper is to present the methods relating to the ethical and regulatory issues of this study and to describe the current state of the medico-regulatory requirements involved in conducting this kind of study in each country.

Materials and Methods:

Following the GCP–ICH guidelines, a protocol describing the HELENA-CSS was written and approved by all partners. In the pilot study, a case report form adapted to the study objectives and its manual of operation was constructed and used by all partners. All information letters to adolescents and their parents and consent forms were first written in English, then translated into the local language, and adapted to each local situation. All documents were then checked centrally for any deviation and corrected if required. An operation manual relating to ethical issues and other medico-regulatory requirements was also developed. This paper presents the current status of the medico-regulatory requirements from each HELENA-CSS participant country.

Results:

Before the beginning of the study, most centers had satisfied the medico-regulatory requirements of IEC approval and agreement with other national or local regulatory authorities/organizations. For a few centers, some problems were detected and corrective actions were taken to improve missing information to reach a high level of quality assurance of ethical issues.

Conclusion:

The GCP–ICH guidelines about nontherapeutic biomedical research are interpreted and applied differently across Europe. This study shows that high-quality nontherapeutic biomedical research can address the ethical issues included in the GCP–ICH regulations and can be harmonized among the HELENA European partners.

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Acknowledgements

The HELENA Study takes place with the financial support of the European Community Sitxth RTD Framework Programme (Contract FOOD-CT-20056007034). The content of this paper reflect only the authors’ views and the European Community is not liable for any use that may be made of the information contained therein. The researchers from the University of Zaragoza, Spain (MIM, LAM) are complementary supported by FUNDACIÓN MAPFRE (Spain).

Author information

Author notes

  1. L Béghin, M Castera, Y Manios, C C Gilbert, M Kersting, S De Henauw, A Kafatos, F Gottrand, D Molnar, M Sjöström, C Leclercq, K Widhalm, M I Mesana, L A Moreno and C Libersa: L Béghin and M Castera: These authors contributed equally to this study.

  2. See Appendix at the end of the supplement on page S82.

Authors and Affiliations

  1. EA-3925, Lille 2 Law and Health University Faculty of Medicine, Lille, France

    L Béghin & F Gottrand

  2. CIC-9301 CH&U-Inserm Lille, and Therapeutic and Predictive Medicine Institute, Lille, France

    L Béghin, M Castera & C Libersa

  3. Department of Nutrition & Dietetics, Harokopio University, Athens, Greece

    Y Manios

  4. Campden & Chorleywood Food Research, Gloucestershire, UK

    C C Gilbert

  5. Research Institute of Child Nutrition Dortmund, Dortmund, Germany

    M Kersting

  6. Department of Public health, Faculty of Medicine and Health Science, Ghent University, Ghent, Belgium

    S De Henauw

  7. Preventive Medicine & Nutrition Unit, University of Crete School of Medicine, Heraklion, Crete, Greece

    A Kafatos

  8. Department of Paediatrics, Medical Faculty, University of Pécs, Pécs, Hungary

    D Molnar

  9. Karolinska Institutet, Huddinge, Sweden

    M Sjöström

  10. INRAN - National Research Institute for Food and Nutrition, Rome, Italy

    C Leclercq

  11. Department of Paediatrics and Adolescents Medicine, Medical University Vienna, Vienna, Austria

    K Widhalm

  12. Escuela Universitaria de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain

    M I Mesana & L A Moreno

Authors
  1. L Béghin
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  2. M Castera
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  4. C C Gilbert
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  5. M Kersting
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  6. S De Henauw
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  7. A Kafatos
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  8. F Gottrand
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  9. D Molnar
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  10. M Sjöström
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  11. C Leclercq
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  12. K Widhalm
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  13. M I Mesana
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  14. L A Moreno
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  15. C Libersa
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on behalf of the HELENA Study Group

Corresponding author

Correspondence to L Béghin.

Additional information

Conflict of interest

Frédéric Gottrand has received consulting fees from Numico Clinical Nutrition, lecture fees from SMS and grant support from Danone Research. The remaining authors state no conflict of interest.

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Béghin, L., Castera, M., Manios, Y. et al. Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study. Int J Obes 32 (Suppl 5), S12–S18 (2008). https://doi.org/10.1038/ijo.2008.179

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