To conduct clinical research or translational research often requires human biological samples or clinical and biological data related individuals. These samples and data are either:
- collected prospectively from sick or healthy volunteers,
- hold in biobanks or in sample collections established in the context of previous research or care.
Regardless the geographical origin of the samples and data, working with samples and data from human origin should comply with good practices and regulations set by each country involved in the scientific partnership. This explains why European and French regulations are applicable for research conducted partially on French territory or in collaboration with French teams.
The application of good practices and compliance with regulatory requirements from the early steps of the projet conception and along its execution guaranties:
- the protection and respect of the samples and data donors,
- compliance with the granting parties’ expectation on ethical and regulatory conformity,
- compliance with the scientific editors’ expectation for acceptance of future publications,
- protection from institutional and personal legal and penal risks,
- the image of excellence of Institut Pasteur and its partners by promoting responsible research.
Anticipating these requirements from the very beginning of clinical or translational projects and seeking advice from the competent departments of your institution is a key factor of success of conducting those research project. Without anticipation, the procedures could be much more complex and lengthy without ensuring their success within a timeframe compatible with the project.
To get advice or help for projects involving the Institut Pasteur:
contact the Guichet Unique of the Centre for Translational Sciences (firstname.lastname@example.org)
- International ethical guidelines for health-related research involving humans, CIOMS, 2016 (other language on the CIOMS website)
- Secondary use of samples: useful information and contacts,
- Ethical issues and research during infectious disease outbreaks and pandemic,
- Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, WMA, 2016