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Responsible research (ethics and safety in clinical trials) GRI 103-1
Materiality and boundaries
BioGaia has built a unique network of international researchers with whom the company collaborates to conduct research. It is important that the research BioGaia is involved in is carried out in a transparent, independent and ethical manner, both for the sake of the participants and for the reliability of the results. BioGaia’s level of control over the research conducted with the company’s strains and products varies, from being highly involved, to only providing study products, to in some circumstances not having any influence at all.
GRI 103-2
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For research in humans sponsored by BioGaia, local ethical approval must be obtained prior to study start. All participants must be informed of the study and be willing and able to give written informed consent for participation. Participants can discontinue freely at any time, for whatever reason, without affecting their right to an appropriate follow-up investigation or future care. Pre-clinical studies in animals must be justified and the principles of the 3R:s – replacement, reduction and refinement – must be applied. BioGaia encourages transparent results from researchers. The studies must be registered on a public website such as ClinicalTrials.gov prior to study start.
GRI 103-3
Progress and priorities going forward
During 2020, BioGaia has further developed the company’s policies in relation to research and specified in greater detail what BioGaia and its research partners should comply with and aim for. This work has resulted in additions to policy documents and updates of standard research contract templates.
All research, pre-clinical and clinical, which BioGaia is involved in should comply with the highest possible ethical standards. The researchers should adhere to international and national legislation as well as the Helsinki Declaration’s ethical principles for medical research when applicable.
Code of Conduct and international principles guiding ethics
Additionally, BioGaia’s patent team has implemented a process where the potential adverse health impacts due to patent enforcements are considered in the patent registration process. However, due to the type of product and a focused patent registration strategy the risk of adverse impacts is considered low.
BioGaia’s high level ethical research policies are stipulated in the company’s internal Code of Conduct and the specific requirements are stipulated in the research contracts. BioGaia’s research partners are encouraged to apply the highest ethical standards in all pre-clinical and clinical research.
Moving forward, BioGaia will evaluate how it can further develop and specify its own policies as well as the need for implementing additional methods to ensure and/or influence its research partners to comply with the highest ethical standards within research.