Invivo Clinical Ltd Future Research Consent Statement


As scientific progress in the microbiome field is constant, Invivo would like to, with your consent, retain the remainders (if any) of your microbiome sample(s) for up to 50 years. Invivo will use them for future research projects that will help us to better understand the Human Microbiome. This future research will only be related to your microbiome and not to you as a person. All samples within the Invivo Clinical Ltd’s Biobank will be pseudonymised and data/results will not be traceable back to you. Your data and results will be pseudonymised and stored securely, in line with GDPR, for up to 50 years at Invivo Clinical Ltd. Results and/or data resulting from future research investigations may be published in scientific journals and/or presented at scientific conferences. No individual(s) will be identified in these outputs. Invivo Clinical Ltd will securely store all microbiome samples and data and will not sell or distribute for profit, your microbiome sample(s) and associated data/results. As part of this future research, Invivo may share your microbiome sample(s) and associated pseudonymised data with collaborators or third parties. These collaborators and third parties may include, but are not limited to, academic institutions, Invivo-registered Health Care Practitioners, and for-profit industrial partners, both within and outside of the United Kingdom. These collaborators will always be screened and approved by Invivo Clinical Ltd. You will not be identified to these collaborators, nor will any information generated by analyses be identifiable to you. If Invivo’s future research activities result in the launch of a commercially viable product or service, you will not be entitled to financial gain or intellectual property rights. Individual results generated from future research projects that utilise your donated microbiome sample(s) will not be identifiable and therefore will not be returned to you.  

We understand and respect the right to change your mind. Therefore, you are free to withdraw your consent for future research at any time, without reason. Upon withdrawal, your microbiome sample(s) will be destroyed, and no new data will be generated. Data previously generated may still be used and processed. Any sample(s) that are fully anonymised will not be traceable and therefore cannot be destroyed upon withdrawal of consent. To withdraw your consent please email us at research@invivohealthcare.com. 

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Definitions:  

Commercial Microbiome Testing Service’, ‘Testing Service’, or ‘ Commercial Testing’ means Invivo Clinical’s Testing Services; processing and analysis of your stool, saliva, vaginal swab or urine samples, collected and sent to us via our GI, Oral, Vaginal or Urinary testing kits (e.g. GI EcologiX) and the results report returned to you. 

 

‘Future Research Use’ means the potential pseudonymisation, storage and utilisation of your surplus (if any) microbiome samples, by Invivo Clinical Ltd or approved third parties, for scientific investigations, research studies, and/or experiments that aim to advance our understanding of the microbiome’s role in health and disease. 

 

‘Invivo’, ‘we’, ‘us’ or ‘our’ means Invivo Clinical Ltd, a company registered in England and Wales, with company registration number 06187743. Our registered office is at The Coach House and Admin Building, Lewiston Mill, Stroud, GL5 2TE.  

 

‘Microbiome Samples’, ‘samples’ or ‘devices’ means the protein and/or DNA samples extracted from your stool, saliva, urine or vaginal swab sample(s) that you collected and returned to us for either commercial microbiome and health marker testing services (e.g. Urinary EcologiX, or GI Health Markers Only) or participation in a research study.  

 

‘Pseudonymised’ means samples that have had personally identifiable details (such as name or telephone number) replaced with pseudonyms or codes, allowing for privacy protection whilst still enabling reidentification by authorized personnel at Invivo.  

 

‘R&D’ or ‘Research’ means research and development activities performed by Invivo Clinical Ltd or third parties on your volunteered pseudonymised samples. R&D activities are project specific and will include relevant study information. Such projects may include, but are not limited to, improving our testing services, quality control activities, conducting analysis of data and/or new product development. 

 

‘User’, ‘you’, or ‘your’ means you, and the person being authorised to use our testing services by giving informed consent.