This is the public, informational version of the document. The copy signed on joining the donor programme prevails; for questions write to info@microbiomebank.com.
The purpose of this document is to provide you, prior to your participation in the donor programme, with detailed information on the process, risks, rights and obligations associated with faecal microbiota transplantation (FMT) donation, and to record your free, informed and explicit consent given on the basis of your understanding of this information.
1.1Faecal microbiota transplantation (FMT) is the transfer of intestinal flora (microbiota) obtained from a healthy donor into the intestinal tract of a patient recipient, for therapeutic purposes. The donation programme enables healthy adults to take part, through their donated stool samples, in the treatment of patients suffering from severe disorders of the intestinal flora (in particular recurrent Clostridioides difficile infection).
1.2The objective of the donor programme of MicroBiome Bank Ltd. is: the screening of eligible donors, the safe processing of donation samples, and the delivery of the graft to the indicated recipients. The programme welcomes applications from healthy adults between 18 and 50 years of age.
You complete the online application form and the Donor Screening Questionnaire (DSQ). The questionnaire contains approximately 100 questions on state of health, dietary and lifestyle habits, and family history. The time required for completion is approximately 15–20 minutes.
Following a positive pre-screening, you take part in a comprehensive laboratory examination (blood sampling, stool sample), which includes: complete blood count, hepatitis B/C, HIV and syphilis serology, stool parasitology, bacteriology and screening for multidrug-resistant (MDR) pathogens. The detailed list of tests is set out in the screening test schedule constituting Annex No. 5 to the Donation and Screening Agreement.
After the successful completion of the eligibility assessment, you sign the Donation and Screening Agreement and its related annexes, including the Data Processing Consent Statement.
On each donation occasion you receive a sampling kit in which you provide the stool sample. The minimum contractual term is 3 Donation cycles (15 occasions in total). One Donation cycle consists of 5 consecutive Donation occasions.
During the donation period you undergo regular re-screening in order to maintain safety. The schedule is set out in Annex No. 5.
Every sample is registered with a unique identifier. For 60 days following the donation you are obliged to report any new infection or relevant health event, so that the safety of the recipients can be guaranteed.
3.1The donation of stool does not involve any significant physical risk. The donation itself takes place at home, in a private environment.
3.2The customary risks associated with blood sampling (minor bruising, rarely a coagulation disorder, infection at the puncture site) do exist.
3.3From a psychological and social point of view: participation is voluntary, and you may withdraw at any time (after the expiry of the Minimum Term by ordinary termination, or earlier by mutual agreement). The donor's status is confidential; apart from the anonymised donation identifier, the recipient may not learn your identity.
3.4Time burden: ~15–20 minutes for the questionnaire, ~1 hour for each laboratory examination, ~5–10 minutes of sample preparation per occasion. The total commitment during the minimum term is estimated at ~25–30 hours.
6.1It is a fundamental principle in the spirit of the donation programme that the donor receives no payment for the donation — pursuant to Article 12 of Directive 2004/23/EC, financial gain in connection with substances of human origin is prohibited.
6.2You are entitled to reimbursement of costs: the Company assumes the cost of the screening tests upon completion of the Minimum Term (3 cycles, 15 occasions). The detailed conditions relating hereto are set out in Section 6 of the Donation and Screening Agreement.
6.3AutoBiome capsule preparation: from 10% of the donated stool a capsule preparation is produced for your own use, which may not be sold and may not be transferred.
7.1The data controller is MicroBiome Bank Ltd.; MicroBiome Bank Kft. (laboratory) also participates as data processor.
7.2The legal bases are: performance of a contract (Article 6(1)(b) GDPR), your explicit consent (Article 6(1)(a) and Article 9(2)(a) GDPR), as well as the sectoral legislation applicable to the processing of health data.
7.3The detailed data processing information notice is set out in the Data Processing Consent Statement constituting Annex No. 2 to the Donation and Screening Agreement.
I, the undersigned, have read and understood the above information and have had the opportunity to ask questions. I declare that: