SINT1A is a randomized double-blind placebo-controlled prevention study, which is described in detail HERE (PMID: 34753762; SINT1A: Clinicaltrials.gov-ID NCT04769037).

SINT1A participants are aged between 7 days and 6 weeks at enrollment and have a greater than 10% risk to develop multiple beta cell autoantibodies by age 6 years as determined by a genetic risk score (GRS); 1144 children will be enrolled, enrollment is still ongoing.  Children are treated daily with B. infantis EVC001 or placebo (randomization 1:1), and followed with regular blood samples up to age 6.5 years.

1. Letter of Intent (LOI)

To obtain data and/or biomaterials from GPPAD projects, a 1-2 page project description (background, hypothesis, objectives, robustness of methodology, impact and innovation) should be submitted to GPPAD (cc@gppad.org). This should include information on the type of data, or type of biomaterial requested and the number and quantity (volume) of biospecimens requested, and a justification why samples from children <= age 2 years are required. The LOI will be evaluated by the GPPAD team in a timely manner and the applicants will be contacted for further discussion.

2. Data and Material Transfer Agreement and Standard Contractual Clauses

GPPAD is required to execute a Data and Material Transfer Agreement for each approved Investigator (approved LOI). A copy can be found HERE.

In addition, investigators from third party countries (eg. USA, Australia) have to sign Standard Contractual Clauses Module one (HERE) or Standard Contractual Clauses Module two (HERE) and in some cases the execution of a Transfer Impact Assessment (TIA) might be required.

Investigators agree to comply with all applicable European, and GPPAD Consortium Member State, Data-​Protection and Privacy-​Protection Laws, Rules and Regulations then in effect.

If you have questions about GPPAD data and biobank sample sharing, please email us to cc@gppad.org.

3. Agreement to data share policy

Investigators agree to conduct all research activities and manage all Intellectual Property in a manner that ensures open sharing of data. Investigators agree that generated data will be transferred back to GPPAD and stored at the GPPAD server.

Data Sharing Policy

• One of GPPAD’s goals in providing biobank material is to have all generated research be available in the manner most conducive to furthering scientific research. Investigator agrees to conduct all research activities and manage all Intellectual Property in a manner that ensures open sharing of data as described in subsections (c) and (d) below to the extent legally permissible.
• The requirements of this Section include, but not by way of limitation, that sharing of data must comply with all applicable European, and GPPAD Consortium member State, Data-Protection and Privacy-Protection Laws, Rules and Regulations then in effect.
• Investigator’s data sharing obligations with respect to GPPAD biobank activities include:
  • Deidentified data generated through the use of GPPAD biobank material will be made available publicly no later than twelve months after the completion of the research activities.
  • Data will be maintained by GPPAD Data Share or by a third-party public repository for a period of at least 1 year following the first date on which the data was made publicly available.

4. Ethics approval or exempt letter copy

GPPAD is required to have a current Institutional Review Board (IRB)/ Ethical Board approval for each approved Investigator/project before any data or samples from the GPPAD biobank can be distributed; if not required by your IRB, please provide a letter from the IRB explaining that an approval is not required.

5. Participation in GPPAD meetings and scientific discussion

Scientists who receive data or biomaterial are expected to report regularly to GPPAD about the progress of the project, and participate in GPPAD meetings, and in scientific discussions during the collaboration.

6. Funding for the analysis or biosample measurements must be secured