Data and Biomaterial Application

GPPAD carries out newborn screening in the general population to identify infants at high genetic risk of developing type 1 diabetes, and offer them participation in trials to prevent disease initiation (for more details see HERE (https://onlinelibrary.wiley.com/doi/10.1111/pedi.12870, PMID: 31192505) (Clinicaltrials.gov-ID NCT03316261). By August 2022, GPPAD has screened over 350,000 newborns.

Available data:

• HLA derived from SNPs rs17426593, rs2187668 and rs7454108
• Genotyping results of the SNPs used in the calculation of the genetic risk score
• Sex
• First Degree Relative with type 1 diabetes – yes/no

POInT is a randomized double-blind placebo-controlled prevention trial, which is described in detail HERE: https://bmjopen.bmj.com/content/9/6/e028578.long; PMID: 31256036; POInT: Clinicaltrials.gov-ID NCT03364868, EudraCT-No.: 2017-000600-15.

POInT participants are aged 4-7 months 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); 1050 children were enrolled, and enrollment is complete. Children are treated with daily oral insulin or placebo (randomization 1:1). POInT children are followed with regular blood samples up to age 7.5 years. As of March 2023, 53 children have developed multiple islet autoantibodies by age 2 years.

Already measured biomarkers:

• 47 SNP genetic risk score
• OLINK®EXPLORE (3072 panel):  771 participants from dried blood spots (DBS) at birth
• Illumina Global Screening Array-24: 771 participants from DBS at birth
• Illumina Human Methylation EPIC Array: 749 participants (once ~1.5-2 years of age) –complete by end of 2022
• Microbiome (16SV4/WGS Sequencing): 458 POInT samples (once ~2-3 years of age) –complete by end of 2022
• Selected virus antibodies at age 1.3 years.

Information on additional metadata available, please contact GPPAD Coordination Center.

The GPPAD-Biobank stores longitudinal samples of children enrolled in POInT:

By September 2022, all POInT children will be age 2 years or older. Biosamples up to age 2 years are now available. Please contact GPPAD Coordination Center to get more detailed information.

OLINK measurements

• OLINK®EXPLORE (3072 panel):  771 POInT samples from DBS at birth
• Illumina Global Screening Array-24: 771 POInT samples from DBS at birth
• Illumina Human Methylation EPIC Array: 749 POInT samples (1.5-2 years of age)
• Microbiome (16SV4/WGS Sequencing): 458 POInT samples (2-3 years of age)

SINT1A is a randomized double-blind placebo-controlled prevention study, which is described in detail HERE: https://bmjopen.bmj.com/content/11/11/e052449.long; 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.

Data and bio-material will be made available as soon as all participants are enrolled and followed for a minimum of 2 years.

1. Letter of Intent:
   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 GPPAD Coordination Center. 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 GPPAD Coordination Center.
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

1. 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.
2. 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.
3. Investigator’s data sharing obligations with respect to GPPAD biobank activities include:
   1. 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.
   2. 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.