Due to the limited quantity of individual samples from unique populations (e.g., periviable births), the Neonatal Biorepository aims to optimize sharing of samples with investigators and minimize samples being used in redundant studies or experiments. The following protocols for sample and data sharing are used to maximize impactful scientific progress, facilitate productive collaborations, reduce waste of samples, and ensure recipient investigators who generate genomic data are provided the option to be involved in additional studies that use said genomic data.

A. Sample Sharing

• a. The Recipient Investigator will request sample quantity in an amount that is reasonable and proportionate to the experimental methodology being used.
• b. Any sample material remaining after the approved use will either be (i) returned to the repository at the conclusion of the study, or (ii) with repository PI permission, will be kept by the recipient investigator for additional study.
  • i. Recipient investigators who are approved to retain sample material will use remaining sample material for additional experiments only after communication with repository PI. The repository PI may require the recipient PI to complete a new biorepository request (via REDCap) and receive steering committee approval if sample material is to be used for a substantially different study or methodology than the original study (e.g., sequencing instead of genotyping, etc.).
• c. The Recipient Investigator will not share sample material with other investigators without approval by Repository PI and steering committee.
  • i. Other investigators will be required to complete a biorepository request (via REDCap), receive steering committee approval, and complete a biorepository usage agreement.

B. Data Sharing

• a. The Recipient Investigator will carefully consider what demographic and phenotypic data is necessary to complete the approved study and will do their best to ensure additional data that will not be used is not requested.
• b. The Recipient Investigator will not share biorepository data (e.g., demographics, diagnoses, etc.) with other investigators without approval by Repository PI and steering committee.
  • i. Other investigators will be required to complete a biorepository request (via REDCap), receive steering committee approval, and complete a biorepository usage agreement.
• c. The Recipient Investigator agrees to return data generated (e.g., genotypes, WES results, etc.) to the biorepository at the conclusion of the approved study.
  • i. The Biorepository will maintain the data for future use by new Recipient Investigators who are interested in different analytic approaches or other phenotypes.
  • ii. The Biorepository PI will facilitate communication between the Recipient PI and new Recipient Investigators who request data generated by the original Recipient Investigator so that the original Recipient Investigator can form a collaboration with the new Recipient Investigator, contribute to publications, and/or inform the new Recipient Investigator about methodological details.
  • iii. Recipient Investigators interested in using data generated by other recipient investigators will be required to complete a biorepository request (via REDCap), receive steering committee approval, and complete a biorepository usage agreement.

Click the link to download a copy of Biorepository Sample and Data Sharing Protocol.