The distribution fee covers the distribution of archived/existing data or specimens and the processing of ancillary study data returned to Strong as described below. for large-scale distributions.
1. Distribution of archived/existing data
a. Consult on data available and applicable to research proposed.
- Review data request form for appropriateness.
- Identify specific datasets to include in the transfer based on the dataset request form submitted by researcher.
b. Ensure all required paperwork is correctly completed and processed before data are sent.
- DMDA
- IRB Approval
- Third Party Agreement, when necessary
- Invoicing
c. Apply correct ID system to data.
- Create project specific random IDs, when appropriate
- Swap to different ID system, when appropriate
- Apply consent restrictions.
d. Create distribution dataset.
- Bundle all datasets.
- Bundle all related documentation.
e. Data transfer
- Set up a secure transfer.
- Additional costs may apply for additional transfers.
f. Up to 3 hours of additional consultation (up to 5 hours for large-scale distributions.
2. Distribution of specimens
a. Review research application and DMDA.
b. Identify and retrieve appropriate specimen set. Create daughter aliquots if needed.
c. If these are DNA specimens,
- Custom aliquotting of DNA to user specification (concentration, amount, plating format).
- DNA forensic genotyping to ensure sample ID.
d. Prepare manifest.
e. Schedule a pre-shipment conference call with representatives from the testing laboratory, the SHS laboratory and data management groups and the ancillary study PI.
- Description of specimen set [sample type, number, volume, labeling, packaging]
- Guidelines for care/storage/usage of SHS specimens
- Shipping information [confirm address, date of shipment, shipping company
- Details of assay [analytical measuring range, quality control, estimated timeline
- Details of data return [formatting, QC to be reported, secure file transfer
f. Organize specimen shipment to testing laboratory.
3. New Research Data
If the research produces new data on SHS participants, the fees also cover the following items regarding data returned to SHS in respect of data sovereignty of participating tribal nations, who are the owners of SHS data and who task SHSCC to manage those data to advance scientific research in indigenous communities.
a. Follow-up with investigators at preliminary data return, request reporting changes as needed.
- Return raw data sets, including images (if applicable) and measurements.
- Return cleaned data sets, including derived measures that are used for publications.
- Return documentation of data cleaning procedures
b. Consult with investigators upon final data submission.
c. Remove any information from samples or data where participants’ identity cannot be confirmed and/or have withdrawn consent.
d. Prepare dataset documentation.
e. Organize return of specimens to the SHS when needed. Inventory specimen set and update biorepository records.
**Acknowledgement: This Service Unit has been modeled after The Framingham Heart Study