Data Sharing Principles
The Framingham Heart Study advocates sharing its data. Here, we spell out general principles for Data Sharing of data collected by the Study (including main contract and ancillary studies). The Study endorses guidelines established by NIH detailed below; the Study requires that core and ancillary studies follow these guidelines; furthermore, the Study recommends sharing cleaned data, data collection protocols, and coding manuals as early as possible.Two main principles are held by the study.
- All data collected on Framingham Heart Study participants through any mechanism (grant, contract or other) needs to be returned to the Data Management team of the Study to be incorporated into the Framingham Study database.
- All data collected on Framingham Study participants are available to FHS investigators, to repositories such as dbGaP and BioLINCC and to qualified scientific investigators outside FHS.
The material below sets out guidelines for these two principles. Our goal is to be consistent with NIH Guidelines. As NIH Guidelines evolve, the FHS guidelines will also evolve to maintain consistency.
The guidelines are divided into two general sections: 1) genetic and genomic data and 2) phenotype data. In each section, there is a link to NIH guidelines, a list of data types covered by the guidelines, and a brief statement of guidelines for FHS studies.
- Genetic and genomic data
- NIH Guidelines
- Genetic/Genomic Data include but are not limited to
- Data used for genome-wide association studies (GWAS), including genotypes and imputed data
- single nucleotide polymorphisms (SNP) arrays
- genome sequence
- Gene Expression/Transcriptomic (e.g., expression arrays, RNA-seq)
- Epigenomic (e.g., methylation)
- Metabolomic (e.g., metabolites and other biomarkers obtained through high throughput protocols)
- To be returned to FHS after data cleaning and quality control, generally within 3 months after data have been generated. (see appended Table summarizing NIH guidelines)
- If investigators providing the data expect the time needed to clean and return new data is greater than 3 months, a justification and expected timeline should be provided.
- Once data have been received at FHS and reviewed by FHS Data Management for quality, data are available for release by FHS to dbGaP at the next available submission and to qualified investigators who have completed an FHS research application.
- Phenotypic Data
- NHLBI Guidelines
- If conducting research with genetic/genomic data, phenotype data are to be returned to FHS generally within 3-6 months after data collection to enable deposit by FHS in dbGaP.
- If conducting non-genetic/genomic research, phenotype data are to be returned no later than 1 year after the completion of data collection for deposit by FHS in BioLINCC (Biological Specimen and Data Repository Information Coordinating Center)
- Note that the NHLBI guidelines specify, "Data from each cycle of an examination or follow-up component are prepared by the study coordinating center and sent to the NHLBI PO for distribution as a data set no later than 3 years after the completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized within the study for analysis for use in publication, whichever comes first."
- Our contract with NHLBI says, "Incorporate ancillary study data into the contract study data set after an appropriate period of time (generally 12 months after completion of data collection). Include such ancillary study data in data sets prepared for the NHLBI Data Repository in accordance with NHLBI Policy on Data Sharing from Clinical Trials and Epidemiological Studies." Hence we have established a one year deadline after completion of data collection for data to be returned to FHS.
- Once data have been received at FHS and reviewed by FHS Data Management for quality, data are available for release to BioLINCC at the next available submission and to qualified investigators who have completed a research application.
Notification to FHS investigators when data they collected are requestedPolicies for Informing/Requesting Permission of Principal Investigators (PIs) who collected data
- For new datasets going forward, inform the PIs as part of the ancillary study review and approval process. Data should not be deposited in repositories, including dbGaP, by anyone other than FHS staff unless permission has been given in advance by the FHS Executive Committee.
- For datasets deposited with FHS < 2 years ago, inform PIs and ask permission to distribute the dataset
- For datasets deposited 2 or more years ago, but less than 5 years ago, inform the PIs that the dataset will be distributed
- For datasets deposited 5 or more years ago, distribute without informing PIs
In all distributions, data requestors will be notified of the requirement to acknowledge the grants/contracts that collected the data