Starting a Cohort Study
Recruiting from the population, and following them over time to understand human health
Dr Rachel is starting a cohort study at her institution in Singapore. This study will recruit from the adult population to study their long-term health and longevity. She intends to invite cohort participants for a follow-up visit every 5 years. It involves collecting health-related data and human biological materials.
Key considerations
- To recontact participants to follow-up on their health, and/or to participate in other health-related research.
- To allow linkage of the data collected with additional records held by national electronic health records, registries, government organisations etc.
- To allow secondary use of data and human biological materials.
- To allow sharing of coded data and human biological materials with third parties.
- Human Biomedical Research Act (HBRA):
- Any intervention to research participants.
- Collection and use of individually-identifiable information or biological materials.
- Banking tissues for secondary use.
- Personal Data Protection Act (PDPA)
- Safekeeping and management of personal data by a trusted third party (TTP) to safeguard against unauthorised use of personal data.
- Trusted Third Party (TTP) to handle individually-identifiable data.
- Minimise possibility of re-identification of participants through the data.
- Findable, Accessible, Interoperable, Reusable (FAIR) principles to make research resources findable online with the necessary metadata, access procedures to optimise the reuse of scientific resources with appropriate consented use and credit to the original data custodians.
- Findable: Making resources (e.g., metadata, data, code) available online with rich descriptors to enable their appropriate use.
- Accessible: Clear and secure process for access according to applicable licenses, data use agreements and informed consent.
- Interoperable: Ability to share and integrate data from different sources with traceable original data sources and versioning.
- Reusable: Enable the optimal reuse of data with the appropriate consent, facilitating research in the wider community.
- Biological samples collected, their processing and long term storage will have a major impact on the future scientific usefulness as new technologies and measurement methods become available.
- Where feasible, collect, process and store samples to serve a wide range of scientific hypotheses as possible.
- Standardise collection and processing methodologies to ensure long term integrity of samples with robust inventory systems.
- Protect from freeze-thaw degradation by storing multiple aliquots.
- Develop a communication strategy to keep participants and public informed of study’s progress and findings.
- To recontact participants to follow-up on their health, and/or to participate in other health-related research.
- To allow linkage of the data collected with additional records held by national electronic health records, registries, government organisations etc.
- To allow secondary use of data and human biological materials.
- To allow sharing of coded data and human biological materials with third parties.
- Human Biomedical Research Act (HBRA):
- Any intervention to research participants.
- Collection and use of individually-identifiable information or biological materials.
- Banking tissues for secondary use.
- Personal Data Protection Act (PDPA)
- Safekeeping and management of personal data by a trusted third party (TTP) to safeguard against unauthorised use of personal data.
- Trusted Third Party (TTP) to handle individually-identifiable data.
- Minimise possibility of re-identification of participants through the data.
- Findable, Accessible, Interoperable, Reusable (FAIR) principles to make research resources findable online with the necessary metadata, access procedures to optimise the reuse of scientific resources with appropriate consented use and credit to the original data custodians.
-
- Findable: Making resources (e.g., metadata, data, code) available online with rich descriptors to enable their appropriate use.
-
- Accessible: Clear and secure process for access according to applicable licenses, data use agreements and informed consent.
-
- Interoperable: Ability to share and integrate data from different sources with traceable original data sources and versioning.
- Reusable: Enable the optimal reuse of data with the appropriate consent, facilitating research in the wider community.
- Biological samples collected, their processing and long term storage will have a major impact on the future scientific usefulness as new technologies and measurement methods become available.
- Where feasible, collect, process and store samples to serve a wide range of scientific hypotheses as possible.
- Standardise collection and processing methodologies to ensure long term integrity of samples with robust inventory systems.
- Protect from freeze-thaw degradation by storing multiple aliquots.
- Develop a communication strategy to keep participants and public informed of study’s progress and findings
References
- Elliott P, Peakman TC. The UK Biobank sample handling and storage protocol for the collection, processing and archiving of human blood and urine. International journal of epidemiology. 2008 Apr 1;37(2):234-44. doi: 10.1093/ije/dym276
- Coppola L, Cianflone A, Grimaldi AM, Incoronato M, Bevilacqua P, Messina F, Baselice S, Soricelli A, Mirabelli P, Salvatore M. Biobanking in health care: evolution and future directions. Journal of translational medicine. 2019 Dec;17:1-8. doi: 10.1186/s12967-019-1922-3
References
- Wilkinson, Mark D et al. “The FAIR Guiding Principles for scientific data management and stewardship.” Scientific data vol. 3 160018. 15 Mar. 2016, doi:10.1038/sdata.2016.18
- GO FAIR. FAIR Principles. Retrieved from https://www.go-fair.org/fair-principles/
- García-Closas, Montserrat et al. “Moving Toward Findable, Accessible, Interoperable, Reusable Practices in Epidemiologic Research.” American journal of epidemiology vol. 192,6 (2023): 995-1005. doi:10.1093/aje/kwad040