Learn More About COLS

COLS will achieve many “firsts” in the world of biobanking:

• First to collect sociological data matched with biological specimens from participants simultaneously
• First to use state-of-the-art rigorous methods of collection and storage of biological samples to allow future measurement of not just DNA, but RNA, proteins, lipids, metabolites, and other small molecules.
• First to collect data on a wide variety of participants throughout time, allowing researchers to study data prior to disease development

By collecting data from a diverse population of people with different health conditions over time, COLS will allow researchers for the first time to look “back through time” to understand factors that were present before the disease is diagnosed. Identifying those factors can lead to initiatives that screen for and prevent disease before it begins or diagnose and treat it at very early stages.

There is no question that COLS is needed by researchers. The bigger question is why doesn’t it already exist? There are many challenges to building this type of biobank and the COLS team has spent three years researching, consulting scientific and cultural experts, and visiting other biobanks around the world to design a program to overcome these challenges.

We will begin enrolling participants in the initial pilot project in Fort Collins, Colo., in 2022. Following a successful pilot project and additional funding, recruitment in Fort Collins will be expanded and COLS will begin adding additional recruitment sites across the state to ensure the inclusion of participants  representing the racial, geographic, age, and socioeconomic diversity of the state. To do this, COLS has already begun partnering with community organizations to help us understand the concerns and needs of each unique population. COLS collection sites, which we call Engagement Centers, also have been carefully selected to provide easier access for participants from many different communities.

To provide enough data to help researchers investigate disease progression, COLS vision is to track participants for 10 years. COLS will collect biological specimens annually, while surveying participants several times yearly on personal health and lifestyle factors. To retain participants throughout the program, COLS has developed a digital program that makes it easy and fun for participants to remain active. COLS also will use predictive analytics to identify participants at risk for discontinuing, triggering outreach and interventions to reduce drop-out rates.

COLS will begin its pilot project collecting blood from the initial participants and will later begin collecting urine and stool samples annually. These specimens will be broken down into multiple fractions, with different storage methods to preserve a variety of molecules. COLS will use rigorous collection protocols and will perform quality control on all samples. Samples are linked to each Engagement Center and staff member so that issues can be identified quickly and interventions such as re-training can be performed. Quality assurance and quality control systems will be modeled after the Quality System developed by the Clinical Laboratory and Standards Institute.

COLS will be collecting biological specimens and sociological data from all participants. Before datasets are provided to researchers, a variety of methods will be used to remove and/or mask personal data to protect the privacy of our participants.

Data collected will include:

• Biological specimens: Blood will be collected from initial participants (with the possibility of adding urine and stool collection in the future)
• Multiple biological molecules will be preserved: DNA, RNA, proteins, lipids, metabolites, other small molecules
• Social determinants of health data:
  • Economic stability
  • Neighborhood and physical environment
  • Health care
  • Education
  • Community and social context
  • Emotional and physical health self-assessments

COLS has partnered with the Human Performance Clinical Research Laboratory (HPCRL) at Colorado State University (CSU) to provide clinical support at its first recruitment site in Fort Collins. HPCRL will conduct the informed consent process with participants, collect blood samples, and provide lab technician and biospecimen storage.

As COLS grows, it will contract with a world-class biorepository to store and maintain all biological specimens. This partner will have proven operational expertise and technology – including robotic automation, high throughput capacity, and disaster recovery programs – necessary to effectively and efficiently manage coordination of the complex biorepository being developed by COLS.

It is our goal to collect specimens and data for at least 10 years. Biological specimens will be collected annually; sociological data will be collected several times per year. Biological specimens will be separated and stored in fractions so that many researchers can access them without degrading the samples’ integrity. The collection will be preserved indefinitely as long as the resource is useful to researchers.

The COLS information technology platform is being custom designed with the highest level of encryption to ensure data security. All personal health information collected through surveys and health records will be stored in a data vault by the Colorado Community Managed Care Network (CCMCN) to ensure the highest caliber of data security. CCMCN has almost two decades of experience storing protected health information and currently stores the electronic health records for all Federally Qualified Health Centers in Colorado. CCMCN’s capabilities and track records are renowned as among the best state health programs and is one of the reasons Colorado was selected to host COLS.

COLS is designed as a repository to enable researchers from around the world to conduct research for decades to come. Therefore, the biological specimens and personal/social health information must be stored in a common data language. All COLS data will adhere to the FAIR principles (Findable, Accessible, Interoperable, and Reusable) as outlined by the Office of Data Science Strategy (ODSS) within the NIH.

All biological specimens and personal/lifestyle data will be collected and stored in accordance to the federal HIPAA Privacy Rule and policies approved by the Institutional Review Boards (IRBs) overseeing all research utilizing COLS data. Data will be provided to researchers in a de-identified form with all names, addresses, dates, and other identifiers removed. Relational databases will use a unique, anonymous code to link participant records. COLS will protect all personal health identifiers while still maximizing access to sensitive data through anonymization and the creation of synthetic datasets that statistically recapitulate features of PHI.