Research Samples Vs. Clinical Samples: A Deep Dive

The Strength of Cohorts

Connect is an observational cohort study, one of the most powerful methods scientists use to study health. Participants in this long-term study are helping Connect set the stage for future generations of researchers to advance science and uncover insights for health, including cancer prevention. A key piece of longitudinal studies like Connect is that they go on for decades, during which time participants share data repeatedly through different sources, such as biological samples and surveys. This allows researchers to study important exposures and record changes in behaviors and health status over time.  

Cohort studies like Connect have helped us learn how certain behavioral factors affect health and disease risk and have changed guidance around prevention, diagnosis, and treatment for a range of diseases. Take diet, for example. These days, we hear a lot about how diet and risk of various diseases are related. Have you ever wondered just how researchers discovered key connections between diet, lifestyle, and risk of diseases such as cancer? One excellent example is the National Institutes of Health AARP Diet and Health Study, which included 567,000 retirement-age Americans, making it one of the largest observational cohort studies of its time. Many of the study’s findings have changed the way we think about cancer and diet, including the association between drinking coffee and a lower risk of death from all causes. Still, nearly three decades later, researchers continue to study the data shared by participants to learn more about associations between health behaviors and cancer risk. This is a feature of cohorts that extends to Connect; researchers will use the data gathered through this study for years to come.  

Connect’s Unique Design

The Connect cohort now includes over 60,000 participants from health care systems throughout the nation! Each day we are steadily growing toward our goal of including 200,000 participants from many communities. Nearly 70% of Connect participants have donated their first biological samples, including blood, urine, and saliva. These samples are like time capsules that contribute to a better understanding and identification of factors associated with human health and diseases, including cancer.  

Connect will continue for decades to “observe” participants, during which time we collect additional information from participants without intervening in their lives or healthcare. We collect samples from participants every few years and securely store those samples in the Connect central laboratory. Collecting new samples periodically allows us to capture snapshots of information at distinct points in time during the follow-up period of the study. This information will help us identify factors associated with human health and cancer risk. As researchers begin to run tests on the samples, we plan to share some of the things we learn with participants.  

Deep Dive: Research and Clinical Samples 

Below, we outline how the handling and testing of research samples differ in important ways from the handling and testing of the samples you provide as part of your regular clinical care. We cover how these sample types differ in purpose, processing and storage, testing, consent process, rules guiding sample use, and sharing of results.  

Purpose: 

• Research samples are collected specifically for scientific research as part of Connect. They are usually not intended for immediate clinical decision making or for diagnosing a health condition. Research samples aim to answer scientific questions and advance medical knowledge for all people, rather than serving the individual from whom they were collected.  

• Clinical samples are collected as part of a doctor’s order to diagnose, monitor, screen, or treat a specific medical condition. As such, clinical samples address individual patient needs and directly inform health care decisions. Connect does not collect clinical samples for this purpose. 

Processing and Storage: 

• Research samples are processed in a way that allows them to be stored for long periods of time at the Connect central laboratory. The data from these samples are coded and stored without any personal identifying information to protect participant privacy.  

• Clinical samples collected by your provider are most often processed immediately to get accurate and timely results for diagnosis or treatment. These samples are not typically stored for the long term and are most often discarded after use. 

Testing: 

• Many of the tests run on research samples in Connect are exploratory and not validated for clinical use. They are for research to study health and cancer prevention, not to guide patient care. Research samples donated for Connect are not substitutes for samples you provide as part of your clinical care, and participating in the study does not replace getting regular medical care from your doctors. We encourage participants to maintain their regular health care. 

  • Connect does not provide medical care, diagnosis, or treatment recommendations, including for cancer. We will not use the tests done on your research samples to predict disease risk for clinical purposes. However, your sample contributions support future research that may inform cancer prevention and treatment guidance, benefitting communities for generations to come. 

• The tests run on clinical samples are intended to immediately diagnose, monitor, screen, and/ or gather information about health and inform treatment guidance for an individual patient. 

Consent Process: 

• For research studies like Connect in which participants are donating samples, participants provide informed consent for the use, storage, and study of samples and sample data.  

• Consent for collection of clinical samples is generally implicit within the context of your provider visits and routine medical care.  

Rules Guiding Sample Use: 

• Research sample collection and handling are governed by ethics boards (such as the National Institutes of Health Institutional Review) and Connect research protocols.  

• Clinical sampling must meet medical standards for patient care.  

Sharing Results:

• In the future, we will return some findings from tests run on research samples studied as part of Connect. Some results, like genetic traits (for example, cilantro taste preference) may be for general interest. Others results, such as circulating insulin levels from samples donated at time points in the past, may have uncertain benefits. This is because we cannot say for sure how these results may be used to inform health.  

  • A guiding principle of Connect is to respect the choice of participants and their information. We will always give you the option to receive results from research tests we run, along with key information needed to put the results in context (for example, what can you do with the results we share? What do they mean for you now?). This is important, considering that most results will be returned long after the samples were donated. 

• Clinical sample results are used immediately and directly for patient care. They are often available in your online patient portal (such as MyChart) or shared with you by your provider or a nurse over the phone.  

Research and clinical samples differ in important ways. We hope this article helped to set clear expectations around the samples we collect as part of Connect and what information we’ll return to you as a study participant. We’ll continue sharing updates over time.  

Our team is grateful for your participation in this cancer prevention research- thanks for being part the Connect community!