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Initial CDAS Request Approval
Jul 1, 2006
Willingness of Study Subjects to Provide Biological Specimens to be Stored for Future Research
With the advent of new molecular techniques in the last decades, many epidemiologic and clinical studies make use of biological specimens, most often blood, to measure individual subjects’ genetic or immunologic parameters as factors related to disease risk or outcome. Often components of these specimens are stored indefinitely to make maximal research use of these often difficult and expensive to collect samples. As resources become available or as science and technology advances, such samples and the associated individual data can be utilized to test new hypotheses, known or unknown at time of specimen collection, related to disease risk in a cost efficient and expeditious manner. However, due to concerns about privacy, lack of trust, or lack of understanding, research subjects may be more or less reluctant to provide samples, and we hypothesize that this willingness may vary by demographic, lifestyle and health related characteristics. This differential has practical implications regarding approaches to recruitment as well as scientific implications in terms of potential selection bias related to a study population.
In PLCO, the subjects in the intervention arm were asked if they were willing to let their blood samples or samples collected related to diagnosis or treatment be used in 1) future cancer research, and 2) future research on diseases other than cancer. Persons in the control arm were asked, by mail, to consent to their willingness to store buccal swabs for 1) future cancer related research and 2) future research for diseases other than cancer.
We are analyzing 1) what individual characteristics, such as age, sex, race/ethnicity, marital status, geographic location, family history of cancer and comorbidities, may be related to the responses obtained for these questions on the two informed consents, and 2) evaluate if subjects refusing future studies on stored materials are disproportionately represented among those with abnormal suspicious results from screening tests or among those diagnosed with various PLCO cancers.
Pam Marcus (Division of Cancer Prevention)