Informed consent for biobanking research: cancer patient recruitment from rural communities in Maine.
Biobanking research seeks to improve the diversity, availability, and quality of human specimens critical for translational research, including biospecimen collections from disadvantaged minorities. American rural whites are seldom represented in such initiatives as geographic isolation makes obtaining informed consent challenging. We report a case series of 83 newly diagnosed cancer patients, attending a rural community medical center, who consented to participate in cancer research. To enable pooling with population studies, we created a BioGeoBank using 2007 NCI and ISBER Best Practices, after a protocol approval by Eastern Maine Medical Center (EMMC) IRB and OHP HRPO. Informed consent forms were at Flesch-Kincaid 8th Grade reading level, supplemented by NCI educational brochures. Of 108 patients identified, 85 were eligible. Of these, 83 patients (49 lung cancer, 21 breast cancer, and 13 other cancers) consented to donate data, blood, and tissue specimens for future research, and maintained eligibility. Two years later, we executed a legacy protocol to transfer specimens to NCI's biorepository. Of the 69 surviving patients, 9 patients could not be contacted. All those contacted (60) agreed to provide additional data on environmental risks, and consented to specimen transfer. Self-organizing map analyses showed no evidence that age, education, income, familial susceptibility, or lifestyle factors were associated with consent to donate data or biospecimens. Cancer cases reported 1-3 co-morbid chronic diseases (mostly cardiovascular), near lifetime smoking and/or alcohol consumption; familial cancer risks, and many had a prior cancer history. Anecdotally, willingness to consent was based on altruistic hopes that research would generate knowledge to reduce cancer incidence. Our study shows that cancer patients from disadvantaged white rural communities with health disparities associated with geographic isolation are motivated to consent to participate and support biobank research.
1 Maine Institute for Human Genetics and Health , Brewer, Maine.
Deborah G
DG
Morrison
Christopher
C
Farah
Janet M
JM
Hock
D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D035843:Biomedical Research; D004522:Educational Status; D005260:Female; D005843:Geography; D006801:Humans; D007182:Income; D007258:Informed Consent; D008281:Maine; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology*; D018579:Patient Selection; D012307:Risk Factors; D012424:Rural Population / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires