Mayo Clinic

Mayo Clinic BiobankJ.R. Cerhan & Colleagues Clinic (Rochester MN)General biobank“Library for researchers” to use samples and information already collected instead of looking for volunteers for each new projectAll Mayo Clinic patients at least 18 years oldUnlimited20,000Blood donation. Health questionnaire (background, environment, family history). Allow access to medical records now and in future.Blood/DNA/genetic information; Medical record data; Tissue specimensGeneral Template: Leftover samples (e.g., tumor, blood, urine); “Some of your health info’ to be stored; Continued review of medical record to update health information; Specific studies: Tissues/specimens collected de novo for research (e.g., blood; skin biopsy); Questionnaire data; Other data (e.g., radiology findings)Access determined by Biospecimen Trust Oversight Group (BTOG) comprised of Mayo Clinic employees. Local residents on Biobank’s Community Advisory Board (CAB). Access may include non-Mayo researchers with Mayo collaborator. Data (‘disguised’) may be entered into databases shared with other researchers.Unspecified genetic researchIndefinite, including after deathNot informed if researchers access records. Results may be returned based on decision of researchers, doctors, and Community Advisory Board.May be mailed additional questionnaires for voluntary completion. Not more than two contacts per year. May be asked for additional voluntary blood donation.Unique code assigned to samples and personal medical information. Genetic information is unique ‘like your fingerprint so it is impossible…to fully hide your identity”. Contagious diseases must be reported under MN law.VoluntaryOpt out for use of “extra tissue” from surgeries or procedures; Opt out of allowing family access to samples after participant’s death.Emotional (questionnaire); Physical (blood draw); Future risks: a. Loss of privacy. Small chance of accidental release. Federal Genetic Information Nondiscrimination Act (GINA) prohibits employers and insurers from discrimination; b. Risks related to test results. If valuable information, BTOG and CAB will decide whether to release to participants and how to best release. Learning results may lead to emotional upset, changes in family relationships, insurance or job discrimination. May need to meet with Mayo health care professional to learn test results..Coded samples and data; Certificate of Confidentiality from Fed’l Govt.No direct benefits; General societal benefits.Right to leave the project at any timeNo cost Remuneration by choice of items worth up to $20.No compensationWithdrawal at any time during life. Upon death, samples considered ‘gift’ to Mayo Clinic regardless of family wishes. Family may wish access to sample after death since it may contain valuable genetic information. May deny family access. Options for withdrawal:1. no longer wish to be contacted, but allow continued use of samples and personal medical information; 2. destroy remaining sample, but allow use of previously provided information and samples; 3. destroy remaining samples and stop using personal medical information. No option for withdrawal of samples and information: 1. studies alreadyd begun; 2. samples or information shared with other research institutions; 3.cannot remove medical information in database, but biobank staff will stop using this info.Multiple contact phone numbers depending on type of question (e.g., PI, IRB, Research Subject Advocate)Yes, adult subjectYes. States that genetic data are inherently and uniquely identifiable9/15/2010MNUSAeMerge