Research Tissue Bank with Certificate of ConfidentialityGeneral template for use by PIs for studies involving collection and storage of tissue samples to be used by multiple researchers over time. May be modified for specific studies. HealthCare SystemGeneral ‘research tissue bank’General Template: ‘collect, process, store samples until researchers need them to do research’. Specific Studies: Determined by each PI for each study.Adults at least 18 years old in Partners HealthCare System. Minors (less than 14 years old).Unlimited20,000General Template: None if leftover samples and medical record data are used. Specific Studies: Determined by each PI for each study.General 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)General Template: Medical record; Specific Studies: Determined by each PI for each study.General Template:Researchers at MGH, BWH, and other Partner Institutions, as well as non-Partners academic institutions or for-profit companies. Samples will not be sold for profit. Researchers at Partner Institutions may review medical record to collect more information after approval by Ethics Board. Specific Studies: Determined by each PI for each study.General template: Research related to condition (understanding, prevention, diagnosis, treatment) including new research questions that arise over the next years. Also may be used for research on other conditions, including mental illness, HIV/AIDS, cancer. If genetic research, include brief explanation of genes. If cell lines to be created, include brief explanation. If iPS cells to be created, included brief explanation. If GWAS or large scale gene sequencing, include brief explanation. If tissue/data to be sent to NIH or other repository, include brief explanation and state that ‘samples and whole genome information is important for the study of virtually all diseases and conditions....the samples/data banks will provide study data for researchers working on any disease”. Specific Studies: PIs may restrict sample/data use to the condition under study, to a specific group of investigators, to the sample collected (e.g., no cell lines).Indefinite. May include establishment of permanent cell lines. Code linking samples to medical record may be retained indefinitely for future research.No specific results returned to participant or doctor. No information from the research will be placed in medical records .May receive newsletter with general findings. Specific Studies: Certain information from the research that relates to your general medical care may be included in your regular medical record (description of information to be included). This information may not be protected by the Certificate of Confidentiality.Future contact by tissue bank staff at medical visit or by phone to update information on medical condition or health statusIdentifiable information to be collected, stored and updated. Info may be shared with sponsor of research; data use and safety group; Partners’ data storage companies, insurers, and lawyers; federal and state agencies; public health and safety authorities. No data placed in medical record.VoluntaryNo optionsGeneral Template: Potential loss of privacy; Risk that information about taking part in a genetic study may influence insurance companies and/or employers; Risk that participation may have a negative impact on family members; Specific Studies: Risks if additional blood draws, biopsies, or other procedures.Coded samples and data; Certificate of Confidentiality from Fed’l Govt; Discouraged from sharing information about participation with family members; No data placed in medical record (unless as specified in individual study).No direct benefits; General societal benefits.Right to withdraw at any time; Participation or withdrawal not affect continued care with Partners.No cost. No payment for samplesNo payment from future products or technologies No compensationWithdrawal at any time. Samples and information will be destroyed, but not possible to destroy samples/info already given to researchers. If samples stripped of all identifiers and codes that link to identifiers, the samples and data cannot be withdrawnPhone numbers for tissue bank staff and Partners Human Research CommitteeYes, subject or subject advocate, guardian, health care proxy, durable power of attorney, or family member/next- of-kin. If minor subject, parental/guardian signatures plus assent for children 14-17 or assent for children ages 7-13.No. Does not state that biological materials are inherently identifiable4/10/2015