Here are answers to some of the most important questions about BioMe at The Institute for Personalized Medicine.
By volunteering you are contributing to research that may create new ways to prevent and treat disorders that could affect you, your family, or your friends. Heart disease, cancer, asthma, diabetes, and Alzheimer's disease are just a few of the conditions BioMe™ may help scientists understand. BioMe does not require any interventions, nor does participation affect your clinical care in any way. Participation involves a one-time blood draw and one-time family health history questionnaire. Your consent, which is required, will provide a lifetime of benefits to the research world and future generations. In addition, by studying family members, we can learn much about genetics and why people develop certain diseases.
To be eligible, you must have received preventative and/or clinical care at the Mount Sinai Health System. If you have already participated in BioMe in the past, you cannot participate a second time. However, the BioMe Clinical Research Coordinator may offer you the opportunity to update your family health history by completing the most current questionnaire. The more data you are able to provide, the more robust the Biobank will be. Once you sign the research consent form, you will be expected to complete the questionnaire and provide a blood sample in order to complete enrollment.
After our Coordinator explains the BioMe Biobank Program and answers your questions, you will be asked to read and sign a “Consent Form to Volunteer in a Research Study” that the Coordinator will also co-sign. You will be offered a copy of this consent form for your records. The Coordinator will administer the family health history questionnaire, which will take approximately fifteen minutes. You will then have a small amount of blood drawn from your arm. The blood may be drawn at the same time as your routine blood draw for medical care, as part of your participation in another Mount Sinai research study, or solely for BioMe™ Biobank purposes. You will be consenting to unlimited, retrospective and prospective access to your de-identified medical record by ethics committee-approved investigators. You are consenting to giving them access for pre-specified phenotypic criteria, broad future research, and the possibility of future contact by the BioMe™ Biobank team.
Subject rights, confidentiality, and privacy are protected in various ways and at every stage of participation in BioMe, all while allowing research to be performed on de-identified clinical information from Mount Sinai's data warehouse system. In storage and when shared with researchers, your samples and health information will only be identified by a code. No names or other identifying information will be shared with anyone without your prior approval. BioMe takes the privacy of all participants seriously and, for that reason, the National Institutes of Health awarded BioMe a "Certificate of Confidentiality," which helps assure confidentiality and privacy. BioMe also safeguards its subjects through careful ethics committee reviews and through data quality assurance. For more information, contact BioMebiobank@mssm.edu.
Our semi-annual BioMe Newsletter is sent to enrolled BioMe participants to keep them abreast of our research.