The BioGene Cohort goal is to establish a large collection of DNA samples, linked with electronic and other sources of medical information, to develop and support a broad array of research activities. The BioGene Cohort is a critical part of an overall program in Human Genetics and Personalized Medicine that is being designed to advance understanding of the genetic contributions to human health and illness, both within and outside (where appropriate) the Northwell Health enterprise.
Enrollment in the BioGene Cohort is open to all patients who receive care, either as inpatient or outpatient, in any of the owned or sponsored health care facilities of the Northwell Health enterprise. This resource will enable research studies across the entire range of diseases and medical problems that exist within Northwell Health, including medical, surgical, psychiatric, pediatric and obstetric conditions.
Any patient who is being treated within the health system and their family members, who may or may not be treated at Northwell Health, may be asked to participate in the BioGene Cohort program. Participation involves contributing one tube of blood for DNA preparation at enrollment as well as the collection of discarded biological materials that may become accessible for research in the future (e.g. left over tissue from surgery or any other test). By signing the consent, subjects are allowing indefinite access to their medical information available through Northwell Health.
Access and Utilization
Data held by the BioGene Cohort is available for research projects by all professional personnel within the Health System. Interested individuals should contact Peter K. Gregersen, MD at firstname.lastname@example.org, or Gila Klein at email@example.com, to explore options for data utilization.
Key Elements of the BioGene Cohort Program:
- Consent and assent (when appropriate) will be obtained.
- Additional one tube of blood (about 2 teaspoons) will be collected at the time of routine blood draws and stored at The Feinstein Institute for Medical Research.
- At the time of enrollment, participants will provide contact information allowing the study personnel to re-contact participants for follow up information.
- Fill out a health and lifestyle questionnaire.
- A sophisticated database and information management system will track the DNA samples and store medical information using systems and procedures designed to preserve patient confidentiality.
- Detailed clinical and demographic data on subjects may be obtained by the BioGene Bank Cohort. Additional relevant clinical data may be obtained from a variety of other sources within the Health System, such as paper medical records and electronic databases.
- The Committee Of Participant Protections (COPP) at The Feinstein Institute for Medical Research (FIMR) will oversee the utilization and access to the DNA samples and the stored clinical information by approved investigators.
- A Community Advisory Board (CAB) was established in 2010 to provide advice about social, ethical and communal matters to investigators conducting research under the auspices of The Feinstein Institute for Medical Research (FIMR). Assuring subjects genetic and medical information is maintained confidentially, is a fundamental element of the program. Stringent procedures to protect subjects’ privacy include the BioGene Bank Cohort Oversight Committee, strictly limited access to identifiable data, based on role based database security as well as paper documents being stored in secured locations.
Over 7,000 subjects have participated in the BioGene Bank as of July, 2012.
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