The Michigan Genomics Initiative (MGI) is a collaborative research effort among physicians and researchers at the University of Michigan with the goal of harmonizing patient electronic medical records with genetic data to gain novel biomedical insights.
The Michigan Genomics Initiative (MGI), an exceptional resource for medical and genetic research is now available to all UMICH faculty. An institutional repository of DNA and genetic data that is linked to medical phenotype and electronic health record (EHR) information, MGI comprises a broad portfolio of data from tens of thousands of individuals, and continues to add approximately ten thousand new participants annually.
MGI enrolls participants using a modern, pictographic, patient-centric informational pamphlet describing the program, and a simple, opt-in informed consent form. Participants agree to provide the study team with access to EHR data for clinical information and biospecimens for genotyping. MGI enrollees may also be asked to answer survey questions depending on the clinic from which they are recruited. Each participant also understands that he/she may be re-contacted in the future for follow-up studies if he/she has a genotype or clinical condition of interest to investigators across the U-M research enterprise. U-M Precision Health will make concerted efforts to grow this resource with other data sources.
Biospecimens collected in the clinic (usually a tube of blood or a vial of saliva) are sent the Central Biorepository for processing. DNA is isolated from the biospecimens. A portion of that DNA is set aside for genotyping, and the remainder is kept in cold storage for future research needs, accessible to approved investigators. Unique identifiers are used to code biospecimens and derivatives (like DNA) to participants, and all steps, from collection to processing to distribution, are electronically tracked, ensuring sample provenance. The Central Biorepository is accredited by the College of American Pathologists, and operations are managed under a robust Quality Management System, safeguarding sample integrity and patient privacy. All prospective biorepository programs, including MGI, utilize the same information pamphlet and informed consent templates, allowing for data and biospecimen access across studies.
The Biorepository sends a portion of DNA from each MGI participant to the DNA Sequencing Core for genotyping using a customized Illumina Human Core Exome Array. Standard Operating Procedures, stringent quality control, and electronic sample tracking are employed to assure genotyping results.
More than 65,000 participants have enrolled as of July 23, 2019.
copyrighted image taken from: Beesley, L.; Salvatore, M.; Fritsche, L.; Pandit, A.; Rao, A.; Brummett, C.; Willer, C.J.; Lisabeth, L.D.; Mukherjee, B. The Emerging Landscape of Epidemiological Research Based on Biobanks Linked to Electronic Health Records: Existing Resources, Analytic Challenges and Potential Opportunities. Preprints 2018, 2018090388 (doi: 10.20944/preprints201809.0388.v1).
IRB approval will be required for data access.
All IRB applications should go through IRBMED and not IRB-HSBS.
Type of IRB approvals needed by investigators for clinical and/or genetic data:
- Aggregate datasets: No IRB application required.
- De-Identified datasets: Will need IRB application. At a minimum receive a “not-regulated” status.
- Datasets with protected health information (PHI): Will require a full IRB review and approval.
For IRB applications, please reference MGI HUM00071298.
De-Identified data and genomic data requests on their own are pre-approved by the MGI committee, and do not need a specific letter or commitment to submit to IRB. Biospecimen requests and re-contact of MGI patients will need MGI committee approvals.
Contact DOCTR with any IRB-related questions: DataOffice@umich.edu.
Researchers may use DataDirect, a self-service tool, to assemble a patient cohort of interest (e.g., specific medical phenotypes, procedures, encounters, demographics), and then request associated genetic data. Researchers will also have the opportunity to request datasets of ancestry-derived “matched controls,” or develop their own custom control dataset within DataDirect. Analyzed genetic data can be transferred to a secure, virtual machine environment pre- loaded with a wide range of tools for researchers’ custom analyses. In addition to the cohort data, researchers can also request access to DNA for additional analyses.
Researchers may use DataDirect to assemble a patient cohort and request associated biospecimens. Investigators must submit a Use Proposal Form, which details the scientific rationale for use of the biospecimens, for access to DNA biospecimens. The Use Proposal Form will be reviewed by the Precision Health Steering Committee. Biospecimens are always delivered in a coded manner. For details on how to submit a Use Proposal Form, see the Get Access page on the Central Biorepository website.
MGI Expansion and Enriching Data Resources
U-M Precision Health aims to grow the MGI participant pool to incorporate new types of relevant data and to encompass a diversity of participants that is more representative of the general population. To achieve this, we are charting new approaches to recruitment, retention, and data collection. Specifically, Precision Health aims to:
- Enhance cohort diversity to be more reflective of the population of the State of Michigan and the United States
- Expand MGI to include 1,000-2,000 adult patients recruited through outpatient clinics each year, as well as 1,000 pediatric patients
- Enrich the cohort dataset with novel datastreams including wearables, new sensors, and focused sub-groups of participants in laboratory settings
- Integrate publicly available datasets regarding environmental exposure, socioeconomic status, and disparities into the dataset
- Ensure outreach/participant communication plans to increase engagement in follow-up focused sub-studies for specific sensors, devices, or conditions
- Transparently curate and clean data to allow researchers access to re-usable datasets
- Incorporate privacy techniques to minimize the risk of privacy loss, while maximizing re-use of data
How to become an MGI Participant
Currently, all patients 18 years of age or older undergoing surgery at the University of Michigan Health System are potentially eligible for participation in MGI.
Current participation involves filling out a short questionnaire and giving a small blood sample. DNA is extracted from part of the aliquoted blood and genetically sequenced. The rest of the blood sample is stored securely at U-M. Patients consent to be contacted in the future for any applicable study conducted through U-M’s Central Biorepository.
If you are interested in collaborating with MGI, contact us at PHDataHelp@umich.edu.