COVID-19 Enterprise Research Initiative

Working with the Division of Infectious Diseases, Departments of Microbiology and Pathology, as well as other UAB divisions and departments and coordinated by the CCTS, the IRB has endorsed an Enterprise Research Platform for COVID-19 to shepherd the safe and efficient consent process and collection of specimens and clinical data, which is ongoing. CCTS Informatics, with the Center for Outcomes & Effectiveness Research, Informatics Institute and multiple schools, is coordinating clinical data and longitudinal follow-up for rigorous secondary analysis that ensures efficient and respectful engagement of research participants. This new Enterprise Platform will serve to anchor and enable all COVID-19-related human subjects research across the campus.

Enterprise Advantages:
- Recruitment process that protects the safety and health of research teams and patients
- Coordinated strategy for specimen and data collection that respects the good will of the participant
- Consent of affected individuals and healthy controls for longitudinal follow-up, recall and invitation to participate in future studies
- Inclusion of broad spectrum of infection (healthy, asymptomatic, ambulatory, inpatient, ICU, autopsy) and vaccination statuses (null, partial, full, boosted)
Biospecimen

The COVID-19 Enterprise Biorepository is approved to collect a wide-variety of specimens, including research-specific samples as well as remnant clinical and autopsy specimens. Due to the constraints restricting non-essential personnel in the hospital and limiting specimen volumes/quantity, it is essential that we work together in a coordinated fashion to maximize this resource.

COVID Enterprise Biorepository at a Glance (PDF) – a brief description of the specimen sources, types and quantities as well as the demography of the participant enrollment.

For more information or to discuss specimen needs, please contact Dr. Jennifer Croker.

Teams: Biospecimen Governance Committee (Goepfert), Host Genomics Work Group (Korf), Immune Response Work Group (Lund)

INVESTIGATOR GUIDANCE
Biocontainment Considerations

IRB Requirements

Specimen Options

Special Instructions for Tissues

There are special handling and processing considerations required when working with infectious materials. Please consult with the UAB COVID-19 Containment Guidance for Researchers to make sure that your research plans meet required biocontainment standards.

IRB Proposals: The COVID-19 Enterprise protocol addresses the consent process and specimen/data collection on behalf of the entire research community. Investigators will be able to leverage these specimens and data through independent IRB submissions describing specific research goals that can “bolt on” to the coordinated frame.

IRB-300005127: COVID-19 Enterprise Biorepository
Paul Goepfert, MD, Principal Investigator
Paul Benson, MD, Jeffrey Edberg, PhD, Nathan Erdmann, MD, Co-Principal Investigators

How to decide which protocol type:

NHSR – the COVID-19 Biospecimen Governance Committee provides a letter that indicates the investigator will only receive completely de-identified data or biospecimens (no dates, no PHI). These data can be coded, but must be stripped of everything else.

Exempt – this is only for identifiable, private data for secondary use (can’t use exempt for use of biospecimens). They could also use this if they wanted to contact the participant for a survey (however, they could not link the survey with the clinical data obtained.)

Expedited – this would be for identifiable, private biospecimens. This would also be the case if an investigator wanted to contact the participant for surveys and link those responses to the clinical data collected and organized by the Enterprise protocol.

For more information and language for IRB protocols, please contact Dr. Jennifer Croker.

As part of the COVID-19 Enterprise Research Initiative, efforts are underway to collect the following:

Blood, Plasma, Serum
PBMCs
Genomic DNA
Tracheal Aspirates
Oral Saline Rinse
Nasal Swabs
Urine
Autopsy Tissues

At this time, fecal swabs and bronchoalveolar lavage (BAL) are not possible in the current emergency state due to limitations of PPE, reliance on clinical staff, elevated risk for patients & staff and increased time, effort and reagents. The committee is willing to revisit this possibility at a later date as the constraints in the health system ease.

Outline for Provision of FFPE Material from COVID-19 Positive Autopsy Cases for Research Investigations

For those interested in accessing autopsy samples, please see the FAQs below and the guidance at the link above and fill out the Biospecimen Request Form (below). These requests are reviewed on a rolling basis by the Governance Committee. When endorsed by the committee, investigators will be referred to the UAB Tissue Biorepository (TBR; Pathology), who will follow-up to obtain additional details to fulfill the request. The TBR may require the investigator to complete an additional form to make sure PIs understand additional terms and conditions of use.

What is included in the repository?

How do I obtain unstained slides?

What approvals are needed in advance?

Are digital slides available?
* This form is to be completed in one sitting. Review the form here to ensure you have all necessary information prepared when you begin. Note: If you have already entered the form once before and encounter an issue starting a new submission, clear your browser's cache.

Biospecimen Request Form

Clinical Data

The COVID-19 Collaborative Outcomes Research Enterprise (CORE) is leading the initial and longitudinal data collection and information curation to support a broad set of research goals. Through the CORE, investigators benefit from the permissions established by the COVID-19 Enterprise Research Platform to use clinical data (HIPAA Limited and Detailed Data Sets), to access protected health information and to allow longitudinal follow up.

For more information or to discuss data needs, please contact Dr. Michael Mugavero.

Teams:

Health System Data Team (Willig, Wyatt)
Questionnaires & PRO Data (Hall, Fletcher)
Community & Public Health Data (Asif, Aswani)
Research Coordination (Mugavero, Levitan)

Resources:

Self-service data access through CCTS Informatics i2b2 portal
ACT Network, which includes data from 40+ CTSAs nationwide
National COVID Cohort Collaborative (N3C), an initiative creating a national, centralized, secure portal for COVID-19 clinical data.

The COVID-19 Biomedical Data Science website contains an array of useful resources. Connect with an expert, request data sets, explore analysis tools, and engage in educational offerings.

The purpose behind this effort is threefold:
1. Integrate COVID-19 epidemiology, viral genomics, clinical informatics, imaging, mulit-omics, and other data for basic scientists, data scientists, translational researchers, and clinicians.
2. Provide online training for next-generation biomedical data scientists to practice data-driven COVID-19 research in knowledge curation, data management, open science, and machine learning.
3. Foster fast, data-driven, high-quality knowledge discoveries and precision medicine in COVID-19 with multi-disciplinary team-based scientific research and development.

Organization & Governance

This enterprise platform is an effort that has and continues to involve a multitude of departments and schools across the UAB campus.

COVID-19 Biospecimen Leadership Team:	COVID-19 Data Leadership Team:
Paul Goepfert, MD (PI) Paul Benson, MD (Co-PI) Jeffrey Edberg, PhD (Co-PI) Nathan Erdmann (Co-PI)	Michael Mugavero, MD, MHSc (PI) Emily Levitan, PhD (Co-PI)

Working Groups:

Activities:
- UAB School of Public Health & the COVID-19 Pandemic: The SOPH shares resources, in addition to what faculty and students have been doing during the COVID-19 outbreak.
- UAB Office of Research COVID-19 Resources: The Office of Research regularly updates critical research information.
- UAB DOM Covid Clinical Research Projects: Summary of Clinical Research on COVID-19 at UAB
- COVID-19 Biomedical Data Science: Biomedical informatics resources in the fight against COVID-19.
- School of Medicine & Hugh Kaul Precision Medicine Institute Awards: The SOM & PMI recently awarded several pilot awards to advance COVID-19 research.
Forms:
- Documentation of Consent Process for Verbal Consent: This document provides a means to document verbal consent.
- COVID-19 Screening Tool: This document guides the screening for COVID-19 infection before engagement of a participant in research.
Additional Information:
- Beyond the Blog: Shareable Science with Dr. Neil Lamb: Hudson Alpha's Neil Lamb, PhD, shares a vlog that helps make sense of the COVID-19 outbreak.
- Open Mike (NIH Extramural Nexus): This blog will 'connect you to the NIH perspective'.
- COVID-19 Research Dataset (CORD-19): NIH Resource to Analyze COVID-19 Literature representing the most comprehensive, freely available library of machine readable coronavirus scholarly literature to date, with hundreds of AI tools and technologies already created.
The following content is meant to assist in a thorough literature review when studying COVID-19. To add literature of relevance or special interest, simply share it with our team.

Literature containing information on the disproportionate burden of COVID-19 on minorities:
COVID-19 News Feeds:
Contact

For questions or more information:

Jennifer Croker, PhD
Assistant Professor of Medicine
jcroker1@uabmc.edu

Paul Goepfert, MD
Professor of Medicine
UAB Department of Medicine, Division of Infectious Diseases
paulg@uab.edu

Michael Mugavero, MD, MHSc
Professor of Medicine
UAB Department of Medicine, Division of Infectious Diseases
mmugavero@uab.edu

Robert Kimberly, MD
Director
Center for Clinical and Translational Science
rkimberly@uabmc.edu

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