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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)
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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-
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.
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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 InvestigatorsHow to decide which protocol type:
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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.
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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.)
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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.
This email address is being protected from spambots. You need JavaScript enabled to view it. . -
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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 TissuesAt 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.
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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?
In the event of autopsy, the COVID-19 Enterprise Biorepository may have access to a variety of tissues available for study, including lung, heart, brain, liver, kidney and some intestine tissue.
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How do I obtain unstained slides?
The request for the unstained slides, will need to be submitted through the COVID-19 Enterprise Protocol Biospecimen Request Form (see Biospecimen tab).
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What approvals are needed in advance?
The Enterprise protocol captures consent for research use and access to clinical data that accompanies the biomaterials.
Investigators must still seek an independent, IRB-approved NHSR protocol (or in rare cases, an expedited HSP). Please consult with the IRB for details.
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Are digital slides available?
The Pathology department has made de-identified H&E digitally available at the UAB Heersink School of Medicine PEIR website. Google chrome is recommended for use. There are currently 45 COVID-19 cases and one H1N1 case available for viewing. Just click on the H&E slide to pull up the virtual viewer. These slides are de-identified. Digital slides are also available for download once IRB approval is received (and/or any MTA is approved).
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What is included in the repository?
* 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 -
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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
This email address is being protected from spambots. You need JavaScript enabled to view it. .Teams:
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Health System Data Team (Willig, Wyatt)
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Questionnaires & PRO Data (Hall, Fletcher)
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Community & Public Health Data (Asif, Aswani)
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Research Coordination (Mugavero, Levitan)
Resources:
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Self-service data access through CCTS Informatics i2b2 portal
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ACT Network, which includes data from 40+ CTSAs nationwide
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National COVID Cohort Collaborative (N3C), an initiative creating a national, centralized, secure portal for COVID-19 clinical data.
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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:- Integrate COVID-19 epidemiology, viral genomics, clinical informatics, imaging, mulit-omics, and other data for basic scientists, data scientists, translational researchers, and clinicians.
- 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.
- Foster fast, data-driven, high-quality knowledge discoveries and precision medicine in COVID-19 with multi-disciplinary team-based scientific research and development.
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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:
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Biospecimen Governance Committee
Membership
Paul Goepfert (PI)
Nathan Erdmann (Co-PI)
Paul Benson (Co-PI)
Jeffrey Edberg (Co-PI)
Robert Kimberly (CCTS)
Fran Lund (Micro)
Olaf Kutsch (ID)
Sadeep Shrestha (SOPH)
Kevin Harrod (SEBLAB)
Suresh Boppana (Peds)
Cindy Joiner (ex officio - DOM)
Jennifer Croker (ex officio - CCTS)
Justin Roth (ex officio – EH&S)
Jason Nichols (ex officio – VPR’s office and SOO) -
Collaborative Outcomes Research Enterprise (CORE)
Purpose: To engage a collaborative working group to coordinate, collate, and facilitate the rigorous and expeditious completion of COVID-19 health services, outcomes and population health studies conducted by interdisciplinary research teams addressing prescient questions germane to the individuals, communities and populations we serve in our city, county, state, and Deep South region.
TEAMS:
Health System Data Team (Willig, Wyatt)-
Define case definitions for cohorts (e.g., testing, PUI, confirmed cases)
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Determine harmonized catalog of health systems data elements
- Determine structured data elements amenable to query
- Determine unstructured data elements requiring abstraction
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Develop data management / data coordination procedures
Questionnaires & PRO Data (Hall, Fletcher)
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Identify potential questionnaires / validated instruments and Patient Reported Outcomes (PROs) for adjunctive data capture
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Determine prioritization for questionnaire and PRO administration
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Define timing, frequency and preferred modality of questionnaire and PRO administration
Community & Public Health Data (Asif, Aswani)
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Identify and collate sources of COVID-19 community data capture
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Liaise with Jefferson County Health Department and Alabama Department of Public Health re: COVID-19 surveillance data capture
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Liaise with the City of Birmingham #BHMstrong team re: non-health related data capture germane to COVID-19 (e.g., economic, employment)
Research Coordination (Mugavero, Levitan)
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Determine humans subjects and regulatory considerations with IRB
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Develop COVID-19 CORE Concept Proposal
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Develop procedures for project coordination following concept proposal submission in collaboration with data management / data coordination and BERD (Biostatistics, Epidemiology, Research Design)
Advisory Committee:
Robert Kimberly (CCTS Director)
Kenneth Saag (COERE Director)
Jeanne Marrazzo (Med/ID, SOM)
Paul Muntner (Epidemiology, SOPH)
Jim Cimino (Informatics Institute)
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Biomedical Data Science Working Group
GOALS:
Integrate COVID-19 epidemiology, viral genomics, clinical informatics, imaging, mulit-omics, and other data for basic scientists, data scientists, translational researchers, and clinicians.
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.
Foster fast, data-driven, high-quality knowledge discoveries and precision medicine in COVID-19 with multi-disciplinary team-based scientific research and development.
http://ubrite.informatics.uab.edu/covid19/ -
Host Genomics Working Group
Membership
Bruce Korf
Nita Limdi
Hemant Tiwari
Sadeep Shrestha
Jim Cimino
Greg Cooper (HAIB)
Greg Barsh (HAIB)
Devin Absher (HAIB)
Jake Chen
Jeff Edberg
Noha Sharafeldin
Robert Kimberly
Jennifer Croker
Renie Moss -
Immune Response Working Group
In Development
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Therapeutic Discovery Working Group
In Development
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Biospecimen Governance Committee
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Activities:
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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.
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UAB Office of Research COVID-19 Resources: The Office of Research regularly updates critical research information.
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UAB DOM Covid Clinical Research Projects: Summary of Clinical Research on COVID-19 at UAB
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COVID-19 Biomedical Data Science: Biomedical informatics resources in the fight against COVID-19.
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School of Medicine & Hugh Kaul Precision Medicine Institute Awards: The SOM & PMI recently awarded several pilot awards to advance COVID-19 research.
Forms:
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Documentation of Consent Process for Verbal Consent: This document provides a means to document verbal consent.
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COVID-19 Screening Tool: This document guides the screening for COVID-19 infection before engagement of a participant in research.
Additional Information:
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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.
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Open Mike (NIH Extramural Nexus): This blog will 'connect you to the NIH perspective'.
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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.
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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
This email address is being protected from spambots. You need JavaScript enabled to view it. .Literature containing information on the disproportionate burden of COVID-19 on minorities:
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Doctors can't treat COVID-19 effectively without recognizing the social justice aspects of health
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Hospitalization and Mortality among Black Patients and White Patients with Covid-19
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How environmental racism is fuelling the coronavirus pandemic
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How to address the coronavirus’s outsized toll on people of colour
COVID-19 News Feeds:
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Contact
For questions or more information:
Jennifer Croker, PhD
Assistant Professor of MedicineThis email address is being protected from spambots. You need JavaScript enabled to view it.
Paul Goepfert, MD
Professor of Medicine
UAB Department of Medicine, Division of Infectious DiseasesThis email address is being protected from spambots. You need JavaScript enabled to view it.
Michael Mugavero, MD, MHSc
Professor of Medicine
UAB Department of Medicine, Division of Infectious DiseasesThis email address is being protected from spambots. You need JavaScript enabled to view it.
Robert Kimberly, MD
Director
Center for Clinical and Translational ScienceThis email address is being protected from spambots. You need JavaScript enabled to view it.
COVID-19 Funding Opportunities & Information
Notice of Special Interest (NOSI): Competitive and Administrative Supplements for the Impact of COVID-19 Outbreak on Minority Health and Health Disparities
Accepting Submissions: Obesity seeks submission of scientific data on the following topics: risks of COVID-19 infection and the risks of COVID-19 related hospitalization and death for individuals with obesity, as well as mechanisms underlying this association; response to therapy, based on obesity status, in patients undergoing investigational treatment and prevention protocols; psychological impact of the pandemic on those with obesity; and other aspects of the relationship between obesity and COVID-19 that would be of interest to our readers.
More COVID-19 Funding Opportunities
The S10 Instrumentation Programs
Shared Instrumentation Grant Program
Shared Instrumentation for Animal Research Grant Program
High-End Instrumentation Grant Program
SBIR/STTR Opportunities
HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management
- RFA-NS-20-011; SBIR R43/R44 - Phase I, Phase II, and Fast-Track (Clinical Trial Not Allowed)
- RFA-NS-20-009,STTR R41/R42- Phase I, Phase II, and Fast Track (Clinical Trial Not Allowed)
- RFA-NS-20-008,STTR R41/R42- Phase I, Phase II, and Fast Track (Clinical Trial Required)
- RFA-NS-20-010,SBIR R43/R44 - Phase I, Phase II, and Fast Track (Clinical Trial Required)
Training
Roundup of Research Career Development (K) Award Resourceshttps://nexus.od.nih.gov/all/2019/10/03/roundup-of-research-career-development-k-award-resources/
The Doris Duke Charitable Foundation 2020 Physician Scientist Fellowship Competition
Research
- CTSA Health Alliance 2020 Pilot Grant Funding
- Notice of Special Interest: Research through NCATS' Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Awards (U01 and R21)
- Strategies to Improve Health Outcomes and to Reduce Disparities in Rural Health Populations (RFA-NR-20-001) (RO1 Clinical Trial Optional)
- Ethical Issues in Translational Science Research (R01 Clinical Trial Optional) (RFA-TR-20-001)
- Utilizing Health Information Technology to Scale and Spread Successful Practice Model Using Patient-report Outcomes (PA-17-077; R18)
- Biomedical Data Translator: Development (OT-19-009; OT2)
- Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (PAR-18-462; U34) (Clinical Trial Not Allowed)
- Notice of Special Interest: Nutrigenetics and Nutrigenomics Approaches for Nutrition Research (NOT-DK-19-019)
o PA-19-055, Research Project Grant (Parent R01 Clinical Trial Required)
o PA-19-056, NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
o PA-18-330, Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK (R01
Clinical Trial Required)
o PAR-19-099 - Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative Innovation Award (U01 Clinical Trial Optional).
o PAR-19-100 - Limited Competition: Clinical and Translational Science Award (CTSA) Program: Exploratory Collaborative Innovation Awards (R21 Clinical Trial Optional).
"Rare Diseases Are Not Rare!" Challenge Prize Competition
OnCore Enterprise Support (non-Cancer Center)
Main Inbox for OnCore support
-Naseem Anjum
-Michael McEwan
-Mackenzie Roberts
O’Neal Comprehensive Cancer Center Support
Judy MillerManager, Data Collection and Analysis
205-975-3144
OnCore Enterprise Calendar Support
Main Inbox for OnCore Calendar Services
-Shamilla Chapman
-Alicia Mallard
-Symone Stamps
-Jennifer Uzochukwu
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OnCore Financial Support
OnCore Training Support
HSIS Help Desk
Generic password and general OnCore assistance205-934-8888