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  • About OIR
    • OIR Leadership & Staff
      • Nina F. Schor, M.D., Ph.D.
      • Richard G. Wyatt, M.D.
      • Janice Lee, D.D.S., M.D., M.S.
      • Andy Baxevanis, Ph.D.
      • Charles R. Dearolf, Ph.D.
      • Nadine Fonrose, M.A.
      • Arlyn García-Pérez, Ph.D.
      • Carl Hashimoto, Ph.D.
      • Roland A. Owens, Ph.D.
      • Kathryn M. Partin, Ph.D.
      • Rena Rodriguez, B.S.
      • Dierdre S. Andrews
      • Diana Gomez
      • Chanee' M. Jackson
      • Margaret McBurney, M.B.A.
      • Karen Nemes
      • Lisa L. Coronado, M.B.A.
      • Dan Fogarty, M.A., FACHE
      • Bonny Harbinger, Ph.D., J.D.
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      • Parker Ruhl, M.D., M.H.S.
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      • IRP Repository for COVID-19 Samples
      • Rapid Review of Human Subjects Research Related to the SARS-CoV-2 Pandemic
      • Donating Personal Protective Equipment (PPE) and COVID-19 Testing Supplies
      • Exceptional Use of IC Funds for Per Diem Quarantine for Non-FTE Trainees (VF/IRTA/CRTA)
      • Student IRTA/CRTA and Student Special Volunteers
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    • Processes for Reviewing NIH Intramural Science
      • Boards of Scientific Counselors (BSC)
        • Addendum to BSC Policies and Procedures
      • Blue Ribbon Panel Reviews of IC Intramural Research Programs
      • Role and Review of Scientific Directors and Clinical Directors
    • Intramural Program Oversight
      • Human Subjects Research
        • NIH IRP Clinical Directors
      • Intramural Data Sharing
        • 2023 NIH Data Management and Sharing Policy
        • Genomic Data Sharing
        • Human Data Sharing
        • Guide to FDAAA Reporting Research Results
          • Frequently Asked Questions: NIH Clinical Trial Definition
          • Assistance Available to Help with Results Reporting to ClinicalTrials.gov
            • Points of Contact for FDAAA Compliance at ICs
      • Laboratory Safety
      • Management Controls Survey
    • Intramural Administrative Management Council
      • List of Council Members
      • List of Trans-NIH Committees
    • Personnel
      • IPDs and Appointment Mechanisms
        • Official List of Approved Intramural Professional Designations (IPDs)
        • Senior Investigator
        • Investigator
        • Senior Clinician
        • Senior Scientist
        • Assistant Clinical Investigator
        • Staff Clinician
        • Staff Scientist
        • Senior Research Assistant / Research Assistant
        • Adjunct Investigator
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        • Senior Clinical Fellow
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        • Senior Research Fellow
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          • Independent Research Scholar Program
        • Student Opportunities
        • Contractors
        • Guest Researchers / Special Volunteers
        • Research Collaborators
      • Policies and Recruitment Processes
        • 5-Year / 8-Year Duration Rule
        • Departing Staff Request to Remove Copies of NIH Records
        • Example IC Check Sheets / Checklists
        • Exceptional Extensions of IRTA and Visiting Fellowships to a 6th Year
        • Fair Review Principles for Nominations of Staff Scientists for Associate Scientist and Senior Associate Scientist Titles
        • Guide for Avoiding Undue Foreign Interference with IRP Research
        • Guidelines for Parental/Family Excused Absence for IRTAs, CRTAs, and Visiting Fellows
        • Keep The Thread Policy
        • Mandated Training for Scientific Staff Working in NIH Facilities
        • Policy for Reassignment or Early Termination of Awards to Postbaccalaureate Fellows
        • Policy for Reassignment or Early Termination of Awards to Postdoctoral Fellows
        • Policy for Reassignment or Early Termination of Awards to Predoctoral Fellows
        • Policy for Use of Contract Workers to Support Scientific Functions in the IRP
        • Policy on Use of English for Official Scientific Communication in NIH Laboratories and Branches
        • Postdoctoral Fellows (IRTA/CRTA/VF) Temporary Exceptional Extensions Policy
        • Roles of Lab and Branch Chiefs (or Equivalent)
        • Telework Policies for IRTA/CRTA and Visiting Fellows
        • Working with Displaced Title 42 Staff Scientists/Clinicians
      • IRP Demographics
        • Intramural Research Program Personnel Demographics (End FY22)
        • Foreign Nationals in the Intramural Research Program (End FY22)
        • Intramural Research Program Personnel Demographics (End FY21)
        • Foreign Nationals in the Intramural Research Program (End FY21)
        • Intramural Research Program Personnel Demographics (End FY20)
        • Foreign Nationals in the Intramural Research Program (End FY20)
        • Intramural Research Program Personnel Demographics (End FY19)
        • Foreign Nationals in the Intramural Research Program (End FY19)
        • Intramural Research Program Personnel Demographics (End FY18)
        • Foreign Nationals in the Intramural Research Program (End FY18)
        • Intramural Research Program Personnel Demographics (End FY17)
        • Foreign Nationals in the Intramural Research Program (End FY17)
        • Intramural Research Program Personnel Demographics (End FY16)
        • Foreign Nationals in the Intramural Research Program (End FY16)
      • Quality-of-Life Features
      • Sabbaticals
        • NIAAA Sabbatical Program
        • NEI Sabbatical Program
        • NICHD Sabbatical Program
        • PHS Foreign Work / Study Program Policy
      • Opportunities for Short Assignments / Details at the NIH
    • Tenure in the NIH Intramural Research Program
      • Tenure-Track Overview
      • Search & Selection
        • Search Process for Senior Investigators, Tenure-Track Investigators, Senior Clinicians and Senior Scientists
        • Role of Search Committee Members
      • Additional Tenure-Track Policies
      • Resources
      • Policy on IC Tenure Review Committees
      • Tenure Overview
      • Search & Selection
      • Criteria for Tenure at the NIH
      • Statement About PI Involvement in Diversity, Equity, Inclusion, and Accessibility
      • De-Tenuring Process
    • Awards, Fellowships, & Grant Opportunities
      • The Director’s Challenge Innovation Award Program
        • 2020 Director’s Challenge Awards
        • 2022 Director’s Challenge Awards
      • Early Career (Bridge) Awards Open to IRP Scientists
      • Eligibility of Intramural Investigators for NIH Common Fund Awards
      • K99/R00 Grant Award Information
        • Application Approval Process and Additional Information
        • K99/R00 Environment and Institutional Commitment Statement
        • Update from Scientific Directors
      • NIAID Support of Intramural Biodefense Research from ICs Other Than NIAID
    • Ethical Conduct
      • Research Misconduct
        • Anonymous Reporting of Research Misconduct Concerns
        • Taraswi Banerjee, Ph.D.
        • Alfredo R Sancho, Ph.D., M.P.H.
      • Guidelines on Conduct of Research
      • Research Ethics
        • NIH Policies
          • Intramural / Extramural Collaborations
            • NIH Staff Involvement on Extramural Awards - Cooperative Agreements
              • Opportunities for Collaborative Research at the Clinical Center (U01)
              • NIH Bench-to-Bedside Program
            • Activities with Outside Organizations
          • Investigation of Allegations of Research Misconduct
        • NIH Guidelines
          • Guide for Human Biospecimen Storage and Tracking
            • Frequently Asked Questions
            • List of Biospecimen Liaisons
      • Special Research Considerations
        • Dual-Use Research
        • Human Stem Cell Use
          • Human Embryonic Stem Cell (hESCs) Use
          • Induced Pluripotent Stem Cells (iPSCs) Use
          • Human Embryo Research and Cloning Prohibitions
        • Policies & Procedures for Human Fetal Tissue Research
          • Policies on the Acquisition and Use of HFT
          • Procedures for Obtaining HFT
      • Responsible Conduct of Research Training
        • Instruction in Responsible Conduct of Research - Postdoc IRTA, CRTA, VF, Research Associates
          • Reproducibility Training
          • Introduction to “My Laboratory”
        • Instruction in Responsible Conduct of Research - Postbacs and GPP Students
        • Resources for Training Directors
        • Annual Review of Ethics (Case Studies)
          • Research Cases for Use by the NIH Community
            • 2021 Ethics Case Facilitator Training
        • Processes for Authorship Dispute Resolution
      • Government Ethics
        • Guidelines for Non-FTEs (Trainees) for NIH-Related Activities, Outside Activities, and Awards
      • Bioethics
    • Mentoring & Training
      • Guide to Training and Mentoring
      • Guidelines for Mentors at NIH
      • Guidelines for Trainees at NIH
      • Guidelines for Annual Progress Review of Trainees
      • Scientific Director Policy Updates for Mentors and Trainees
      • Goals for Enhanced Mentoring in the IRP
      • FelCom Mentoring Committee
      • The DDIR Implementation Plan in Response to the FelCom Subcommittee Report on Mentoring
      • Mentoring Cases for Discussions
    • Submitting Research Publications
      • PubMed Central (PMC) Deposition Requirements
      • Intramural Directions for Submitting to PubMed Central via NIHMS
      • NIH Publishing Agreement Forms
        • Procedures for Non-Peer-Reviewed Publications
      • Publication and Abstract Clearance
    • Intramural Research Communications & Resources
      • Annual Reports and Bibliographies
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  • IRP Website
    • A premier environment where creative scientists conduct fundamental research for the betterment of human health – we are the IRP
    • Visit Website
  • NIH Research Festival
    • The NIH Research Festival is the showcase for intramural research
    • Visit Website
  • The NIH Catalyst
    • A publication for and about the NIH intramural research community
    • Visit Website
  • NIDB
    • The NIH Intramural Database collects and disseminates information about research being performed in the Intramural Programs
    • Visit Website

IRP Repository for COVID-19 Samples

Purpose

Provide all Intramural Investigators with COVID-19 approved protocols the opportunity to store samples in a stable biorepository.

Introduction

DCEG/NCI is committed to stand up, maintain and administer a biorepository for COVID-19 approved protocols within the Intramural Research Program. Once an investigator within the NIH IRP has approval to begin to collect human biospecimens, DCEG will house, store and distribute the biospecimens according to the Principal Investigator’s written instructions. Biospecimens will be stored in the state-of-the-art facility at the Frederick National Lab under the Leidos contract. The DCEG staff, who regularly oversee the biorespository of more than 11.2 million human biospecimens, will work with each PI to develop a processing and storage plan, perform the appropriate steps for the biobanking and ensure timely distribution of sets of aliquots (not single samples).

Basic Principles of the COVID-19 IRP Biobank

  • Full biorepository support for all COVID-19 related IRP protocols that are IRB approved and have at least one IRP PI, who oversees the scientific purpose and execution of the protocol specific aims.
  • Each study will be under the provenance of the PI and who will have the authority to delegate others to approve movement of biospecimens.
  • The COVID-19 IRP Repository will house human biospecimens but not viral isolates for propagation or study (consult the nascent NIAID biorepository).
  • The Repository will provide state-of-the art tracking of samples and aliquots in a safe, secure and stable manner, according the needs of the sample, through the existing Biospecimen Inventory (BSI) system.
  • Special aliquoting or manipulation can be arranged through Leidos as part of an agreement (not done at the actual biorepository but done at a Leidos lab). Cost will be considered and discussed on an individual basis.
  • The biorepository can adapt lab-specific protocols that differ from the posted standard SOPs. Nomenclature must follow existing DCEG guidelines and a key is always generated for linkage by the PI, when necessary.
  • Each sample received will be assigned a BSI/Leidos biorepository tracking number, which will be shared with the PI and their coordinators. The PI will be responsible for linking tracking numbers to the separately collected and archived clinical/phenotype data.
  • Personal Identifying Information (PII) will not be stored by the Biorepository; a BSI number will be assigned to each sample according to the current IT system in place.
  • Timely provision of samples upon request and written approval of the PI of the study will occur through coordination with DCEG staff.
  • There will be regular review of status of specimens in study.
  • An oversight committee will be convened to ensure the timely use of resources and address challenges as they arise. The oversight committee will be advisory. The primary responsibility for oversight and use of stored specimens will reside with the Study PI.

Additional Value Added Components

  • Guidance will be provided for the use of the DCEG contract data base for managing covariates/phenotypes/clinical information but DCEG will not assume responsibility for the covariates/phenotypes/clinical information.
  • In development is a dashboard available within NIH IRP (and not outward facing) that will list the studies and sample types of all COVID-19 IRP IRB approved studies. This will be available to IRP PIs to search for possible collaborations. It will include protocol title and hot-link to protocol.

Additional Comments

  • The Biobank will not serve as an omnibus protocol for receiving samples collected. All stored samples must be collected under an IRB-approved protocol with specific scientific aims.
  • Receipt of payment or funds from extramural PIs is not permitted. All samples must come through collaboration with NIH intramural PIs and under the auspice of an IRB-approved IRP-led protocol. The Frederick contract prohibits direct receipt of grants – so if extramural materials arrive, the associated costs must be covered by the IC directly under the purview of the IC approved IRB protocol.
  • The advisory committee will consider steps necessary to assume provenance of studies if the PI retires or departs from NIH.

This page was last updated on Monday, August 9, 2021

Main navigation

  • Intramural COVID-19 Guidance and Resources
    • IRP Repository for COVID-19 Samples
    • Rapid Review of Human Subjects Research Related to the SARS-CoV-2 Pandemic
    • Donating Personal Protective Equipment (PPE) and COVID-19 Testing Supplies
    • Exceptional Use of IC Funds for Per Diem Quarantine for Non-FTE Trainees (VF/IRTA/CRTA)
    • Student IRTA/CRTA and Student Special Volunteers
    • Extension Exceptions for Non-FTE Trainees for COVID-19
    • 2020 Virtual Postbac Poster Day
  • Board of Scientific Directors
    • Board of Scientific Directors Membership
    • Board of Scientific Directors Sub-Committees
  • Committees Advisory to the DDIR
    • Advisory Committee to the DDIR
    • Assembly of Scientists (AOS)
    • Committee on Scientific Conduct and Ethics (CSCE)
    • Central Tenure Committee (CTC)
    • Chairs of the Boards of Scientific Counselors
    • Tenure-Track Investigators Committee
    • Training Directors Committee
    • Fellows Committee (FelCom)
    • Office of Intramural Training and Education (OITE) Steering Committee
    • PostBac Committee
    • Senior Biomedical Research Service (SBRS) Policy Board
    • Women Scientist Advisors (WSA) Committee
    • Human Subjects Research Advisory Committee (HSRAC)
    • Animal Research Advisory Committee (ARAC)
    • Dual Use Research of Concern (DURC) Committee
    • NIH Intramural Embryonic Stem Cell Research Oversight (ESCRO) Committee
    • Facilities Working Group
    • NIH Space Recommendation Board
    • PHS Technology Transfer Policy Board
  • Processes for Reviewing NIH Intramural Science
    • Boards of Scientific Counselors (BSC)
      • Addendum to BSC Policies and Procedures
    • Blue Ribbon Panel Reviews of IC Intramural Research Programs
    • Role and Review of Scientific Directors and Clinical Directors
  • Intramural Program Oversight
    • Human Subjects Research
      • NIH IRP Clinical Directors
    • Intramural Data Sharing
      • 2023 NIH Data Management and Sharing Policy
      • Genomic Data Sharing
      • Human Data Sharing
      • Guide to FDAAA Reporting Research Results
        • Frequently Asked Questions: NIH Clinical Trial Definition
        • Assistance Available to Help with Results Reporting to ClinicalTrials.gov
          • Points of Contact for FDAAA Compliance at ICs
    • Laboratory Safety
    • Management Controls Survey
  • Intramural Administrative Management Council
    • List of Council Members
    • List of Trans-NIH Committees
  • Personnel
    • IPDs and Appointment Mechanisms
      • Official List of Approved Intramural Professional Designations (IPDs)
      • Senior Investigator
      • Investigator
      • Senior Clinician
      • Senior Scientist
      • Assistant Clinical Investigator
      • Staff Clinician
      • Staff Scientist
      • Senior Research Assistant / Research Assistant
      • Adjunct Investigator
      • Scientist Emeritus
      • Intramural Research Training Award (IRTA) Fellow
      • Visiting Fellow
      • ORISE Senior Fellow
      • Senior Clinical Fellow
      • Clinical Fellow
      • Senior Research Fellow
      • Research Fellow
        • Independent Research Scholar Program
      • Student Opportunities
      • Contractors
      • Guest Researchers / Special Volunteers
      • Research Collaborators
    • Policies and Recruitment Processes
      • 5-Year / 8-Year Duration Rule
      • Departing Staff Request to Remove Copies of NIH Records
      • Example IC Check Sheets / Checklists
      • Exceptional Extensions of IRTA and Visiting Fellowships to a 6th Year
      • Fair Review Principles for Nominations of Staff Scientists for Associate Scientist and Senior Associate Scientist Titles
      • Guide for Avoiding Undue Foreign Interference with IRP Research
      • Guidelines for Parental/Family Excused Absence for IRTAs, CRTAs, and Visiting Fellows
      • Keep The Thread Policy
      • Mandated Training for Scientific Staff Working in NIH Facilities
      • Policy for Reassignment or Early Termination of Awards to Postbaccalaureate Fellows
      • Policy for Reassignment or Early Termination of Awards to Postdoctoral Fellows
      • Policy for Reassignment or Early Termination of Awards to Predoctoral Fellows
      • Policy for Use of Contract Workers to Support Scientific Functions in the IRP
      • Policy on Use of English for Official Scientific Communication in NIH Laboratories and Branches
      • Postdoctoral Fellows (IRTA/CRTA/VF) Temporary Exceptional Extensions Policy
      • Roles of Lab and Branch Chiefs (or Equivalent)
      • Telework Policies for IRTA/CRTA and Visiting Fellows
      • Working with Displaced Title 42 Staff Scientists/Clinicians
    • IRP Demographics
      • Intramural Research Program Personnel Demographics (End FY22)
      • Foreign Nationals in the Intramural Research Program (End FY22)
      • Intramural Research Program Personnel Demographics (End FY21)
      • Foreign Nationals in the Intramural Research Program (End FY21)
      • Intramural Research Program Personnel Demographics (End FY20)
      • Foreign Nationals in the Intramural Research Program (End FY20)
      • Intramural Research Program Personnel Demographics (End FY19)
      • Foreign Nationals in the Intramural Research Program (End FY19)
      • Intramural Research Program Personnel Demographics (End FY18)
      • Foreign Nationals in the Intramural Research Program (End FY18)
      • Intramural Research Program Personnel Demographics (End FY17)
      • Foreign Nationals in the Intramural Research Program (End FY17)
      • Intramural Research Program Personnel Demographics (End FY16)
      • Foreign Nationals in the Intramural Research Program (End FY16)
    • Quality-of-Life Features
    • Sabbaticals
      • NIAAA Sabbatical Program
      • NEI Sabbatical Program
      • NICHD Sabbatical Program
      • PHS Foreign Work / Study Program Policy
    • Opportunities for Short Assignments / Details at the NIH
  • Tenure in the NIH Intramural Research Program
    • Tenure-Track Overview
    • Search & Selection
      • Search Process for Senior Investigators, Tenure-Track Investigators, Senior Clinicians and Senior Scientists
      • Role of Search Committee Members
    • Additional Tenure-Track Policies
    • Resources
    • Policy on IC Tenure Review Committees
    • Tenure Overview
    • Search & Selection
    • Criteria for Tenure at the NIH
    • Statement About PI Involvement in Diversity, Equity, Inclusion, and Accessibility
    • De-Tenuring Process
  • Awards, Fellowships, & Grant Opportunities
    • The Director’s Challenge Innovation Award Program
      • 2020 Director’s Challenge Awards
      • 2022 Director’s Challenge Awards
    • Early Career (Bridge) Awards Open to IRP Scientists
    • Eligibility of Intramural Investigators for NIH Common Fund Awards
    • K99/R00 Grant Award Information
      • Application Approval Process and Additional Information
      • K99/R00 Environment and Institutional Commitment Statement
      • Update from Scientific Directors
    • NIAID Support of Intramural Biodefense Research from ICs Other Than NIAID
  • Ethical Conduct
    • Research Misconduct
      • Anonymous Reporting of Research Misconduct Concerns
      • Taraswi Banerjee, Ph.D.
      • Alfredo R Sancho, Ph.D., M.P.H.
    • Guidelines on Conduct of Research
    • Research Ethics
      • NIH Policies
        • Intramural / Extramural Collaborations
          • NIH Staff Involvement on Extramural Awards - Cooperative Agreements
            • Opportunities for Collaborative Research at the Clinical Center (U01)
            • NIH Bench-to-Bedside Program
          • Activities with Outside Organizations
        • Investigation of Allegations of Research Misconduct
      • NIH Guidelines
        • Guide for Human Biospecimen Storage and Tracking
          • Frequently Asked Questions
          • List of Biospecimen Liaisons
    • Special Research Considerations
      • Dual-Use Research
      • Human Stem Cell Use
        • Human Embryonic Stem Cell (hESCs) Use
        • Induced Pluripotent Stem Cells (iPSCs) Use
        • Human Embryo Research and Cloning Prohibitions
      • Policies & Procedures for Human Fetal Tissue Research
        • Policies on the Acquisition and Use of HFT
        • Procedures for Obtaining HFT
    • Responsible Conduct of Research Training
      • Instruction in Responsible Conduct of Research - Postdoc IRTA, CRTA, VF, Research Associates
        • Reproducibility Training
        • Introduction to “My Laboratory”
      • Instruction in Responsible Conduct of Research - Postbacs and GPP Students
      • Resources for Training Directors
      • Annual Review of Ethics (Case Studies)
        • Research Cases for Use by the NIH Community
          • 2021 Ethics Case Facilitator Training
      • Processes for Authorship Dispute Resolution
    • Government Ethics
      • Guidelines for Non-FTEs (Trainees) for NIH-Related Activities, Outside Activities, and Awards
    • Bioethics
  • Mentoring & Training
    • Guide to Training and Mentoring
    • Guidelines for Mentors at NIH
    • Guidelines for Trainees at NIH
    • Guidelines for Annual Progress Review of Trainees
    • Scientific Director Policy Updates for Mentors and Trainees
    • Goals for Enhanced Mentoring in the IRP
    • FelCom Mentoring Committee
    • The DDIR Implementation Plan in Response to the FelCom Subcommittee Report on Mentoring
    • Mentoring Cases for Discussions
  • Submitting Research Publications
    • PubMed Central (PMC) Deposition Requirements
    • Intramural Directions for Submitting to PubMed Central via NIHMS
    • NIH Publishing Agreement Forms
      • Procedures for Non-Peer-Reviewed Publications
    • Publication and Abstract Clearance
  • Intramural Research Communications & Resources
    • Annual Reports and Bibliographies
  • Email
  • Print
  • Share Twitter Facebook LinkedIn

Main navigation

  • About OIR
    • OIR Leadership & Staff
    • Diversity & Inclusion
    • Intramural Targeted Anti-COVID-19 (ITAC) Awards
    • DDIR Innovation Awards
    • Long-Term IRP Planning
    • OIR Offices
  • Sourcebook
    • Intramural COVID-19 Guidance and Resources
    • Board of Scientific Directors
    • Committees Advisory to the DDIR
    • Processes for Reviewing NIH Intramural Science
    • Intramural Program Oversight
    • Intramural Administrative Management Council
    • Personnel
    • Tenure in the NIH Intramural Research Program
    • Awards, Fellowships, & Grant Opportunities
    • Ethical Conduct
    • Mentoring & Training
    • Submitting Research Publications
    • Intramural Research Communications & Resources
  • WALS
    • About WALS
    • Current Lecture Season
    • Past Lecture Seasons & Speakers
    • Named & Honorific Lectures
    • WALS Lunch Request
    • Continuing Medical Education Credits
  • SIGs
    • SIGs by Name
    • SIGs by Scientific Focus Area
  • IRP Website
    • A premier environment where creative scientists conduct fundamental research for the betterment of human health – we are the IRP
    • Visit Website
  • NIH Research Festival
    • The NIH Research Festival is the showcase for intramural research
    • Visit Website
  • The NIH Catalyst
    • A publication for and about the NIH intramural research community
    • Visit Website
  • NIDB
    • The NIH Intramural Database collects and disseminates information about research being performed in the Intramural Programs
    • Visit Website
  • Department of Health and Human Services
  • National Institutes of Health
  • USA.gov

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