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      • 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)
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        • 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
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        • Instruction in Responsible Conduct of Research - Postbacs and GPP Students
        • Resources for Training Directors
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          • Research Cases for Use by the NIH Community
            • 2021 Ethics Case Facilitator Training
        • Processes for Authorship Dispute Resolution
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      • Mentoring Cases for Discussions
    • Submitting Research Publications
      • PubMed Central (PMC) Deposition Requirements
      • Intramural Directions for Submitting to PubMed Central via NIHMS
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        • Procedures for Non-Peer-Reviewed Publications
      • Publication and Abstract Clearance
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    • A premier environment where creative scientists conduct fundamental research for the betterment of human health – we are the IRP
    • Visit Website
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    • Visit Website
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    • A publication for and about the NIH intramural research community
    • Visit Website
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    • The NIH Intramural Database collects and disseminates information about research being performed in the Intramural Programs
    • Visit Website

Procedures for Obtaining Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH

  1. All NIH intramural investigators must be fully aware of and in compliance with all applicable legal requirements, including laws that govern research using human fetal tissue and research involving transplantation of fetal tissue. A summary of relevant laws and policies are described within the Policies on the Acquisition and Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH section of the NIH Sourcebook. All experiments using human fetal tissue must be reviewed and approved in advance either by the NIH Office of IRBO or the NIH IRP IRB (NIH Intramural Institutional Review Board), which entails approval by the Scientific or Clinical Director.
    1. For de-identified tissue (that will not be covered on an IRB-approved protocol), NIH Intramural Investigators must:
      1. Submit a request for a determination of “Not Human Subjects Research (NHSR) Determination” in the electronic IRB (eIRB) submission system, including donor consent for the use of tissue in research.
      2. Attach the completed Investigator Attestation I form in the eIRB system for review and certification.
    2. For identifiable tissue, tissue for which the NIH researcher is aware of the identity of the donor OR when the tissue will be used as part of an IRB-approved protocol, NIH Intramural Investigators must:
      1. Submit a new protocol or an amendment to an existing protocol, including donor consent for the use of identifiable human fetal tissue for the research, if applicable (see Subpart B of 45 CFR 46), for IRB approval, in the eIRB system.
      2. Attach the completed Investigator Attestation II form (identifiable tissue) or Investigator Attestation I form (de-identified tissue) in the eIRB system for review and certification.
  2. NIH Intramural Investigators must obtain HFT, as determined by the needs of their specific research projects, in a manner consistent with all applicable legal requirements.
  3. For HFT provided from commercial suppliers:
    1. NIH Intramural Investigators must request the tissue with involvement from an NIH Institute and Center purchasing agent.
    2. Investigators must provide purchasing agents with a copy of the appropriate Attestation (I or II) prior to ordering materials.
    3. Purchasing agents must be aware of applicable legal requirements associated with acquiring and obtaining HFT (U.S.C. §§289g-2) and maintain the Attestation I or II with related transaction records.
    4. Investigators must collect documentation that the commercial supplier has complied with the applicable Federal laws and policies and keep a record of this documentation.
  4. For HFT obtained from an academic institution, clinic, or hospital:
    1. Investigators must ask their Technology Transfer Office to execute an MTA or Collaborative agreement.
    2. The MTA/CA includes a statement, that NIH expects informed consent to have been obtained from the donor for any NIH-supported research using HFT. Intramural Investigators must obtain proof of consent from the external institution and keep a record of this documentation.
    3. As part of the request, they should complete and submit an Investigator Attestation for MTA/DTA/CA and include the executed Attestation I or II (see below for attestations).
    4. Investigators must collect documentation that the external institution is in compliance with the applicable Federal laws and policies or information on comparable restrictions in force in their country, when applicable, and share it with Tech Transfer.
  5. NIH Intramural Investigators are required to maintain a copy of all documentation mentioned above in their research records and submit it to their SD and to the NIH Intramural Compliance Officer including:
    • A copy of the appropriate Attestation Form (I and/or II; MTA/DTA/CA, if applicable)
    • A copy of the “Not Human Subjects Research” Determination or IRB protocol approval letter with a précis
    • A copy of all documentation from the supplier of the research material
  6. NIH Intramural investigators will be required to indicate on the annual Biospecimen Report whether HFT was acquired, used or stored for a specific research project in the current fiscal year.
  7. Scientific Directors will be required to provide additional information on the use of human fetal tissue, and the transplantation of human fetal tissue, in the annual Management Control Survey.

Attachments

  • Investigator Attestation I
  • Investigator Attestation II

This page was last updated on Wednesday, November 16, 2022

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
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      • Clinical Fellow
      • 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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  • 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
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    • Submitting Research Publications
    • Intramural Research Communications & Resources
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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
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