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  • About OIR
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      • 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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      • Exceptional Use of IC Funds for Per Diem Quarantine for Non-FTE Trainees (VF/IRTA/CRTA)
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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
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      • 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

Policies on the Acquisition and Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH

The use of HFT for research is sensitive and researchers must be mindful of its ethical implications. Researchers must ensure that allowable uses of HFT is in accordance with applicable federal, state, and local laws, regulations and policies. This includes the need for NIH approval prior to acquiring HFT (see Procedures for Obtaining Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH), the need for informed consent from the donor, and the need for continuous oversight review during the performance of the research.

  • Acquisition, Use and Storage of HFT
  • Federal Law, Regulation, and NIH Policy
  • Intramural Oversight of HFT

Acquisition, Use and Storage of HFT

Researchers may acquire, use and store HFT (human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus, but does not include established human fetal cell lines) for intramural research projects. Acquisition, from either a commercial source or from an academic institution, clinic, or hospital, requires prior approval (see Procedures for Obtaining Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH). Researchers are also required to report annually on their acquisition, use or storage of HFT (see Guide for Human Biospecimen Storage and Tracking). Use of HFT is reported annually on the publicly-facing Research, Condition, and Disease Categories (RCDC) by intramural project number. Intramural researchers with HFT projects are at times required to answer data calls on various aspects of their use of HFT.

Research on transplantation of HFT for therapeutic purposes is permitted but requires additional intramural regulatory oversight because of the statutory provision(s) addressing such research. Please contact the Office of Intramural Research if you are considering research in which HFT or cells would be transplanted as part of clinical research.

Federal Law, Regulation, and NIH Policy

  • 42 U.S.C. 289g-1 and 289g-2 set forth specific requirements and prohibitions on research involving human fetal tissue. 42 U.S.C. 289g-2 provides that:
    • “It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.”
    • The full text of 42 U.S.C. 289g-1 is available at: https://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-1.htm.
    • The full text of 42 U.S.C. 289g-2 is available at: https://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-2.htm.

Research involving human fetal tissue is also subject to the HHS Regulations for the Protection of Human Subjects (45 CFR 46 Subparts A and B).

  • §46.204 Research involving pregnant women or fetuses.
    • ~ (a) – (g)
    • (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
    • (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
    • (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
  • §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
    • Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
    • If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
  • The full text of the HHS Regulations for the Protection of Human Subjects is available at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

Research is also subject to NIH policy on informed consent for HFT research, as specified in:

  • NOT-OD-16-033 NIH Policy on Informed Consent for Human Fetal Tissue Research

Intramural Oversight of HFT

All intramural scientists are informed of the policies and legal requirements applying to human fetal tissue research. Oversight of human fetal tissue research conducted by intramural investigators is summarized below.

  • NIH Office of Human Subjects Research Protections (OHSRP). The Office of Human Subjects Research Protections (OHSRP) provides guidance to intramural investigators who are using or contemplate using human fetal tissue. All experiments using human fetal tissue must be reviewed and approved either by the NIH Office of IRBO or the NIH IRP IRB.
  • Biospecimen Survey. Intramural investigators with NIH supported projects that entail the acquisition, use or storage of HFT must submit an annual biospecimen survey that tracks this tissue. The Office of Intramural Research and the Scientific Directors of each Institute/Center direct investigators to specifically identify when human fetal tissue is used during the reporting period.
  • Clinical and Scientific Directors. The Clinical and Scientific Directors, who provide immediate oversight of intramural research in each institute, are aware of the legal requirements governing acquisition and use of fetal tissue. They are directed to ensure that all scientists who use human fetal tissue in their research assure fetal tissue is used and acquired in accordance with the legal requirements.
  • Management Controls. In the annual Management Controls review, each Scientific Director will be asked to verify that he or she has reviewed the legal requirements regarding fetal tissue acquisition and use for research in their intramural program, and to identify and correct any potential problem areas.

This page was last updated on Wednesday, November 17, 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
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  • 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
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      • 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
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