Skip to main content
NIH Office of Intramural Research

Navigation controls

  • Search
  • Menu

Main navigation

  • About OIR
    • OIR Leadership & Staff
      • Nina F. Schor, M.D., Ph.D.
      • Roland A. Owens, Ph.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.
      • Kathryn M. Partin, Ph.D.
      • Rena Rodriguez, B.S.
      • Dierdre S. Andrews
      • Diana Gomez
      • Chanee' M. Jackson
      • Margaret McBurney, M.B.A.
      • Karen Nemes
      • Risa Isonaka, Ph.D.
      • Parker Ruhl, M.D., M.H.S.
      • Lisa L. Coronado, M.B.A.
      • Bonny Harbinger, Ph.D., J.D.
      • David B. Resnik, J.D., Ph.D.
      • Richard G. Wyatt, M.D.
    • Diversity & Inclusion
    • Intramural Targeted Anti-COVID-19 (ITAC) Awards
    • DDIR Innovation Awards
    • Long-Term IRP Planning
    • OIR Offices
  • Sourcebook
    • Board of Scientific and Clinical Directors
      • Board of Scientific and Clinical Directors Membership
      • NIH IRP Scientific Directors
      • NIH IRP Clinical Directors
      • Board of Scientific and Clinical Directors Subcommittees
    • 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
      • Fellows Committee (FelCom)
      • Office of Intramural Training and Education (OITE) Steering Committee
      • PostBac Committee
      • Women Scientist Advisors (WSA) Committee
      • 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
        • Process for Appeal to a BSC Review
      • Blue Ribbon Panel Reviews of IC Intramural Research Programs
      • Role and Review of Scientific Directors and Clinical Directors
    • Intramural Program Oversight
      • Electronic Lab Notebooks
        • Intramural Electronic Lab Notebook Policy
        • Frequently Asked Questions About the Use of ELNs at NIH
      • Human Subjects Research
      • 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
          • Explanation of Staff Scientist Position and Titles to Academic Colleagues
        • 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
      • Faculty Development
        • 2024 OITE/OIR Professional Development Curriculum for NIH Faculty
        • Senior Advisors for Faculty Development
      • Policies and Recruitment Processes
        • 5-Year / 8-Year Duration Rule
        • Addendum to On-Site Research Collaborators (RC) Policies: On-Site RC Conducting Human Subjects Research at NIH
        • Clarification on Searches for Scientific Director and Clinical Director
        • Departing Staff Request to Remove Copies of NIH Records
        • Extension Exceptions for Non-FTE Trainees for COVID-19
        • 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 a Letter of Agreement for Staff Scientists
        • 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 FY24)
        • Foreign Nationals in the Intramural Research Program (End FY24)
        • Intramural Research Program Personnel Demographics (End FY23)
        • Foreign Nationals in the Intramural Research Program (End FY23)
        • 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
        • 2024 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
          • NIH Human Biospecimen Program
            • Frequently Asked Questions
            • List of Biospecimen Liaisons
          • Investigation of Allegations of Research Misconduct
        • NIH Guidelines
      • Authorship Guidelines and Resources
        • Authorship Resources
        • NIH IRP Authorship Conflict Resolution Process
      • Special Research Considerations
        • Dual-Use Research
        • Policy on the Ordering or Provision of Synthetic Nucleic Acids in the IRP
        • 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
      • 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
      • 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
  • Lectures & Events
    • WALS
      • About WALS
      • Current Lecture Season
      • Past Lecture Seasons & Speakers
        • Browse by Season
        • Browse by Speaker
      • Named & Honorific Lectures
        • NIH Director’s Lecture
        • Rolla E. Dyer Lecture
        • G. Burroughs Mider Lecture
        • Marshall W. Nirenberg Lecture
        • Margaret Pittman Lecture
        • J. Edward Rall Cultural Lecture
        • Astute Clinician Lecture
        • Robert S. Gordon Jr. Lecture
        • George Khoury Lecture
        • Florence Mahoney Lecture on Aging
        • William E. Paul Lecture
        • DeWitt Stetten Jr. Lecture
      • Continuing Medical Education Credits
    • NIH Research Festival
      • The NIH Research Festival is the showcase for intramural research
      • Visit Website
  • SIGs
    • SIGs by Name
    • SIGs by Scientific Focus Area
      • Biomedical Engineering and Biophysics
      • Cancer Biology
      • Cell Biology
      • Chemical Biology
      • Chromosome Biology
      • Clinical Research
      • Computational Biology
      • Developmental Biology
      • Epidemiology
      • Genetics and Genomics
      • Health Disparities
      • Immunology
      • Microbiology and Infectious Diseases
      • Molecular Biology and Biochemistry
      • Molecular Pharmacology
      • Neuroscience
      • RNA Biology
      • Social and Behavioral Sciences
      • Stem Cell Biology
      • Structural Biology
      • Systems Biology
      • Virology
  • IRP Website
    • A premier environment where creative scientists conduct fundamental research for the betterment of human health – we are the IRP
    • 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

Human Subjects Research

  • Allegations of Non-Compliance with Clinical Research Requirements: Role of Institutional Official
  • NIH IRP Clinical Directors
  • Office of Human Subjects Research Protections (OHSRP)

This page was last updated on Thursday, April 11, 2024

Main navigation

  • Board of Scientific and Clinical Directors
    • Board of Scientific and Clinical Directors Membership
    • NIH IRP Scientific Directors
    • NIH IRP Clinical Directors
    • Board of Scientific and Clinical Directors Subcommittees
  • 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
    • Fellows Committee (FelCom)
    • Office of Intramural Training and Education (OITE) Steering Committee
    • PostBac Committee
    • Women Scientist Advisors (WSA) Committee
    • 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
      • Process for Appeal to a BSC Review
    • Blue Ribbon Panel Reviews of IC Intramural Research Programs
    • Role and Review of Scientific Directors and Clinical Directors
  • Intramural Program Oversight
    • Electronic Lab Notebooks
      • Intramural Electronic Lab Notebook Policy
      • Frequently Asked Questions About the Use of ELNs at NIH
    • Human Subjects Research
    • 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
        • Explanation of Staff Scientist Position and Titles to Academic Colleagues
      • 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
    • Faculty Development
      • 2024 OITE/OIR Professional Development Curriculum for NIH Faculty
      • Senior Advisors for Faculty Development
    • Policies and Recruitment Processes
      • 5-Year / 8-Year Duration Rule
      • Addendum to On-Site Research Collaborators (RC) Policies: On-Site RC Conducting Human Subjects Research at NIH
      • Clarification on Searches for Scientific Director and Clinical Director
      • Departing Staff Request to Remove Copies of NIH Records
      • Extension Exceptions for Non-FTE Trainees for COVID-19
      • 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 a Letter of Agreement for Staff Scientists
      • 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 FY24)
      • Foreign Nationals in the Intramural Research Program (End FY24)
      • Intramural Research Program Personnel Demographics (End FY23)
      • Foreign Nationals in the Intramural Research Program (End FY23)
      • 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
      • 2024 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
        • NIH Human Biospecimen Program
          • Frequently Asked Questions
          • List of Biospecimen Liaisons
        • Investigation of Allegations of Research Misconduct
      • NIH Guidelines
    • Authorship Guidelines and Resources
      • Authorship Resources
      • NIH IRP Authorship Conflict Resolution Process
    • Special Research Considerations
      • Dual-Use Research
      • Policy on the Ordering or Provision of Synthetic Nucleic Acids in the IRP
      • 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
    • 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
    • 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
    • Board of Scientific and Clinical 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
  • Lectures & Events
    • WALS
    • NIH Research Festival
  • 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
  • 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

Footer

  • Home
  • Contact Us
  • HHS Vulnerability Disclosure
  • Web Policies and Notices
  • Site Map
  • Search