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  • Home (current)
  • About the VPR Team (current)

    Staff Directory

    • About ORSP
    • About Research Development

    Strategic Investments in Research

    • Calls for Proposals: Seed Translational Research Projects
    • Center for Catastrophe Modeling and Resilience
    • Strategic Investments: Propose a Center

    Announcements

    Events

  • Find Funding (current)

    Internal Funding Opportunities

    • Faculty Research Grants (FRG)
    • Faculty Innovation Grants (FIG)
    • Collaborative Research Opportunity (CORE) Grants
    • Accelerator Grants

    External & Sponsored Funding Opportunities

    • Limited Submissions

    University Sabbatical Fellows Program

    Visiting Scholars Program

  • Proposal & Contract Submissions (current)

    Proposal Development & Writing Support

    • Individual Research Strategy & Proposal Narrative Consultation
    • Proposal Library: Examples of Successfully Funded Proposals

    Planning for Human & Animal Participants

    Step-by-Step Requirements for Sponsored Research Submissions

    • New Faculty Researcher Guide: Before You Propose
    • Effort Planning and Allocation
    • Federal Agency Requirements for Reporting of Professional Activities and Sources of Support

    LIRA System: Submit Sponsored Research Proposal

    • LIRA Disclosure Process and Resources
    • LIRA System FAQs

    Submit Internally Funded Research Proposal: InfoReady System

    Submit a Contract For Review, Negotiation, and Final Approval

    • Components of a Federal Contract Submission
    • Contract FAQs
    • Federal Contracts
    • Other Agreements
    • Sponsored Research Agreements
  • Manage an Award or Project (current)

    New Faculty Researcher Guide: After You Receive an Award

    Budget and Spending Tips

    Research Accounting

    Effort

    Payroll

    Travel

    Outgoing Subawards

    Transfer an Award

    Commercialize Your Invention or Technology

  • Close Out an Award or Project (current)
  • Explore Trainings & Education (current)

    Research Handbook: Understand Popular Terms

    • Handbook: Allowable Charges on Sponsored Awards
    • Handbook: Collaborating Academic Visitors
    • Handbook: Cost Sharing
    • Handbook: Data Management and Stewardship of Research Materials
    • Handbook: Effort Allocation, Certification, and Salary Recovery
    • Handbook: Export Controls and Trade Sanctions
    • Handbook: External Sponsored Funding: Proposal Development and Submission
    • Handbook: Financial Conflicts of Interest Related to Research and Sponsored Programs
    • Handbook: Foreign Talent Programs
    • Handbook: Human Subjects and Biospecimens
    • Handbook: Lab Safety and Regulated Research Materials
    • Handbook: Legal Agreements and Signature Authority
    • Handbook: Managing an Award with External Collaborators
    • Handbook: PI-Required Reports
    • Handbook: Roles and Relationships
    • Handbook: Vertebrate Animals

    Responsible Conduct of Research (RCR) Training

    LIRA System Training & Education

    IRBnet Training Materials

    ORCID and SciENcv Instructions and Resources for Faculty

  • Policies, Guidance & Forms (current)

    Federal Forms

    Laboratory Shutdown Procedures

    Rate Agreements

    Audio and Video Conferencing in Human Subjects Research

    Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC)

    Conducting Research Using Crowdsourcing Platforms: Best Practices

    Ethical Issues in Research

    European Union’s General Data Protection Regulation (GDPR)

    Export Control Information for Faculty

    FDA Regulations for Human Subjects Research

    FERPA: Federal Education Rights and Privacy Act

    Guidance: Conducting Research in Schools

    Guidance: Data Security and Privacy

    Guidance: Data and Safety Monitoring of Clinical Trials Research

    Guidance: Deidentfied Data

    Guidance: Electronic Informed Consent

    Guidance: Financial Conflicts of Interest and Faculty Startups

    Guidance: General Data Protection Regulation (GDPR)

    Guidance: Iran Sanctions

    Guidance: Readability and Comprehension Standards

    IACUC: Approved Vendor List For Animal Purchases

    IRB application & review processes for international research involving undergraduate students

    Information for International Travelers

    License Information

    Maintenance Funds

    Payments to Research Participants

    Research Design Guidance

    Single IRB (sIRB) Review for Multi-Site Cooperative Research

    Student Investigators' Guide

    Unaffiliated Investigators

    Policy on the Protection of Human Subjects in Research

    Policy: Additional Compensation for Faculty Supported on Research or Sponsored Programs

    Policy: Application of Facilities and Administrative (F&A) Rates for Sponsored Activities

    Policy: Children as Research Subjects

    Policy: Composition and Membership of the Institutional Review Board

    Policy: Cost Reallocations for Research or Sponsored Program Indexes

    Policy: Developing, Revising, and Posting Research Administration Policies

    Policy: Documentation of Informed Consent and Waiver of Documentation of Informed Consent

    Policy: Eligibility to Serve as Principal or Co-Principal Investigator on Sponsored Projects

    Policy: End Approval Dates

    Policy: Expedited IRB Review

    Policy: Export Control

    Policy: Financial Conflicts of Interest Related to Research and Sponsored Programs

    Policy: Foreign Talent Recruitment Programs - Restrictions and Disclosure Requirements

    Policy: Human Subjects Research Principal Investigator

    Policy: IRB Conflict of Interest

    Policy: IRB Exempt Determinations

    Policy: IRB Researcher Training

    Policy: Informed Consent and Waiver of Informed Consent

    Policy: Major Instrumentation

    Policy: Participant Support Costs

    Policy: Proposal Submission

    Policy: Reporting Unanticipated Problems/Adverse Events to the IRB

    Policy: Research Involving Cognitively Impaired Individuals

    Policy: Research Involving Fetuses, Pregnant Women or Human In-Vitro Fertilization

    Policy: Research Involving Prisoners as Research Subjects

    Policy: Subcontracting - Establishing, Managing, and Monitoring Subawards

    Policy: Suspension, Termination, or Expiration of IRB Approval

    Policy: Use of Lotteries, Raffles, and/or Drawings in Research

    Reporting New Information to the IRB

    Research Administration Policy and Procedure Development

    Cognizant Agency Detail

    Guidance: Additional Requirements for Human Subjects Research Supported by Other Federal Agencies

    Guidance: Animal Transport

    Guidance: Collecting Demographic Information from Human Subjects

    Guidance: Consenting Subjects Who Do Not Read, Speak or Understand English

    Guidance: Human Subjects Research Engagement

    Guidance: IACUC External Resource Materials

    Guidance: IRB Authorization Agreements for Human Subjects Research

    Guidance: Informed Consent Process for Exempt Research

    Guidance: International Data Transfers

    Guidance: International Research

    Guidance: International Shipments

    Guidance: Justifying the Number of Animals in Research

    Guidance: Major and Minor Surgical Procedures

    Guidance: Racial Equity Considerations in IRB Review

    Guidance: Reporting Animal Welfare Concerns and Policy Violations to the IACUC

    Guidance: Required and Additional Elements of Informed Consent (Non-Exempt Research)

    Guidance: ResearchMatch -- Example Contact Message

    Guidance: ResearchMatch -- Find Research Participants

    Quick Reference Codes and ID Numbers

    Rates - FY 25 Tuition - Graduate Students

    Rates: Fringe Benefit

    Rates: Indirect Cost

    SOP: Carbon Dioxide Euthanasia of Rodents

    SOP: Collaborative Work with Outside Institutions

    SOP: Congruency Review

    SOP: Developing a Technology Control Plan

    SOP: Export Control Compliance Review of Purchases

    SOP: Post-Approval Monitoring

  • Research Integrity (current)

    Human Subjects in Research

    • Exempt Categories
    • Levels of IRB Review
    • Training Requirements for Personnel on IRB Applications
    • Expedited Review
    • Full Committee Review
    • IRB: Amendments / Modifications to Protocols
    • IRB: Frequently Asked Questions
    • IRB: Glossary
    • IRB: Renew an Expiring Protocol
    • IRB: Reporting an Unanticipated Problem
    • IRB: Submit Research Status Check-In Report
    • IRB: Submit a New Protocol
    • What Types of Activities Require IRB Review?

    Vertebrate Animals in Research

    • IACUC: Engage in Contracted / Subcontracted Vertebrate Animal Research
    • IACUC: Modify an Existing Protocol
    • IACUC: PHS AWA / USDA Registration
    • IACUC: Protocol Review Process
    • IACUC: Resources
    • IACUC: Training and Qualifications

    Export Control

    • Export Control Compliance Manual
    • Export Control Glossary
    • Export Control Training Materials
    • Export Control: Frequently Asked Questions
    • Export Controlled Chemicals
    • Export Controlled Items
    • High Performance Computing and Export Control at Lehigh
    • Sanctioned Countries

    Foreign Talent Programs

    Financial Conflicts of Interest in Research and Sponsored Programs

    • Determining if an SFI is Related
    • LIRA Disclosure Process and Resources
    • Public Accessibility of a COI Related to Public Health Service-Funded Research
    • fCOI: Additional Resources
    • fCOI: Frequently Asked Questions
    • fCOI: Glossary

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  3. Guidance: Additional Requirements For Human Subjects Research Supported By Other Federal Agencies

Guidance: Additional Requirements for Human Subjects Research Supported by Other Federal Agencies

  • Department of Defense
  • Department of Energy
  • Department of Justice
  • Education Department
  • Environmental Protection Agency
  • U.S. Food and Drug Administration (FDA)

Sidebar Navigation

  • Home (current)
  • About the VPR Team (current)
    • Staff Directory
      • About ORSP
      • About Research Development
    • Strategic Investments in Research
      • Calls for Proposals: Seed Translational Research Projects
      • Center for Catastrophe Modeling and Resilience
      • Strategic Investments: Propose a Center
    • Announcements
    • Events
  • Find Funding (current)
    • Internal Funding Opportunities
      • Faculty Research Grants (FRG)
      • Faculty Innovation Grants (FIG)
      • Collaborative Research Opportunity (CORE) Grants
      • Accelerator Grants
    • External & Sponsored Funding Opportunities
      • Limited Submissions
        • NSF Major Research Instrumentation (MRI) Program
    • University Sabbatical Fellows Program
    • Visiting Scholars Program
  • Proposal & Contract Submissions (current)
    • Proposal Development & Writing Support
      • Individual Research Strategy & Proposal Narrative Consultation
      • Proposal Library: Examples of Successfully Funded Proposals
    • Planning for Human & Animal Participants
    • Step-by-Step Requirements for Sponsored Research Submissions
      • New Faculty Researcher Guide: Before You Propose
      • Effort Planning and Allocation
      • Federal Agency Requirements for Reporting of Professional Activities and Sources of Support
    • LIRA System: Submit Sponsored Research Proposal
      • LIRA Disclosure Process and Resources
      • LIRA System FAQs
    • Submit Internally Funded Research Proposal: InfoReady System
    • Submit a Contract For Review, Negotiation, and Final Approval
      • Components of a Federal Contract Submission
      • Contract FAQs
      • Federal Contracts
      • Other Agreements
      • Sponsored Research Agreements
  • Manage an Award or Project (current)
    • New Faculty Researcher Guide: After You Receive an Award
    • Budget and Spending Tips
    • Research Accounting
    • Effort
    • Payroll
    • Travel
    • Outgoing Subawards
    • Transfer an Award
    • Commercialize Your Invention or Technology
  • Close Out an Award or Project (current)
  • Explore Trainings & Education (current)
    • Research Handbook: Understand Popular Terms
      • Handbook: Allowable Charges on Sponsored Awards
      • Handbook: Collaborating Academic Visitors
      • Handbook: Cost Sharing
      • Handbook: Data Management and Stewardship of Research Materials
      • Handbook: Effort Allocation, Certification, and Salary Recovery
      • Handbook: Export Controls and Trade Sanctions
      • Handbook: External Sponsored Funding: Proposal Development and Submission
      • Handbook: Financial Conflicts of Interest Related to Research and Sponsored Programs
      • Handbook: Foreign Talent Programs
      • Handbook: Human Subjects and Biospecimens
      • Handbook: Lab Safety and Regulated Research Materials
      • Handbook: Legal Agreements and Signature Authority
      • Handbook: Managing an Award with External Collaborators
      • Handbook: PI-Required Reports
      • Handbook: Roles and Relationships
      • Handbook: Vertebrate Animals
    • Responsible Conduct of Research (RCR) Training
    • LIRA System Training & Education
    • IRBnet Training Materials
    • ORCID and SciENcv Instructions and Resources for Faculty
  • Policies, Guidance & Forms (current)
    • Federal Forms
    • Laboratory Shutdown Procedures
    • Rate Agreements
    • Audio and Video Conferencing in Human Subjects Research
    • Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC)
    • Conducting Research Using Crowdsourcing Platforms: Best Practices
    • Ethical Issues in Research
    • European Union’s General Data Protection Regulation (GDPR)
    • Export Control Information for Faculty
    • FDA Regulations for Human Subjects Research
    • FERPA: Federal Education Rights and Privacy Act
    • Guidance: Conducting Research in Schools
    • Guidance: Data Security and Privacy
    • Guidance: Data and Safety Monitoring of Clinical Trials Research
    • Guidance: Deidentfied Data
    • Guidance: Electronic Informed Consent
    • Guidance: Financial Conflicts of Interest and Faculty Startups
    • Guidance: General Data Protection Regulation (GDPR)
    • Guidance: Iran Sanctions
    • Guidance: Readability and Comprehension Standards
    • IACUC: Approved Vendor List For Animal Purchases
    • IRB application & review processes for international research involving undergraduate students
    • Information for International Travelers
    • License Information
    • Maintenance Funds
    • Payments to Research Participants
    • Research Design Guidance
    • Single IRB (sIRB) Review for Multi-Site Cooperative Research
    • Student Investigators' Guide
    • Unaffiliated Investigators
    • Policy on the Protection of Human Subjects in Research
    • Policy: Additional Compensation for Faculty Supported on Research or Sponsored Programs
    • Policy: Application of Facilities and Administrative (F&A) Rates for Sponsored Activities
    • Policy: Children as Research Subjects
    • Policy: Composition and Membership of the Institutional Review Board
    • Policy: Cost Reallocations for Research or Sponsored Program Indexes
    • Policy: Developing, Revising, and Posting Research Administration Policies
    • Policy: Documentation of Informed Consent and Waiver of Documentation of Informed Consent
    • Policy: Eligibility to Serve as Principal or Co-Principal Investigator on Sponsored Projects
    • Policy: End Approval Dates
    • Policy: Expedited IRB Review
    • Policy: Export Control
    • Policy: Financial Conflicts of Interest Related to Research and Sponsored Programs
    • Policy: Foreign Talent Recruitment Programs - Restrictions and Disclosure Requirements
    • Policy: Human Subjects Research Principal Investigator
    • Policy: IRB Conflict of Interest
    • Policy: IRB Exempt Determinations
    • Policy: IRB Researcher Training
    • Policy: Informed Consent and Waiver of Informed Consent
    • Policy: Major Instrumentation
    • Policy: Participant Support Costs
    • Policy: Proposal Submission
    • Policy: Reporting Unanticipated Problems/Adverse Events to the IRB
    • Policy: Research Involving Cognitively Impaired Individuals
    • Policy: Research Involving Fetuses, Pregnant Women or Human In-Vitro Fertilization
    • Policy: Research Involving Prisoners as Research Subjects
    • Policy: Subcontracting - Establishing, Managing, and Monitoring Subawards
    • Policy: Suspension, Termination, or Expiration of IRB Approval
    • Policy: Use of Lotteries, Raffles, and/or Drawings in Research
    • Reporting New Information to the IRB
    • Research Administration Policy and Procedure Development
    • Cognizant Agency Detail
    • Guidance: Additional Requirements for Human Subjects Research Supported by Other Federal Agencies
    • Guidance: Animal Transport
    • Guidance: Collecting Demographic Information from Human Subjects
    • Guidance: Consenting Subjects Who Do Not Read, Speak or Understand English
    • Guidance: Human Subjects Research Engagement
    • Guidance: IACUC External Resource Materials
    • Guidance: IRB Authorization Agreements for Human Subjects Research
    • Guidance: Informed Consent Process for Exempt Research
    • Guidance: International Data Transfers
    • Guidance: International Research
    • Guidance: International Shipments
    • Guidance: Justifying the Number of Animals in Research
    • Guidance: Major and Minor Surgical Procedures
    • Guidance: Racial Equity Considerations in IRB Review
    • Guidance: Reporting Animal Welfare Concerns and Policy Violations to the IACUC
    • Guidance: Required and Additional Elements of Informed Consent (Non-Exempt Research)
    • Guidance: ResearchMatch -- Example Contact Message
    • Guidance: ResearchMatch -- Find Research Participants
    • Quick Reference Codes and ID Numbers
    • Rates - FY 25 Tuition - Graduate Students
    • Rates: Fringe Benefit
    • Rates: Indirect Cost
    • SOP: Carbon Dioxide Euthanasia of Rodents
    • SOP: Collaborative Work with Outside Institutions
    • SOP: Congruency Review
    • SOP: Developing a Technology Control Plan
    • SOP: Export Control Compliance Review of Purchases
    • SOP: Post-Approval Monitoring
  • Research Integrity (current)
    • Human Subjects in Research
      • Exempt Categories
      • Levels of IRB Review
      • Training Requirements for Personnel on IRB Applications
      • Expedited Review
      • Full Committee Review
      • IRB: Amendments / Modifications to Protocols
      • IRB: Frequently Asked Questions
      • IRB: Glossary
      • IRB: Renew an Expiring Protocol
      • IRB: Reporting an Unanticipated Problem
      • IRB: Submit Research Status Check-In Report
      • IRB: Submit a New Protocol
      • What Types of Activities Require IRB Review?
    • Vertebrate Animals in Research
      • IACUC: Engage in Contracted / Subcontracted Vertebrate Animal Research
      • IACUC: Modify an Existing Protocol
      • IACUC: PHS AWA / USDA Registration
      • IACUC: Protocol Review Process
      • IACUC: Resources
      • IACUC: Training and Qualifications
        • IACUC Qualifications Form
    • Export Control
      • Export Control Compliance Manual
      • Export Control Glossary
      • Export Control Training Materials
      • Export Control: Frequently Asked Questions
      • Export Controlled Chemicals
      • Export Controlled Items
      • High Performance Computing and Export Control at Lehigh
      • Sanctioned Countries
    • Foreign Talent Programs
    • Financial Conflicts of Interest in Research and Sponsored Programs
      • Determining if an SFI is Related
      • LIRA Disclosure Process and Resources
      • Public Accessibility of a COI Related to Public Health Service-Funded Research
      • fCOI: Additional Resources
      • fCOI: Frequently Asked Questions
      • fCOI: Glossary

Office of the Vice Provost for Research

  • Phone Number 610-758-5212
  • Fax Number 610-758-5810
  • Address

    Lehigh University
    Alumni Memorial Building
    27 Memorial Drive West
    Bethlehem, PA 18015
    United States

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