Below is a list of policies, guidance, standard operating procedures, and documents/templates issued by the Office of the Vice Provost for Research, the Office of Research & Sponsored Programs, or Research Integrity.
Research Policies
- Children as Research Subjects
- Composition and Membership of the IRB
- Documentation of Informed Consent / Waiver of Documentation of Informed Consent
- End Approval Dates
- Exempt Determinations
- Expedited Reviews
- Human Subjects Research Principal Investigator
- Informed Consent / Waiver of Informed Consent
- IRB Conflict of Interest
- Lehigh University Policy on the Protection of Human Subjects in Research
- Reporting Unanticipated Problems/Adverse Events to the IRB
- Research Involving Cognitively Impaired Participants
- Research Involving Fetuses, Pregnant Women or Human In-Vitro Fertilization
- Research Involving Prisoners as Research Subjects
- Researcher Training
- Suspension / Termination / Expiration of IRB Approval
- Use of Lotteries, Raffles, and/or Drawings in Research
- Additional Compensation for Faculty Supported on Research or Sponsored Programs
- Application of Facilities and Administrative (F&A) Rates for Sponsored Activities
- Cost Reallocations for Research and Sponsored Program Indexes
- Major Instrumentation
- Participant Support Costs
- PI Eligibility
- Proposal Submission
- Subcontracting - Establishing, Managing, and Monitoring Subawards
Guidance and Procedures
Guidance
- Export Control Compliance Manual (updated 4-Nov-22)
- Export Controlled Items
- Export Controlled Chemicals
- Export Control Purchasing Compliance Review Flowchart
- High Performance Computing (HPC) and Export Control
- Information for Faculty
- Information for International Travelers
- International Data Transfers
- International Shipments
- Iran Sanctions
- License Information
- Sanctioned Countries
Procedures
Guidance
- What Types of Activities Require IRB Review
- Assessing Risk Level Using Magnitude of Harm
- Certificates of Confidentiality (CoC) - NIH Policy
- Conducting Research in Schools
- Crowdsourcing Platforms for Conducting Human Subjects Research: Best Practices
- Data and Safety Monitoring of Clinical Trials Research
- Data Security and Privacy
- Collecting Demographic Information from Human Subjects
- Electronic Informed Consent
- Engagement in Human Subjects Research
- Ethical Issues in Research
- FDA Regulations for Human Subjects Research
- Family Educational Rights and Privacy Act (FERPA)
- General Data Protection Regulation (GDPR)
- Informed Consent Process for Exempt Research
- Informed Consent: Required and Additional Elements (for non-exempt research)
- International Research and Research with Non-English Speaking Populations - guidance and forms
- IRB Authorization Agreements for Human Subjects Research
- Levels of IRB Review
- Payments to Research Participants
- Readability and Comprehension
- Reporting New Information to the IRB
- Research Design Guidance
- ResearchMatch - Recruitment Tool for Clinical / Health-Related Research
- Single IRB (sIRB) Review for Multi-Site Cooperative Research
- Student Investigators' Guide
- Unaffiliated Investigators
- Video Conferencing in Human Subjects Research
- Additional Requirements for Human Subjects Research Supported by Other Federal Agencies
- Racial Equity Considerations in IRB Review
ResearchMatch
- Guidance on Emeritus Faculty Member Service as PI
- Hiring Consultants
- Laboratory Shutdown Procedures
- Long Term Research Appointments
- NSPM33 Disclosures (May 2024)
- ORCID and SciENcv
- ORSP Record Retention Guidance
- ORSP Roles and Responsibilities Matrix
- Short Term Research Appointments
- Subrecipient Monitoring Guidance
- SOP: Cost Reallocations for Research and Sponsored Programs Indexes
- SOP: Subcontracting - Establishing, Managing, and Monitoring Subawards
Forms, Templates, and Documents
Forms
- Baggage (BAG) Export License Exception Certification
- Deemed Export Screening Form
- Technology Control Plan (TCP) Template
- Temporary Export (TMP) Export License Exception Certification
- Visa Deemed Export Screening Form
Tools and Lists
- Consolidated Screening List
- Specially Designated Nationals and Blocked Persons List (SDN)
- Commerce Control List (CCL)
- CCL Index
- CCL Commerce Country Chart
- United States Munitions List (USML)
- OFAC Sanctions Programs and Country Information
- BIS Export Control Classification Interactive Tool
- ITAR Compliance Risk Matrix (Universities)
- NSTC Critical and Emerging Technologies List (2024 Update)
- ATA Carnets: Frequently Asked Questions
Templates
Worksheets
- Advanced Account Request Form
- Cost Reallocation Form (2024)
- Cost Reallocation Justification Form (2024)
- Determination of Dominant Locale of Research Form
- Independent Contractor vs Employee Form
- Internal Budget Template (October 2024)
- Research and Testing Agreement Template (Word)
- Sponsored Research Agreement Template (Word)
- Subrecipient Commitment Form (2020)
- Subrecipient Determination Form (2022)
- Testing Services Agreement Template (2019)