The digital platforms for Institutional Review Board (IRB) submissions (using IRBNet) and CITI Program trainings contain features that may not be accessible to all users. To request an accommodation for equally effective alternative access, please contact Research Integrity & Security.
Policy Manual Definitions
Browse definitions of the technical terms in the Research Integrity & Security Policy Manual.
Oversight of Human Research Protection
- 1. The University's Human Research Protection Program
- 2. Institutional Authority for Human Research Protection
- 3. Designation of IRB for Non-Exempt Human Research
- 4. The Role of Non-University of Nevada, Reno (External) IRBs, Single IRB and Independent Investigator Agreements
- 5. Independence of the University's IRBs
- 6. Flexibility Policy
- 21. Training Requirements for Human Research
- 25. Responsibilities: Responsible Official
- 26. Responsibilities - Research Integrity & Security Director and Staff
- 27. IRB Committee Membership
- 30. Responsibilities of IRB Members, Chair, and Co-Chair
- 35. Requirements and Responsibilities of Principal Investigators for Human Research Projects
- 38. Responsibilities - Researchers
- 48. Outreach to Research Participants and the Community
Overview: Ethical Standards and Federal Regulations for Human Research Subjects
- 50. Ethical Foundation - The Belmont Report
- 51. DHHS Regulations for the Protection of Human Research Participants
- 52. DHHS Regulations - The Common Rule
- 53. DHHS Regulations - Criteria for IRB Approval
Agency-Specific Requirements for Human Subject Research
- 60. Department of Defense (DoD) Regulations for Human Research
- 75. Department of Education (DoEd) Regulations for Human Research
- 76. Additional DoEd Regulations - Family Educational Rights and Privacy Act (FERPA)
- 77. DoEd: Exceptions to FERPA Requirements
- 78. Additional DoEd Regulations - Protection of Pupil Rights Amendment (PPRA)
- 80. Department of Energy (DoE) Regulations for Human Research
- 85. Department of Justice (DoJ) Regulations for Human Research Protection
- 90. Environmental Protection Agency (EPA) Regulations for Human Research
- 100. Overview of FDA Regulations, Information Sheets and Guidance
- 101. FDA Regulations for the Protection of Human Research Participants
- 105. FDA Regulations for IRB Review and Approval
- 110. Investigational Drug Research
- 115. FDA Regulations for Treatment or Emergency Uses of Investigational Drugs
- 120. Investigational Device Research and Exempted Device Investigations
- 125. Humanitarian Use Devices
- 130. Emergency, Compassionate, Treatment, and Continued Uses of Investigational Devices
- 135. Clinical Trial Requirements
- 137. HIPAA and Human Research Conducted under the University's Human Research Protection Program
- 140. VA Regulations and Requirements for the Protection of Human Participants: Overview
- 145. Additional VA Requirements - Recruitment and Consent
- 150. Additional Requirements for VA Research Involving Vulnerable Populations
- 155. Additional Requirements - IRB Review and Documentation for VA Research
- 165. Problems in VA Research - Reporting, Review, and Notification
- 170. Nevada State Laws for Human Research
- 175. Process for Resolving Conflicts Between Federal, State, and Local Laws
Research Populations
- 200. Selection of Research Participants
- 201. Exempt Research and Vulnerable Populations
- 210. Research Involving Pregnant Women, Fetuses, and Neonates
- 211. Research with Pregnant Women or Women with the Potential to Become Pregnant
- 215. Research Involving Prisoners
- 216. Unexpected Incarceration of a Research Participant
- 230. Research Involving Children
- 240. Research Involving Adults with Impaired Decision-Making Capacity
- 246. Research Involving Economically or Educationally Disadvantaged Persons
- 250. Research Involving Persons Who Do Not Speak English
- 280. For Investigators Conducting International Research
- 285. Secondary Use of Data
Recruitment and Consent
- 300. Recruitment Settings and Procedures
- 302. Recruitment Materials and Combined Recruitment/Consent Materials
- 305. Inherently Influential Recruitment Situations
- 308. Recruitment Incentives/Payment for Participation
- 310. Assessing for Eligibility
- 315. Requirements for Recruitment by External Researchers
- 325. Informed Consent Requirements
- 326. Short Form Written Consent Documentation
- 330. Informed Consent - Greater than Minimal Risk Research
- 335. Waiver/Alteration of Informed Consent and Waiver of Documentation of Consent
- 340. Informed Consent for Exempt and Minimal Risk Research
- 342. Informed Consent and Incomplete Disclosure or Deception
- 343. Informing Participants of Research Costs
- 345. Photo and Video Release Forms
- 346. Consent and Early Withdrawal or Cessation of Participation
Risks, Benefits, and Safety Monitoring
- 351. Research Risks
- 360. Benefits
- 370. Assessing Reasonableness of Risks in Relation to Benefits
- 375. Monitoring Data for Participant Safety
Privacy and Confidentiality
- 400. Participant Privacy versus Data Confidentiality
- 405. Protecting Participant Privacy
- 410. Maintaining Data Confidentiality
- 420. Disclosing Findings to Participants
- 425. Certificates of Confidentiality
Submission Requirements
- 500. Submission Types in IRBNet
- 501. Requirements for External Investigator to Use a University IRB
- 506. New Projects - Submitting for Human Research Determination
- 507. New Projects that May or May Not Be Human Research
- 510. New Projects - Submission Requirements for Full Committee Review
- 511. New Projects - Submission Requirements for Expedited Review
- 512. New Projects - Submission Requirements for Exempt Review
- 513. New Projects - Submission Requirements for Administrative Review
- 515. Continuing Review: Submission Requirements for Full Committee Review
- 516. Continuing Review or Progress Report: Submission Requirements for Expedited Studies
- 518. Updated Documentation for Use of External IRB
- 520. Project Amendments: Overview of Requirements
- 521. Submitting Amendments for Full Committee or Expedited Review
- 522. Changes to Personnel or Study Sites for Non-Exempt Research
- 540. Closing a Research Project Involving Human Participants
Review Types and Processes
- 550. Research Integrity & Security Oversight and IRB Review
- 551. IRB Review Types
- 552. Research Integrity & Security Assessment for Completeness and Review Type
- 554. Research Integrity & Security Assessment for Completeness Clinical Trial Agreement
- 556. Reviewer Assignment and Notification
- 557. Using Consultants for IRB Reviews
- 559. Review Materials and Worksheets
- 560. New Projects: Full Committee Review
- 561. New Projects: Expedited Review
- 562. Continuing Reviews, Full Committee
- 563. Continuing Reviews, Expedited
- 564. Amendment Reviews, Full Committee
- 565. Amendment Reviews, Expedited
- 566. Exempt Review and Approval
- 574. IRB Review of Community Based Participatory Research
- 575. IRB Review of International Research
- 576. IRB Review of Research with Potentially Hazardous Biological Agents
- 580. Documentation of Reviewer Recommendations
- 585. IRB Actions
- 590. Notifying Investigators and Others of Review Results
- 591. IRB Requested Revisions: Investigator Response and IRB Review
- 595. Determining Dates for Full Committee and Expedited Reviews
IRB Records
- 600. Evaluation of IRB Membership and Selection of Reviewers
- 610. Project Status
- 615. Using Consultants for IRB Reviews
- 626. IRB Minutes
- 630. IRB Meetings
- 650. IRB Records
Problems
- 700. Reporting Complaints and Problems in Research
- 705. Assessment of Complaints and Problems in Research
- 720. Noncompliance
- 730. Unanticipated Problems Involving Risks to Participants or Others
- 735. Protocol Deviations
- 740. Suspensions or Terminations of IRB Approval
- 750. IRB Notification Requirements for Reportable Events
Quality Improvement Program
- 800. Quality Improvement Program
- 801. Random Scheduled Review
- 802. Directed On-Site Review
- 803. Informed Consent Review
- 804. Internal Assessment Review
- 815. Educational Outreach