Policy Manual Definitions
Browse definitions of the technical terms in the Research Integrity 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 IRBs for Non-Exempt Human Subject Research
- 4. External 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: RIO Director and Staff
- 30. Responsibilities of IRB Members, Chairs, and Vice Chairs
- 31. Responsibilities: IRB Members
- 35. Requirements for University of Nevada, Reno and University Affiliate Principal Investigators
- 36. Principal Investigator Responsibilities
- 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 Subjects
- 52. DHHS Regulations: The Common Rule
- 53. DHHS Regulations: Criteria for IRB Approval (45 CFR 46.111)
Agency-Specific Requirements for Human Subject Research
- 60. Department of Defense (DoD) Regulations for Human Subject Research (32 CFR 219)
- 75. Department of Education (DoEd) Regulations for Human Subject Research (34 CFR 97)
- 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 (34 CFR 98) (PPRA)
- 80. Department of Energy (DoE) Regulations for Human Subject Research
- 85. Department of Justice Regulations for Human Research Protection
- 90. Environmental Protection Agency (EPA) Regulations for Human Subject Research (40 CFR 26)
- 100. Overview of FDA Regulations, Information Sheets and Guidance
- 101. FDA Regulations for the Protection of Human Subjects
- 105. FDA Regulations for IRBs with FDA Exemption Categories
- 110. Investigational Drug Research
- 115. FDA Regulations: 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
- 140. VA Regulations and Requirements for the Protection of Human Subjects: 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 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 Childrenand Mature Minors
- 240. Research Involving Adults with Cognitive Impairment
- 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
- 505. Using an External IRB
- 506. New Projects: Submitting for Human Research Determination
- 507. New Projects that May or May Not Be Human Subject 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: Submission Requirements for Expedited Review
- 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. RIO Oversight and IRB Review
- 551. IRB Review Types
- 552. RIO Assessment for Completeness and Review Type
- 556. Reviewer Assignment and Notification
- 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
- 577. Multi-Site Research
- 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. IRB Membership and Evaluation
- 610. Project Status
- 615. Using Consultants for IRB Reviews
- 626. IRB Minutes
- 630. IRB Meetings
- 650. IRB Records
Problems
- 700. Reporting Complaints, Deviations, Noncompliance, or Problems
- 705. Assessment of Complaints, Deviations, Noncompliance, and Problems
- 720. Noncompliance
- 730. Unanticipated Problems and Adverse Events
- 731. Deviations versus Noncompliance; Adverse Events versus Unanticipated Problems
- 735. Protocol Deviations
- 740. Suspensions or Terminations of IRB Approval
- 750. IRB Notification Requirements for Reportable Events
Quality Improvement Program
- 800. Quality Improvement Program (QIP)
- 801. Purpose
- 802. Objective
- 803. Selection of Studies for Quality Review
- 804. Types of Quality Reviews of Research Team Files and Activities
- 805. Arranging for Quality Reviews of Research Team Files and Activities
- 806. Elements of Quality Reviews of Research Team Files and Activities
- 807. Report of Review Findings for Quality Reviews of Research Team Files and Activities
- 808. Response to Review Findings and Corrective Action Plan
- 809. IRB Review of Report Findings and Corrective Action Plan
- 810. Types of Quality Reviews of the RIO and the IRB
- 811. Elements of Quality Reviews of the RIO and the IRB
- 812. Report of Review Findings for Quality Reviews of the RIO and the IRB
- 813. Audit Reports Submitted from Outside the RIO
- 815. Educational Outreach