Human Research Protection Policy Manual
Policy Manual Definitions
Browse definitions of the technical terms in the Research Integrity Policy Manual.
Below is the complete Human Research Protection Policy Manual.
Contact us with any questions at (775) 327-2368.
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
- 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
- 49. Fees for External User IRB Review
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
- 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)
- 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 Children
- 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
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
- 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
- 553. RIO Assessment for Completeness and Review for Community Based Participatory Research
- 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
- 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
- 740. Suspensions or Terminations of IRB Approval
- 750. IRB Notification Requirements for Reportable Events
Quality Improvement Program
- 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