IRB Policies and Procedures

The policies and procedures of the Institutional Review Board provide detailed directions and explanations on a multitude of topics pertaining to research.

Download The Institutional Review Board Policies and Procedures Manual for Research with Human Subjects

Section 1: Introduction

• 1.0 Background
• 1.1 Institutional Review Board
  • 1.1.1 Administration of Research Ethics at Texas Tech University
  • 1.1.2 Composition of the Institutional Review Board

Section 2: The IRB and Training

• 2.0 Committee Members
• 2.1 Education/Training

Section 3: Institutional Review Board Procedures

• 3.0 Does the project involve human subjects research?
• 3.1 Proposal Processing and Assignments
• 3.2 Types of Proposals
  • 3.2.1 Exempt Proposals
  • 3.2.2 Expedited Proposals
  • 3.2.3 Full Board Proposals
• 3.3 Review Criteria
• 3.4 Appeals of IRB Decisions

Section 4: Background of Proposals

• 4.0 General
• 4.1 IRB Approval from TTUHSC and other Institutions
• 4.2 Proposals Involving External Funding
• 4.3 Payment to Research Subjects
• 4.4 Recruiting of Subjects by Subjects
• 4.5 Risk
• 4.6 Electronic Data Policy
• 4.7 Subject Pools

Section 5: Preparing and Submitting Proposals

• 5.0 About Proposals
• 5.1 Recruiting Materials
• 5.2 Informed Consent
  • 5.2.1 Written Consent Form
  • 5.2.2 Elements of Consent
  • 5.2.3 Multiple Form Written Consent – Part I, Part II and Part III
  • 5.2.4. Internet Research Consent
  • 5.2.5 Waiver or Alteration of the Elements of Consent
  • 5.2.6 Waiver of Written Consent Form
• 5.3 Continuing Review, Annual Progress Reports, and Termination of Projects
• 5.4 Reporting Adverse Events or Noncompliance
• 5.5 Modifications to Approved Protocols

Section 6: Procedures for Research with Vulnerable Populations

• 6.0 Protected Populations in Research
• 6.1 Inclusion of Fetuses, Pregnant Women, and Human In Vitro Fertilization
• 6.2 Inclusion of Children in Research
• 6.3 Inclusion of Prisoners in Research
• 6.4 Inclusion of People with Limited Competence

Appendices

• A. Nuremberg Code
• B. The Belmont Report
• C. 45 CFR 46
• D. 63 FR 60364-60367
• E. Memorandum of Understanding between Texas Tech University and Texas Tech University Health Sciences Center
• F. Electronic Data Policy Statement
• G. Example Cayuse Proposal for Research Using Human Subjects
• H. Required Elements of Consent
• I. Reviewer Checklist for IRB Proposals
• J. Recruiting Materials
• K. Consent Form Instructions, Examples, Assent Form, and Waivers
• L. IRB Approval Criteria for Prisoner Research