Policies & Guidance Institutional Review Board

Human Research Protection Program

100-01

Federal-Wide Assurance

100-02

Components of the Human Research Protection Program

100-03

State Laws Related to Human Subject Research

100-04

Fees

IRB Membership

200-01

IRB Membership

200-03

Conflict of Interest - IRB Members

200-04

IRB Autonomy and Function

IRB Review Process

300-01

Research Which Requires Review by the IRB

300-02

Exemptions

300-03

Review Procedure

300-04

Continuing Review

300-05

Expedited Review

300-06

Modifications and Protocol Amendments

300-07

Informed Consent

300-08

Short Form Consent

300-09

Research Involving Children

300-10

Research Involving Pregnant Women, Fetuses and Neonates

300-11

Research Involving Prisoners

300-12

Research Involving Cognitively Impaired

300-13

Reporting Problems

300-14

Data Safety Monitoring

300-15

Department of Defense

300-16

Department of Education

300-17

Environmental Protection Agency

300-18

International Research

300-19

Payment to Participants

300-20

Multi-site Research

300-21

Certificate of Confidentiality

300-22

Performance of Biopsies and Other Medical Acts

300-23

Departmentally Funded Protocols

300-24

Research Personnel Not Licensed to Practice Medicine in the State of Texas

Investigational Drugs & Devices

400-01

Investigational Drugs, Agents and Biologics

400-02

Investigational Device

400-03

Humanitarian Device

400-04

Individual Patient Expanded Access Investigational Drug or Biologic

400-05

Individual Patient Expanded Access Investigational Device

IRB Responsibilities

500-01

Appeals to IRB Decisions

500-02

Reporting

500-03

Suspension and Termination of IRB Approval

500-04

Human Subjects Research Non-compliance

500-05

Quality Assurance

500-06

Subject Calls

Principal Investigator Responsibilities

600-01

Principal Investigator Requirements and Responsibilities

Documentation

700-01

Developing Approving and Maintaining IRB Policies

700-02

Record Keeping

Additional Guidance

Contact Us

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Institutional Review Board

3.634 Rebecca Sealy

301 University Boulevard

Galveston, TX 77555-0158

Mail Route: 0158

irb@utmb.edu