Welcome to the UT Southwestern Human Research Protection Program (HRPP) policies and guidance page. Our goal is to help ensure compliance with University policies as well as state and federal regulations through education and collaboration with the research community.

The HRPP Policies and Procedures are divided into 10 sections. Use the links below to jump to each section and then you may access each individual policy.

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  0. Information about the HRPP Policies and Procedures
  1. HRPP Office Review
  2. IRB Review
  3. Informed Consent
  4. Recruitment and Advertising
  5. Researcher Education and Training
  6. IRB Composition and Function
  7. FDA Regulated Research
  8. Documentation
  9. Compliance
  10. Miscellaneous
   

  0. Information about the HRPP Policies and Procedures

  0.0 ABOUT THE HUMAN RESEARCH PROTECTION PROGRAM

  1. HRPP Office Review

  1.1. RECEIVING, ROUTING, AND ADMINISTRATIVE REVIEW OF IRB SUBMISSIONS
  1.2. DETERMINING WHETHER AN ACTIVITY IS RESEARCH INVOLVING HUMAN SUBJECTS
  1.3. EXEMPT REVIEW OF RESEARCH
  1.4. STUDY CLOSURE AND INACTIVATION
  1.5. COMMUNICATION WITH OTHER COMMITTEES AND OFFICES
  1.6. RELIANCE ON NON-UT SOUTHWESTERN IRB

  2. IRB Review

  2.1. INITIAL REVIEW OF RESEARCH
  2.2. CONTINUING REVIEW OF RESEARCH
  2.3 MODIFICATIONS TO RESEARCH
  2.4 DOD RESEARCH
  2.5 EXCEPTION FROM INFORMED CONSENT FOR PLANNED EMERGENCY RESEARCH
  2.6 RESEARCH INVOLVING INDIVIDUALS WITH DIMINISHED AUTONOMOUS DECISION-MAKING CAPACITY
  2.7 EXCEPTION FROM INFORMED CONSENT GUIDANCE
  2.8 COLLABORATIVE RESEARCH INVOLVING EXTERNAL INVESTIGATORS/INSTITUTIONS REVIEWED BY UTSW IRB
  2.9 REPOSITORY

  3. Informed Consent

  3.1 INFORMED CONSENT REQUIREMENTS
  3.2 INFORMED CONSENT BY SURROGATE
  3.3 INFORMED CONSENT WAIVERS AND ALTERATIONS
  3.4 INFORMED CONSENT OF SUBJECTS WITH LIMITED ENGLISH PROFICIENCY

  4. Recruitment and Advertising

  4.1 IDENTIFICATION AND RECRUITMENT
  4.2 GUIDANCE FOR ADVERTISING TO RESEARCH SUBJECTS

  5. Researcher Education and Training

  5.1 PRINCIPAL INVESTIGATOR RESPONSIBILITIES IN THE CONDUCT OF HUMAN RESEARCH
  5.2 RESEARCH EDUCATION AND TRAINING
  5.3 FINANCIAL CONFLICT OF INTEREST MANAGEMENT

  6. IRB Composition and Function

  6.1 APPOINTMENT AND EVALUATION OF IRB MEMBERS AND CHAIRS
  6.2 IRB APPROVAL OF RESEARCH
  6.3 CONDUCT OF FULL BOARD MEETINGS
  6.4 IRB MEMBER AND CONSULTANT CONFLICT OF INTEREST

  7. FDA Regulated Research

  7.1 DRUG RESEARCH POLICY AND PROCEDURE
  7.2 DEVICE RESEARCH
  7.3 HUMANITARIAN USE DEVICE (HUD)
  7.4 EXPANDED ACCESS TREATMENT USE OF AN UNAPPROVED DRUG/BIOLOGIC
  7.5 EMERGENCY USE OF AN INVESTIGATIONAL DRUG OR DEVICE

  8. Documentation

  8.1 IRB MINUTES
  8.2 REPORTING POLICY AND PROCEDURE
  8.3 RECORDKEEPING

  9. Compliance

  9.1 COMPLAINTS
  9.2 UPIRSO and UADE (unanticipated problems)
  9.3 NONCOMPLIANCE REVIEW
  9.4 SUSPENSION OR TERMINATION OF RESEARCH
  9.5 REPORTABLE EVENTS GUIDANCE
  9.6 CLINICALTRIALS.GOV REQUIREMENTS

  10. Miscellaneous

  10.0 GLOSSARY OF HUMAN RESEARCH TERMS