Investigator Handbook
Full Table of Contents

1. INTRODUCTION TO HUMAN SUBJECTS RESEARCH
   Ethical Principles
   The Nuremberg Code
   The Declaration of Helsinki
   The Belmont Report
   Good Clinical Practice
   Scientific Pre-Review
   
   
2. INVESTIGATOR RESPONSIBILITIES
   Human Subjects Protection Education
   Maintenance of Research Study Documents
   Overview of UTHSC-H Process for Reviewing Human Subjects Research
   Clinical Trials Registration
   
   
3. THE ROLE OF THE CPHS
   Federal Wide Assurance
   Areas of Jurisdiction for the CPHS
   CPHS Committee Guidelines and Membership
   IRB Fees
   
   
4. THE CPHS REVIEW
   Research Subject to CPHS Review and the Review Process
   Submitting a Research Protocol for CPHS Review in iRIS
   Enter/Submit the Protocol and Grant Application thru iRIS
   Attach Informed Consent Documents, Releases and Translations
   Attach Letters of Support/Approval
   Attach all Educational and/or Recruitment Material
   Determining if you are exempt from CPHS Review
   Determining if your review can be expedited
   Risk/Benefit Analysis
   The Full Review
   Continuing Review
   If Your Approved Research is Changed
   Review of Deviations or Violations to Your Protocol
   
   
5. THE INFORMED CONSENT
   Reasons for the Informed Consent
   Eight Elements of Informed Consent
   Additional Elements of Informed Consent
   Authorization
   Format and Style of Informed Consent Documents
   Translating Informed Consent
   Waivers or Changes to the Informed Consent
   Guidelines For Enrolling Emergency Department Patients In Research Studies.
   Protocols Using Deception In Research.
   Certificate of Confidentiality
   Consent for use of Fetal Tissue in Research
   Consent for Stored Specimens
   Telephone Consent
   
   
6. RESEARCH SUBJECTS
   Guidelines to Recruitment of Research Subjects
   Finder's Fees
   Payments to Subjects
   Vulnerable Populations
   Children
   Pregnant Women, Neonates, or Human Fetuses
   Prisoners
   Confidential Follow-up Forms
   Conducting Genetic Research
   
   
7. INVESTIGATIONAL DRUGS, AGENTS, BIOLOGICS, AND DEVICES
   Investigational New Drug (IND) Applications
   Trial Phases Involving Investigational Drugs and Biologics
   Research Not Requiring an IND
   Investigator Responsibilities Under INDs
   Treatment Use of Investigational Drugs
   Consenting Individuals Under INDs
   Devices
   Investigational Medical Device
   Determining Non-Significant Risk and Significant Risk
   Exemptions for IDE Requirements
   Use of an Investigational Device
   Humanitarian Use Device
   Physician or Health Care Responsibilities for the Use of HUD
   
   
8. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT
   Direct Identifiers (18 HIPAA Identifiers)
   Permitted Use or Disclosure of PHI in Research
   Authorization
   Waiver of Authorization
   De-Identified Data
   Limited Data Set
   Reviewing PHI Preparatory to Research
   Tracking Requirements for Disclosures of PHI
   HIPAA Exemptions
   
   
9. UNANTICIPATED PROBLEMS, SAEs AND EMERGENCIES
   Unanticipated Problems
   Serious Adverse Events (SAEs)
   Reporting SAEs to the CPHS
   Adverse Event Evaluation/Reporting Guide
   Definitions
   Data Safety Monitoring Boards
   Correspondence with Outside Agencies
   Using an Investigational Drug or Unapproved Medical Device in an emergency
   Emergency Use of an Investigational Drug
   Emergency Use of an Unapproved Medical Device
   
   
10. OTHER CONSIDERATIONS
    Medical Record Review for Research Purposes
    Guidelines For Blood Draws in Pediatric Populations
    International Research
    Research Conflicts of Interest
    Compliance and Auditing
    FDA Inspections
    Responding to Research Subjects’ Complaints or Requests for Information
    Classroom Projects

Other Resources

• UT HOOP
• FDA Human Research Regulations
• FDA Good Clinical Practice
• Glossary
  
• NIAID template for Minimal Risk Projects