Research Handbook of Policies and Procedures

SUMMARY:
The following handbook provides a comprehensive guide for UH faculty, staff, employees and students regarding the protection of human subjects.

COMPLIANCE AND MONITORING
The Executive Director of Research Services and the Director of Research Compliance are responsible for reviewing and monitoring research protocols involving the use of human subjects.

  Policies: The CPHS Policy Manual

1. BACKGROUND OF CPHS AT UH

• 1.1 Historical Significance of Human Subject Research

• 1.2 Codes of Research Ethics

• 1.3 Administration of Research Ethics - Federal

• 1.4 Administration of Research Ethics - University of Houston

• 1.5 CPHS Authority

2. CPHS STRUCTURE

• 2.1 The Institutional Review Boards' Charge

• 2.2 Membership and Structure of the CPHSs

• 2.3 The Office of Research Policies, Compliance and Committees (ORPCC)

• 2.4 CPHS Meetings

• 2.5 CPHS Policies

• 2.6 Conflict of Interest

3. WHAT IS SUBJECT TO REVIEW?

• 3.1 Definition of Research

• 3.2 Definition of Human Subject

• 3.3 Scope of Review

• 3.4 Research Conducted by "Affiliated Faculty"

• 3.5 Research Projects in which the Researcher is a Consultant

• 3.6 Research Conducted by Students - The Faculty Sponsor's Responsibility

• 3.7 Research Conducted in University Courses

• 3.8 Research Conducted at Another Institution

• 3.9 Research Conducted at UH by Investigators from Other Institutions

• 3.10 Research as Part of Multicenter Clinical Trials

• 3.11 Research in Foreign Countries

• 3.12 Research at a Pilot or Feasibility Stage

• 3.13 Quality Improvement/Program Evaluation Research

• 3.14 Research Involving Secondary or Archival Data

• 3.15 Research Involving Tissue/Blood Samples

• 3.16 Research Involving Deception

• 3.17 Research Involving the Internet

• 3.18 HIPAA and Research

4. HOW TO APPLY FOR REVIEW

• 4.1 The CPHS Process

• 4.2 Primary Types of Review

• 4.3 Full Review

• 4.4 Expedited Review

• 4.5 Administrative Review for Exempt Status

• 4.6 Appeal of CPHS Determination

• 4.7 Application Forms and Original Signatures

• 4.8 Preparing the Application

• 4.9 Designating the Principal Investigator

• 4.10 Summary of Proposal: Rationale and Methods

• 4.11 Specifying the Number of Research Subjects

• 4.12 Women and Minorities in Study Populations

• 4.13 Students or Employees as Research Subjects

• 4.14 Children as Subjects

• 4.15 Prisoners and Institutionalized Persons

• 4.16 Persons Who are Impaired in their Decision-Making

• 4.17 Incentives for Participation

• 4.18 Advertising and Recruitment

5. THE PROCESS OF CONSENT

• 5.1 A Process - Not a Form

• 5.2 When to Discuss Participation

• 5.3 General Requirements of a Consent Form

• 5.4 What Must be Said about the Conduct of the Research

• 5.5 Assessing the Subject's Understanding

• 5.6 Documenting the Subject's Consent with a Consent Form

• 5.7 When to Submit the Form to the CPHS

• 5.8 When the Consent Requirement can be Waived

• 5.9 Confidentiality

• 5.10 Certificates of Confidentiality

• 5.11 Children and Adolescents

• 5.12 Consent and Language Barriers

• 5.13 Cross-Cultural Consent Issues

6. REPORTING UNANTICIPATED PROBLEMS TO THE CPHS

• 6.1 What to Report

• 6.2 Definitions

• 6.3 CPHS Review of Unanticipated Problems

7. NON-COMPLIANCE

• 7.1 Investigation of Allegations of Non-compliance

• 7.2 Reporting Allegations of Non-compliance

• 7.3 Review of Allegations of Non-compliance

• 7.4 Suspension and Reporting

• 7.5 Investigation of Allegations of Non-compliance

• 7.6 Appeals/Reconsideration

• 7.7 Dissemination of Findings

8. CONTINUING REVIEW

• 8.1 Continuing Review

• 8.2 Making Changes in Research Protocols

• 8.3 New Findings

• 8.4 Keeping Records

9. HUMAN SUBJECT RESEARCH TRAINING REQUIREMENTS

• 9.1 Human Research Protection Training
  

• 9.2 Renewal of Training for Human Research Protection
  

10. Sponsored Projects: Additional Requirements

• 10.1 The OCG Transmittal Form
  

• 10.2 Special Situations

• 10.3 Changing the Title of a Research Project

• 10.4 Unfunded Proposals

GLOSSARY TERMS