The Investigator's Guide to
Research Involving Human Subjects

Table of Contents

 INTRODUCTION

• Purpose and history of the Institutional Review Board
• Authority of the Human Research Review Board
• Jurisdiction of Human Research Review Board

FREQUENTLY ASKED QUESTIONS

• When to obtain Human Research Review Board Approval
• Working with the approved protocol
• Submitting the protocol
• Other FAQ's

GETTING STARTED

• What is Human Subjects Research?
• What is an Institutional Review Board
• Who is elgible to be a Principal Investigator?
• What kind of approval do I need to begin my human subject research study?
• How do I get started?
• What do I need in order to submit a protocol for Human Reseach Review Board review?
• Modifications to approved reseach

WHAT LEVEL OF REVIEW DO I NEED 

• Exempt Research
• Expedited Research
• Full Committee Research

SPECIAL RESEARCH CONCERNS

• Emergency use of a test article or procedure
• Use of children as research subjects
• Use of fetuses, pregnant women and human in vitro fertilization
• Use of cognitively impaired subjects
• Use of prisoners as subjects
• Use of Baptist Health System staff, residents and employees as subjects

PREPARING AND SUBMITTING THE PROTOCOL AND CONSENT

• Preparing the protocol
• Preparing the consent document
• Submitting the protocol/consent forms
• Additional review requirements

• Issues in recruiting and enrolling subjects
• Changes (Modifications) in the protocol
• Obtaining continuing review
• Obtaining informed consent
• Preparation and maintenance of a research audit file
• Managing the flow of information on the protocol
• Reporting potential adverse experiences/events
• Procedures for resolving regulatory noncompliance

• Exempt Research
• Expedited Research
• Full Committee Research

APPENDIX I: SUBMISSION INSTRUCTIONS

APPENDIX II: PROTOCOL PREPARATION CHECKLIST

APPENDIX III: CONSENT FORM PREPARATION CHECKLIST

FORMS

• Amendment
• Continuing Review
• Elements of Informed Consent
• Emergency Use Form
• New Application
• SAE Inside BHS
• SAE Outside BHS
• Surrogate Consent
• Termination
• Consent Form