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BaptistHealth System
Human Research Review Board

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
MANAGING THE PROJECT
  • 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
CLOSING OUT THE PROJECT
  • 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
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