The Investigator's Guide to
Research Involving Human Subjects
Table of Contents
- Purpose and history of the Institutional Review Board
- Authority of the Human Research Review Board
- Jurisdiction of Human Research Review Board
- When to obtain Human Research Review Board Approval
- Working with the approved protocol
- Submitting the protocol
- Other FAQ's
- 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
- 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
- Amendment
-
Continuing Review
-
Elements of Informed Consent
-
Emergency Use Form
-
New Application
-
SAE Inside BHS
-
SAE Outside BHS
-
Surrogate Consent
-
Termination
-
Consent Form
