Institutional Review Board

Brookwood Baptist Health, its clinical staff, residents, and employees are guided by the ethical principles regarding all research involving human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the "Belmont Report) regardless of whether the research is subject to Federal regulation or with whom conducted or the source of support.

The Institutional Review Board at Brookwood Baptist Health is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted at all inpatient facilities and/or diagnostic or treatment facilities in a hospital owned or operated by the Brookwood Baptist Health. The Brookwood Baptist Health Institutional Review Board is also responsible for ensuring institutional compliance with those ethical considerations contained in the Common Rule. The Institutional Review Board maintains guiding principles and operating policies demanding the highest professional standards in dealing with human subjects and reviews all research projects involving humans subjects to ensure that appropriate standards are met and do not infringe upon the safety, health, welfare, or life of those subjects.

Safeguarding the rights and welfare of human subjects in research is a general institutional policy delegated by the BBH Board of Trustees through the President's Advisory Group to the Institutional Review Board. The Chairman of the Institutional Review Board is responsible for exercising appropriate administrative oversight to ensure that the Brookwood Baptist Health policies and procedures designed for protecting the rights and welfare of human subjects of research are effectively applied in compliance with its Federalwide Assurance from the Office of Human Research Protections (OHRP).

Human Subjects Research Training and Certification

Before submitting an IRB Application, researchers must complete an online orientation and certification course addressing the ethics of human subject research. All key personnel involved in a project (i.e., individuals who will have contact with human subjects, with confidential data about human subjects, data that will be obtained from human subjects, or with chart review) must complete training and provide certification of completion as part of the IRB Application.

Certification must be maintained throughout any human subject research conducted by an investigator. Certification must be renewed every three years.

CITI

The preferred BBH-IRB training is provided by the Collaborative Institutional Training Initiative (CITI) at the University of Miami, which can be found online here. You can also go directly to their website at www.citiprogram.org to register and take the training.

First time users must create an account and associate themselves with Brookwood Baptist Health. Once completed, CITI will issue a completion certificate and notify the BBH-IRB.

The Investigator's Guide to Research Involving Human Subjects

Table of Contents

 INTRODUCTION

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

FREQUENTLY ASKED QUESTIONS

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

GETTING STARTED

  • What is Human Subject Research?
  • What is an Institutional Review Board
  • Who is eligible 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 IRB review?
  • Modifications to approved research

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 Brookwood Baptist Health 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

IRB INFORMATION AND FEE SCHEDULE

  • IRB MEMBERSHIP FWA LETTER
  • 2017 DEADLINE AND MEETING SCHEDULE
  • IRB FEE SCHEDULE

APPENDIX I: SUBMISSION INSTRUCTIONS AND CLOSING OUT THE PROJECT

APPENDIX II: PROTOCOL PREPARATION CHECKLIST

APPENDIX III: CONSENT FORM PREPARATION CHECKLIST

FORMS