Medical College of Georgia - Research - Office of Human Research Protection - IRB

HAC Policies and Procedures

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1

General Information (PDF)

                        Types of Research

                        Performance Sites

                             External Sites

                        Life Cycle of a Typical Protocol

 
2

HAC Policies for Initial Submission of Protocols (PDF)

                       

                        Required Education

                       

                        OCIS Health Service Review Office (HSRO)

                       

                                   Review Levels

                                    Full  

                                                Drugs, device and biologics

                                                Clinical Investiagtional Drug Service

                                                Medical Device Research  

                                    Expedited

                                    Exempt  

                                    Emergency Use Exemption

                        Description of Research Proposal

                        Vulnerable Subjects

                                    Pediatric

                                    Cognitively impaired

                                    Non-English Speaking Subjects

                                    Illiterate Persons

                                    Pregnant Women and other pregnancy related issues

                                    Prisoner Research

                        Genetic Research of Human Biological Specimens

                        Data and Safety Monitoring Plans and Boards

                        Subject Injury and Financial Responsibility  

Research Informed Consent

Waiver of Written Consent

HIPAA, the Privacy Board and HAC

Certificate of Confidentiality  

Recruitment Process

                                    Advertisements

                                    Flyers

                                    Brochures

                                    Recruitment Plans

HAC Submission Fees  

3

 HAC Polices for Ongoing Research Activities (PDF)

                        Amendments

                        Unanticipated Problems

                        Adverse Events/Serious Adverse Events  

                        Investigational New Drug (IND) Safety Reports 

                        Protocol Deviations/Violations             

                        Continuing Review

4

HAC Polices for Termination/ Closure of A Study (PDF)

                        Closing or Termination of a Protocol                

Record Storage

                                    Investigator

                                    HAC

5 Augusta Veterans Administration Medical Center (VAMC) Information (PDF)
6 Research Non-Compliance (PDF)
7 HAC Membership Polices and Procedures (PDF)
8 HAC Administrative Office Staff Information (PDF)

 

Revised 11/19/2007, 1/30/2008