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

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1	General Information (PDF) Types of Research Case Studies Educational Activities that May Involve Human Subject Research Pilot or Feasibility Research Development Only Protocols Research Using Data, Documents, Records and Biological Specimens Waste or Extra Biological or Diagnostic Specimens Specimens Obtained From "Banks" 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) Initial Submission Of A Study Documents for Submitting for Initial Review and Approval Review Levels Full Investigational Drugs Clinical Investigational Drug Service Form FDA 1572-Statement of the Investigator Investigational Device Research Expedited Exempt Emergency Use Exemption Description of Research Proposal HIPAA, the Privacy Board and the HAC Certificate of Confidentiality Vulnerable Subjects Children/Pediatric Research Cognitively Impaired Non-English Speaking Subjects Illiterate Persons Pregnant Women, Fetuses and Neonates Prisoner Research Data and Safety Monitoring Plans and Boards Subject Injury and Financial Responsibility Genetic Research on Human Biological Specimens Informed Consent P rocess and Documentation Informed Consent Documents/Childrens' Assent Document Waiver of Consent Recruitment Process (Advertisements, Flyers, Brochures and Recruitment) HAC Submission Fees
3	HAC Polices for Ongoing Research Activities (PDF) Conducting an Ongoing Proctocol Amendments Unanticipated Problems Adverse Events, Related and Unexpected Serious Adverse Events Investigational New Drug (IND) Safety Reports for Industry Sponsored Studies Protocol Deviations/Violations Continuing Review
4	Activities Associated with Routine Closure of a Protocol Routine Closure of a Protocol Record Storage
5	Charlie Norwood Veterans Administration Medical Center (VAMC) Information (PDF)
6	Research Non-Compliance (PDF)
7	Information for HAC Members and OHRP Staff Member Information HAC Member Education and Training Conflict of Interest HAC Roster Updates and Registration Updates with DHHS Emergency Use Protocols Exempt Protocols Expedited Protocols Full Review Protocols Amendments and Modifications Continuing Review Unanticipated Problems, Adverse Events and Serious Adverse Events Serious or Continuing Non-Compliance Communication Minutes Documentation HAC Record Storage HAC Members Stipend HAC Administrative Office Staff Information

Revised November 18, 2008. Please send comments, suggestions or questions about this page to Angela Randazzo, hac@mcg.edu.

HAC Policies and Procedures

OHRP-HAC, Pavilion III, CJ-2103
1474 Laney Walker Blvd.
Augusta, GA 30912

706-721-3110 phone
706-721-1482 phone
706-721-1479 fax

Angela Randazzo, hac@mcg.edu

Click here for directions on how to search the PDF's

General Information (PDF)

HAC Policies for Initial Submission of Protocols (PDF)

HAC Polices for Ongoing Research Activities (PDF)

Activities Associated with Routine Closure of a Protocol

Charlie Norwood Veterans Administration Medical Center (VAMC) Information (PDF)

Research Non-Compliance (PDF)

Information for HAC Members and OHRP Staff