Surgical Research - New Study Guidelines

What should I do if I want to start a new study?
The first step in starting any new study is to consult with the Surgical Research Service if your research is coordinated through this office.
Surgical Research will assist you with all submissions.

What does Surgical Research do for me once I make the contact?
We assist you with all activities related to the development, submission and management of your research project. This includes, but is not necessarily limited to, assisting with:

  • Proper content for your electronic IRB submission;
  • Development of informed consent/parental consent/assent documents;
  • Development of questionnaires/surveys/diaries/ads;
  • All necessary institutional approvals including the following, as needed:
    • Office of Clinical Investigative Services Review;
    • Health System budget approval, if applicable — required when Health System personnel, supplies equipment, buildings, patients, medical records are used;
    • Safety approvals — radiation, biosafety, chemical committees;
    • VAMC R&D Committee, if study is conducted at VAMC.

Once a study is approved, the Surgical Research Service provides the following:

  • Safety reports/adverse event reporting;
  • Protocol deviations/violations reporting;
  • Amendment development/submission for IRB approval;
  • Annual IRB continuation submission;
  • IRB completion/termination reports.

What education and training are required?

  • CITI program required for research team members at »Æ¹Ï¶ÌÊÓƵ (once every three years) and VAMC (bi-annually) chemical, biosafety and bloodborne pathogen modules, if required for your project;
  • Online safety course;
  • One-time attendance at four-hour didactic safety course for anyone working in the lab;
  • Animal training, radiation training, if applicable.

Additional Support
We also offer the following on a fee-for-service basis, based on the level of support needed and the funding available for the study in question:

  • Budget development and routing of budget materials for approval;
  • Institutional Review Board application preparation, submission and maintenance of regulatory documents;
  • Assistance with continuation approvals from the HAC;
  • The services of certified clinical research coordinators (CCRC);
  • Screening of potential subjects for entry into clinical trials;
  • Coordination of the informed consent process;
  • Follow-up according to the protocol requirements;
  • Scheduling of required procedures and laboratory tests;
  • Arrangement for advertising for studies, where appropriate and approved;
  • Collection, processing, storage and shipping of laboratory specimens — all staff are certified to ship hazardous specimens;
  • Storage of blood/fluid in appropriate refrigerators, minus 20 or minus 80 freezers;
  • Completion of case report forms;
  • Assistance with preparation for audits (FDA or sponsor);
  • Assistance with grant application and manuscript writing;
  • Assistance with budget development for any project.

Affiliations / Cooperative Relationships
The Surgical Research Service enjoys a cooperative relationship with Augusta's Charlie Norwood Department of Veterans Affairs Medical Center and Eisenhower Army Medical Center at Fort Eisenhower. Scientific collaborations also exist with the University of Georgia, Georgia Institute of Technology, the University of Florida, Emory University, Duke University, the University of California at San Francisco, the University of California at Los Angeles, the University of California at San Diego, Philadelphia College of Osteopathic Medicine/Georgia Campus, Oregon Health Sciences University, Stanford University Memorial Sloan Kettering, the University of Texas, Southwestern University, Johns Hopkins University, the Medical University of South Carolina, the Department of Energy/Savannah River National Laboratory and National Institutes of Health/Department of Defense.

Our hospital and clinics are fully accredited by the Joint Commission on Accreditation of Healthcare Organizations. We are a member of the Council of Teaching Hospitals of Children's Hospitals and Related Institutions, and the University Health Systems Consortium. Our Hospital is designated a Level 1 Trauma Center, with 478 adult beds; the Children's Hospital of Georgia provides another 154 beds for state-of-the-art pediatric care.