GGC IRB SUBMISSIONS REQUIREMENTS - Submission Protocols

GGC IRB SUBMISSIONS REQUIREMENTS - Submission Protocols

GGC IRB SUBMISSIONS REQUIREMENTS - Submission Protocols

The Georgia Gwinnett College IRB will accept both paper and electronic submissions.

For paper submissions, full copies of all materials must be provided to the IRB.
Submissions mailed to the IRB should be addressed to:

Georgia Gwinnett College Institutional Review Board
c/o Dean, School of Liberal Arts
1000 University Center Lane
Lawrenceville, Georgia 30043

Paper submissions may also be hand-delivered to the office of the Dean of the School of Liberal Arts.

GGC Faculty and Staff Research
For faculty and staff research, all materials, including the research protocol, instruments to be administered, and proposed Informed Consent Forms must be submitted at least two (2) weeks prior to the monthly IRB meeting. A copy of the Proposal Submission Form must accompany the proposal. The IRB will complete initial reviews of faculty research projects within four weeks of their submission.

GGC Student Research and Classroom Projects
For student research and classroom projects, all materials must be submitted two (2) weeks prior to the initial decision date desired. This proposal should include a brief description of the research protocol, instruments, the proposed Informed Consent Forms, and a copy of the Proposal Submission Form. The faculty advisor must serve as the PI for student research projects and classroom projects. Whenever permissible, the IRB will handle these projects according to the timeline and procedures for Expedited Review (see below).

Investigators Unaffiliated with Georgia Gwinnett College

As stated above, human subject researchers who are not affiliated with GGC (individuals who are not GGC College students, faculty or staff) must obtain a GGC research sponsor (faculty or staff) who will share responsibility for the conduct of research on campus. These approvals may be indicated in a letter or e-mail to the IRB, or by signature on the Proposal Submission Form. Researchers not affiliated with GGC must also submit an Unaffiliated Investigator Agreement Form and proof of approval (or conditional approval) by the IRB at the researcher’s home institution.

While GGC IRB approval is required before the start of research, it is not required for investigators to contact potential research partners at the college. Such consultations with GGC faculty and staff are informal and are not subject to IRB review or approval until a formal application is made. However, we highly recommend that an outside investigator obtain IRB approval at his or her home institution before contacting GGC faculty, as some college personnel may understandably hesitate to invest effort in a project that has not been vetted by an IRB. Potential GGC research sponsors will typically also want to review the research protocol and recruitment plan, know what that person’s rights (e.g. access to data or a report of the findings) and responsibilities (e.g. recruitment of participants from the GGC community, administration of instruments) will be, and know about the intended uses of the data to be gathered. A list of GGC departments with links to faculty lists may be accessed at:

Documentation Required for Submission of IRB Protocol

The following is a checklist of the required documentation for proposals. All documents can be downloaded from the GGC website.

Required documents for investigators applying for initial approval of a proposed research protocol:

  • Human Subjects Research Form, signed by the Investigators, and their Advisor (if applicable)
  • Investigator Letter of Assurance of Compliance
  • Student Consent to Release of Educational Record (students only)
  • Letters of Cooperation
  • Questionnaires & assessment instruments
  • Proposed informed consent document/Assent (if applicable)
  • Proposed subject instructions
  • Documentation of completion of approved research training course
  • Supporting material, such as examples of recruitment advertising, etc.
  • Grant application (if applicable)
  • DHHS-approved sample consent document (when one exists)
  • The complete DHHS-approved protocol (when one exists)
  • Data Safety Monitoring Plan (DSMP) or Data and Safety Monitoring Board (DSMB), if applicable for more than minimal risk research
  • Investigator Brochure, or device specifications (if applicable)
  • In addition, applicants may be required to submit:
  • Financial Disclosure Statement
  • Documentation of completion of required human subjects education (when requested)
  • FDA Form 1572 (drug study) or signed Investigator Agreement (device study)
  • HIPAA form (if applicable)
  • If additional IRB review being sought at another institution: Name, address and telephone number of IRB, and copy of the other IRB’s approval.
  • Documentation of approval by another university committee, e.g. Biosafety Committee and Radiation Committee
  • Grant or contract of funding agency minus the budgetary pages

Required documents for investigators applying for acknowledgement of Exempt Status for a proposed research protocol:

  • Exempt Certification Form with all appropriate signatures
  • Questionnaires, Survey, Interview Questions (if applicable)
  • Informed consent (if appropriate)
  • Advertisements (if applicable)
  • Documentation of completion of required training (when requested)
  • Letters of cooperation
  • If additional IRB review being sought at another institution: name, address and telephone number of IRB, and copy of the other IRB’s approval.

Submission Requirements for Protocol Change and Continuing Review

During the approval period, Investigators must submit documentation to inform the IRB about proposed changes to the study including, but not necessarily limited to:

  • Completed Protocol Change Form
  • Current approved consent/assent document (if applicable)
  • Revised IRB Human Subject Review Form or Exempt Certification Form if change is significant
  • Investigator’s Protocol or Sponsor’s protocol (if applicable)
  • Any other relevant documents provided by the Investigator
  • Interim results

Incorrect/Incomplete Documentation

If the IRB Vice Chairperson or IRB Staff determines that the submitted documents are not adequate, Investigators may be required to submit additional information, or their presence may be required to answer questions or explain the details of the study. No incomplete submissions will be reviewed by the IRB.

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