Full Board Review
Full Board Review Process
Full board review applies to human subjects research deemed to involve more than minimal risk or for which a wider range of expertise is required for review. In addition, full board review is required for most research activities involving vulnerable subject populations including, but not limited to: pregnant women and fetuses, international research, prisoners, and cognitively impaired/psychiatric patients. Full board review is required for most studies involving active deception.
The research proposal is presented and discussed at a meeting at which a quorum of IRB members are present. For the research to be approved, it must receive the approval of a majority of those voting members present. (Note that, in effect, an abstention counts as a negative vote.) If assigned to full board, you have the opportunity to be available during the meeting to provide additional information or answer questions.
Full board research projects are reviewed annually for renewal and can be renewed as long as the project remains ongoing. The IRB application pieces (narrative, informed consent, etc) must be updated to accurately reflect the research to receive renewal.
Forms are updated regularly to capture changes in regulatory requirements. Use current forms from the website for all submissions.
Preferred submission method: Single email to irb@georgiasouthern. Applications with hand written signatures can be scanned and emailed or official Adobe electronic signatures are accepted.
All applications for full board review must be complete and in the Research Integrity office by the deadlines listed here.
|Please download the forms to edit. Forms can not be opened in Google Drive.|
|Form Name||Additional Form Information|
|IRB Application||Complete for all expedited and full board reviews. Note: Do not include dissertation or thesis chapters. Information required for review must be condensed into the application format.
REQUIRED FOR ALL EXPEDITED AND FULL BOARD- replaces the previous cover page and narrative forms.
|COVID Safety Plan||All research that includes procedures that require in person interaction with participants requires a COVID safety plan. The type of plan is dependent on the research. Follow the decision tree to the correct form for your research.|
|CITI Human Subjects Training||CITI Program training provides social/behavioral content training. Online certificate will be provided to you once the course is completed. Attach certificate or transcript to each protocol submitted. Certificates are not maintained by the IRB. Training certificates from previous submissions are not readily available. Click here for instructions. REQUIRED ATTACHMENT EACH TIME YOU APPLY.|
(Consent format not required.)
|This is a sample of an informed consent document provided on an electronic version of GS letterhead. Any information in the sample should be edited as appropriate for the population you are using and the type of research you are conducting. Click here for further information on HIPAA consent criteria.|
|Informed Consent Checklist||Tool for the construction of an Informed Consent document. – REQUIRED|
(Assent format not required.)
|This is a sample of a minor assent document provided on an electronic version of GS letterhead. Any information in the sample should be edited as appropriate for the population you are using and the type of research you are conducting. Your assent should be on a reading level appropriate for the participant’s age.|
(Consent format not required.)
|Parental consent can follow the same guide as the general consent but should be addressed to the parent and focus on the risk and benefits to their children. Any information in the sample should be edited as appropriate for the population you are using and the type of research you are conducting.|
|Instrument||Please include a copy of all instruments to be used in the research (surveys, questions, etc.)|
|Recruitment Materials||Please include a copy of all materials to be used for recruitment (flyers, emails, etc.)|
|Georgia Southern Survey Policy||Georgia Southern’s Policy on the distribution of surveys to faculty, staff, and students.|
|Sample Letter of Cooperation (LOC or Site Authorization – Not required format)||If subjects are students or employees of another institution, business or unit, you must provide a written letter of cooperation (site authorization) from the institution who is responsible for your subject pool as a condition of your approval. This may be a letter or email from the institutional official who has authority to grant you access. Emails should come from the professional address with the institutional officer and title identified in the email body. All letters of cooperation must clearly identify the investigator and project by title. (See the FAQ for additional information.) Note: If using education data obtained from school records you must include documentation of parental permission for the release of such data under the institution’s Family Educational Privacy Act (FERPA). This may be a copy of the release form, informed consent, or an assurance from the institutional official that such permission has been obtained prior to data release.|
Last updated: 12/8/2020