The rules for IRB review and exemption may differ if the bases for the institutional assurances are founded upon documents other than the Belmont Report and the Common Rule and research is conducted in countries outside the United States by foreign Principal Investigators. Research conducted in countries outside the United States by U.S.-based Principal Investigators is still covered by the US regulation. However, cultural context must be included in the evaluation of risk associated with the research.
Researchers are responsible for compliance with research licensure and approvals required by Foreign jurisdictions.
International Human Research Standards (DHHS compiled listing – not exhaustive)
International Social and Behavioral Research Regulations (Compiled by the NIH – not exhaustive)
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.
|Form Name||Additional Form Information|
|IRB Application–NEW||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.
|International Supplement||Required for all international IRB applications|
|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 EACH TIME YOU APPLY.|
|Informed Consent Sample||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 -UPDATED||Tool for the construction of an Informed Consent document. – REQUIRED|
|Minor’s Assent Form Sample||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.|
|Parental Informed Consent Sample||This is a sample of a parental 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.|
|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)||If subjects are students or employees of another institution, include a written letter of cooperation from the subjects. This may be a letter or email from the institutional official’s 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 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: 3/9/2020