Forms
| Form | Description |
|---|---|
| Amendment Form | Use to request an amendment to an approved IRB protocol. (Must be accompanied by the updated protocol with changes in underlined text. Only include documents that have changed.) |
| Informed Consent or Authorization Waiver Request | Use this form to request any alteration to the informed consent process, HIPAA authorization or letter of cooperation. |
| Extensions and Terminations | See Continuing Review requirements based on approval type. |
| Adverse and Unexpected Events Reporting Form | Use to report adverse events or unexpected events during the course of a research project. Unrelated events do not need to be reported. (e.g., subject injury in a car accident on the way to the intervention) |
| PHI Authorization Language | Additional information required in an informed consent for use of PHI |
| HIPAA De-Identification Certification Form | Use to certify receipt of data in a de-identified format for HIPAA Safe Harbor purposes |
| Human Subjects Financial Conflict of Interest Disclosure | Use this form to disclose a potential conflict of interest where the researcher has a financial interest in the outcome of the human subjects research. |
| Termination | Direct link to the termination portal |
Tools
| Name | Additional Information |
|---|---|
| Transcriptionist/Translator/Statistician Agreement | Confidentiality Agreement for Use with work for hire translation/transcription/statistics |
| Student Photo Release | Georgia Southern University license to use student photo for commercial and educational purposes |
| License to Use Student Work | Georgia Southern University license to use student work for commercial and educational purposes |
| Georgia Southern University Researcher Participation Standard Release | A waiver of liability for students participating in research projects as student researchers. Waivers should be maintained by the faculty member. If the faculty member leaves GS, all current waivers (less than 3 years or for ongoing field work) must be turned over to the departmental office for retention. |
| Research Collaborator – Assistant Non-Disclosure | Use where identifiable or restricted use data is shared with Research Associates |
| Research Service Non-Disclosure | Use where 3rd party is used to distribute research materials but is not party to research or GS student |
| Individual Investigator Agreement Template | Used were GS faculty collaborate with investigators who are not associated with federally assured institution. |
| Debriefing Sample Script | Use with informed consent where deception or incomplete information is provided to support research aim. |
| Certificate of Confidentiality | NIH issued to protect identifiable research information from forced disclosure |
| FDP Data Transfer & Use Agreement | Use to set up an agreement for the sharing of data in a collaboration (Special uses – HIPAA and FERPA data transfer) |
Policies
| Name | Additional Information |
|---|---|
| Human Subjects Incentive Policy | Policy on the use of human subjects incentives. (Use form below to record distribution/for reimbursement) |
| Human Subjects Incentive Disbursement and Reconciliation Form | Use to record distribution of research incentives. Tab 2 records incentives outstanding over 30 days.(Note: where incentives are dispersed as cash, a bank withdraw receipt for that cash is recommended for reimbursement documentation.)Use account code – 751110 – Other Per Diems (This would be used if the researcher is requesting the money up front for the incentives) OR 752100 – Reimbursable Expense (This would be used if the researcher has already given out the incentives and is requesting reimbursement) |
| Reciprocal Policy | Use where GS faculty is not the PI and another IRB will hold primary approval or the Co-PIs are from other institutions and will rely on our approval.If you are requesting to rely on another IRB’s approval, please submit this request form along with the supporting documentation. |
| Survey Distribution Policy | Georgia Southern policy on requests from on-campus and off-campus entities for the distribution of surveys to various populations – Note: This policy is not an IRB policy and approvals are administered through the Provost’s Office. |