Policy
| Policy | Information |
|---|---|
| RI_101 – Research Compliance Policy | |
| RI_201 –Human Subjects Protection: (IRB) | |
| RI-211 – Faculty Use of Student Data in Research | Procedures for use |
| RI_707 – Minors in Lab | Mentorship procedures. Minors In Lab Release Form Georgia Southern policy on the presence of minors in a lab. |
| RI -401 – Financial Conflict of Interest | Potential conflict of interest in IRB report form Potential conflicts will not affect approval. Unreported conflicts may result in suspension. |
| Human Subject Incentive Payment Policy and Procedure – FS-AP-1304-01 | This is a Finance and Operations Policy. Incentives control log can be found on the finance page under other forms. (Note: where incentives are dispersed as cash, a bank withdraw receipt for that cash is recommended for reimbursement documentation.)Use Travel and Expense reimbursement account code – 751110 – Other Per Diems – if the researcher is requesting the money up front for the incentive OR 752100 – Reimbursable Expense – if the researcher has already given out the incentives and is requesting reimbursement |
| Data Stewardship and Classification Standard | IT policy – Class I – Confidential; Class II – Sensitive with protection defined |
| Security Standards for Information Systems – IT-3610-00 | IT policy – data security requirements |
| Data – Incident Response Policy | IT policy – procedures in the event of a data security event |
| Whistleblower Policy (Non-Retaliation) | Protection for good faith reporting of violations or compliance concerns |
| Georgia Southern Survey Policy | Enrollment Management policy – Use of the GS email system for survey distribution. Access instructions can be found on the Enrollment Management Office of Institutional Research (ORI) website – survey distribution approval procedure. |
Procedures
| IRB Administrative Procedures | |
|---|---|
| SOP H100: Functions & Responsibilities | |
| SOP H101: IRB Protocol Submission | |
| SOP H102: IRB Review & ApprovalFull Board Medical Expedited Exempt | |
| SOP H103: IRB Informed Consent | |
| SOP H104: Continuing Review | |
| SOP H105: Holds; Suspensions; Terminations | |
| SOP H106: Sanctions and Noncompliance | |
| SOP H107: Reporting Responsibilities of the Investigator | Unanticipated and Adverse Events |
| Investigational New Medical Devices | Contact IRB office during the planning stages |
| New Drug Studies | Contact IRB office during the planning stages |
| Clinical Trials.gov | |
| Single IRB – External IRB | |
| Controlled Substances | |
| Definition | |
| FAQs | |
| IRB Medical Procedures | |
| SOP H200: Verification of Pregnancy Status in Research Participants | |
| SOP H201: Collection of Blood Specimens via Fingerstick | |
| Presidential Commission – Incidental and Secondary Findings in a clinical study | |
| FDA and Common Rule Comparison |
Tutorials & Resources
- Informed Consent – What changed in the New Common Rule?
- When Does the Common Rule Apply? Review of the Basics Under the Revised Rule (18:14 min)
- Overview of Changes to Exemptions in the Revised Common Rule – (26:06 min)
- Regulatory Options for Secondary Research with Private Information and Biospecimens (Pt 1-24:59 min and Pt 2-16.02 min)
- Broad Consent in the Revised Common Rule – (17:30 min)
- What’s New in IRB Review under the Revised Common Rule – (8:22 min)
- NIH Clinical Research Videos – What is research?; Clinical Trials; Questions to Ask; Randomization (3 to 7 minutes)
- IRB Short Videos – You must be logged into your my.georgiasouthern.edu portal to view.