Templates & Forms
On this page, you will find a variety of forms and templates for use in your IRB submission.
- Not Human Subjects Research and .118 Letter Determination Templates
- Protocol Templates
- Consent Templates
Not Human Subjects Research and .118 Letter Determination Templates
These forms should only be used in cases in which IRB review and approval of your study are not needed. If you have determined that your project requires IRB review and approval, do not submit these forms with your application.
- Not Human Subjects Research Determination (HRP-503e) – If you believe your project does not require IRB review but would like a formal determination of Not Human Subjects Research from the IRB, you may submit this form in RAMP.
- .118 Determination Letter Request (HRP-503d) – 46.118 Determinations can be granted to satisfy federal sponsor requirements (e.g., Just-In-Time) to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects.
Protocol Templates
Every IRB submission requires a study protocol (or a determination form, as described in the section above). Each of the available templates is available below. Please contact the IRB if you have questions about determining which template is most appropriate for your study.
| Template | Description |
|---|---|
| Exempt Protocol | For use with studies that meet the regulatory criteria for exemption. See the IRB's Exempt Review Guidance for more information. |
| Secondary Use Protocol | For use with studies involving ONLY the use of data and/or specimens collected for a purpose other than the current research study. |
| Social-Behavioral Protocol | For use with non-exempt studies involving primarily socio-behavioral research methods. |
| Biomedical Protocol | For use with studies involving biomedical research procedures and/or FDA-regulated drug or device products. |
Consent Templates
Most studies involving interventions and/or interactions with research participants will require some form of consent. You are not required to use these templates, though it is strongly recommended. These templates are designed to meet all of the consent requirements set forth in the regulations and GMU policy.
Exempt Research Consent Templates
For use with studies that meet the criteria for exemption.
| Template/Sample | Description |
|---|---|
| Exempt Consent Template | For use with studies meeting the regulatory criteria for exemption. |
| The following are consent samples which may be adapted and used for Exempt Research instead of the template above | |
| Anonymous Survey - Email Anonymous Survey - Online Anonymous Survey - Paper | For use with anonymous surveys (no identifiers collected) |
| Confidential Survey - Email Confidential Survey - Online Confidential Survey - Paper | For use with confidential surveys (identifiers collected) |
| Focus Group Information Sheet | For use with focus groups |
| Interview Information Sheet | For use with interviews |
| Exempt Research Talking Points Verbal Script | For use in scenarios consent is collected verbally |
Expedited and Full Board Consent Templates
For use with non-exempt studies.
| Template | Description |
|---|---|
| Minimal Risk Consent | For use with studies that are no more than minimal risk and are not regulated by the FDA |
| Social-Behavioral Consent | For use with studies involving Social-Behavioral research methods. If your study is no more than minimal risk, consider using the Minimal Risk Consent Template (above) instead. |
| Biomedical Consent | For use with studies involving biomedical procedures and/or FDA-regulated drugs and devices. |
| Assent | For use with studies enrolling minors and/or adults with diminished decision-making capacity |
| MRI Consent Template | For use with studies involving MRIs |
SONA Recruitment Template
SONA Recruitment: HRP-502e – TEMPLATE SONA Posting Form