- Review the information on the Charles Center's Research Involving Human Subjects webpage. All human subjects research must be reviewed by the W&M Institutional Review Board (IRB).
- You and your faculty mentor/PI must complete the CITI training modules.
- Choose one of the following options:
- If you or your faculty mentor have already obtained or requested approval from the IRB for your summer research project, provide the IRB number on your grant application (format is IRB-year-month - Study Name).
- If you know you will conduct research with human subjects later on in your project but are not yet ready to request IRB approval, please begin a protocol through the SPARCS system and choose "118 Determination" under "Type of Review/Overview" in the Overview section. After answering the questions and submitting the protocol, provide the IRB number on your grant application (format is IRB-year-month - Study Name).
- IRB number must be included on your application to be considered for funding. You must have submitted a IRB protocol or .118 Determination for approval before applying for a Charles Center research grant (it is okay if you are still waiting for approval at the time you apply).
- If you have questions, please contact researchcompliance@wm.edu.
This determination letter allows you to receive grant funding when you intend to conduct human subjects research in the future (90 days or later from award setup), but are not at the point where you have a definite plan ready for review by the IRB. Here are the questions you will be asked on the .118 Determination Form:
- Provide a non-technical description of the research project as is currently known, such as the purpose, study population information, procedures, etc.
- Describe what must be done before human participants would be involved in the research project (e.g., development of measures, recruitment materials, assays, etc.)
- Provide a timeline for the protocol development and when it is expected that an application for research involving human subjects will be submitted to the IRB.
- Please upload any documents related to this .118 Determination, such as the grant application, a brief protocol document, etc.
Please note that while you may obtain a .118 Determination Letter at the time you submit your grant application, you still submit a protocol to the IRB and receive full approval before beginning human subjects research.
Allow at least 3-4 weeks for approval after submitting your IRB protocol- start early! Allow even more time for research conducted involving participants from countries outside the U.S.