New Study Application
NOTE FOR MAC USERS: If completing IRB forms using a MAC computer, please place an “X” next to any check boxes that need checking.
Expedited/Full Board New Application
- Expedited/Full Board New Application (UPDATED)
- Appendix A – International (NEW)
- Appendix B – Drugs (NEW)
- Appendix C – Device (NEW)
- Appendix D – Samples (NEW)
- Appendix E – Genetics (NEW)
- Exempt New Submissions Application
- Determining if Research is Exempt
- PowerPoint Presentation on Exempt Studies
Still Unsure Which Application to Complete
The exempt application can be used for research that is not subject to the regulations that govern human subjects research. Once the IRB has determined that your research is “exempt,” there is no need for further communication with the IRB unless the protocol changes. You can use the exempt application for several types of clearly defined research. These are listed at the beginning of the exempt application. In addition, use the exempt application if you are not sure whether what you plan to do even meets the definition of human subjects research. The IRB will make that determination for you once you submit an exempt application.
What type of research does not fall into the exempt category? In general, your research is not exempt (and you must use the Expedited/Full Board application) if:
- it is greater than “minimal risk” (Federal regulations define “minimal risk” as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
- it involves administration or use of drugs or devices
- it involves prisoners as subjects
Please submit the forms to firstname.lastname@example.org or to our address: Institutional Review Board, 25 Buick Street, Room 157, Boston, MA 02215.