When to Submit an IRB Application

BSU, along with many other institutions and organizations, has a federalwide assurance (FWA) on file with the U.S. Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP). This FWA indicates that BSU will protect the rights and welfare of human subjects and comply with all applicable regulations, including the Common Rule. The Common Rule (45 CFR part 46, subpart A) is the federal policy for the protection of human research subjects. Regardless of source of support (e.g., federal or otherwise), the BSU IRB has all human subjects research undergo IRB review that conforms to federal regulations. Investigators should consult BSU's IRB Guidelines for Investigators.

Does My Project Fall Within the Scope of the Regulations?
OHRP has posted an educational video online that discusses how to know when regulations on human research protections apply. The video can be accessed on OHRP's Educational Webinars page. Four key questions that should be considered (in order) are discussed in the video:

  1. Does the activity involve research?
  2. Does the research involve human subjects?
  3. Is the human subjects research exempt?
  4. Is your institution engaged in the human subjects research?

 
An additional resource that can be consulted is the OHRP Human Subject Regulations Decision Charts. Regarding question #3, there are certain instances when human subjects research may be exempt from regulations on human research protections. However, BSU follows OHRP’s recommendation that investigators not make the determination of exemption themselves. Therefore, the only way that a study can be officially determined to be exempt and supporting documentation issued is through formal application to the BSU IRB.

In general, if investigators are unclear as to whether or not they should submit an IRB application, the best course of action is to file an application with the BSU IRB. Visit the related page, “IRB Agreement with Bridgewater State University (BSU).”