IRB Information for Researchers

If your project/research meets the federal definitions of “research” AND “human subject” your research must be reviewed by the IRB. “Research”  is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. “Human subject” is defined as a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information”.  

A formal determination can be made by completing and submitting a completed “Review Determination Form” which can found in the “Forms and Templates” section in the online submission system, IRBNet (www.irbnet.org).  Please note you must register with the system (create a user name, password and affiliate with BGSU) to access this system.  

Step one (Training):

Need completed Research with Human Subjects Training within the past 5 years.

• If you’ve never completed human subjects training, you’ll complete basic training.  BGSU offers online training via CITI (www.citiprogram.org).  
• You can find basic and refresher training information here: http://www.bgsu.edu/research‐economic‐development/office‐of‐research‐ compliance/institutional‐review‐board/human‐subjects‐review‐board‐training‐ schedule.html

Step two (Register with IRBNet):

Register with the online protocol submission system IRBNet (www.irbnet.org). 

• You can find directions on how to register with IRBNet noted below under IRBNet Guidance - IRBNet Registration.  

Step three (Find IRB forms): 

• Once logged into IRBNet, click the Forms and Templates button on the left hand side of the screen to find the New Protocol Application Form.
• If you’ve never written a consent document, you may find the Consent Document Skeleton helpful.

Step four (Prepare and submit materials):

Typically a complete application consists of four types of documents.  These include:  

• IRB application form.  
• Recruitment materials (e.g., verbal script, flyer, email text, etc.).
• Consent document (and child assent document if applicable).   
• Data collection tool(s) (e.g., survey questions, interview questions, description of exercise protocol, etc.).

Directions on how to submit your materials to the IRB for review via IRBNet  are noted below under IRBNet Guidance - Submitting a New Project.