Need to know how to submit a research study (called a protocol)? This page is the right place to start!
1st step: Learn about the relevant federal regulations and research ethics standards to be sure your study is compliant with those standards. A web based training is available from the Collaborative Institutional Training Initiative, Miami, FL. This free training program offers dozens of modules related to human subjects research protections. Start with the BASIC modules of either Biomedical studies or Social, Behavioral and Educational (SBER) research modules whichever is more relevant to your study. Then review the list of all other modules to see if any may be relevant to your study, e.g. research involving persons with diminished cognitive capacity. The pass rate for the completion certificate for any module is 80%. Tests may be repeated as often as desired. Training link is here: CITI Training.
Save the module completion certificate to your research file on your hard drive as a labeled document and include it with your protocol submission form as evidence of training. Certificates are good for three years and refresher modules are available at CITI.
2nd step: Describe your proposed study in detail using the new GVSU online application form. Answer each required question as fully as possible in the space provided or indicate that additional materials are attached as separate documents. If you are unsure whether your study requires exempt or non-exempt review, the categories for each review level can be found here. Determining Level of Review . The link to the application forms is here. Note: Only new applications may be completed using these forms. All other types of submissions (amendments, continuing review, unexpected problem reports, etc.) must be submitted using the existing MSWord document forms available in the IRBNet library. Note: Completing the application form on the GVSU web site will not automatically constitute applying for review. The application forms, when completed and saved to your hard drive, will produce a PDF file that then must be uploaded to a new protocol file on IRBNet.org. See step 3 below.
3rd Step: Submit ALL your study documents for a new project via IRBNet. These may include consent forms, surveys, authorization forms from school principals or others, data collection forms, etc. If you are a first time user of IRBNet you will need to register as a user and affiliate with GVSU. Read the IRBNet information( IRBNet Information) to learn how to start a new project, upload and share your study information with your study team members and your Authorizing Official (AO) and submit the package for HRRC review. Once submitted, the package is automatically locked and you will not be able to modify its contents. Be sure you understand the difference between a new project (research protocol study) and a new package (collection of documents submitted for the same protocol). If you have any questions please call the Research Protections Program help desk at 616-331-3197 or email at firstname.lastname@example.org
4th step: Your unit head or their designee (if faculty) or your research advisor (if a student) must electronically sign and authorize your study on IRBNet. For student researchers, some departments require both faculty advisor and unit head authorizations, so check if you are unsure. Note: Your authorizing official must first be registered on IRBNet to access your study materials, review them, and approve your study. The study will not be reviewed by the HRRC until the AO signs the package. You can monitor the date of the AO signature by reviewing the protocol package on IRBNet.
All protocols also must be approved by the Human Research Review Committee before research activities can begin, including exempt protocols. Conduct of unauthorized research is considered serious non-compliance with university policy for the protection of research participants.
You will find answers to commonly asked questions in the FAQ Section.