FAQs

BGSU's Institutional Review Board (IRB) reviews all research projects involving human subjects.

If your project/research meets the federal definitions of "research" with a "human subject" your research must be reviewed by the IRB (see below).

Resources for submitting protocols in Cayuse can be found at the Research Compliance Enhancements page. Please email irb@bgsu.edu for any questions.

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizalble knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." (45 CFR 46.102.d)

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information." (45 CFR 46.102.f)

(Revised 07/02/2026)

• Research involving prisoners (e.g. individuals in prisons, halfway houses, certain parolees - e.g., those residing in a treatment facility as a condition of parole)
• Some types of research with children (<18 years old) - for example if a waiver of parental consent if requested
• Research with other vulnerable populations (e.g. insitutionalized individuals, pregnant women)
• Research presenting more than minimal risk
• Research including heightened physical discomfort, risk of injury, or invasion of privacy
• Research involving abuse, drug use, or sexuality
• Certain biomedical and/or experimental procedures
• Use of regulated drug/device, dietary manipulation, or medical/clincal assessment of identifiable patients/volunteers

All BGSU researchers are required to take the CITI Program's Social & Behavioral Research training. Trainings should be completed prior to submission.

CITI trainings are not transferable. This is because institutions can alter which modules are offered within courses.

Before submitting an IRB application, all research personnel are required to complete BGSU’s Human Subjects Training through the CITI Program website. Once the training has been successfully completed, students and graduate students must email irb@bgsu.edu to request access to a Cayuse account.

After receiving access to Cayuse, researchers can begin completing the IRB application, which is available through the system.

Researchers should then develop their informed consent documents.

After all required materials have been prepared, submit the completed IRB application along with any applicable recruiting materials, informed consent documents, and data collection instruments or research protocols (such as questionnaires, focus group questions, interview questions, etc.) through Cayuse for review.

Yes. The IRB periodically revises the protocol application form in order to clarify what information researchers must provide about the proposed study. Using the most recent version of the form will ensure that your submission is processed and reviewed in a timely manner.    

Beginning August 26, 2013, the IRB will utilize an exempt review procedure. This is in addition to the expedited and full board review procedure. In order to facilitate the routing of submissions, the first page of the protocol application form has been updated. 

• For projects receiving Exempt and Expedited review during the academic year, expect to receive results of reviews in 10 to 14 business days following acknowledgement. *Note - turnaround times may vary depending upon the number of submissions in Cayuse.
• Projects requiring full board review are reviewed at the Board's monthly meetings, generally held on the 1st Wednesday of each month. The Office of Research Compliance strives to get review results back to Principal Investigators within 7 - 10 business days of the meeting at which the project is reviewed, depending upon the number of projects on the meeting agenda. See the Institutional Review Board (IRB) for submission deadlines.
• Important - Regardless of the type of review, if you have not heard back from the Institutional Review Board within 15 - 20 business days of submission, please check the status of your submission in the Cayuse system or email the IRB office at irb@bgsu.edu.  

• For projects receiving Exempt and Expedited review you should submit your IRB application at least six weeks in advance of your planned start.
• For projects receiving full Board review you should submit your IRB application for review at the IRB meeting two months in advance of your planned start. See the IRB home page for monthly meeting dates and associated submission deadlines.
• In most cases, following these guidelines should provide sufficient time to allow your project to receive final approval in advance of its planned start date.

The federal regulations governing research with human subjects require review of an active research project no less frequently than once a year. Therefore, the IRB can only approve a project for a maximum of a 12 month period. After the initial approval period, a project can be continued for an additional period at the request of the investigator. Any modifications from the original project must be approved.

Eleven months (or less depending upon specific project characteristics) after initial review, an investigator (and advisor, if the researcher is a student) should receive a Continuing Review Update email.

Complete a Request for Modification/Addendum form and return it and relevant supporting materials (e.g., new/revised recruiting documents, consent forms, data collection instruments, etc.) to Cayuse. The form is available through Cayuse under the More tab in the Letters category. The response commitment for review of modification requests is the same as for new applications (see question 3 above).

Guidance from OHRP states even projects in the analysis stage should receive continuing review. Therefore, you should fill out the form indicating the project is in analysis and return it to Cayuse.com for continuing review processing. For graduate students working on their thesis or dissertation work, it also makes sense to do so just in case their committee asks them to collect more data or recontact participants. Enrollment is open; no enrollment to date. - Submit a Continuing Review/Renewal in Cayuse.

I am actively enrolling subjects according to the IRB protocol; study enrollment is open and ongoing. - Submit a Continuing Review/Renewal in Cayuse.

I finished my work with human subjects and I’m analyzing the data. Should I consider my project completed? -Guidance from OHRP states even projects in the analysis stage should receive continuing review. Therefore, you should fill out the form indicating the project is in analysis and return it to Cayuse for continuing review processing. For graduate students working on their thesis or dissertation work, it also makes sense to do so just in case their committee asks them to collect more data or recontact participants. - Submit a Continuing Review/Renewal in Cayuse. 

Treatment and/or active follow up continues - Submit a Continuing Review/Renewal in Cayuse.

I am no longer requesting more time; the study is completed. - Submit a Project Closure in Cayuse.

Yes, you should be aware of the Health Insurance Portability and Accountability Act (HIPAA) and its impact on research with human participants. This act was passed in 1996 as part of an effort by the Federal government to standardize and provide safeguards for the electronic transmission of health information of U.S. citizens. Two standards or "rules" have been published - The Transaction Rule and the Privacy Rule. The Privacy Rule has specific requirements related to the use and/or disclosure of protected health information for research purposes .

This PowerPoint presentation provides basic information regarding the "Privacy Rule" and research. Contact the Office of Research Compliance for assistance.

Department of Health and Human Services' Office for Civil Rights on research aspects of the Privacy Rule.

The Department of Health and Human Services has developed a page to provide more information about the HIPPA Privacy Rule and Research.

Since the launch of Cayuse, we no longer stamp consent forms. Researchers must always use the most recently approved version.

If you are requesting BGSU institutional data (e.g., number of students, emails for specific groups of students, etc.) for projects that include human subjects data, then you must get IRB approval for your project prior to submitting the Data Request Form to the Office of Institutional Research, https://www.bgsu.edu/institutional-research/RequestForms.html.

The IRB has the authority to require submission of a completed IRB application by anyone conducting research in which BGSU faculty, staff and/or students are involved as participants. Please contact the IRB Office for additional information.

When you leave BGSU, IRB approval of your project is no longer applicable. If you plan to continue the project at your new institution you should seek IRB review through that organization.

The federal Office for Human Research Protections (OHRP) has developed an International Compilation of Human Subject Research Protections (Note - this compilation has been updated for 2026). This compilation lists the laws, regulations, and guidelines of 84 countries (over 900 laws regulations, and guidelines). The compilation can be accessed on the OHRP website at: http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html.

EU Projects: The General Data Protection Regulation (GDPR) is a European Union (EU) privacy law that governs how organizations collect, use, store, and share personal data of individuals located in the EU. GDPR may apply to research conducted by BGSU if researchers collect, process, or analyze personal data from individuals in the EU, even when the research is conducted in the United States. Researchers planning to recruit participants in the EU or use identifiable data from EU residents should consult the IRB and appropriate university offices early in the project planning process to ensure compliance with applicable privacy requirements.

An Inter-University Authorization Agreement (IAA) can be used for collaborations on non-Exempt IRB projects. The IAA should be issued by the institution at which the IRB is to be the IRB of record, typically wherever the project has already been reviewed and approved by an IRB. If you have an approved BGSU IRB application and would like to get an IAA started, please email irb@bgsu.edu with your name, approved project name and title, and the name(s) of collaborators and their affiliated institution(s). Please allow up to five business days for the IAA request to be processed.

*Note: Not all institutions are willing to enter into an IAA and review times may be longer (weeks to months). Exempt projects are NOT eligible for an IAA, per federal regulations. BGSU does not enter IAAs with external individuals not working for an organization that does not have an active FWA.