FAQ - IRB
Questions about the IRB
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).
The IRB strongly suggests that you confirm if your project needs review with the Office of Research Compliance. An informal determination can be made by calling the office (419-372-7716) and a formal determination can be made by completing and submitting the Review Determination Form.
The Review Determination Form can be found in IRBNet. The completed form must be submitted in IRBNet to the BGSU IRB. Instructions for using IRBNet can be found on the IRB home page and in IRBNet under the Forms and Templates section.
“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable 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)
- 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 is requested
- Research with other vulnerable populations (e.g. institutionalized individuals, pregnant women)
- Research presenting more than minimal risk
Researcher Training Requirements
Effective February 1, 2001 BGSU instituted a policy which requires the Principal Investigator (PI) and the PI's advisor (if the PI is a student) to have obtained human subjects training in order for a research project to be reviewed by the HSRB. See the IRB Training page for information.
CITI training completed at another institution is accepted as long as the other institution required the same modules (or more) in the CITI human subjects training as BGSU's. Completed modules and training completion certification must be provided in IRBNet for Board viewing.
Researcher's Questions for IRB Reviews
First, you must complete Human Subjects Training. The University has a requirement that the Principal Investigator (and the project advisor, if the Principal Investigator is a student) complete the training in order to get a project reviewed. Training can be accomplished either by attending a "live" training session or completing web-based training. Information regarding those alternatives can be found here.
Following successful completion of the training, complete the IRB application, which can be found in IRBNet.org.
Next, you should develop informed consent documents. For help in putting the document together, the IRB created an Informed Consent Checklist that identifies the necessary pieces of information to be included in the consent document, and a suggested outline for the consent document. These documents can be found in IRBNet.org.
Finally, submit the completed IRB application, recruiting materials, consent documents and associated data collection instruments or protocol (e.g., questionnaires, focus group questions, interview questions, etc.) as appropriate, in IRBNet.org. Directions on how to submit materials using IRBNet are found on the IRB home page.
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 expedited review during the academic year, expect to receive results of the initial review in 10 to 14 business days following submission. Note that the turnaround time may vary depending upon the number of submissions in IRBNet.
- 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 IRB Review Schedule 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 IRBNet.org system or call the office at 419-372-7716.
- For projects receiving expedited review you should submit your IRB application at least five 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 Review Schedule 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, however (see question 8 for more information on this).
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 form via email. This form asks the investigator to provide information regarding the project, such as the status of the project (completed or continuing), the number of subjects involved, if any adverse events occurred. This form should be returned, along with copies of current consent documents, to IRBNet.org. If the project has been completed, the file will be marked as such and archived. If the project is continuing, it will be reviewed by the IRB. The investigator will be notified of the results of the review, including any changes to consent documents that may be required as the result of guidance provided by the federal government. When approval is granted, it will usually be for a 12-month period, but could be shorter depending upon the specific characteristics of the project. Continuing Review reminders will be sent each year until the project is completed.
Often investigators are students who have finished the project and left BGSU. In that case, it is the advisor's responsibility to complete the form and return it to the Office of Research Compliance along with current copies of consent documents. It is also the advisor's responsibility to know the number of subjects used and whether or not there were any adverse events, withdrawals, etc.
The IRB and Office of Research Compliance appreciate the efforts taken by many of you to complete updates for projects in a timely manner. If you have any questions about the continuing review process contact the IRB - firstname.lastname@example.org/419-372-7716.
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 IRBNet.org. The form is available through www.IRBNet.org. The response commitment for review of modification requests is the same as for new applications (see question 4 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 IRBNet.org 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.
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.
Whenever possible within diverse research protocols, it is recommended that researchers educate themselves about and use inclusive and bias-free language. The Institutional Review Board (IRB) recognizes that there are many types of research and research designs. The IRB reviews research proposals for adherence to ethical principles and guidelines for the protection of human subjects research: Respect for Persons, Beneficence, and Justice.
Protection of Human Subjects Policy 3341-7-7 Research & Economic Development
University Terms and Definitions Key BGSU - Division of Diversity and Belonging
Bias-free Language American Psychological Association Topics include: age, disability, gender, participation in research, racial and ethnic identity, sexual orientation, socioeconomic status, intersectionality
Gender and sexual orientation inclusive language Survey Monkey
The Office for Human Research Protections (OHRP) has issued guidance that recommends Institutional Review Boards put approval and expiration dates on all approved consent documents for projects that undergo Expedited and Full Board. Only the most current dated consent form should be used when obtaining consent. Exempt projects do not have to submit yearly continuing reviews or have consent documents stamped once initial approval is given. Modifications to Exempt projects that change the risks to the subjects must be submitted for review and approval by the IRB.
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. If IRB review and approval is required, see IRB Procedure Statement 03-11-002 Initial Review of IRB Applications – External Researchers at IRB Procedure Statements for instructions.
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 Office of Research Compliance for additional information. If IRB review and approval is required, see IRB Policy/Procedure statement - Initial Review- External Researcher Applications on the IRB Procedure web page for instructions.
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 2008). 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.
Updated: 09/22/2022 08:04AM