Frequently Asked Questions

What is the IRB?

The Institutional Review Board (IRB) is an administrative body that is charged with ensuring the rights of all human subjects participating in research projects are protected.

 

Do I need to submit my research to the IRB for approval? 

A research project must undergo a full review by the IRB if it qualifies as “research," and involves “human subjects." "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. "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.

Your research may be exempt from IRB review if it falls under one of the categories in Appendix 1 of the IRB Manual, which may be found on the "IRB Manual" link on the side bar of this page. You must apply for exemption. Your research may qualify for expedited IRB review if it falls under one of the categories in the list found in Appendix 2 of the IRB Manual. You must apply for expedited review. The proper forms to apply for an exemption or expedited review may be found on the "Forms" link on the side bar of this page.

If you are unsure if your research project requires a full review of research, or qualifies for exemption or expedited review, please consult the advising faculty member overseeing the research.


Can I begin my research and then apply for approval? 

No. Research must be approved by the IRB before any research begins.

 

My research qualifies as “exempt” or “expedited review.” Do I need to submit anything to the IRB?

Yes. You will need to submit the appropriate request form(s) according to the deadlines below. "Exempt" and "Expedited" reviews still require that the investigator provide enough information to fully review the research for risks to the participants, the investigator(s), and the university. The "Request For Research Review" form outlines the information needed in order to reach a decision. 

 

What criteria will the IRB use to decide if my research is approved or not? 

See Section 7 in the IRB Manual, which may be found on the "IRB Manual" link on the side bar of this page.

 

How do I submit my research to the IRB for approval? 

You need to submit the applicable forms to irb@fhu.edu  according to the schedule below. Please note that all requests must have the signature of an advising faculty member.

 

What do I need to to do to complete online ethics training? 

You will be required to complete the Social-Behavioral-Educational Basic (SBE) online ethics training offered by the CITI Program at https://about.citiprogram.org/en/course/human-subjects-research-2/. For FHU faculty, staff, and students, the training is available for free. To create a free account, select "buy now," "register to purchase," and then "Register." Type "Freed-Hardeman University" into the first box to select your organizational affiliation, and follow the registration instructions from there. Research advisors and course instructors might require additional training modules/courses, so please check with your advisor/instructor. 

Completing the certification should take about three hours. Once completed, a certificate is provided. It must be included with your submission to the IRB. Please note that each member of the research team as well as the faculty advisor must submit certification that includes name and date the course was completed. The same certificate can be used for three years. If certified through a training program other than CITI, contact the IRB to ensure it can be substituted for the recommended CITI training.


When do I need to submit my research to the IRB for approval? 

All forms and attachments must be submitted to irb@fhu.edu two weeks prior to the IRB's monthly meeting. Any submissions that are not fully completed by the given due dates will not be considered at the next meeting.

For specific meeting dates, contact the IRB at the email address listed above or by calling the Office of Academics at 731-989-6438.


When should I expect to know if my research was approved? 

You will receive a written notification of the decision within one week after the meeting at which your research was reviewed.

 

Once my research is approved, am I done with the IRB?

No. Your research will need to be reviewed at least once a year if your research project lasts that long. Each year, you will need to apply for project continuation. Please see above for project continuation form.

 

What is informed consent and how can I be sure that I comply with its requirements? 

Human subjects may not be involved in research unless the researcher has obtained informed consent of the subject, unless special circumstances exist. This ensures that the subjects are aware of the risks they may be exposed to as part of the research study. Please see the IRB policy on informed consent in Section 7B of the IRB Manual.

As part of your research request, you will need to document your informed consent procedures. The Informed Consent Templates may be found on the "Forms" link on the side-bar of this page.

If human subjects involved in the research are under the age of 18, you will need to document both your informed consent procedures for obtaining consent from a parent/guardian AND your informed assent procedures for obtaining assent from the minor who is participating. Assent forms provide similar information as the consent form, but use language and terms that are simplified to an age-appropriate level of understanding.


Who serves on the IRB? 

Mrs. Wendy Gean, Chair of IRB and Assistant Professor of Biology

Dr. Aarek Farmer, Associate Professor of Education 

Dr. Paul Helton, Associate Professor of Psychology

Dr. Lee Hibbett, Professor of Marketing

Mr. Perry Hardin, Instructor of Spanish

Mr. Ben Reese, Physician Assistant, Main Street Family Medicine, Henderson, TN

 

What are my intellectual property rights regarding my research?

Please see FHU's policy regarding intellectual property. The text of this policy may be found on the "Forms" link on the side bar of this page.