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 review by the IRB if it qualifies as “research," and involves “human subjects." In order to have your research approved by the IRB, you must submit your research review request application to CFLOW.
"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) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
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. Even you if 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 project falls under the authority of the IRB, 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.
What is the difference in a "full" review, "expedited" review and "exempt" review? Do all types of research reviews require IRB approval?
All research must be reviewed regardless of the type of review (i.e., full, expedited, or exempt). In order to have your research approved by the IRB, you must submit your research review request application to CFLOW.
The criteria to determine the type of review can be found in the Research Review Request Application as well as in the IRB Manual. "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.
A full review requires the review of the entire IRB.
An expedited review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB at the monthly IRB meeting.
An exempt review must be reviewed, but is exempt from review by the full IRB.
What criteria will the IRB use to decide if my research is approved or not?
See Section 7 in the IRB Manual.
How do I submit my research to the IRB for approval?
A Research Review Request Application should be submitted to CFLOW in order to obtain IRB approval. Specific steps and forms can be found on the Submitting a Research Review Request Application page.
What do I need to to do to complete online ethics training?
You will be required to complete the Social & Behavioral Research online ethics training offered by the CITI Program, which can be accessed here: CITI Program Registration link. For FHU faculty, staff, and students, the training is available for free. To create a free account, type "Freed-Hardeman University" into the first box to select your organizational affiliation, and follow the registration instructions from there. The course consists of 10 required modules plus one elective module from a list of six options. Research advisors or course instructors might require additional training modules/courses, so please check with your advisor/instructor, if applicable.
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 Administrator at firstname.lastname@example.org to ensure it can be substituted for the recommended CITI training.
When do I need to submit my research to the IRB for approval?
The Research Request Review Application to CFLOW, along with all documents and forms can be submitted at any time, however, the submission to CFLOW should take place two weeks prior to the IRB's monthly meeting in order to allow time for review by all committee members. Any submissions that are not fully completed by the given due dates may not be considered at the next meeting.
What decisions might the IRB reach about my research?
The IRB may (a) approve, (b) request modification, or (c) deny research.
A. If approved, you will receive an official letter from FHU's IRB to your email. At that point, you will work with your faculty advisor to begin data collection at the appropriate time. Your approval is good for one year, unless otherwise noted in your approval letter.
B. If modifications are required, you will receive an email with comments and required modifications from the IRB. You will work with your faculty advisor to make revisions. Once revisions have been made, you will modify your original application in CFLOW and upload to CFLOW any necessary documents.
C. If denied, you will receive an official letter from FHU's IRB to your email. You may not carry out any research without an approval letter. You may redesign your study and submit a new research review request application to FHU's IRB, if desired.
When does the IRB meet?
The IRB is scheduled to meet once a month. For specific meeting dates, contact the IRB Administrator at email@example.com.
When should I expect to know if my research was approved?
For full research review requests notification of the IRBs decision should be provided through email within two weeks after the IRB meeting. For exempt and expedited research review requests, a decision may be reached sooner.
Once my research is approved, am I done with the IRB?
Submit the Request for Project Continuation form to the IRB Administrator at firstname.lastname@example.org if you need to extend your study beyond the approved timeframe (most studies are approved for one year).
Submit the Request to Amend Approved Research form to the IRB Administrator at email@example.com if you need to amend your approved research (i.e., adjust your population, instruments, design, etc.).
Once your study is complete, you are required to submit the Notice of Completion form to the IRB Administrator at firstname.lastname@example.org.
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 Review Application, you will need to explain your informed consent procedures. The Informed Consent templates can be found on the Submitting a Research Review Request Application page.
If human subjects involved in the research are under the age of 18, you will need to explain 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.
What are my intellectual property rights regarding my research?
Please see FHU's policy regarding intellectual property. The text of this policy can also be found on the Research Review Request Application.
Who serves on the IRB?
Dr. Aarek Farmer, Chair of IRB and Associate Professor of Education
Mrs. Wendy Gean, Assistant Professor of Biology
Mr. Perry Hardin, Instructor of Spanish
Dr. Lee Hibbett, Professor of Marketing
Dr. Melissa Judd, Asst. Principal, Chester County Middle School
Dr. Stephen Marvin, Professor of Education
Dr. Kimberly Street, Assistant Professor of Clinical Mental Health Counseling
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