What is the IRB?
The Institutional Review Board (IRB) at Cecil College is a formally appointed group of faculty, staff, and administrators who serve to protect the welfare and rights of human subjects involved in research. The IRB follows federal protocols in order to assess the safety of research activity and is guided by the U.S. Department of Health and Human Services Office for Human Research Protections.
For additional information on the importance of the IRB in human subjects research, please see these training videos from The Office of Human Research Protections:
- How IRBs Protect Human Research Participants, a short introduction to the importance of IRBs; and
- www.hhs.gov training videos, a series that explains the nuances of how IRBs work.
What is human subject research?
According to 45 CFR 46.102 (Protection of Human Subjects 2018), a human subject is a "living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
According to 5 CFR 46.102 (Protection of Human Subjects 2018) research is "a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
Why do we need an IRB at Cecil College?
The IRB formed at Cecil following recognition that: IRBs are in place in most academic institutions in the State of Maryland, including community colleges ; research involving human subjects was being conducted on campus; some faculty and staff needed IRB approval for publication and presentation reasons.
How will I know if I need IRB approval?
If your human subjects research will be published (even as a thesis or dissertation) or given as a presentation outside of a Cecil College classroom, you will need IRB approval for your research. Typically, research done for a class presentation, unless it is to be published or presented elsewhere, does not require an IRB approval. However, if the data collected would present a ‘risk’ to the participants in regards to their physical, mental, or psychological health, IRB approval may be necessary.
For more detailed information, please refer to the section titled "Does My Project Need Review?".
My class is doing research for an oral history project, do I need to obtain IRB approval?
No, you do not. This is not considered research because the information collected from the interviews is not intended to develop or contribute to generalizable knowledge. However, if this will be published or presented outside of the classroom you will need approval. Please see the information on class projects under Education & Training.
Does animal testing require IRB approval?
No, animal testing does not need IRB approval. The IRB is responsible for protecting human subjects, not other animals.
What does exempt, expedited, and/or full review mean, and which one does my project require?
Exempt research still requires submission of an application. The determination of the level of review is dependent on the purpose of research, the human subjects under review, the type of intervention to be studied, and the data to be collected and analyzed. More information to help you decide on what level of submission your project requires can be found under New Projects.
When do I need to obtain IRB approval?
IRB approval is required before starting any data collection. Completed applications must be submitted ten (10) business days prior to the next IRB meeting. You may find the application process under New Projects.
What is the application timeline?
The IRB meets monthly during the academic year. Refer to the IRB meeting schedule for more information.
What happens if I wish to start my research in the summer?
Review of applications received during the summer months may be delayed until the end of the second week of the fall semester depending on urgency.
When is the Annual Review Form due?
All projects will submit Annual Review Forms forty-five (45) days prior to the date of the IRB meeting when the initial application was approved.
What if I need to make a change to my research? Can I proceed without approval?
If the PI feels it is necessary to make changes to the research project, the PI must complete the Change Form and submit it to the IRB. No changes or modifications can be made until the IRB has approved them.
What if I identify an adverse event in my research?
Submit an Adverse Advent Form within twenty-four (24) hours. The IRB chair or designee will contact the PI and arrange an interview within ten (10) business days. Data collection must be temporarily discontinued.
What training must be completed as part of the Cecil College IRB process?
PIs and research teams that seek IRB approval will need to complete mandatory training through the CITI program within the past five (5) years. Please refer to Education & Training for more information.