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Frequently Asked Questions

Frequently Asked Questions

Who are the members of the IRB committee?
The most current IRB committee membership can be viewed here.
What is the difference between the IRB and the ARC?
The Academic Research Committee (ARC) supports university research through encouraging research initiatives and training, as well as reviewing and awarding funding grants for academic research conducted by Southern faculty. The IRB is a subcommittee of the ARC that is primarily responsible for reviewing, approving, and overseeing all research conducted by Southern faculty and students.
Who needs to submit an application to Southern’s IRB?
Any Southern faculty, staff, and students (undergraduate or graduate) conducting research are required to receive approval from the IRB before initiating research. 

Researchers not affiliated with Southern but who wish to conduct research on Southern's campus are also required to receive IRB approval before proceeding with research activities.
Do I need IRB review if my study is not funded?
Yes, all research must be approved by the IRB regardless of funding status.
What does the IRB look for when reviewing an application?
The IRB looks to ensure that:
  • Risks to participating subjects are minimal and reasonable in relation to anticipated benefits
  • Privacy and confidentiality is protected to the fullest extent possible and at all points in the research process
  • All aspects of the project (research methodology, objectives, consent processes, etc.) meet both federal regulatory and SAU standards
How long will it take to receive IRB approval?
The process of receiving IRB approval can take anywhere from a few days to a few months, depending on the research project and level of review. Factors such as incomplete applications, lack of information or materials, level of proposed risk, and research project scope may impact this process. 

To ensure you receive approval by your projected starting date, please plan ahead.
Can I start recruiting study participants or collecting data while waiting on IRB approval?
No. Projects that are active without prior IRB approval will be found non-compliant and reported to the Academic VP for further action.
Can I make changes to my research study after it is approved?
Yes, minor changes may be requested by submitting a Form B to irb@southern.edu. Major changes will require an updated Form A application to be submitted and approved before moving forward.
What is an adverse event, and what do I do if an adverse event happens during the course of my research project?
Injury associated with the study procedures, deviations from the study protocol, and any breach of human subject protection are examples of adverse events that must be reported to the IRB by submitting an Adverse Event Report Form.
How long should I as the Principal Investigator retain my records?
You should retain all records for a minimum of three (3) years after completion of your research. Specific regulations may require records to be maintained for longer periods.
How long does SAU’s IRB retain my records?
The IRB office maintains application records for at least the minimum length required by the relevant federal regulations. Records are maintained electronically and in a secure manner.
I am a researcher not affiliated with SAU but want to conduct research on your campus. How can I do this?
SAU's IRB office does not act as the reviewing body for research conducted by those not currently enrolled or employed at SAU. 

If you are a researcher at another institution and would like to include SAU as a data collection site in your research (e.g., disseminate a survey to SAU students/faculty or recruit study participants), you must receive permission from our IRB. You must still have IRB approval from the accredited IRB with which you are affiliated. 

Please email irb@southern.edu with your request to conduct research at SAU.

Basic Terms

Research
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. 

A systematic investigation is a research activity defined by a planned approach that includes both data collection (quantitative or qualitative) and data analysis to answer a specific question. If the investigation is designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or internal program (e.g., publications and presentations), it is developing or contributing to generalizable knowledge.

Some common examples of systematic investigations include surveys and questionnaires, interviews, focus groups, analysis of existing data, and cognitive and perceptual experiments.

The intent to contribute to generalizable knowledge qualifies an experiment or data collection as research, regardless of publication. Research that never is published is still research. Human subject participants in research studies deserve protection whether or not the research is published.
Human Subjects Research
Human subjects research is defined as any research that involves living humans about whom a researcher obtains information through intervention or interaction, or identifiable private information.
Generalizable Knowledge
Generalizable knowledge includes conclusions or information that are applicable to populations outside the research subjects, can be used to predict future events, and/or can be broadly applied to enhance scientific or academic theories or principles. Research does not have to be published to be considered as contributing to or developing generalizable knowledge.
Private Information
Private information is any kind of information gathered in a context in which an individual can reasonably expect to not be observed or recorded. Private information also includes information provided by an individual for specific purposes and with the understanding that identifying characteristics will not be made public.
Identifiable Private Information
If the identity of the individual is associated with the information, or may be readily ascertained by the researcher, this is considered identifiable private information

Identifiers may be direct (e.g., name, address, social security number, ID number) or indirect (e.g., a combination of non-direct identifiers, such as demographic information, that can be used together to deduce a participant’s identity, or a code that can be linked back to the participant).
Human Subject
A human subject is living individual about whom an investigator (whether professional or student) conducting research (1) obtains 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.

The investigator does not have to directly interact with the human subject to be conducting human subject research. If the investigator is conducting research involving identifiable private information or identifiable biospecimens, they are considered to be engaging in human subjects research.
Intervention
An intervention includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction
An interaction includes communication or interpersonal contact between the researcher and participant, commonly done through surveys or interviews. This can be done by phone, email, video conference, online, or in-person.

Need More Help?

For further resources or assistance, visit the Center for Learning Innovation and Research (CLIR) or the McKee Library.