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Types of Research

Human subjects research is defined as a systematic investigation designed to develop or contribute to “generalizable knowledge.”

Use the IRB Decision Tree to determine if your activity qualifies as research. If it does not qualify as research, use the Survey Notification Form located on the IRB Forms page. Survey notification is reserved for internal Columbus State projects. 

Human subjects research at Columbus State is conducted in three categories – Exempt, Expedited and Full Human Subjects Protocols. The principal investigator (PI) will make the initial category selection but the final category determination is the responsibility of the IRB Chair and Committee.

Exempt Review
Research designated as Exempt presents minimal risk to its participants. Federal guidelines define minimal risk as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests". Exempt research requires the approval of the IRB Chair, or an IRB committee member designated by the Chair, not the full committee.

See the Exempt Human Subjects Protocol Form and Guidelines, including samples on the IRB Forms page.

Expedited Review
To be considered for Expedited Review, the research must include activities that (1) present no more than minimal risk to human subjects, and (2) fit within the expedited review categories specified by federal regulations.

An Expedited Review is conducted by the IRB Chair, or a sub-committee of the IRB, or an IRB committee member designated by the Chair. Progress of the review will be communicated to the full board. Disapproval of an expedited protocol can only be made by the full board. 

See the Expedited Human Subjects Protocol Form and Guidelines, including the Consent Form template on the IRB Forms page.

Full Committee Review
A full committee review is required for research that is not eligible for exempt or expedited review and involves more than minimal risk. Those intending to conduct full protocol research should allow extra time to complete the process. Full Protocols must meet the approval of the entire committee. Federal regulations also require a review of active research - Continuing Review - at least once a year. Continuing Review reminders will be sent until the project is complete.

Below are the categories of research which require full IRB approval:

  1. Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.
  2. Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
  3. Projects that involve sensitive or protected populations (such as minors or cognitively impaired individuals).
  4. Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).

See the Full Human Subjects Protocol Form and Guidelines, including the Consent Form template on the IRB Forms page.

Letter of Support for External Researchers to Recruit Columbus State Students, Faculty, Staff, or Administrators

A letter of support to recruit Columbus State students or employees will be considered as long as no Columbus State Community College employees or agents will be engaged in your research study (see interpretation of engagement below). If there is no institutional engagement, see the list of requested information and documents below. If there is institutional engagement, see the other types of research listed above for the appropriate form and documents to submit to the Columbus State IRB.

Interpretation of Engagement of Institutions in Human Subjects Research from the Office for Human Research Protections (OHRP):

In general, an institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of the research project obtain:

    1. data about the subjects of the research through intervention or interaction with them;
    2. identifiable private information about the subjects of the research; or
    3. the informed consent of human subjects for the research.

Columbus State applies this definition to Exempt and non-Exempt research. 

To request a letter of support, submit the following information to the IRB Administrator at irb@cscc.edu:

  • Full name of the Principal Investigator (please include the names of the faculty advisor/supervisor and the student conducting the study, if applicable) 
  • Name of the institution for the IRB of record
  • Study number, if available
  • IRB approval letter from the IRB of record, if available
  • Study title
  • Study abstract/summary
  • Survey/interview/focus group questions and any additional materials provided to Columbus State students and/or employees, as applicable
  • Recruitment material to be used on-site or sent to Columbus State students and/or employees, as applicable
  • The specifics of the assistance you are seeking from Columbus State employees and/or students

Continuing Review
Federal regulations (45 CFR 46.109(e)) require any research involving human participants - Full Human Subjects protocols - to be reviewed no less than once per year.

See the Continuing Review Report-Final Report Form located on the IRB Forms page.

Modifications to Research
Any changes in previously approved research must be sent to the IRB before implementing the proposed modifications.

See the Request for Modification Form located on the IRB Forms page.

Training
Principal Investigators who will be conducting Expedited or Full Protocol research are required to complete an ethics education course. The training is free for Columbus State employees and is available through Collaborative Institutional Training Initiative (CITI). Click on Register, select Columbus State Community College as your Organization Affiliation, and continue to create your account. 

Data Security and Disposal
Suggestions for safely maintaining and disposing of data are provided on the Research Data Security and Disposal guide located on the IRB Forms page.

Survey Design
The Office of Institutional Effectiveness can assist with the design of surveys. For assistance, please select "survey request" on the OIE Information Request Form. 

Department Contact

Academics Department

(614) 287-0000

academics@cscc.edu