Completed applications will be submitted to the IRB chair, Bob Kachelski, via email. For student research projects, the application must be submitted by the faculty advisor.
Regardless of the type of application you are submitting you must ensure that participants understand the nature of the study and agree to participate. Not all studies require written informed consent; however, expedited and full reviews must have a written consent form. Further information on the consent form and the elements of informed consent are located at the informed consent link. An informed consent template is also provided.
Many research protocols may meet the definition of research, yet may be exempt. The CSB/SJU IRB committees' guidelines require that researchers who believe their study meets exempt criteria must submit an IRB application using the Exempt Form. The application will be reviewed by the IRB chair to verify that the study meets the exempt criteria.
Research with children, prisoners, and other "vulnerable" populations do NOT qualify for exemption. Research that may be considered exempt includes:
A more comprehensive checklist is provided within the IRB Exempt Form. The researcher must identify which criterion promotes eligibility for exemption.
If the research does not meet the criteria for exempt status, the application will undergo either expedited or full review.
Research that involves no more than minimal risk may qualify for expedited review. Minimal risk is defined 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" [CFR, vol 56 no. 117, sec 102 (i), pp. 28013-28014). If you believe that your study meets the criteria for expedited review, submit an IRB application using the Expedited Review Form. A subcommittee will review the application within two weeks of submission.
Categories of minimal risk may include:
If the research does not meet the criteria for exempt status or expedited review, the application will undergo full review.
Research that involves more than minimal risk or involves vulnerable populations must undergo full IRB review. If you believe that your study meets the criteria for full review, submit an IRB application using the Full Review Form. The full committee meets on the 2nd and 4th Wednesdays of the month when school is in session to review these applications. The application must be submitted to the committee chairperson two (2) weeks prior to the meeting.
Categories of research that involve more than minimal risk include:
Research with Vulnerable Populations
According to the Federal Register, populations such as children, prisoners, pregnant women, mentally disabled persons, or economically disadvantaged persons are "vulnerable". Research involving these populations is required to have additional safeguards to protect the rights and welfare of these subjects. Studies involving prisoners will not be reviewed and approved by the IRB; these will be referred to the appropriate state or federal agency that oversees that prison system. Children are defined as individuals under the age of eighteen (18) years. Research with children will be reviewed only if (1) the procedures do not present greater than minimal risk, (2) a plan is developed for obtaining informed consent from at least one legal representative (guardian), and (3) a plan is developed for obtaining assent from children ages seven (7) and older.
If you have received prior IRB approval for a study you are conducting, and need to make changes to the study, you will need to submit a Project Revision Form. Federal regulations require IRB approval before implementing proposed changes. Changes that need prior approval include changes to the protocol, consent form, or any supportive materials.
Continuation of Research
Approval of the research extends for one year from the date of the initial approval letter. Continuation of the protocol beyond the one year approval requires submission of the Renewal/Extension of Research Form.