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:
- Surveys that are done in a completely anonymous manner
- Research that has been already approved by another institutional review board (documentation of this approval is required by the IRB, submit to the committee chair)
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (1) research on regular and special education instructional strategies, or (2) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified
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:
- Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
- Voice recording made for research purposes such as investigations of speech defect.
- Moderate exercise by healthy volunteers or vigorous activity by physically trained individuals if appropriately screened by a physician or nurse practitioner prior to participation in said activity.
- The study of existing data, documents, records, pathological specimens or diagnostic specimens. [Note: ALL of the data, documents, records, or specimens must be in existence before the project begins.]
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
- Deception that is designed to distract, but does not significantly misrepresent the research and is anticipated to result in no more than minimal discomfort to the participant at the time of debriefing.
- Collection of blood samples by finger stick or venipuncture by trained personnel, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years or older and who are in good health and not pregnant.
- Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
- Collection of excreta and external secretions including sweat, and uncannulated saliva.
- Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
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:
- Deception that significantly misrepresents the research or the risk involved, and may involve more than minimal discomfort to participants. If deception is used in the study, a debriefing will need to be described in the research protocol.
- New or experimental drug research.
- Activities that include stress at greater levels than that of daily life.
- Data collection that includes highly sensitive information (for example, sexual orientation or behavior, alcohol and drug use, immigration status, illegal activities, etc.).
- Research with vulnerable populations (children, pregnant women, homeless, prisoners, etc.).
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.