Institutional Review Board: Frequently Asked Questions
What needs review and why?
Faculty, staff, and some graduate student research-or any other efforts to add to the fund of human knowledge-must be approved by St. Cloud State University's Institutional Review Board (IRB) if the activities:
- intervene in people's lives, observe human behavior, or use data obtained directly or indirectly from living individuals and
- involve the name, employees, or facilities of the University.
SCSU requires these research activities-whether or not they are supported by federal funds-to comply with the Federal Policy for the Protection of Human Subjects. It is an academic offense to conduct unapproved research.
How is research reviewed and how long does review take?
IRB applications may receive either full or expedited review. Research that does not fit Expedited Review categories (see categories) or that involves more than minimal risk (see definition) will receive full review by the entire IRB at a regularly scheduled, biweekly meeting. Applications must be submitted at least two weeks before a meeting. Research that involves no more than minimal risk and falls into one or more of the IRB's Expedited Review categories may be reviewed by a subcommittee of the IRB. Expedited Review is usually completed within 5 to 10 working days after applications have been submitted. See the Expedited Review Worksheet in the IRB application for more information.
When can research begin?
Researchers may not begin recruiting or contacting potential subjects until their application has been approved by the IRB.
Who's responsible for the research?
The researcher always assumes primary responsibility for the ethical treatment of human subjects. But if your study has been approved, then you can truthfully say so to potential subjects, and you can have the assurance that an independent group of experienced reviewers has helped you think through the implications of your research strategy.
Faculty advisors and class professors are responsible for guiding student projects and for assessing whether any project activities present more than minimal risk. The IRB will review any projects presenting more than minimal risk. (See Definition of Minimal Risk)
What does the IRB consider during review?
The IRB reviews for such criteria as:
- minimizing physical and psychological risk
- avoiding inadvertent stigmatization (especially of children)
- securing free and informed consent
- avoiding needless deception
- maintaining confidential handling of personal data (or anonymity)
- obtaining written cooperative agreements from off-campus research sites; and
- identifying benefits to the subject (e.g. the educational experience of being a research subject) and benefits to society (e.g. increased knowledge, improved safety, technological advances, etc.)
Far from impeding research, the IRB attempts to reach workable solutions that improve a research project. Researchers are invited to consult with an IRB member as they are preparing an application. Campus research centers may work with the IRB to set up routine review for repetitive research protocols: the Human Performance Lab and the Survey Center have done this.
What types of research projects receive expedited review?
Faculty projects such as opinion polls, surveys, interviews, and studies related to ordinary classroom techniques usually receive Expedited Review-as long as they do not involve sensitive topics (e.g. alcohol/drug abuse, sexual orientation, illegal activities, violence, etc.) that could place subjects at risk of civil/criminal liability or damage their financial standing, employability, insurability, or reputation. See the Expedited Review Worksheet in the IRB application for more information about categories of research that are eligible for Expedited Review.
What activities do not require review?
Customer satisfaction questionnaires, information gathering purely for internal use in an office or a department, data collection for departmental or program assessment, and class evaluations do not need to be submitted for review.
Most student projects (graduate/undergraduate/thesis) or class assignments involving human subjects do not need review. The student's faculty research advisor or class professor should determine whether the project fits the federal definition of research designed to develop generalizable results and presents more than minimal risk. The faculty advisor/class professor is also responsible for guiding and supervising any project involving human subjects.
Does all research require signed informed consent?
In some cases, the IRB may waive the requirement for signed informed consent. For example, with anonymous surveys or questionnaires, the basic elements of informed consent are often included in a cover letter along with a statement explaining that when subjects return the survey/questionnaire, they are indicating their voluntary consent to participate (implied consent). See the IRB's handout on Informed Consent for more information. Also, most opinion polls do not require a signed consent form. Simply tell potential respondents that you are conducting a poll on a certain subject, ask whether they are willing to answer questions, and assure them that they may discontinue at any time.
