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.
What it the criteria requiring review of student projects?
As defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46) , "research" is "a systematic investigation designed to develop or contribute to generalizable knowledge." Most undergraduate and graduate student assignments/projects are unlikely to lead to "generalizable results" and thus do not require IRB review.
Student projects involving human subjects should be submitted for IRB review only if:
- The research involves physically or psychologically invasive, intrusive, stressful procedures or, in the judgment of the instructor/faculty sponsor, has the potential for placing subjects at more than minimal risk, as defined below.
Minimal risk, as defined in 45 CFR 46, subpart A , exists when "the risks of harm anticipated in the proposed research are not greater considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
Student projects that fit the categories below are usually considered minimal risk and do not require IRB review:
- Research conducted in an educational setting involving normal education practices, such as research that examines or compares regular and special education including but not limited to instructional strategies/techniques, curricula, or classroom management methods.
- Research involving the use of educational tests, survey procedures, and interview procedures.
- Observation of public behavior if confidentiality or anonymity is maintained.
- Research with subjects who are elected or appointed public officials or candidates for public office-regardless of whether the subjects may be identified or the information is sensitive.
- Research on individual/group characteristics or behavior or research employing oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies on areas such as perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior, etc. if confidentiality or anonymity is maintained.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if one of the following is true: the sources are publicly available or information is recorded by the investigator in a way that subjects cannot be directly or indirectly identified.
What are additional circumstances requiring IRB review of student projects?
Student projects involving human subjects that meet either of the criteria below must always be submitted for IRB review-even if the projects do not meet the criterion in section I above.
- Externally-funded projects
- Projects involving vulnerable populations, including minors* (except when engaged in public activities in which the investigator does not participate, such as non-participatory observations of playground or classroom interaction), pregnant women, fetuses, prisoners, people with mental or cognitive handicaps, or individuals who cannot communicate in a language known by the student conducting the project.
*Officially registered SCSU students under the age of 18 who participate in minimal-risk classroom research activities are not considered a vulnerable population.
How will my application be reviewed?
- Research involves more than minimal risk.
- The full IRB reviews the application during a regularly scheduled meeting.
- The application must be submitted two weeks before a meeting. Meetings are held monthly. Researchers are encouraged to attend their application review.
- Research falls within one or more of the expedited categories outlined on the Review Worksheet and involves no more than minimal risk.
- A subset of the IRB reviews the application—usually within 10 to 15 working days.
- Research falls within an exempt category outlined within the IRB protocol and involves no more than minimal risk.
- Exempt status MUST be determined by a subset of the IRB—usually within 10 to 15 working days.
What else should I know about completing and submitting my application?
Some individuals reviewing your application may be unfamiliar with your field, so present information clearly without jargon and define technical terms. Also, avoid delays in the process by answering questions completely, providing requested documentation, and signing the certification page.
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.
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-excluding thesis/dissertation) 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.