Institutional Review Board

Purpose and Function

The National Research Act of 1974/1983 (PL 93‑348) dictates that, in order for institutions to be eligible for behavioral or biomedical research grants from federal sources (e.g., The Department of Health and Human Services and its various research institutes), an institutional Review Board (IRB) must be established and maintained to review research involving human subjects. The charge of this IRB is to protect the rights of those subjects participating in such research at this institution. The IRBs review of the applications is guided by the Code of Federal Regulations (Title 45, Part 46), which sets the minimum standards for protection of human subjects.

Who Must Apply for IRB Approval (and Why)?

Activities that may not seem like research must get IRB approval if they involve gathering information from people. For example, asking students to write down personal experiences for a class assignment is research if their answers are later published or presented (even without names); sending questionnaires to community members about their perceptions of the services the University provides is research if the information is used for generalizable knowledge by publishing or presenting it; and observing the interactions of parents and their children at the park is research if the observations are systematically recorded and reported in scientific journals, at professional meetings or as aggregated data. Any of these examples would need to be reviewed.

Research conducted by faculty, students, staff, or others on the premises of any site governed by Northwest Missouri State University, as well as research conducted elsewhere (including mailed questionnaires) by any representative of Northwest Missouri State University in connection with his/her institutional responsibilities require IRB approval before the investigation can be conducted. Northwest Missouri State University students enrolled in graduate programs need IRB approval for thesis projects.

Classroom curriculum projects, workshop evaluations, and administrative review projects need not be reviewed by the IRB if they are not research, if results will not be distributed outside the classroom or if they are used solely to evaluate or review a program in order to build a better program. However, if faculty, graduate students, or undergraduate students are actively gathering information from classrooms and wish to publish or otherwise distribute the results, the project must be reviewed. If in doubt, it is wise to have the project reviewed.

Noncompliance with Northwest Missouri State University IRB guidelines is a violation of Northwest Missouri State University multiple project assurance, federal wide assurance, and the federal regulations for the protection of human subjects.

Note: Research projects in which participants have been contacted or data has been collected before IRB approval is complete cannot be considered for approval.

When to Submit

Applications for IRB approval can be submitted at any time. During the academic year, the IRB works continuously on the review of applications and meets on a monthly basis, usually in the first week of each month. Research applications that are received by the 15th of each month will be acted upon at the meeting that takes place during the following month.

For example, if a proposal needing a full committee review is submitted by October 15th, a committee decision concerning that proposal will be reached during the November meeting. A proposal submitted on the 16th of October, however, is not guaranteed committee action until the December meeting. Thus, the turnaround interval for committee action on a reviewed proposal can be as brief as three weeks, or as long as six weeks. Note that if the 15th of the month falls on a weekend or holiday, the deadline for receipt of a proposal is extended to 5:00 p.m. on the next full work day.

The IRB recommends that lead time for committee approval be figured into the schedule for the conduct of research, especially since committee action (i.e., discussion and vote on approval of the project) is not necessarily equivalent to or a guarantee of committee approval. Furthermore, it should be noted that the same turnaround schedule cannot be guaranteed during the summer months, because some of the committee members are on nine‑month University contracts, and are thus unavailable to review projects or attend meetings during the summer months.

What to Submit

There are three review categories/applications: Exempt, Expedited, and Full Review. Use the following criteria to determine which category your research falls within before completing your application:

Determine the potential risk associated with your research.
The level of review is determined by the potential risks/discomforts, hazards, or inconveniences to the participants as well as the vulnerability of your participants.

Examples of vulnerable populations are children, prisoners, persons with mental disabilities, and pregnant women. Research that may be considered as less than minimal risk for nonvulnerable adults may be considered as minimal risk when conducted with vulnerable participants. Thus, in addition to the focus and content of the research, the participant population is considered a factor in determining risk.

The types of risk include:

Psychological, emotional, or sociological risk such as stress, anxiety, guilt, invasion of privacy, breach of confidentiality, harassment, and lessening of an individual’s identity.
Physical pain or risk of injury.
Legal risks to a community or a group of individuals.
Economic or inconveniences such as those that would affect subject’s financial standing, employability, insurability, or reputation.

Research considered to be less-than-minimal risk is research in which there is no known risk. Research considered a minimal risk is that which presents only the kinds of moderate risk encountered in daily life by most people (e.g., moderate exercise testing; psychological tests producing minor stress; or surveys involving sensitive topics such as society’s recreational drug use or sexual practices). Greater-than-minimal risk procedures are those that may include risk beyond that ordinarily encountered by subjects (e.g., maximal exercise testing, stressful psychological testing, questions about participant’s sexual practices or illegal activities).

This chart can be used as a guideline but the category can vary according to the project.

*Risk Level*	*Non-vulnerable Participants*	*Vulnerable Participants*
Less-than-minimal risk	Exempt	Expedited or Full Review
Minimal Risk	Expedited	Full Review
Greater-than-minimal risk	Full Review	Full Review

Review Categories and Forms

Application for the Exempt Category
The exempt category is used for studies presenting less-than-minimal risk to non-vulnerable subjects. This category does not apply to research involving deception of participants or to sensitive topics (e.g., recreational drug use, sexual practices, sue of alcohol by minors, criminal behavior). Although the title of this category is “exempt” the study is not exempt from review. It is exempt from some of the regulations governing more risky research.

Application for the Expedited Category
The expedited category is used for research that involves less-than-minimal risk to vulnerable subjects or research that involves no more than minimal risk to non-vulnerable subjects.

Application for the Full Review Category
The full review category is used for research that involves minimal or greater-than-minimal risk to vulnerable participants or research that involves greater-than-minimal risk to non-vulnerable participants.

Additional Resources:

Information to develop this site has been gathered and adapted from the University of Kansas, the University of Nebraska at Lincoln, and the University of Wisconsin at Madison.