Research Integrity

Under FDA regulations, an Institutional Review Board (IRB) is a committee established by an institution to protect the rights and welfare of human subjects recruited to participate in research activities. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. Federal and state regulations require all human subjects research conducted by Mohave Community College faculty, staff, and students to be approved by the IRB before the research can be conducted.

The IRB does not assume the role of evaluating the soundness of the proposed research study, the merits of the research design nor the potential contribution of the research to scholarly literature.

IRB safeguards individuals involved in federally supported research by ensuring that:

• risks have been considered and minimized;
• the potential for benefit has been identified and maximized;
• research-volunteers are provided with substantial information about the study and volunteer only after being provided with legally effective informed consent;
• that all private information will be handled with confidentiality; and
• that research is conducted in an ethical manner and in compliance with established standards.

In the federal regulatory meaning, research, is “a systematic investigation that is designed to develop or contribute to generalizable knowledge.” This includes research development, testing, and evaluation that contributes to generalizable knowledge.

To determine if a proposed project qualifies as research, the IRB must know the intent of the researcher. For example: will findings be published or presented to external audiences? Will any outcome of the study, whether in the form of data analysis or methodological advances or anything else, be reported as a means to disseminate knowledge and advance the field? These possibilities should be considered when deciding if the project needs to be reviewed by the IRB.

• Projects done in fulfillment for a course or “class project” and that will be presented to the class aren’t considered to contribute to generalizable knowledge.
• Program evaluation projects in which the findings are reported to an oversight agency or other interested party or used to develop a quality improvement plan also are not considered to contribute to generalizable knowledge.

According to federal regulations (45 CFR 46), Institutional Review Boards are responsible for overseeing the ethical standards in research involving human subjects. This responsibility is broken down in more detail in the following answers to clarify what projects should and what projects should not be reviewed by the IRB.

According to the U.S. Department of Health & Human Services Office of Human Research Protections, a human subject as a “living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.”

Research involving records from deceased individuals, such as in historical studies, does not need to be reviewed by the IRB. Projects in which information about a thing, such as a process, is collected from individuals, but personal identifiers or any information about the informant is not collected, also do not need to be reviewed by an IRB. Research collecting private information must be reviewed by the IRB.

Private information is information that can cause the identity of the participant to be associated with the information provided or allow the participant’s identity to be readily ascertained by the researcher.

Projects that meet the criteria described under both of the questions above require review by an IRB. That is, the project must both:

• be research, as defined above
• involve living human subjects

• the primary purpose is a learning experience in the methods and procedures of research;
• there’s uniformity in the research methods conducted by all students (i.e., all students will use the same instruments or methods (surveys, questionnaires, interview guides), to collect the data and/or consent procedures);
• Involve no more than minimal risk;
• the project doesn’t include sensitive topics or vulnerable populations, such as children or prisoners;
• the data must be recorded anonymously by the students (i.e., with no names, social security numbers, or any other codes that can be linked to a list of names, or the recorded data will not identify the subjects through their behavior);
• where and whenever possible, the research takes place in a public setting with public access, such as: a classroom, department, dormitory, or other campus setting, a shopping center, park or street;
• the data will not be used beyond the classroom environment (i.e., the data is only used for instructional purposes, which can include a course paper or oral class presentation only. The data cannot be published or presented at a conference, colloquium, department colloquium or poster presentation and cannot be used in further research by the student, other class members and/or the instructor).