Institutional Review Board (IRB)

Research Methods Classes, Student Projects, Theses and Dissertations

The University of Montana (UM) requires that all research involving human subjects conducted by faculty, staff, or students engaged with the university be reviewed and approved by the Institutional Review Board (IRB) prior to initiation. Investigators may not solicit subject participation or begin data collection until they have received written approval from the IRB.

The IRB further requires that all student research activities are supervised by a faculty member.  Most types of student research activities do not require IRB review above and beyond faculty supervision. UM supports a wide range of both undergraduate and graduate student research projects involving human subjects ‐‐ from course‐related research exercises to dissertation studies. This document is intended clarify IRB policy and procedures as they relate to student and classroom research projects.

Independent Research Projects 

Independent research projects that include human subjects and employ systematic data collection with the intent of contributing to generalizable knowledge will require IRB review. Theses, dissertations, and honors research projects involving human subjects that are considered research as defined by 45 CFR 46 (i.e., “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”) always require review by the IRB. Investigations designed to develop or contribute to generalizable knowledge are those that seek to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. While such research is often disseminated through scholarly publication or presentation of the data, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. For additional information regarding the submission and review of such projects, please visit the IRB website or contact the IRB office.

Research Methods Training/Curriculum

Research projects for which the overriding and primary purpose is a learning experience in the methods and procedures of research does not meet the federal definition of research and is therefore generally not subject to (i.e., is excluded from) IRB review/approval. Curriculum projects in which students conduct research involving human subjects need not be reviewed by the IRB if the following conditions are satisfied:

1. The project involves minimal risk to subjects (i.e., 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").
2. The project does not involve sensitive topics or confidential information that could place a participant at risk if disclosed.
3. The project does not involve persons from vulnerable populations as participants.
4. The project must involve the voluntary participation of individuals without any coercion or pressure being placed upon them by the researcher.  Though not required, it is recommended that instructors/students consider providing a consent document to participants and fully informing them of the research they will be taking part in.
5. The results of the project will never be distributed outside the classroom and/or institutional setting or used for publication, although the results may be presented to instructors or peers for educational purposes or as part of a class assignment. If the possibility exists that either the instructor or the student would consider disseminating the data as generalizable knowledge, then the research must be submitted for IRB review. If after collection of data the instructor or student deems the results to represent generalizable knowledge worthy of dissemination, the student and instructor should immediately submit a protocol describing the method and results to the IRB for review/approval. Please note that approval under such circumstances is not guaranteed, and any data formerly collected under a classroom project may not be disseminated prior to IRB approval.

Responsibility for Oversight of Student Projects/Classroom Activities

Each faculty member and department has the responsibility for: (1) assessing whether student projects/classroom activities involving human participants require review or are excluded from IRB review, (2) overseeing these activities, and (3) assuring that ethical principles are adhered to in the conduct of those activities.

With regard to classroom projects, faculty instructors are encouraged to become fully familiar with each student's project(s). A checklist is available (below) for assessing whether or not classroom projects meet the criteria for exclusion from IRB review.  It is also important that instructors who teach research methods courses educate students regarding the relevant ethical issues surrounding the use of human subjects in research.  IRB staff is available to conduct presentations on human subjects research in your class – for further information, please contact IRB staff.  

Classroom Research Project Checklist

This Classroom Research Project Checklist is intended to assist UM instructors in assessing whether classroom research projects may be excluded from review and approval by the UM Institutional Review Board (IRB). All items must be satisfied for classroom projects to proceed outside of IRB review.  For questions relating to such projects, we encourage instructors to contact the IRB office.

Definitions

Minimal Risk ‐ Student research projects that fit the categories below are generally considered minimal risk.  For additional information or specific questions regarding this standard, please feel free to contact the IRB office.

1. Research conducted in an educational setting involving normal education practices, such as research that examines or compares regular and special education curriculum including but not limited to instructional strategies/techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests, survey procedures, and interview procedure. 
3. Observation of public behavior if confidentiality or anonymity is maintained.
4. 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.
5. Research on individual/group characteristics or behavior in such areas as perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior, etc. provided that confidentiality or anonymity is maintained.
6. Research employing oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
7. Collection of data from voice, video, digital, or image recordings for research purposes.
8. 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 the information is recorded by the investigator in a way that subjects cannot be directly or indirectly identified.

Sensitive Topics – Any interview, survey or questionnaire that proposes to investigate opinions, behaviors, and/or experiences regarding, but not limited to, any of the following sensitive topics requires IRB approval:

• sexual orientation, incest, rape, sexual molestation, deviant sexual behaviors or attitudes regarding sexual conduct (pedophilia, bestiality, etc.), practices of contraception, abortion and/or pregnancy
• substance use and/or abuse including, but not limited to, alcohol, marijuana, steroids, amphetamines, narcotics and any prescription medication legally or illegally obtained
• questions regarding mental health (e.g., suicide, depression, obsessive compulsive behaviors including, but not limited to, gambling, smoking, eating, etc.)
• traumatic experiences of an individual, including war or combat experiences of veterans

Vulnerable Populations (for the purposes of classroom research) may include: pregnant women, fetuses, children (with the exception of observational studies), prisoners, persons at high risk of incarceration or deportation, or mentally disabled.  Projects involving such subjects require IRB review and submission of a protocol for approval prior to beginning the research.