IRB Guidelines and Procedures
- Required Components of an IRB Submission
- Indigenous People
- Investigator Training
- IRB Checklist/Application
- IRB Review, Exemptions and Approval Procedure
- Standard Operating Procedures for Review of Research Proposals
- Research Exempt from Review
- Expedited Approval
- Full Committee (Convened) IRB review
- Continuing Review
- Research Methods Classes and Student Research Projects
- Adverse Event reports and Non-compliance
- Contact us
New and continuing applications for review may be submitted at any time to Office of the Vice President for Research in UH 116 by hardcopy or by email to email@example.com.
Please go to the IRB Forms page to secure the most current forms. However, if a proposal must be reviewed by the full committee (for sensitive content, vulnerable populations, risk factors, etc.), the application must be received by the first business day of the month for consideration at the next IRB meeting.The IRB Coordinator will provide the proposals to the IRB members at least 7 days prior to the IRB meeting at which the project will be considered to allow off-campus IRB members adequate time to read the submission.
In order to be considered by the UM IRB, all specified information must be submitted for review. The Project Director must complete the IRB Checklist (Form RA-108) and attach any required written informed consent, assent, or permission forms and all flyers or recruitment documents. Additionally, all researchers involved in a project must complete an online self-study course on the protection of human research subjects. If the research has been previously approved by another IRB, the complete approved application and related documents may be submitted on the other institution’s forms.
All investigators conducting research with human subjects shall complete an education course on the protection of human research subjects every three years. In order to comply with this policy, all investigators on projects involving human subjects will complete an online, self-administered training course. Each investigator on the project will certify that they have completed the course on the Checklist (Form RA-108) and supply the date of completion.
A. Indicate the project director(s) involved and the project title and description; obtain the appropriate signatures.
- Faculty and staff may email the completed form as a Word document to the IRB at firstname.lastname@example.org. Electronic submission of this from your University email constitutes your signature. You must certify completion of the self-study course on protection of human research subjects within the last three years. Disregard the "Student" section.
- Students: The Checklist, with attachments, must be read and approved by the faculty member supervising your research project. Student submissions must be from their UM email and a companion email from the supervising faculty must be received by the IRB before review will proceed. Hard copies signed by both the faculty supervisor and the student may be submitted in lieu of electronic submission. In addition, you and your faculty supervisor must certify that you have both taken a self-study course on protection of human research subjects within the last three years.
B. The project information requested on the form must be provided in full. Information requested includes:
- The purpose of the research project and an explanation as to why the study is being done. Include literature related to the problem, hypotheses, and discussion of the problem's importance.
- Identification of the subjects. Note explicitly whether they include minors (under age 18, per Montana law) and/or members of physically, psychologically or socially vulnerable populations. Explain why the subjects would be considered physically, psychologically or socially vulnerable.
- The procedure(s) for recruiting or selecting subjects. Include copies of all flyers, advertisements, etc. that will be used in the recruitment process; these require UM IRB approval.
- Where the study will take place. (Physical location, not geographic.) If permission will be required to use or access any facilities, indicate those arrangements. Submission of written permission may expedite your proposal; i.e., from school administrators, class instructors, etc.
- A precise and explicit description of the activities the subjects will perform and. Describe the instrumentation and procedures to be used and kinds of data or information to be gathered. Provide enough detail so the IRB will be able to evaluate the intrusion from the subject's perspective.
- The benefits of the research, if any, to the human subjects and to scientific knowledge. If the subjects will not benefit from their participation, so state.
- The risks and discomforts to which the subjects will be exposed. Such deleterious effects may be physical, psychological, professional, financial, legal, spiritual, or cultural. Some research involves violations of normal expectations, rather than risks or discomforts; such violations, if any, should be specified. It is highly unusual to state there are no risks or discomforts.
- A description of how each deleterious effect or violation will be minimized.
- The means by which the subject's personal privacy will be protected, and the confidentiality of information maintained. Copies of written consent, assent, or permission forms to be signed by the subjects, if used. An informed consent form is required when a project involves more than minimal risk but may be used whenever the researcher desires. It may be helpful for the subjects to read about the experiment or project so that they are very clear as to what they are agreeing.
- A copy of the informed consent form must be offered to all subjects, including parents/guardians of subjects less than 18 years of age.
- All subjects under the age of 18 must have written parental (or custodial) permission, as well as give written assent.
- Assent by child subjects: All child subjects are to be given a clear and complete picture of the research they are being asked to engage in, together with its attendant risks and benefits, as their developmental status and competence will allow them to understand.
- All children from 10 to 18 years of age are required to give written assent. Children less than 10 years of age and all individuals, regardless of age, with delayed cognitive functioning (or with communication skills that make expressive responses unreliable) will be denied involvement in any research that does not provide a benefit/risk advantage.
- Good faith efforts will be made to assess the actual level of competence of child subjects where it is in doubt. The Child Assent form must be written at a level that can be understood by the child.
- A waiver of written informed consent/assent, if justified. If the research would normally require written informed consent because it involves more than minimal risk or a vulnerable population, but is not used for the research design or other reasons, a waiver is necessary.
- If the project is federally funded, a copy of the grant abstract must be submitted to ensure that the work to be done under the grant is the same as that being proposed to the IRB.
The University of Montana requires that all research projects involving human subjects conducted by UM faculty, staff and students be approved by UM's IRB unless exempted as outlined in the document "Is your project Human Subjects Research?" Any employee, adjunct faculty member, or student who, on behalf of the University of Montana, conducts research using human subjects must receive IRB approval prior to recruiting or screening human subjects, and the necessary forms must be submitted prior to the research proposal being submitted to a sponsor for funding. IRB approval is granted for a maximum of one year, unless otherwise noted.
The UM IRB will not review proposals for projects conducted at off-campus locations which do not involve UM personnel or students. However, it must review projects conducted at off-campus locations that involve UM personnel or students who are engaged in research with human subjects (see guidance on engagement: http://www.hhs.gov/ohrp/policy/engage08.html). Interagency agreements currently exist with Montana State University (MSU), St. Patrick Hospital/Community Medical Center, and the Rocky Mountain Tribal IRB such that a project that has been approved by one of their IRBs does not need review by the UM IRB.
Subcontracted Research: When a UM researcher is engaged in a subcontracted portion of a non-exempt human subjects research study, regardless of whether that portion considered by itself would meet an exemption, the subcontracted researcher must obtain IRB review and approval for that activity. The researcher may take either of the following actions:
- Submit an application to the UM IRB for review of the subcontracted portion of the study. The complete, approved application from the parent organization’s IRB may be submitted to the UM IRB provided that it contains sufficient detail of the subcontracted work. Otherwise, a separate UM application needs to be submitted along with the determination letter from the parent organization’s IRB.
- Contact the UM IRB to inquire whether a reliance agreement can be entered into with the parent organization, it which case the researcher would need to comply with their application and review procedures.
The following standard procedures will be followed for all human research proposals submitted to the UM IRB.
- Upon receipt by the UM IRB office, each proposal for human subject research will be date stamped as received and will be given to the UM IRB Chair and/or Coordinator.
- The UM IRB Chair and/or IRB Coordinator will review the proposal for completeness and will determine if full IRB review is required or if the proposal can receive Expedited Review or be Exempted from Review.
- The UM IRB Chair or IRB Coordinator will contact the Project Director(s) if there are deficiencies in the application materials. For applications requiring full-committee review, if there is sufficient time between receipt of the proposal and the deadline for providing the material to the committee members, the IRB Chair/Coordinator will include the corrected documents with the proposal.
- An agenda, supplemental information (i.e., minutes and memos from the previous IRB meeting), and each complete proposal will be emailed to each IRB member prior to the IRB meeting.
- At the scheduled UM IRB meeting, each proposal will be reviewed and discussed, as time allows. The IRB Coordinator will take notes of required action and items arising from the discussion.
- Within five (5) working days of the UM IRB meeting, the IRB Coordinator will send the results of decisions made by the UM IRB on the proposal to the Project Director. This will include a copy of the signed and dated checklist with the results or approvals checked off and may include a memorandum outlining any deficiencies in the proposal.
- If approved, the applicant may proceed with the study upon receipt of a copy of the approved checklist.
- If conditions must be met for approval, these must be submitted to the UM IRB Chair for review and approval; if approved, the signed checklist will be sent to the Project Director(s) informing them that the study may be initiated unless the full IRB has determined that the revised proposal must come back to the full committee for final approval, in which case the proposal must be revised and resubmitted for review by the entire IRB at the next scheduled meeting.
- Action taken by the UM IRB on Expedited Review and Exempted Proposals will be communicated to the Project Director by sending a copy of the signed checklist via email. This communication is typically performed by the Administrative Associate in the Office of the Vice President for Research and Development.
Exempt status is granted by the IRB Chair and/or IRB Coordinator to proposals which do not involve research subjects from statutorily vulnerable populations, or do not involve more than minimal risk. This includes:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
If the IRB Chair or Coordinator concludes that the project is Exempt, he/she will classify it as such without convening the full Board. If the Chair or Coordinator is unable to determine if the proposal should be Exempt, the Chair may seek another opinion either from another current IRB member or from an expert in the research area under consideration. If the Chair does not find the project is exempt, he/she may grant the project Expedited approval, ask the Project Director to revise the IRB Checklist, or submit it for full IRB review.
Expedited approval may be granted by the IRB Chair to proposals which fail to meet the criteria for Exempt Status and:
- The subjects are not from certain statutorily vulnerable populations and the research involves minimal risk.
- Minimal risk projects are those which involve risks similar to those encountered in daily life by the subjects and may not require written informed consent. Examples of minimal risk procedures include: administration of anonymous opinion questionnaires, measurements such as reaction time or hand-eye coordination, and interviews on non-threatening topics.
- Proposals must fit in one of the nine allowable categories to be eligible for expedited review (see categories).
The IRB Chair may, at the Chair's discretion, administratively approve the project without convening the full board. If Chair is unable to determine if expedited review is warranted, the Chair may seek another opinion either from a current IRB member or from an expert in the research area under consideration.
Full IRB review will be necessary when the project involves a population that is statutorily defined as vulnerable or involves more than minimal risk to the human subjects; and, as such, written informed consent is required of the subjects unless a waiver is granted as part of the review process.
The IRB Chair shall present the IRB Checklist to the IRB at its next meeting (noting that a copy of the proposal will be emailed to the Board one week prior to the meeting to allow them time to review it). The project director and team will be encouraged to attend this meeting as a source of additional information.
Possible IRB Actions:
- Designate the research as Exempt from IRB review and approve the research. The research may involve some risk to subjects, but the IRB does not consider the risk to be unreasonable and/or the researcher has taken all practical steps to minimize the risk.
- Conditionally approve the research. This approval is for minor corrections to the proposal. If authorized by the IRB, the conditions placed on the proposal will be reviewed and approved by the IRB Chair. Once final approval has been given, the researcher may proceed with the project. Conditions might include revising the consent form to more clearly explain the procedure; adding a foreign language version of the consent form; receiving appropriate clearance from a particular agency or department, such as the Student Health Service; or discontinuing the research if deleterious effects occur.
- Ask for resubmission of the proposal. If the proposal does not contain enough information for the IRB to make an informed judgment or when it feels the research design contains clear dangers and should be revised to reduce the risk of harm to human subjects, the Project Director can be asked to resubmit the proposal or submit new information.
- Disapprove the research. If the proposed research does not adequately protect the subjects, the proposal may be disapproved and will not be reviewed again by the IRB. A new submittal with a different research plan may be submitted, but it will be treated as a new submittal. Reasons for the disapproval will be given to the Project Director.
Because of the potential risks to the subjects, all research projects that are not exempt require periodic or continuing IRB review, usually annually. However, the UM IRB may specify that a project requires review more frequently than once per year. Cases in which this might occur involve investigations in which vulnerable populations are exposed to high risk during the study. The IRB shall determine intervals and mechanisms for which reviews will be undertaken that are appropriate to the degree of subject risk. All research projects, however, shall be reviewed not less than once per year.
Project Directors will receive a notification at least 30 days prior to the expiration of their approval and they must respond within (at least) one week prior to the expiration date in order to guarantee that the continuation can be processed. In addition to the continuation report, Project Directors must submit clean copies of the recruitment and consent forms. Additionally, a copy of one of the last signed consent forms must be submitted. In order to preserve confidentiality of the subjects, the name of the subject should be redacted, but the date should be left readable. Submission of the last-used consent form allows the IRB to compare what has most recently been used in the field with what they have on file. In addition, IRB staff will be doing random file reviews in the future to further ensure that research is being done in accordance with approvals.
Study Closure: A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes the using, studying, or analyzing identifiable private information. Once all such activities described in the IRB-approved protocol are finished, the research project no longer needs to undergo continuing review and may be closed. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. At that point, the IRB can formally close the IRB file for the project and advise the investigator of that action.
Similarly, simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review. If a study is in data analysis only AND the Project Director has destroyed all private information about the subjects, the IRB can be notified and they will close the study.
All signed Informed Consent forms must be retained by the PI for at least 3 years after completion of the research, per federal regulation [45 CFR 46.115(b)]. The forms must be stored in a secure, locked location separate from the de-identified data.
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:
- 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").
- The project does not involve sensitive topics or confidential information that could place a participant at risk if disclosed.
- The project does not involve persons from vulnerable populations as participants.
- 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.
- 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 collected under a classroom projects exclusion 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 here 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.
The Project Director or others involved in research projects will promptly (within 5 working days of the event) report to the IRB Chair or Coordinator any substantial changes in activities of the project that was approved by the IRB, any unanticipated problems, unexpected events, or any serious or continuing non-compliance with the study protocol.
The IRB Chair will immediately investigate the situation(s) and may take the following actions:
- If the situation is severe, immediately place the study on "hold" until the UM IRB can review the information and decide on a course of action.
- Do not place the study on "hold," but refer the situation to the UM IRB for review.
- If the event posed minimal risk to the subject, deal with the matter administratively.
In cases referred to the UM IRB, the IRB can:
- Permanently close the study.
- Request that a revised protocol be submitted which contains modified subject eligibility requirements and/or additional safety procedures.
- Decide that the risk to the subject(s) was minimal and let the study proceed, with or without more frequent reviews.
All cases of serious or continuous noncompliance with study protocols will be reviewed by the UM IRB, which may:
- Permanently close the study.
- Sanction the investigator(s) on all human subject research; sanctions may include suspensions for varying terms or permanent exclusion from participating in human subject research at UM.
- Institute oversight procedures (described in UM's IRB Oversight and Verification policy) on the study and/or all studies of the investigator(s).
- Report to the appropriate UM officials and/or federal department and agency heads.
Institutional Review Board for the Protection of Human Subjects
Office of the Vice President for Research and Development
University Hall 116