Institutional Review Board (IRB)

Guidelines and Procedures

Deadlines

New and renewal submissions for projects must be received in the office of the Chair of the IRB on or before a deadline date for the next meeting. These deadlines are available from the Office of Research and on the UM web site. The IRB office must submit 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.

Required Components of an IRB Submission

In order to be considered by the UM IRB, all 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. Additionally, all researchers involved in a project must complete an on-line self-study course on the protection of human research subjects.

IRB Checklist (Form RA-108)

A. Indicate the project director(s) involved and the project title and description; obtain the appropriate signatures.

1. Faculty and staff may email the completed form as a Word document to the IRB at irb@umontana.edu. Electronic submission of this from from over 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.
   
2. Students: The Checklist, with attachments, must be read and approved by the faculty member supervising your research project. Both you and your faculty supervisor must sign the checklist; students may not submit electronically. 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:

1. the purpose of the research project and an explaination as to why the study is being done. Include literature related to the problem, hypotheses, and discussion of the problem's importance;
   
2. 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;
   
3. 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.
   
4. 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.
   
5. a precise and explicit description of the activities the subjects will perform and how the experimental subjects will be used. 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.
   
6. 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.
   
7. 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 unusal to state there are no risks or discomforts.
   
8. a description of how each deleterious effect or violation will be minimized.
   
9. the means by which the subject's personal privacy will be protected, and the confidentiality of information maintained. A plan for the destruction of the confidential materials is also required.
   
10. 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.
    
    1. Acopy of the informed consent form must be offered to all subjects, including parents/guardians of subjects less than 18 years of age.
    2. All subjects under the age of 18 must have written parental (or custodial) permission, as well as give written assent.
    3. 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.
       
       1. 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.
       2. 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.
11.  a waiver of written informed consent, if justified.  If the research would normally require written informed consent because it involves some risk or a vulnerable population but is not used for the research design or other reasons, a waiver is necessary.

IRB Review, Exemptions and Approval Procedure

The University of Montana requires that all research projects involving human subjects be approved by UM's IRB. 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 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. Also, the UM IRB must review all on-campus studies, even if they are not conducted by UM personnel.

Procedures for Review of Research Proposals

The following standard procedures will be followed for all human research proposals submitted to the UM IRB.

1. Upon request 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.
   
2. The UM IRB Chair 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.
   
3. The UM IRB Chair will contact the Project Director(s) if there are deficiencies.
   
   If there is sufficient time between receipt of the proposal and the deadline for preparing packets to be mailed to the IRB Membership, the IRB Chair will try to get the corrected documents into the proposal.|
   
4. An agenda, supplemental information (i.e., minutes and memos from the previous IRB meeting), and each complete proposal will be mailed to each IRB member at least 7 days prior to the IRB meeting.
   
5. At the scheduled UM IRB meeting, each proposal will be reviewed and discussed, as time allows. The IRB Chair will take notes of required action, items arising from the discussion, and the discussions will be audio-recorded for subsequent transcription.
   
6. Within five (5) working days of the UM IRB meeting, the IRB Chair 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 assigned checklist with the results or approvals checked off and may include a memorandum outlining any deficiencies in the proposal.
   
7. If approved, the applicant may proceed with the study upon receipt of a copy of the approved checklist.
   
8. 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. The proposal, with requested changes, could go back to Full Committee if it was so indicated in the meeting where conditional approval was given.
   
9. If the proposal must be revised and resubmitted, the revised application will be submitted for review by the entire IRB at the next scheduled meeting.
   
10. 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 assigned checklist.

Research Exempt from Review

Exempt status is granted by the IRB Chair to proposals which do not involve research subjects from statutorily vulnerable populations, or do not involve more than minimal risk. This includes:

1. 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.
   
2. 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.
   
3. 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.
   
4. 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.
   
5. 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.
   
6. 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 concludes that the project is Exempt, the Chair will classify it as such without convening the full Board. If Chair 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, the IRB Chair may grant the project administrative approval or ask the Project Director to revise the IRB Checklist, prepare an IRB Summary and submit both for full IRB review.

Expedited (Administrative) Approval

Administrative Approval may be granted by the IRB Chair to proposals which fail to meet the criteria for Exempt Status and:

1. The subjects are not from certain statutorily vulnerable populations and the research involves easily manageable risk.
   
2. Minimal or no-risk projects are those which involve no foreseeable danger to the subjects and may not require written informed consent. Examples of no-risk procedures include: administration of anonymous opinion questionnaires, measurements such as reaction time or hand-eye coordination, and interviews on non-threatening topics.

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 (Convened) IRB Review

Full IRB review will be necessary when the project involves a population that is physically, psychologically, culturally, or socially vulnerable or involves more than minimal risk to the human subjects; and, as such, written informed consent is required of the subjects.

The IRB Chair shall present the IRB Checklist to the IRB at its next meeting. The project director may be asked to attend this meeting as a source of additional information.

Possible IRB Actions

1. Designate the research as Exempt from IRB review or can receive Expedited approval.
   
2. 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.
   
3. 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.
   
4. 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.
   
5. 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. Reasons for the disapproval will be given to the Project Director.

Investigator Training

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 the self-administered training course, which is available on the UM IRB web site. Each investigator on the project will certify that they have completed the course on the checklist (Form RA-108)

Continuing Review

Because of the potential risks to the subjects, all research projects that are not exempt require periodic or continuing IRB review. The UM IRB may specify that a project requires continuing or more frequent than annual re-reviews. 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.

Courses Involving Students -- Investigations Using Human Subjects

Many departments on campus offer courses that require students to carry out projects involving investigations using human subjects. These activities may or may not need IRB review and approval. The UM IRB has developed a set of guidelines for instructors who teach courses which require student investigations using human subjects. If students in any class (undergraduate or graduate) are required to carry out a project which requires information to be obtained from human subjects, the instructor of the course must follow the guidelines articulated below. Form IRB-100 must be submitted before the students can recruit, screen or begin data collection, and the IRB must approve the proposal or exempt the proposal.

1. Once per academic year for each course using human subjects (or, given that it might be offered more than once a year, whenever the syllabus of such a course be substantially modified or altered), the instructor must submit an IRB proposal (Form IRB-100) to the IRB for review. This form is available at http://www.umt.edu/research/irb.htm.
   
2. The IRB must approve or exempt the proposal from IRB oversight before students can recruit, screen, or begin data collection.
   
3. Once the IRB has approved the proposal, it is the responsibility of the class instructor to evaluate the ethical soundness and risk level of each student's research project before the student can begin data collection; generally the proposals reviewed by the instructor would fall into an Exempt category.
   
4. The proposal submitted by the instructor to the IRB should include a description of the system the instructor will use to evaluate the level of risk and ethical soundness of each student's research project. That is, the proposal should include a detailed summary of the process through which the instructor will:
   
   
   1. educate the students concerning level of risk to the subjects (e.g., of physical injury in a class on methods of evaluation of athletic performance; or, e.g., of injury to self esteem in a class on methods of interview) and relevant ethical guidelines by means of readings, class lectures, etc.; and
      
   2. assess whether students' projects are ethically sound and of an acceptably low level of risk of physical, social, and psychological injury by means of, for example, a mock IRB proposal that students submit to the instructor or class evaluation of each student's proposal, etc.
      
5. If the predominant focus of the course is to teach research methods, a copy of the class syllabus should be submitted to the IRB. This syllabus should indicate that ethical issues will be discussed in class, and should also indicate what written sources (e.g., textbook, published ethical guidelines) which will be used to educate students concerning ethical issues.
   
6. The IRB Chair may review and Exempt or give Administrative Approval to most proposals for courses which require student investigations with human subjects. If, in the Chair's opinion the nature of the student's projects may involve more than minimal risk to the subjects or will be covered by item #7 below, review by the entire IRB will be required.
   
7. Any student project that involves either (a) vulnerable populations, or (b) more than minimal risk must be submitted as a separate proposal to the IRB. That student must await approval from the IRB before commencing data collection. Therefore, it is the instructor's responsibility to ensure either that (a) student projects do not deal with vulnerable populations or entail more than minimal risk, or (b) any student project that does involve vulnerable populations or more than minimal risk must come before the IRB for review, just as any such research project would.

Prompt Reporting: Unanticipated Problems and Serious or Continuous Non-compliance

The Project Director or others involved in research projects will promptly (within 5 working days of the event) report to the IRB Chair 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:

1. 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.
   
2. Do not place the study on "hold," but refer the situation to the UM IRB for review.
   
3. If the event posed minimal risk to the subject, deal with the matter Administratively.

In cases referred to the UM IRB, the IRB can:

1. Permanently close the study.
2. Request that a revised protocol be submitted which contains modified subject eligibility requirements and/or additional safety procedures.
3. 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:

1. Permanently close the study.
2. 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.
3. Institute oversight procedures (described in UM's IRB Oversight and Verification policy) on the study and/or all studies of the investigator(s).
4. Report to the appropriate UM officials and/or federal department and agency heads.