All projects that meet the definition of research with human subjects (45 CFR 46.102) must be reviewed and approved by an IRB, or receive an exempt determination from the IRB office, prior to beginning the research. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review.  Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.

The type of IRB review and the associated review process (e.g., full board, expedited, exempt, not human subjects research) are determined by the:

• Level of risk to research participants
• Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
• Sensitivity of the research questions or complexity of the research design
• Involvement of vulnerable populations as research participants
• Use of identifiable information or identifiable biospecimens
• Applicability of one or more of the criteria for exempt or expedited review

Deadlines and Review Times

New and continuing applications for review may be submitted at any time. Please allow up to three weeks for Exempt and Expedited review time. This timeline is an estimate; reviews may take longer if they are complex, require significant revisions, or require review by other reviewers or departments, such as Legal Counsel or the Institutional Biosafety Committee. Reviews may also take longer during high volume periods. All applications are processed in the order they are received.

If a proposal must be reviewed by the full committee, the application must be received by 5:00pm on the first business day of the month in order to be considered at the next IRB meeting. If this day falls on a weekend or holiday, applications may be submitted the following business day. Principal Investigators will be informed of the committee's decision by email within a week following the IRB meeting. As revisions are often required, please allow four to eight weeks for final approval to be obtained.  

Application Pre-Review

When an IRB application is submitted, it is first sent to the UM IRB office staff for pre-review. During this process, the application is reviewed for completeness, thoroughness, and accuracy. IRB staff check to make sure that all questions were answered and that the investigator has provided enough information for the application to move to the next step in the workflow process. IRB staff will also review the application for mistakes, such as spelling and grammatical errors (particularly in the informed consent form and any other participant-facing documents, such as flyers) or missed questions. Applications may be returned to investigators at this stage for revisions before it is sent on to the next step in the review process.

Investigators are encouraged to consult with the UM IRB office on complex protocols prior to submission. Clearing up questions and issues beforehand reduces the chances that an application will be returned to the study team for revisions, thus saving time and effort for all involved. 

Assigning a Review Type 

After an application has successfully completed the pre-review process, it will be assigned a review type. In general, an application can be assigned to one of four review categories: Not Human Subjects Research (NHSR), Exempt Review, Expedited Review, and Full Board Review. 

In all cases, but most especially for Expedited and Full Board reviewed studies, IRB staff and members are reviewing protocols to ensure that: 

• Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
• The subject selection is equitable
• Privacy and confidentiality are protected
• Informed consent processes meet federal, state, and UM regulatory requirements

Review Types

Research that is Not Human Subjects Research 

Not all research-related activities that involve people, their data, or their biospecimens are covered by the regulations governing human research. 

Submission to the IRB is not required for the following activities:

• Case studies
• Class activities (with some exceptions; does not include theses and dissertations) 
• Journalism/documentary activities
• Oral history
• Quality assurance and quality improvement activities unless they meet the federal definition of human subjects research
• Research using deidentified data or biospecimens
• Research using publicly available data sets

Please see the UM IRB’s Policies and Procedures manual for more information about these activities and at what point IRB review may be needed. 

Exempt Review

Per university policy, investigators must submit an IRB application for determination of exemption before research begins. It is important to note that an Exempt determination is different than a Not Human Subjects Research determination. Exempt research still meets the federal definition of “human subjects research” but is considered minimal risk, does not involve research subjects from statutorily vulnerable populations, and must fit within one of six very specific Exempt review categories as defined in 45 CFR 46. 

While the use of a formal informed consent form containing all the elements of consent is not required for Exempt research, the UM IRB still requires researchers to provide information, in written form, to potential participants prior to their enrollment in the research. At minimum, this information should include: 

• A statement that participants must be 18 years or older to participate; 
• An explanation of the research, including the expected time commitment;  
• Any potential risks or discomforts related to participation, such as discomfort responding to personal/sensitive questions, privacy concerns, disclosure risks; 
• A statement that the research is voluntary and that they may withdraw at any time;
• How privacy and confidentiality will be protected; 
• Contact information for the PI and the UM IRB;
• And any other key elements of the study that participants should know before agreeing to take part. 

Projects receiving an exempt determination are not subject to the Continuing Review process.  Amendments are required only if the changes to the project would alter the exemption criteria.  An exempt determination does not lessen the researcher's ethical obligations to participants as articulated in the Belmont Report or to the codes of conduct for specific disciplines.

Research involving prisoners or certain types of research with children (e.g. surveys, interviews, observations of public behavior where the investigator interacts with the children) does not qualify for exemption.

Adding Non-UM Collaborators on Exempt Studies

The UM IRB does not do reliance agreements for Exempt status studies. If non-UM collaborators are added to an Exempt UM research project, those collaborators will be responsible for submitting to their own institutional IRB to oversee their specific project activities. If the collaborator does not have their own IRB, then they must fill out an Individual Investigator Agreement (found on our Forms and Templates page), in which they agree to be overseen by the UM IRB. 

The same process must be followed for UM personnel who are added to other institutions’ Exempt IRB projects. 

Expedited Review

Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:

• Minimal risk human research that meets one or more of the OHRP Expedited Review Categories. 
• Minor changes to research previously approved by the full board. 

Applications qualifying for Expedited review are reviewed by the IRB Manager, the IRB Chair, and potentially to one or more experienced IRB members. These reviewers may request additional clarifications or changes from a principal investigator before the application is approved. During an Expedited review process, a submission may be referred to the full board for review instead (for reasons of clarification, expertise, etc.), including in cases of disapproval. Only the full board has the authority to disapprove a study. 

Most studies that qualify for the expedited review process do not require annual Continuing Review.

Expedited studies must meet all of the federal requirements for the elements of informed consent (45 CFR 46.117). These elements may only be waived if the investigator formally applies for such a waiver and the IRB formally grants it. Investigators must have a compelling argument for why a certain element of informed consent, such as a written signature, should be waived. 

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. If the study involves HIPAA, consent forms must be kept for at least 6 years.

The Single IRB Rule: Adding Non-UM Collaborators on Expedited (and Full Board) Studies

As per 45 CFR 46.114(b) (the revised Common Rule), all institutions located in the United States that are engaged in cooperative research conducted or supported by a Federal department or agency must rely upon approval by a single IRB. 

The National Institutes of Health (NIH) also have their own Single IRB policy. This policy applies to any NIH-funded or -supported non-exempt human subjects research study being conducted cooperatively and/or at more than one U.S. site. Please note that as of January 20, 2020, studies that are not subject to the NIH single IRB policy - such as domestic, multi-site, career development (K), fellowship (F) awards, and Other Transaction (OT) awards – must still use a single IRB as required by the provisions in 45 CFR 46.114(b). 

If non-UM collaborators are listed on an Expedited or Full Board UM IRB application, the UM IRB must institute a reliance agreement with the collaborator(s) own institutional IRB. A reliance agreement between UM and the collaborating institution must be in place before a non-UM collaborator may take in part in any human subjects research. If the collaborator does not have their own IRB, then they must fill out an Individual Investigator Agreement (found on our Forms and Templates page), in which they agree to be overseen by the UM IRB.

Cooperative research for which more than a single IRB review is required by law, including tribal law, is not subject to the Single IRB provision. 

Full Board Review

Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves more than minimal risk to human subjects, does not meet the criteria for one of the categories of expedited review, and/or has been referred to the committee by an Expedited Reviewer or the Chair.  Regardless of risk level, the UM IRB may require full board review when the research involves: 

• Vulnerable populations, particularly prisoners
• Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality (CoC) to protect subject data from compelled disclosure
• Research involving genetic/genomic analyses
• A complex research design requiring the expertise of multiple board members to evaluate

If an application is “board ready”, meaning that it contains all of the information and materials necessary for the full board to conduct its review, the application will be assigned to the next IRB meeting date, except where the agenda is already full or a reviewer with the necessary expertise is not available for that meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission.

Possible decisions that can be made by the fully convened IRB include: 

• Approved: the application is approved as submitted.
• Conditional Approval: the application is approved, contingent on submission of specified changes to the protocol, informed consent document(s) and/or other supporting materials. Final approval status is granted when either the IRB or the IRB Chair (if so authorized by the board) has reviewed and approved all requested changes.
• Resubmission: the IRB needs additional information from the investigator before the IRB can make all of the determinations found at 45 CFR 46.111 necessary to approve the study. The principal investigator must submit the requested additional information before the IRB will consider the application for further review.
• Disapproved:  the protocol does not provide adequate protection to human participants, and it is unlikely that it can be modified to provide such protection. The IRB notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision, and provides the opportunity for the investigator to respond to the IRB in person or in writing.

All full board reviewed research is required to be issued an expiration date of no more than 1 year from the original date of approval. Applications must be renewed every year. Projects that are expired must cease all work immediately until the project is brought back into compliance. 

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. If the study involves HIPAA, consent forms must be kept for at least 6 years. 

If you think that your research may require a full board review, please consult with the UM IRB office. The submission deadline for full-board reviewed proposals is the first business day of each month. 

Subcontracted Research

When a UM researcher is engaged in a subcontracted portion of a non-exempt (i.e., Expedited or Full Board Review) 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:

1. 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.
2. 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.

External Reviews

The University of Montana IRB will conduct reviews of appropriate, external, human subjects research proposals on a fee-based schedule.

The UM IRB will only conduct external reviews of proposals for which it is qualified in terms of adequate experience and subject expertise. Specifically, the IRB reserves the right to accept or decline a request for review on a case-by-case basis. In most cases, the IRB authorizes the IRB Chair to make this decision, but accepting or declining review will in some cases be determined by the board. The UM IRB will review proposals at the full-board, expedited, and exempt levels of review as is appropriate to the complexity and risk level of the proposal.

Please see the UM IRB’s Policies and Guidance page (LINK) for more information about external reviews, including a review schedule.