All projects that meet the federal definition of research with human subjects (45 CFR 46.102 ) must be reviewed and approved by the IRB prior to beginning the research. Applications submitted to the IRB for review are evaluated with regard to the degree of “risk” to human participants based on a standard set of criteria found in the Basic HHS Policy for Protection of Human Research Subjects. The IRB 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.
Types of IRB Review
There are three (3) types of review categories for an IRB application: Exempt, Expedited, and Full Committee Review.
- Post Approval, there is also continuing review, see below.
The review category is determined by:
• Level of risk to participants associated with the research
• The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
• The sensitivity of the research questions or complexity of the research design
• The involvement of vulnerable populations as research subjects
“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
• Exempt projects are not subject to continuing review
• Amendments are required only if changes to the project could alter the exempt determination
• An exempt determination does not change researchers’ ethical obligations, including the completion of human subjects protections training (NIH or CITI)
• Review the Common Rule on exempt research: 45 CFR 46.104
Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:
• Minimal risk human subjects research that meets one or more of the OHRP Expedited Review Categories
• Minor changes to research previously approved by full committee review
Applications qualifying for expedited review are accepted and reviewed on a continuing basis. The expedited reviewers have the authority to make a determination or to refer a submission for full committee review for multiple purposes (e.g., clarification, expertise). Only the full committee has the authority to disapprove a study.
For certain kinds of research involving no more than minimal risk, and for minor changes in approved research, the IRB Chair and/or a designated voting member(s) reviews the proposed research rather than the entire IRB. It cannot be assumed that research poses minimal risk because it only involves interview or survey data collection. Sensitive questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to participants, their relatives, and others.
Limited IRB Review is a type of expedited review process required in the Common Rule. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection or use of sensitive, identifiable data (exemptions 2, 3 and 8) and, for exemption 7, that “broad consent” was obtained and (if appropriate) documented according to an approved protocol. For exempt studies involving access to PHI (e.g., from medical records), the required IRB review may be integrated with Limited IRB Review by the same assigned reviewer.
Full Committee Review
Federal regulations and institutional policies and procedures require IRB Full Committee Review for applications where the research involves greater than minimal risk to human participants or has been referred to the committee by an expedited reviewer or the Chair. The committee discusses the study and determines whether the Criteria of Approval for Human Subject Research are met, and makes a decision to approve, approve with modifications, or disapprove the study. Regardless of risk level, MU IRB may require full committee review when the research involves:
• Vulnerable populations, particularly prisoners, research with children (not participating in routine educational practices)
• Sensitive topics, including illegal behaviors
• A complex research design requiring the expertise of multiple committee members to evaluate
Applications requiring full committee review are accepted by the submission deadlines and reviewed by the full committee on the scheduled IRB meeting dates. Researchers are welcome to attend the meeting to answer questions from the committee. At the conclusion of the meeting, the committee votes and issues a determination.
The IRB will advise you when the study is scheduled for full committee review. The ability to schedule a study for review is related to the pre-review response time, the IRB’s meeting agenda and expertise that may be required for the review. Once a study is reviewed by the IRB, the IRB will communicate any changes requested by the IRB and will work with you to resolve any issues. You can find the upcoming IRB meeting schedule here.
The Revised Common Rule removes the requirement for continuing review for minimal risk research and for full committee review research that is in long-term follow-up or data analysis only. Researchers conducting eligible studies will be informed of post-approval requirements at the time of IRB approval.
Even when continuing review is not required, researchers remain responsible for updating the IRB about any adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete by completing the online Continuing Review/Closeout Form.
Definition of Research
Monmouth University follows the Code of Federal Regulations, Title 45 CFR Part 46, Public Welfare, Protection of Human Subjects, specifically code 45 CFR 46.102(l) provides the following definition and guidelines:
(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.