Policy
All research involving human subjects that makes use of CMI resources or that is conducted by students, staff, or faculty on or off campus must be approved by the Institutional Review Board (IRB). The IRB may review other projects if requested, subject to a fee. The IRB is empowered to develop and revise procedures to ensure that all such research is conducted ethically and with regards for the rights and welfare of research subjects. These procedures must follow the rules set forth in the U.S. Department of Health and Human Services regulations for the protection of human subjects (45 CFR 46) as well as any relevant Republic of the Marshall Islands laws.
The IRB is an executive committee of the College and reports to the President of the College via the Vice President of Academic and Student Affairs.
For more information on IRB policy and procedures, click here.
Schedule
The IRB meets on the first Tuesday of every month.
Contact
For more information or to apply for project approval, contact IRB chairperson, Director of Institutional Research and Assessment, Cheryl Vila at cvila@cmi.edu.
IRB FAQs
- What is an IRB?
IRB stands for Institutional Review Board. An IRB is an appropriately constituted group that has oversight on human research. The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) are the two principal federal agencies that set regulations for the conduct of the IRB. - What is CMI IRB?
The College of the Marshall Islands IRB is a standing committee of the college which reports to the Executive Council via the VP of Academic and Student Affairs. - What is the purpose of the CMI IRB?
The purpose of the Institutional Review Board (IRB) is to protect the wellbeing and the rights of individuals participating in research activities, which are conducted under the auspices of the College of the Marshall Islands (CMI). The principles of respect for persons and justice are criteria to be considered for conducting research. College policy requires the IRB to review and approve all research conducted by faculty, staff, and students, on and outside of the campus, that involves human subjects. All research that uses CMI resources must also be approved by the IRB. Further, it is the responsibility of the IRB to review and approve any changes to a previously approved research project before it is finalized should the researcher wish to have the imprimatur of the college included with the research. - Who are the members of CMI’s IRB?
The IRB has five regular voting members and two alternates, all, except for one that is not affiliated with CMI, are qualified members of the CMI faculty and staff. The Director of Institutional Research and Assessment serves ex officio as Chair. The members were selected by the IRB formation committee following recruitment efforts within the CMI community. - How is an IRB application reviewed?
Upon receipt of the IRB application form with the necessary accompanying documents, the IRB Chair reviews the application if it can be considered exempt.
If the application does not qualify for exemption, then the IRB Chair will have fourteen days to assign a primary reviewer(s) who will determine if the application is to be reviewed under the expedited applications or full review procedures. The primary reviewer(s) will have fourteen days to reach a decision and communicate to the researcher that the research has been approved or that it has been referred for the full consideration of the IRB. In the latter case, the researcher will need to complete the full IRB form. The IRB member assigned to review the application will also notify the Chair of this decision.
During a full review of an application, the study is presented by the primary reviewer(s) at a convened IRB meeting and, after discussion by IRB members, a vote for an action is taken. The complete documentation is made available to all members for their review, both before and at the meeting. The materials for review should be received by the membership sufficiently in advance of the meeting to allow for an adequate review of the materials, at least 4 weeks before the regular monthly IRB meeting. At no point may an IRB panel consider an application for approval with fewer than five voting members present.
- What is an exempt application?
Research that involves human subjects but meets the requirements listed under 45 CFR 46.104 may be considered exempt. Exempt applications will be confirmed as such by the IRB Chair. The Chair may also determine that the project requires IRB approval, in which case the researcher will be directed to complete the appropriate application - What qualifies as an expedited application?
Projects that involve only minimal risk may qualify for the expedited application procedure. Expedited projects must meet the requirements listed under OHRP Expedited Review Categories from HHS.gov. Expedited applications will be assigned to a single IRB member to verify expedited status and approve the application - What are the possible outcomes during a full IRB deliberation?
- Approved – if the project meets all requirements for approval
- Approved, subject to minor revisions – if the panel requires a limited number of minor specific changes to the project or the documents submitted; once the researcher abides by the revisions required, the application does not have to go to through the IRB process again
- Revise and resubmit – if the project has serious flaws but can, in the opinion of the panel, be revised to meet the requirements for approval
- Not approved – if the project is fundamentally flawed and cannot, in the opinion of the panel, be revised to meet the requirements for approval. In the case of an application being rejected, the researcher may apply again to the IRB with a new project, but the IRB will not consider the same project unless the researcher initiates the appeals process
- What are the guidelines for approval?
- Risks to subjects must be minimized.
- The risks to subjects must be reasonably proportional to the potential benefits. Only those risks and benefits that result directly from the research and that affect the subjects, as opposed to society at large, should be considered.
- Subjects must be chosen equitably. Special care must be taken on this point when research involves vulnerable populations.
- Informed consent must be obtained from the subjects or their legal representative as defined by RMI law. This consent must be documented and the record maintained. Researchers must submit sample consent forms with their applications and are encouraged to use the forms provided by the IRB as a starting point.
- If relevant, data collected is monitored for the ongoing safety of the research subjects.
- The privacy and anonymity of subjects must be maintained where possible and appropriate. Appropriate safeguards must be in place to avoid the accidental or incidental revelation of a subject’s identity.
- There must be a plan to share findings with the community.
- All researchers involved in the project must have completed NIH’s Protecting Human Research Participants certification via https://phrp.nihtraining.com/index.php.
- In addition to the above requirements, for non-expedited projects, at least one member of the research team, ordinarily the Principal researcher, must have received appropriate research ethics training through the completion of a relevant degree or a program such as that provided by the Collaborative Institutional Training Initiative (Miami University)
- What are the documents that need to be submitted to IRB?
- Includes but not limited to –
- Completed and signed application form
- Informed consent form
- Research instruments
- Evidence of appropriate research ethics training or its equivalent
- IRB approval from other organizations or agencies
- Includes but not limited to –
- What is the best way to submit an IRB application?
- Submit the application with its supporting documents to cmi.irb@cmi.edu
- When does the CMI IRB meet?
- The IRB meets monthly on the first Tuesday of every month or as needed
