IMPORTANT NOTICE-UPDATED: MARCH 23, 2022
The University of the Virgin Islands Human Subject Protection IRB and administration offices is pleased to announce the university human subjects program will resume in-person research effective March 23, 2022. In-person human subjects research may resume by following the “Resuming In-Person Human Subjects Research” guidelines.
If you have an approved IRB protocol and wish to change the human subjects research to be in-person, please submit a modification through IRB Net. Please be patient as we anticipate a large volume of requests at this time.
If you have any additional questions related to the IRB protocols, please contact Diahann Ryan, Assistant Director for Research Compliance, at firstname.lastname@example.org.
The University of the Virgin Islands Institutional Review Board (IRB) is the university committee that reviews and approves human subject research for the purpose of protecting the rights and welfare of those subjects. The Board is charged with the responsibility to formulate and implement procedures to assure the University's compliance with federal, state, and institutional regulations for the safeguarding of the welfare and well-being of human subjects involved in research projects.
The University President/Provost appoints members to the Institutional Review Board. The board also includes the Director of Sponsored Programs who serves as institutional IRB/IACUC administrator, and at least eight faculty/staff and one community member. The members reflect the diversity of the institution and community. During the review of protocols dealing with special prison populations, a non-affiliate alternate is brought in.
A chair is elected at the first meeting of each academic year. No IRB member may participate in the review of a proposal in which the member has a conflict of interest. Specialists may be invited by the IRB to provide technical assistance if the subject matter is deemed outside the expertise of the sitting IRB members.
Names of Current IRB Members
|Noreen Michael, PhD, Chair|
|Kimarie Engerman, PhD|
|Verleen McSween, PhD|
|Suzanne Darrow-Magras, PhD|
|Anna Clarke, PhD|
|Nadia Monrose-Mills, PhD|
|Vivian Palmer-Lewis, DNP|
IRB Meeting Dates and Submission Deadline
The University of the Virgin Islands’ Institutional Review Board (IRB) has set its meeting schedule for Spring Semester 2023. The IRB meets on the 2nd Wednesday of the month.
Applications must be submitted to the Office of Sponsored Programs (OSP) via Cayuse HE. Please be advised that OSP will conduct a pre-review of all applications, utilizing the IRB Submission Matrix, before assigning it to a meeting date. The pre-review process may require that you submit additional documentation or clarification to submitted materials. Any delay may cause your submission to be assigned to a later meeting date.
The below meeting dates are for new applications that do not qualify for exempt or expedited review due to risk level and study population, and for protocols that require continuing review by the IRB. The Office of Sponsored Programs will determine what protocols require full IRB approval based on federal regulatory requirements.
|Submission Deadline||Meeting Dates|
|*See note below||Wednesday, January 11, 2023|
|Wednesday, January 25, 2023, 4:30 pm||Wednesday, February 08, 2023|
|Wednesday, February 22, 2023, 4:30 pm||Wednesday, March 08, 2023|
|Wednesday, March 29, 2023, 4:30 pm||Wednesday, April, 12, 2023|
|Wednesday, April 26, 2023||**Wednesday, May 10, 2023|
The IRB will make every attempt to review your submission on the assigned meeting date. In the event your application is not reviewed on the assigned meeting date, it will be assigned to the next meeting date on the schedule. Submissions received after 4:30 p.m. on the submission deadline date will be assigned to the next meeting date.
Note: Meeting dates are subject to change. * Applications submitted during the UVI Holiday Recess that are complete will be reviewed at the meeting on January 11, 2023. **The final meeting of the spring semester will be held on Wednesday, May 10, 2023. Should your application not be reviewed at the final IRB meeting, it will be moved to the first meeting of the Summer Semester.
Questions about Cayuse and the submission process can be directed to Diahann Ryan, Assistant Director for Research Compliance at email@example.com.
Governmental Regulations Governing Human Subject Research
It is the policy of UVI to follow governmental regulations and laws and to abide by terms and conditions set forth in the operation of university committees regulated by the federal government. We are committed to the principles of the Belmont Report. These principles consist of respect for persons, beneficence, and justice. These principles guide the review of research with human subjects. The UVI IRB operates under a federal-wide Assurance (FWA) #FWA00000374 with the Office for Human Research Protections (OHRP) under the Department of Health and Human Services.UVI has an approved FWA. The FWA states that recipients of federal funding shall comply with the federal policy for the protection of Human Subjects and shall comply with not only the overarching policies and procedures mandated by the U.S. Department of Health and Human Services (HHS) but will also comply with additional human subjects regulations and policies of other federal departments or agencies which conduct or support research and will comply with state, local or institutional laws, regulations, and policies.
The FWA states that the IRB has the authority to approve, require modification in, or disapprove the human subject research. The authority of the IRB to disapprove research cannot be overruled at the Institutional level. Therefore, if the IRB does not approve a research activity, the activity cannot be conducted at UVI or by any employee of UVI.
The following links provide information concerning the ethical principles, codes, and federal regulations that govern the protection of human subjects in research:
The Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects in Research)
The Nuremberg Code (Directives for Human Experimentation)
Department of Health and Human Services (DHHS Code of Federal Regulations 45 CFR 46)
Office of Human Protections (OHRP)
NIH HIPAA Privacy Rule: Information for Researchers
IRB Guidance for Student Research & Class Projects
Federal regulations require Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals or a group. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and the University in violation of federal regulations. At the same time, many class projects are conducted for educational purposes and not as research, and will not require IRB approval. Below is clarification regarding student research versus class projects and guidance that will help you determine whether you need to get approval from IRB before conducting a given activity.
Student research activities include, but are not limited to, projects that result in undergraduate honors theses, senior seminar research, master’s theses, or doctoral dissertations. IRB approval is generally required if interaction with individuals (e.g., in person, via e-mail, mail, web survey, or telephone) are involved.
Student Class Project
Class projects are generally conducted for educational purposes and not as research. Such class projects require neither an IRB application nor a determination that IRB approval is required. Instructors and departments are encouraged to contact IRB for guidance about issues that may still remain, even when IRB approval is not required - such as ways to handle privacy, confidentiality, informed consent, potentially vulnerable population, and professional ethics when class projects are part of the course syllabus. Although IRB is willing to provide guidance for issues relating to student class projects – instructors, advisors, departments, and schools play an even greater role in providing the appropriate guidance and oversight. No IRB approval or determination of human subject status is required for the following class projects:
- Class projects involving secondary data analyses that are assigned and conducted as educational exercises, using data that are either publicly available data, de-identified, or otherwise impossible to be linked to personal identities.
- Class projects or practica that involve direct interaction (e.g. in person, via mail, email, web surveys, or telephone), but where the purpose is training, and educational exercise or professional development, and not research. The project or practicum is not “research” even if students ask people questions as part of learning how to conduct interviews or surveys, take histories, administer assessments, or perform ‘in-house’ evaluations as requested by the practicum site.
Training on Human Subjects Research
The University of the Virgin Islands has subscribed to the Collaborative Institutional Initiative (CITI) Program to provide students, staff, faculty, and faculty advisors with up-to-date information about the ethical requirements for conducting research involving human subjects. The IRB requires that each researcher review core concepts for the ethical conduct of research involving human subjects before submitting an application to the IRB. CITI Program certificates are renewable every 3 years.
CITI Program - Collaborative Institutional Training Initiative
How to register for the CITI Program?
How to select a course in CITI?