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 dryan@uvi.edu.
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.
Alternate Members:
The University of the Virgin Islands’ Institutional Review Board (IRB) has set its meeting schedule for Academic Year 2021-2022. The IRB meets on the 1st and 3rd Wednesday of the month.
Applications must be submitted to the Office of Sponsored Programs (OSP) via IRBNet. Please be advised that OSP will conduct a pre-review of all applications, utilizing the IRB Submission Matrix, before assigning it to the next available meeting date. The pre-review process may require that you submit additional documentation or clarification. Any delay may cause your submission to be assigned to a later meeting date.
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 available meeting date.
Questions about IRBNet and the submission process can be directed to Diahann Ryan, Assistant Director for Research Compliance at dryan@uvi.edu.
Summer 2021 Meeting Schedule and Submission Deadline
AY 2021-2022 IRB Meeting Schedule Submission Deadline
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 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 researchers have the same submission options as any investigator and may submit as Principal Investigator (PI) with a faculty advisor as co-signatory.
IRB approval also is generally required for student research that is limited to a secondary analysis of data, records, or specimens that are publicly available, de-identified or otherwise impossible to be linked to personal identities, or for research-like activities using departmental subject pools even when the activity is conducted for educational purposes as a class requirement.
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:
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 regulatory requirements for conducting research involving human subjects. The IRB requires that each researcher review core concepts for the responsible conduct of research involving human subjects before submitting an application to the IRB. CITI Program certificates are renewable every 3 years.
To provide students and faculty investigators with up-to-date information about the regulatory requirements for conducting research, the IRB requires that each researcher review core concepts for the responsible conduct of research with human subjects. The Office of Sponsored Programs has subscribed to the Collaborative Institutional Training Initiative (CITI Program) In order to submit an application to the IRB, student and faculty Investigators must have completed an NIH Office of Extramural Research (Protecting human research participants) approved training within the last 2 years and submitted documentation to the Office of Sponsored Programs.
CITI Program - Collaborative Institutional Training Initiative
How to register for the CITI Program?
How to select a course in CITI?
Note: The IRB will continue to accept the certificate of completion on Protecting Human Research Participants issued by the National Institutes of Health, Office of Extramural Research. The NIH certificates are valid for 2 years from the date of completion.