OSP is pleased to announce the adoption of IRBNet www.irbnet.org suite of tools bringing on-line submission and electronic protocol management of IRB reviews. Effective fall of 2013, OSP will begin accepting all research protocol applications through IRBNet.
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 review of protocols dealing with special prison population, 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.
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.
The FWA states that "All Institution's human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects (National Commission for the Protection of Human Subject and Biomedical and behavioral Research), or (b) other appropriate ethical standards recognized by federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule.”
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)
Title 34 CFR 99 http://www2.ed.gov/policy/gen/guid/fpco/pdf/ferparegs.pdf
Office of Human Protections (OHRP) http://www.hhs.gov/ohrp/
NIH HIPAA Privacy Rule: Information for Researchers
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 are limited to 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 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 following class projects:
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. In order to submit an 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.
The online training consists of seven modules; each addressing the principles used to define ethical research using humans and the regulations, policies, and guidance that describe the implementation of those principles. Four of these modules are followed by a quiz. The entire course will take approximately 3 hours to complete.