Section 5. Required Special Approvals

Use of Human Participants

Primary responsibility for safeguarding the rights and welfare of human participants in research rests with the faculty or staff member who conducts the research. This responsibility is shared by others involved in the research. All projects, funded or unfunded, involving human participants must be reviewed and approved by the University's Institutional Review Board for Human Research Participant Protection (IRB) before the planned research may begin. Faculty and graduate student advisors who assign or supervise research conducted by students, including doctoral and graduate students, are responsible for assuring that all research and dissertation work has been approved by the IRB.

Institutional Review Board for Human Research Participant Protection (IRB)

The Institutional Review Board for Human Research Participant Protection was established to ensure the ethical conduct of research involving human participants. It is the responsibility of the IRB to assure the University that human participants used in research or educational programs are not at undue risk and that the participants are informed of any risks. The IRB is responsible for advising Research & Sponsored Programs on the University’s compliance with federal guidelines and University policy and procedures regarding the protection of human participants, and to certify to Research & Sponsored Programs that any research project or activity involving human participants has been reviewed and approved by the IRB.

The Institutional Review Board for Human Research Participant Protection (IRB) is a committee of appointed volunteers (both University and non-University representatives) who review and approve the use of human participants in research projects.

The IRB meets on a regular basis. No changes in approved research protocols should be initiated prior to IRB approval unless necessary to eliminate apparent immediate hazards to the participant.  IRB meetings are open to investigators and the public.

When the review has been completed, notification is sent by the IRB to the Principal Investigators (PIs) or researcher. Research & Sponsored Programs will then notify the sponsor, if required. Neither the sponsor nor the university will release funds for a project involving human participants that does not have IRB approval. Further, some federal agencies require assurance that a project has IRB approval before an application will even be reviewed for funding.

Types of IRB Review Exemptions from Full Board Review

Exempt Research

The IRB chair or designee is charged with the responsibility of determining eligibility for exemption. Principal Investigators or researchers who believe their research with human research participants is exempt must submit applications which are complete and in sufficient detail to permit an evaluation of the claim to exemption and to justify its finding. All IRB members will be notified by Research & Sponsored Programs of all projects found to be exempt of IRB review. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after full board review.

Expedited Review

The IRB may use the expedited review procedure to review either or both of the following:

Research found by the reviewer to involve no more than minimal risk, and minor changes in previously approved research during the period of one year or less for which approval is authorized.

Under an expedited review procedure, the review may be carried out by the IRB chairperson or designee and one or more members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after full board review. All IRB members will be notified by Research & Sponsored Programs of all projects reviewed under the expedited review process.

Full Board Review

Any proposal which does not qualify for exemption or expedited IRB review shall be reviewed by the full IRB at a convened meeting in which a quorum (50% of the membership including at least one member whose primary concerns are in non-scientific areas) is present. Only those members present at the meeting may vote on the proposal. No absentee or proxy votes will be allowed. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

Informed Consent

The primary responsibility of the IRB is to ensure protection of human participants. Human participants cannot be fully protected if they are not fully informed. No investigator may involve a human being as a research participant in research unless the investigator has obtained the legally effective informed consent of the research participant or the research participant's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective research participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the research participant or the representative shall be in language understandable to the research participant or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the research participant or the representative is made to waive or appear to waive any of the research participant's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

COMPLETE POLICY, GUIDELINES, REQUIRED TRAINING FOR INVESTIGATORS OR RESEARCHERS, AND APPLICATION FORMS FOR THE IRB CAN BE FOUND HERE.

Use of Animals

The University of West Florida embraces the principles set forth in the Public Health Service Policy on Humane Care and Use of Laboratory Animals and the Guide to Humane Care and Use of Laboratory Animals (National Research Council, 1996), which are as follows:

• Design and performance of procedures on the basis of relevance to human or animal health, advancement of knowledge, or the good of society.
• Use of appropriate species, quality, and number of animals.
• Avoidance or minimization of discomfort, distress, and pain in concert with sound science.
• Use of appropriate sedation, analgesia, or anesthesia.
• Establishment of experimental end points.
• Provision of appropriate animal husbandry directed and performed by qualified persons.
• Conduct of experimentation on living animals only by or under the close supervision of qualified and experienced persons.

The full PHS Policy on Humane Care and Use of Laboratory Animals is available online. In addition, see the National Research Council Guide for the Care and Use of Laboratory Animals (1996).

Institutional Animal Care and Use Committee (IACUC)

The purpose of the Institutional Animal Care and Use Committee (IACUC) is to ensure the welfare and humane treatment of all animals in current or planned use for research, testing, training, instruction, or any other purpose at, or in association with, the University of West Florida regardless of the source of funding.

The University President appoints individuals who are qualified through experience and expertise to oversee the University's animal care and use program, facilities, and procedures.

To apply for the purchase, care, and use of live animals, the UWF Animal Care and Use Application, in addition to an associated grant application or proposal, research protocol, or laboratory syllabus must be delivered to Research & Sponsored Programs. As specified in the “PHS Policy” (Section IV.C.), the IACUC shall review the submitted material to determine that the proposed activities are in compliance with the “PHS Policy.” In making this determination, the IACUC shall confirm that the activity will be conducted in accordance with the Animal Welfare Act, insofar as it applies to the activity, and that the activity is consistent with the “Guide” unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the activity conforms with the University’s Animal Welfare Assurance and meets the requirements set forth in the “PHS Policy” (Section IV.C.1.a.-g.) which implement the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.”

A grant application or proposal involving live animals shall not be mailed to an agency until a completed UWF Animal Care and Use Application has been delivered to Research & Sponsored Programs. When considering granting agency deadlines, at least one month should be allowed for the Institutional Animal Care and Use Committee to complete its review of an application.

COMPLETE POLICY, GUIDELINES, REQUIRED TRAINING FOR INVESTIGATORS OR RESEARCHERS, AND APPLICATION FORMS FOR THE IACUC CAN BE FOUND AT https://nautical.uwf.edu/org/disporg.cfm?OrgUnitID=ANIMAL.

Use of Biohazards and Recombinant DNA

The University of West Florida’s policy and guidelines on the use of biohazards and their disposal can be found on the Department of Environmental Health and Safety Web site or call (850) 474-2525.

Use of Radioactive Materials and Radiation-Producing Devices

The University of West Florida’s policy and guidelines on the use of radioactive materials and radiation-producing devices can be found on the Department of Environmental Health and Safety Web site or call (850) 474-2525.

Classified Access and Export Controlled Information

Projects which involve classified information (security clearance access) or which deal with information, materials, and activities which may be subject to export control regulations must follow specific guidelines. Section 4 University Policy and Guidelines contains Operating Procedures dealing with export control. Additional information may also be found in Section 6 Pre-award and Proposal/Award Processing or contact Carol Rafalski at (850) 474-2825.