Required Special Approvals
1. Use of Human Subjects
The University of Florida (UF) seeks to ensure that research conducted under its jurisdiction does not expose persons who participate as subjects or volunteers to unreasonable risks to their health, general well-being or privacy. Specifically, in all research, development and related activities involving the use of human subjects, UF seeks assurance that;
the rights and welfare of the individuals involved are adequately protected;
the participation of subjects is based on freely given, legally effective, informed consent and;
the risk to subjects is minimized; and risks to the subjects are reasonable in relation to the anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Therefore, all non-exempt human subject research must be reviewed and approved by the appropriate UF Institutional Review Board (IRB), described below, before the planned research may begin. In other words you may not conduct any human research without prior IRB approval.
Primary responsibility for safeguarding the rights and welfare of human subjects in research rests with the investigators and staff who are conducting the research. In addition, 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.
To help ensure that all investigators and research personnel receive a well-rounded education in human subjects protection UF has posted several important sources of information at IRB Training website. In addition, if you are involved in research with human subjects, you MUST complete the UF Required Reading.
Statement about Finder's Fees and Bonus Payments:
Finder's fees for referring potential research subjects are prohibited. Bonus payments based on the rate or timing of subject enrollment are only allowed if the payments are made to the University and not the investigator. When the VA is involved refer to the VA policy concerning bonus payments.
2. Institutional Review Board (IRB)
The University of Florida has four IRBs as well as an Administrative Home Office;
IRB-01 UF Gainesville Campus Health Science Center
IRB-02 UF Gainesville Campus Non Medical
IRB-03 UF Jacksonville Campus Health Science Center
IRB-04 Western IRB (WIRB) has been established for studies that are sponsored by private companies
UF’s Institutional Review Boards (IRBs) are the Authority to review, require modifications, approve, disapprove, suspend or terminate approval of research involving human subjects, as well as to observe, or designate a third party to observe, the subject consent process and/or the research.
Researchers must obtain the appropriate approval from a UF IRB unless the Institutional Official grants a special exception to rely upon the review of another qualified IRB.
The IRB is a committee of appointed volunteers (both UF non-UF representatives) who review and approve the use of human subjects, volunteers, or participants in research projects.
The IRBs meet on a regular basis for the purpose of conducting initial and continuing review of research, for determining which projects require review more often than annually, for reviewing reports to the IRB of changes in research activity, and for reviewing reports of any adverse events experienced by research participants. No changes in approved research protocols should be initiated prior to IRB approval unless necessary to eliminate apparent immediate hazards to the subject. IRB meetings are open to investigators and the public.
While all four IRBs are governed by the same set of federal and state rules, each has its own forms and procedures for review. Before submitting an application to anyone of the IRBs you should visit the appropriate IRB web site for the most up to date instructions and forms.
Regardless of which IRB is used, the review process begins when you submit an application. It is very important your application be complete and accurate, otherwise delays in receiving approval occur.
When the IRB review has been completed, the IRB generates an approval letter that is distributed to the Principal Investigator.
Notify DSR of IRB Approval
If the approval pertains to a sponsored research project it is the responsibility of the Principal Investigator to identify the PeopleSoft Project number or sponsored award and forward a copy to DSR's Award Administration Office via Fax at 392-4522 or email at firstname.lastname@example.org. Award Administration will setup new awards based on Dr. Norton’s August 22, 2012 Memo.
Spending Authority Delayed:
DSR will not release spending authority on a sponsored project that involves human subjects without an IRB approval, unless special circumstances are presented in writing to the Director or Associate Director.
3. Types of IRB Review
IRB review can occur at either a convened meeting of the IRB or through an expedited process. The type of review allowed depends on the type of protocol submitted. The following is intended to assist the investigator in directing his or her protocol to receive the appropriate type of review. It is ultimately the IRB which will decide the type of review a protocol will require.
Full Board Review
In general protocols requiring full board review are those which are considered to be greater than minimal risk for the participants. The Secretary of the Department of Health and Human Services (DHHS) has established, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Code of Federal Regulations also defines certain categories of research that are exempt from the regulations. This list may be found at 45CFR46.101(b).
New protocols may be submitted to the IRB at any time but the approval period can be for no longer than 12 months. Promptly after each IRB meeting the Principal Investigator (PI) will be sent a letter from the IRB office that describes the action taken by the IRB on the investigator's protocol. Possible outcomes of IRB meetings include the protocol is approved as submitted, approvable with explicit changes, tabled, or disapproved (which may be appealed by the investigator).
Research activities that involve no more than minimal risk and that fall within the list of categories identified above can be reviewed and approved by the IRB Chair or a designated experienced member of the IRB. Federal Regulations define minimal risk as meaning that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Expedited protocol submissions are reviewed as they are received; generally, a response is provided within two weeks.
If the condition being treated is immediately life-threatening, there is no standard acceptable treatment available, and there is not sufficient time to obtain IRB approval, a physician may treat the individual immediately with the test article (e.g., investigational drug, device or biologic) and submit a report of this incident to the IRB within five working days.
The FDA has established procedures (called Treatment INDs and Treatment Protocols) under which promising investigational new drugs may be made available to patients with life-threatening or other serious diseases for which no satisfactory alternative drug or therapy exists. This is different from ``Emergent Use'' in that the Treatment IND or Treatment Protocol is always a planned use and thus sufficient time is available to obtain prior IRB review and approval.
Exemptions from Full Board Review
Unless otherwise required by the Office of Human Research Protections (OHRP) at the National Institutes of Health, research in which the only involvement of human subjects will meet criteria described at 45CFR46.101(b) are exempt from IRB review. However, the investigator must get this exemption approved by the IRB by submitting a completed Introductory Questionnaire that includes the criteria under which he/she claims exemption, along with a complete and detailed response to the questions about the project for which exemption is sought. Requests for exempt status are reviewed upon receipt.
Research utilizing survey or interview procedures with children does not qualify for an exemption and must receive full IRB review.
For applications for external funding that do not involve research but where funds are received through the Division of Sponsored Research (i.e., training grants), request for IRB review may be submitted according to Exempt protocol procedures.
4. Informed Consent
The primary responsibility of the IRB is to ensure protection of human subjects. Human subjects cannot be fully protected if they are not fully informed. In order to fully inform subjects, consent forms must be clear and concise, and in language appropriate to the potential subjects (in most cases, understandable by a person with no more than an 8th grade education). In particular, unambiguous explanation of procedures, objectives and risks is an absolute requirement. Consent to participate in research must be considered as an ongoing process.
When the research does not involve drugs or devices, in some cases the informed consent requirement may be waived or modified by the IRB.
5. Use of Animals
The University of 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 at http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the National Research Council Guide for the Care and Use of Laboratory Animals (1996) is available at http://dels.nas.edu/ilar/.
6. Institutional Animal Care and Use Committee (IACUC)
The Institutional Animal Care and Use Committee (IACUC) ( http://iacuc.ufl.edu), which is mandated by two federal laws (Animal Welfare Act and the Health Research Extension Act), reviews activities that involve the use of live vertebrate animals. The IACUC reports to the Vice President for Research and is granted authority to suspend research and teaching programs that do not conform to federal, state or university regulations and policies regarding animal use. For university purposes, animal usage includes the use of live, vertebrate animals for testing, research, or instructional purposes as well as the use of non-living vertebrate materials and the noninvasive observation of wildlife.
At UF both CLAS and the Health Science Center have been accredited by the AAALAC. All faculty, staff, and students in the accredited units using vertebrate animals or their tissues, regardless of location or funding, must obtain approval from the IACUC before funds can be released, or teaching laboratories or experiments begun. Requests for approval must be submitted using the University of Florida Animal Approval form. Most granting agencies allow for IACUC review to occur after the grant has been submitted. reviewed and received a preliminary approval. It is the responsibility of the investigators for knowing the requirements of their particular agency. In general, the IACUC review and approval process takes four to six weeks.
Notify DSR of IACUC Approval
If the IACUC approval pertains to a sponsored research project it is the responsibility of the Principal Investigator to identify the PeopleSoft Project number or sponsored award and forward a copy to DSR's Award Administration Office via Fax at 392-4522 or email at email@example.com. Award Administration will setup new awards based on Dr. Norton’s August 22, 2012 Memo.
Spending Authority Delayed:
DSR will not release spending authority on a sponsored project that involves animals without an IACUC approval, unless special circumstances are presented in writing to the Director or Associate Director.
IACUC meetings are open to researchers and the public
The IACUC is composed of members appointed by University administration for three-year renewable terms and includes faculty, community members and the Attending Veterinarian. The duties and responsibilities of the Committee are as follows:
To review the proposed uses of animals in research, testing, or education.
To insure compliance with Public Health Service and USDA policy and all federal, state and local guidelines and regulations concerning care, treatment and use of animals.
To monitor all animal facilities of the University to assure that professionally accepted standards for care, treatment and use of animals are being followed.
To assure that the type and amount of anesthetic, analgesic and tranquilizing drugs used on animals during actual research are appropriate to relieve all unnecessary pain and distress for the subject animals.
Even though a researcher may be funded for several years, IACUC approval only covers a 12 month period. Investigators are sent a reminder two months before the approval expires. If the project is to continue, the IACUC will request information on the number of animals used, progress towards the experimental goals, and the planned animal use during the next 12 months. Upon receipt of appropriate information and assurances, the approval will be extended for another year.
When significant modifications are made to an approved protocol, enough information must be presented to the IACUC for an adequate review and decision to be made. For example, if more animals are needed than originally planned, it must be clear to the IACUC how they will be used and what happened to cause the increased number of animals needed.
Current information, guidelines, and forms can be found and downloaded from the IACUC page at http://iacuc.ufl.edu/forms.htm. Another excellent resource is the University of Florida's Animal Care Services home page at http://www.health.ufl.edu/acs/index.htm, where many of the manuals produced for faculty and research technicians regarding the proper use of animals can be found online. Please contact the IACUC administration office if you have any questions or concerns (392-9917; Room CB-151B Health Science Center.
7. Use of Biohazards, Biological Toxins and Recombinant DNA
The use of biohazards (infectious agents, transformed cell lines, primary human tumors, and regulated biological materials), acute biological toxins (toxins produced from living organisms with an LD(50) less than or equal to 100 micro g/kg), and recombinant DNA at the University of Florida is monitored by the Biological Safety Office within the Environmental Health & Safety Division.
Prior to the initiation of any project that involves the use such agents, it is the Investigators responsibility to contact the Biological Safety Officer and have the project registered and reviewed by the University's Institutional Biosafety Committee.
For sponsored projects the Principal Investigator shall indicate the use of such agents on the University of Florida Sponsored Projects Approval (DSR-1) Form and/or in Peoplesoft if using the Peoplesoft proposal workflow system.
8. Use of Radioactive Materials and Radiation-Producing Devices
When radioactive materials or radiation-producing devices are involved in research, the procurement, storage, utilization and safety have to be cleared by the Radiation Control & Radiological Services (RC&RS) Department within the Environmental Health & Safety Division.
Prior to the initiation of any project that involves the procurement, storage, or use of radioactive materials or radiation-producing devices, it is the Investigators responsibility to contact the RC&RS (phone 392-7359 or 392-1589 for Health Center faculty) and obtain the appropriate approvals. There are separate application procedures for human and non-human research projects.
For sponsored projects the Principal Investigator shall indicate the use of use of radioactive materials on the University of Florida Sponsored Projects Approval (DSR-1) Form and/or in Peoplesoft if using the Peoplesoft proposal workflow system.
In addition, Investigator must obtain the prior approval from the Radiation Control Officer or Radiation Control Committee to make any change to an approved facility, to increase quantity/levels or change in the use of isotopes, or transfer radioactive materials from one department or laboratory to another. For more information on this subject please contact the Radiation Control Office.