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  • ORSP - Revised - 2014
    subjects research The initial renewal of training in Human Subjects in Research is required every five years Investigators and key study personnel must renew their training by taking a shorter refresher course offered by CITI The Office of Research and Graduate Studies will notify investigators of the expiration of their certification 90 days prior to its occurrence Subsequent renewals are required every three years key study personnel include all individuals including students who contribute in a substantive way to the development conduct and monitoring of studies on behalf of FGCU This includes persons who enroll research subjects obtain informed consent or screen potential subjects and who analyze or report research data open Animals in Research FGCU offers the following on line training courses through the Collaborative Institutional Training Initiative CITI when using animals in research CITI registration and logon instructions can be found by clicking on the above link Working with the IACUC Working with the IACUC Refresher Course Essentials for IACUC Members IACUC Community Members Wildlife Research Working with Amphibians in Research Settings Working with Fish in Research Settings Working with Zebrafish Danio rerio in Research Settings Working with Mice in Research Settings open Conflicts of Interest COI in Research Please refer to the Faculty 2011 2014 Collective Bargaining Agreement the Employee Handbook and FGCU regulation FGCU PR5 012 Outside Employment Activity Regulation for conflicts of interest relating to your employment with the university FGCU offers an online Conflict of Interest course through the Collaborative Institutional Training Initiative CITI The course includes basic background in the elements of the revised Public Health Service PHS federal regulations on financial conflicts of interest and investigator and institutional responsibilities CITI registration and logon instructions can be found by clicking on the above link open Responsible Conduct of Research RCR Both NIH and NSF require universities to provide a foundation in the responsible conduct of research RCR NIH requires that all trainees fellows participants and scholars receiving support through any NIH training career development award individual or institutional research education grant and dissertation research grant receive instruction in responsible conduct of research NSF requires applicant institutions to have in place at the time of proposal submission a plan to provide a foundation in the responsible conduct of research RCR to undergraduate students graduate students and postdoctoral researchers Towards meeting these requirements FGCU offers an online Responsible Conduct of Research course through the Collaborative Institutional Training Initiative CITI The course focuses on the underlying principles of the responsible conduct of research CITI registration and logon instructions can be found by clicking on the above link open Health Information Privacy and Security HIPS The federal HIPAA Privacy Rule protects the privacy of personal health information To meet the training requirements of HIPAA and other US statutory regulatory authorities FGCU offers an online course in health information privacy and security through the Collaborative Institutional Training Initiative CITI The course is also consistent with training requirements of international standards such as that of the ISO Code of

    Original URL path: http://www.fgcu.edu/ORSP/trainingprograms.html (2016-02-07)
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  • ORSP - Revised - 2014
    candidates technicians foreign students seeking advanced degrees and any foreign national conducting research at U S universities or their affiliates International Exchange Visits The Office of International Services provides overall leadership to FGCU in developing coordinating and promoting international education opportunities for students and professionals Application Process FGCU personnel wishing to invite and host a foreign national to the university must apply through the International Services Office well in advance 90 days minimum suggested of an expected start date for the Exchange Visitor as preparations can take several months to ensure necessary compliance and arrangements Please click here for important information requirements guidance and forms regarding the Exchange Visitor Program The International Services Office may be your initial point of contact as you consider hosting a foreign national Exchange Visitor however you may also be referred to the ORSP or Human Resources Office for additional guidance and appropriate procedures as needed No FGCU persons should offer any formal or written invitation to a prospective Exchange Visitor until advised by the International Services Office that all required procedures have been completed Exchange Visitors and Export Compliance All Exchange Visitors must meet and be screened for export compliance requirements The Deemed Export Review Form for J 1 Scholars and Student Interns included in the general application process for hosting the Exchange Visitor must be completed and submitted to International Services Office If further information is needed or any concerns are noted the International Services Office will contact the FGCU host prior to proceeding to formally invite the Exchange Visitor and issue appropriate immigration documents open Red Flags When to Contact Export Compliance Though university activities are often eligible for exceptions and exclusions from export controls the use of such exclusions exemptions may be unavailable in certain circumstances The following provides guidance on circumstances or red flags that require a closer review of potential export control issues These red flags may appear in a number of activities including sponsored research non sponsored research or collaboration with third parties Examples of activities in a university setting that may be subject to export controls follow Export controls may apply if an employee or the university accepts restriction on the publication or dissemination of information Examples of problematic restrictions included Pre publication review by a sponsor or third party Requirement to treat research results as proprietary or confidential A sponsor s right to withhold information from dissemination or publication Export controls may apply if an employee or the university accepts research restrictions including those that Forbid or restrict the participation of foreign nationals Limit research participation to U S persons or U S citizens Designate the research activity content or results as subject to export controls Include a sponsor initiated or Government flow down export control clause other than a general statement of compliance Require a security clearance for participants or Otherwise limits the openness in research activities Export controls may also apply to university activities related to international travel International travel activities that may be subject to export controls include Shipment or hand carry of items materials equipment or technical data including prototypes to another country Travel to a country subject to a U S embargo or sanctions e g Cuba Iran North Korea Sudan or Syria With few exceptions the Fundamental Research Exclusion is limited to research conducted at U S accredited institutions of higher learning Therefore research activity involving a location outside the United States or exchange of technology with a foreign located collaborator may invalidate this exemption In addition collaborative research with any U S embargoed or sanctioned country may be subject to U S export controls or economic sanctions regulations The exclusions described on this site do not apply to the export of hardware software or technology including prototypes to a foreign location An export license may be required for an export shipment depending on what the item is the destination and the foreign recipient s open Exclusions Exemptions from Export Controls Technology or software that is publicly available is typically not subject to U S export controls including the deemed export rule This includes technology or software that Is already published or will be published referred to as the Publicly Available Public Domain Exclusion Arises during or results from fundamental research referred to as the Fundament Research Exclusion or Is educational as defined in the regulations referred to as the Education Exclusion Each of these exclusions and some potential limitations are described in greater detail below Publicly Available Public Domain Exclusion This exclusion is defined as technology and software information that is already published or will be published is not subject to export controls Information is published when it becomes generally accessible to the interested public in any form including Publication in periodicals books print electronic or any other media available for general distribution to any member of the public or to a community of persons interested in the subject matter either free or at a price that does not exceed the cost of reproduction and distribution Readily available at libraries open to the public or at university libraries Patents and open published patent applications available at any patent office or Release at an open conference meeting seminar trade show or other open gathering Limitations It is important to note that this exclusion may not apply to technology or software related to defense military space applications or certain encryption software Fundamental Research Exclusion Fundamental research is defined as basic and applied research in science and engineering conducted at accredited U S institutions of higher education where the resulting information is ordinarily published and shared broadly within the scientific community Such research can be distinguished from proprietary research and from industrial development design or production where the results are typically restricted for proprietary reasons or specific national security reasons Information resulting from fundamental research is typically excluded from export controls As a result a license is not required to release information that qualifies as fundamental research to a foreign national Limitations

    Original URL path: http://www.fgcu.edu/ORSP/exportcontrols.html (2016-02-07)
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  • ORSP - Revised - 2014
    animals is justified and any animal pain or suffering is minimized IACUC Forms IACUC Guidelines Under Construction IACUC Meeting Dates open Submission of Applications Applications are accepted by ORGS on behalf of the committee at any time open Links to General Animal Research Guidelines Animal Welfare Act USDA Animal Welfare Home Page Office of Laboratory Animal Welfare OLAW US Fish and Wildlife Service Endangered Species Permits International Union for Conservation of Nature Recognition and Alleviation of Pain in Laboratory Animals Principles for the Utilization and Care of Vertebrate Animals in Testing Research and Training Guide for the Care and Use of Laboratory Animals National Research Council Guidelines for Ethical conduct in the Care and Use of Animals American Psychological Association American Veterinary Medical Association s AVMA Guidelines on Euthanasia Net Vet open Links to Animal Subject Resources Wildlife in Field Studies USDA Studies of Wild Animals in or from Natural Settings Guidelines of the American Society of Mammalogists for the use of Wild Mammals in Research Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research Guidelines for the Use of Fishes in Field Research Information Resources on Fish Welfare Guidelines for the Use of Live Amphibians and Reptiles in Field and Laboratory Research Guidelines for the Use of Wild Birds in Research open Links to Justify the Use of Animals John Hopkins University Center for Alternatives to Animal Testing Norwegian Reference Centre for Laboratory Animal Science Alternatives Tip Sheet on Literature Searches UC Davis Center for Animal Alternatives Information USDA Alternatives US National Library of Medicine Alternatives of Animal Testing Bibliography open Links to Animal Associations American Association for Laboratory Animal Science AALAS American Fisheries Society American Society of Ichthyologists and Herpetologists American Society of Mammalogists Animal Welfare Information Center USDA AWIC Association for Assessment and

    Original URL path: http://www.fgcu.edu/ORSP/iacuc.html (2016-02-07)
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  • ORSP - Revised - 2014
    protected as mandated by the appropriate federal regulations state statutes and university guidelines Research with human subjects may not be conducted prior to receiving IRB approval IRB FORMS IRB GUIDELINES IRB MEETING DATES open Submission of Applications Applications and protocols are accepted by ORGS on behalf of the board and reviewed weekly by the IRB chairperson or designee Protocols requiring review by the full Institutional Review Board must be received a minimum of one month prior to the Board s meeting date open Links to Human Subjects Research Resources Code of Federal Regulations 45CFR46 Human Subject Protections Office for Human Research Protections OHRP Human Subjects for Behavioral and Social Science Research National Science Foundation NSF International Compilation of Human Research Standards 2014 edition U S Food and Drug Administration PRIM R Public Responsibility in Medicine and Research The Belmont Report Office of Behavioral and Social Sciences Research NIH open IRB Members Dr Clifford Renk Chair College of Arts Sciences 239 590 7482 crenk fgcu edu Dr Robert Triscari Vice Chair College of Education 239 590 7202 rtriscari fgcu edu Dr Terry Wimberley College of Arts Sciences 239 590 7752 twimber fgcu edu Dr Edward Ferguson Community Member Dr Arthur Rubens

    Original URL path: http://www.fgcu.edu/ORSP/irb.html (2016-02-07)
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  • ORSP - Revised - 2014
    of Research and Graduate Studies 10501 FGCU Blvd South Howard Hall 202 Fort Myers FL 33965 6565 research fgcu edu Phone 239 590 7020 Fax 239 590 7843 ISC The FGCU Institutional Safety Committee ISC promotes and facilitates a safe research environment by requiring that research projects meet all federal state and local safety regulations Projects involving bio hazardous materials select agents recombinant DNA controlled chemicals radioactive material or instruments with a radioactive label or processes that result in acutely hazardous waste is reviewed by the committee for compliance with the pertinent federal state and university regulations I SC Form s I SC Guidelines I SC Meeting Dates FGCU Environmental Health and Safety open Protocol Submission Deadlines Applications are accepted by ORGS on behalf of the committee at any time open Links to Safety Guidelines NIH NIH Office of Biotechnology Activities CDC Biosafety in Microbiological and Biomedical Laboratories Occupational Exposure to Bloodborne Pathogens CDC Final Rule Possession Use and Transfer of Select Agents Agricultural Select Agents USDA APHIS Select Agent and Toxin Exclusions Florida Administrative Code Radiation Safety Florida Administrative Code Biomedical Waste FGCU Radiation Safety Manual open ISC Members Ms Rhonda Holtzclaw Environmental Health Safety Director 590 7224 rholtzcl

    Original URL path: http://www.fgcu.edu/ORSP/Isc.html (2016-02-07)
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  • ORSP - Revised - 2014
    202 Fort Myers FL 33965 6565 research fgcu edu Phone 239 590 7020 Fax 239 590 7843 Internal Awards Small Grant for Preliminary Study SGPS An external grant application becomes more competitive by including Preliminary Study in the proposal SGPS provides seed money to produce preliminary data for the feasibility study proof of concept etc The goal of SGPS is to strengthen faculty s external grant applications and lead to

    Original URL path: http://www.fgcu.edu/ORSP/internalawards.html (2016-02-07)
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  • ORSP - Revised - 2014
    Study in the proposal SGPS provides seed money to produce preliminary data for feasibility study pilot study proof of concept etc The goal of SGPS is to strengthen faculty s external grant applications and lead to securing external funding from various sponsoring agencies Deadline First Friday of April by 5 00 pm Award Amount Max 5 000 per award Award Period One Academic Year August 1 st to May 31 st No extension No carryover of Awards Dependent on the merit of each application and total funding availability Award Announcement By June 30 th each year Eligibility All FGCU in unit full time faculty members are invited to apply for this initiative To Apply A proposal in PDF format only must be submitted to ORGS research fgcu edu before the deadline Please contact Ms Aquonna Thornhill athornhill fgcu edu x7020 for inquiries Proposal Format Proposals not conforming to the required format will not be reviewed The proposal is limited to four 8 5 x11 pages with one inch margins on all sides single spaced in Arial 11 point font The following sections are required 1 Project Title 2 PI Name Department College Unit and Contact Information 3 Co PI s Name Department College Unit and Contact Information of each Co PI 4 Abstract 250 words 5 Objectives Goals Specific Aims 6 Innovation and Significance 7 Research Plan 8 Plan to Submit External Grant Application s 8a Specify by title s of external program and sponsoring agency 8b Provide link s to each program and sponsoring agency 9 Timeline 9a To complete the proposed project 9b To submit grant application s to external program s sponsor s 10 History of FGCU Internal Awards Please provide PI s name Internal award title Project title Award amount Award period 10a Specify FGCU internal

    Original URL path: http://www.fgcu.edu/ORSP/sgps.html (2016-02-07)
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  • ORSP - Revised - 2014
    research fgcu edu Phone 239 590 7020 Fax 239 590 7843 LSSF Technology Portal FGCU has partnered with LifeSciences South Florida The overall goals of this initiative are to continue building a South Florida life science cluster foster collaboration enhance education opportunities and increase access to and utilization of expensive instruments Today the database includes a searchable list of scientific instruments manufacturer model and specifications institution and point of contact

    Original URL path: http://www.fgcu.edu/ORSP/12007.asp (2016-02-07)
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