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    Louisiana State University Health Sciences Center
   
 
  Sep 26, 2017
 
 
    
Faculty Handbook

14. Research



14.1 Animal Resources Facility

The mission of the Division of Animal Resources is to provide a high level of animal husbandry care and veterinary services to assist the faculty of this institution in their research endeavors involving animals; to ensure that all applicable laws, policies, and standards of animal care and use are met by the institution; and to serve as an asset to the research program of the institution.

Division offices are located in the Medical School Building in room 9-307.
The three sections of the division (with contact information) are:

Facility operations (animal husbandry care) 5-5651
Veterinary Services 5-5204
Administration 5-5200

To access additional information, see link below:
http://www.medcom.lsuhscshreveport.edu/cfdocs/animalcare/index.cfm

14.2 Assurance Committees

To view the submission deadlines and committee meeting dates, please visit each committee’s webpage located at: http://myhsc.lsuhscshreveport.edu/SchoolofGraduateStudies/AssuranceCommittees.aspx

14.2.1 Animal Care and Use

The LSU Health Shreveport Animal Care and Use Committee (ACUC) is a standing committee of the institution which is responsible for the oversight of the institutional animal care and use program. The committee is created and empowered by the Animal Welfare Act of 1966 (P.L.98-544) as amended by the Animal Welfare Acts of 1970 (P.L. 91-579) and 1976 (P.L. 94-279 and the Food Security Act of 1976 (P.L. 99-198); Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals as depicted in the Health Research Extension Act of 1985 (P.L. 99-158); and the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. The committee ensures that all animals used in research, teaching, and testing are used appropriately and are treated in accordance with the highest standards of humane care.

The ACUC is appointed by the Institutional Official and consists of 21 professional people representing various departments within the institution. They include 12 scientists, 2 Doctors of Veterinary Medicine, 3 community members, and 4 ex-officio members. The ACUC is responsible for reviewing all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories, overseeing training and educational programs, investigating reports of potential noncompliance with regulations and taking corrective actions as necessary.

Prior to working with animals, personnel must be listed on the applicable animal use protocol, must be enrolled in the institution’s Occupational Health Program, and must have completed the institution’s training program on the use of animals in research.

To send comments or submit documents to the ACUC, use the following email address: SHVAnimalCare@lsuhsc.edu

To access ACUC policies, forms, training and occupational health requirements or additional information, see the link below:
http://www.lsuhscshreveport.edu/Research/AnimalCareandUseCommitteeACUC.aspx

14.2.2 Biosafety

According to NIH Guidelines for Research Involving Recombinant DNA Molecules Section IV, the Institution shall establish an Institutional Biosafety Committee whose responsibilities include specifying practices for constructing and handling recombinant DNA molecules. However, this committee need not be restricted to recombinant DNA. Its responsibilities may include organisms and viruses containing recombinant DNA molecules and other chemical and biological hazards.

The Institutional Biosafety Committee (IBC) is responsible for reviewing, approving, and overseeing all projects performed at LSUHSC which involve biological materials that are a potential hazard to investigators or research subjects. The IBC meets on the 2nd Thursday of each month. If there are no new protocols or revisions to be reviewed, an email meeting will take place. Committee review and approval of annual updates are done annually.

The Principal Investigator (PI) must gain the approval of the Institutional Biosafety Committee to proceed with research that utilizes infectious agents/biohazards, chemical agents and recombinant DNA. PIs can have only one active protocol at a time. The PI is responsible for notifying the IBC of any changes to his protocol. If a PI needs to add or make a change to his protocol, he may submit a memo to the committee requesting the change. If the scope of the research is changing, then the PI must submit a new protocol and request to terminate the other. The PI is responsible for renewing the Biosafety protocol each year by submitting an annual update.

To access the Biosafety forms and for more information, please go to: http://myhsc.lsuhscshreveport.edu/SchoolofGraduateStudies/InstitutionalBioSafetyCommittee.aspx

14.2.3 Institutional Review Board

Support staff for the LSUHSC-Shreveport Institutional Review Board (IRB) are located in the Clinical Research Building. The Human Research Protection Program (HRPP) staff work closely with the IRB and are also located in the Clinical Research Building.

The IRB is responsible for reviewing all research projects involving the use of human subjects to determine the following:

  • The risks to the subject are sufficiently outweighed by the benefits to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept those risks.
  • The rights and welfare of the subject are adequately protected.
  • Legally, effective Informed Consent is obtained by adequate and appropriate methods. As defined by federal regulations, IRB authority extends to any study using live human subjects, data, and tissue collected from live humans. It is also an institutional policy that IRB approval must be obtained to collect and use in a study any tissue from a cadaver when that individual had been identified before death as a person from which tissue was needed for a research study.

To view the Standard Operating Procedure of the Louisiana State University Health Sciences Center at Shreveport Institutional Review Board and obtain the appropriate forms, go to: http://www.lsuhscshreveport.edu/Uploads/Public/Documents/HRPP/HRPP%20SOP’s%20Rev.%204.2012.pdf

14.2.4 Radiation Safety

The Louisiana State University Center for Energy Studies maintains Radiation Licensing by the Louisiana Department of Environmental Quality, Office of Environmental Compliance. Each campus in the LSU System is required to maintain a campus Radiation Safety Committee. The LSU Health Sciences Center at Shreveport Campus Radiation Safety Committee is charged with the responsibility and authority to control the use of radioactive materials and radiation sources on a local basis. All use of radioactive sources will be conducted in a manner such that exposure to faculty, staff, students, the public and the environment will be as low as reasonably achievable. No radiation exposure will be received without societal benefit. To achieve an ALARA (As Low As Reasonably Achievable) Radiation Safety Program, the committee establishes and enforces procedures and practices in the following areas: training, personnel monitoring, delivery of radioactive material, radioactive material accountability and waste handling. The Radiation Safety Committee adheres to Permanent Memorandum 30 (PM-30): http://www.lsusystem.edu/docs/PMs/PM-30-09012010.pdf

The Campus Radiation Safety Committee is responsible for:

  • Review and approval of all radioisotope user projects for compliance with license restrictions and university policies and regulations.
  • Assuring that project proposals do not impose unacceptable radiological risk to individuals.
  • Review and approval of radiation producing equipment when requested by the purchasing department.
  • Assuring that University personnel involved in the control and handling of radiation hazards, including project director and technicians, have appropriate training and/or experience.
  • Reviewing the actions of the Campus Radiation Safety Office.

To request the use of radioisotopes, the PI must complete the Radiation Safety Protocol form. To request access to the Medical School Irradiator, the PI must complete an Irradiator Application Form and a Radioactive Material Access Request Form which is provided by the Safety Officer in the Safety Office. To request access to the Small Animal Imaging Center, the PI must submit a Short Form protocol. To access all forms and for more information, go to: http://myhsc.lsuhscshreveport.edu/SchoolofGraduateStudies/RadiationSafetyCommittee.aspx

14.2.5 Radioactive Drug Research Committee (RDRC)

The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July 25, 1975, classifying all radioactive drugs as either new drugs requiring an Investigational New Drug Application (IND) for investigational use (21CFR 312) or as generally recognized as safe and effective when administered under the conditions specified in the RDRC regulations (21CFR 361.1). The RDRC program under 21 CFR 361.1 permits basic research using radioactive drugs in humans without an IND when the drug is administered under the following conditions:

The RDRC is responsible for the review of basic science research protocols using radioactive drugs in humans that are subject to § 361.1. RDRC approval of a research study by the RDRC is based on assurance that the following requirements are met [§ 361.1(d)(1)-(9)]:

  • appropriate limit on the radiation dose
  • appropriate limit on the pharmacologic dose
  • qualified study investigators
  • medical facility properly licensed to possess and handle radioactive materials
  • appropriate selection and consent of research subjects
  • appropriate quality of radioactive drug administered
  • sound research protocol design
  • reporting of adverse events by the investigator to the RDRC
  • approval by an appropriate Institutional Review Board (IRB)

Federal Regulation (21 CFR 361.1 Radioactive drugs for certain research uses.) can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1

14.3 Human Research Protection Program

LSUHSC-S endeavors to promote a human subjects research environment that fosters the respect for the rights and welfare of individuals recruited for, or participating in, human subjects research conducted by or under the auspices of LSUHSC-S. In order to fulfill this mission, LSUSHC-S has established a human subjects research protections program (HRPP). The mission of the HRPP is to:

  • Safeguard and promote the welfare of human research subjects by ensuring that their rights, safety and well-being are protected;
  • Provide timely and high quality review and monitoring of human research projects; and
  • Facilitate excellence in human subjects research.

The HRPP was accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) in June 2009 and reaccredited in June 2012. The goals of the HRPP are to provide education and community outreach regarding use of human subjects in research. The IRB is part of the HRPP.

Policies and procedures for the HRPP/IRB are found at: http://www.lsuhscshreveport.edu/HRPP/HRPPHRPPPolicies.aspx

14.3.1 Clinical Trials Office

The Clinical Trials Office (CTO) provides administrative, research, and educational services to LSUHSC-S researchers conducting clinical trial research. The goals of the CTO are to:

  • Facilitate clinical trials research by providing regulatory and administrative support to LSUHSC-S investigators
  • Provide education to LSUHSC-S researchers about clinical research policies, procedures, issues, and best practices
  • Coordinate community outreach efforts to increase clinical trials awareness and accrual
  • Build and maintain strong partnerships with industry and recruit new clinical trials

The CTO is located in the Clinical Research Building, Rooms 101 and 159. For more information, go to: http://www.lsuhscshreveport.edu/Researc/ClinicalTrialsOffice.aspx

14.4 Office of Research

The Office of Research is located on the first floor of the Biomedical Research Building (BRI), Rooms F1-50 and F1-51. The staff in this office oversee the review process for intramural grants, coordinate operations in the research space in the BRI, keep the financial accounts for the Office of Research and the Office of Graduate Studies and oversee undergraduate and summer student research programs.

For more information, go to: http://www.lsuhscshreveport.edu/Research/Research.aspx

14.5 The Office for Sponsored Programs and Technology Transfer

The Office for Sponsored Programs and Technology Transfer (OSPTT) provides services to faculty and staff at LSU Health Shreveport involved in the acquisition of sponsored projects and technology transfer. OSPTT’s mission is to promote the Institution’s goal to increase the level of sponsored project funding, to protect the interests of the Institution and its faculty and staff, and to provide the highest degree of support services.

14.5.1 Intellectual Property

General Policy

LSU encourages and expects its personnel to engage in creative, scholarly activities as part of their duties. All LSU personnel are required to bring to the attention of an appropriate LSU officer, at an early date, any discoveries, inventions, and works potentially subject to legal protection under patent, copyright, or other law. The inventor, the inventor’s department, and the inventor’s campus gain prestige, and in some cases, financial benefits from commercializing an invention or discovery. Such commercialization is consistent with, and complementary to, LSU’s academic mission.

All intellectual property (IP) generated from Federal, State, and Foundation funds is the property of LSUHSC-S. The Office for Sponsored Programs and Technology Transfer (OSPTT) accepts disclosures and facilitates their review. The OSPTT works closely with staff in the LSU System Office for further development of IP, including patent applications, licensing options, etc. Ownership of IP generated from Scientific Research Agreements is negotiated on a case-by-case basis, depending on the intent of the program. All intellectual property generated from clinical trials agreements is the property of the pharmaceutical company sponsor.

LSU does not have any ownership to this intellectual property, as outlined in the pharmaceutical clinical trial agreement.

The LSU System By-Laws associated with LSU owned intellectual property can be located at the following website: http://www.lsusystem.edu/docs/bylaws/BYLAWS_Chapter%20VII.pdf

14.5.2 Sponsored Programs

The Office for Sponsored Programs and Technology Transfer (OSPTT) is located in Room 1-214 on the first floor of the Medical School at 1501Kings Highway. The OSPTT is a service unit within the Office of Research that assists research faculty and staff in obtaining extramural research funding. The OSPTT is the authorized institutional office to submit extramural research funding proposals. All proposals to outside agencies for support of research must be reviewed and administratively approved through OSPTT prior to submission to the outside agency. The OSPTT offers assistance across the entire spectrum of sponsored programs activities, from identifying a potential source of funding, to reviewing the terms and conditions of awards made to the Institution. In addition, the OSPTT is responsible for:

  • Ensuring all extramural grant proposals submitted to external sponsors (federal or corporate) for funding are compliant with federal and state laws, as well as institutional and sponsor requirements. Review of the grant application, including the budget and budget justification and obtaining the necessary Administrative approvals prior to submitting the grant application. The OSPTT adheres to Chancellor Memorandum 32 (CM-32) for grant submission deadlines: http://myhsc.lsuhscshreveport.edu/Uploads/Public/Documents/CM-32%20Extramural%20Research%20Proposals.pdf
  • Identifying potential funding sources for investigators; funding announcements posted on OSPTT website as well as notification through email system.
  • Grant management, including annual progress reporting, re-budgeting, grant close-outs and facilitating the transfer in/transfer out of awarded grants to LSUHSC-S, upon faculty relocation.
  • Negotiating and facilitating the execution of sponsored research agreements, material transfer agreements, confidentiality agreements and LSUHSC Prime Awardee federal subcontracts.
  • Tracking and reporting research funding for sponsored projects

14.5.3 Technology Transfer

Under the LSU System Policy, inventions developed at LSUHSC Shreveport or its entities must be disclosed to LSUHSC-Shreveport. An invention may be any new and useful process including medical devices, composition of matter, or related improvement. The process of invention begins with conception of the invention, and continues with successful licensing and commercialization of technology transfer. In order for an invention to be patentable it must have utility (be useful), it must be novel (new and original), and it must be non-obvious to one of ordinary skill in the field. An invention may also be a copyrightable creative work. To disclose an invention, faculty must complete a Technology Disclosure Packet. The disclosure form collects important information about the invention. The form also includes an Assignment Agreement that is required as well. Once the packet has been submitted to OSPTT, the PI will be given a Revenue Distribution Agreement to complete. The disclosure is then sent to a group of faculty who will review the disclosure and make recommendations as to whether to request more data, file a patent, or not approve the disclosure.

LSUHSC-S is engaged with professional consultants for review of our technologies as to their relevance to patentability, marketability, and commercial value. LSUHSC-S works to maximize the commercial value of institutionally supported technologies.

For more information, to access the Technology Disclosure Packet, and to access the Permanent Memorandums related to Technology Transfer (PM-16, PM-64, and PM-67), go to: http://myhsc.lsuhscshreveport.edu/Research/TechnologyTransfer.aspx

14.6 Research Core Facility

The Research Core Facility is located on the sixth floor of the BRI and on the ninth floor of the Medical School Building, 1501 Kings Highway. The sixth floor facility, located in Rooms F6-12, F6-13, F6-14, F6-15, F6-48, F6-50, and F6-51, contains an Automated Cellular Imaging System, Confocal Microscopy, DNA Array (Chip) Analysis, Flow Cytometry, Fluorescence Microscopy, Laser Capture Microdissection, Mass Spectrometry-Proteomics, DNA Sequencing and Real-Time PCR. Four fulltime staff members operate these instruments and provide technical support. A computer laboratory in the Research Core Facility runs software packages specifically designed for the available technologies. The Small Animal Imaging Facility located on the ninth floor in the Medical School Building includes a MicroPET, MicroCT, MicroPET/SPECT/CT, and fluorescent imaging systems. A full-time veterinarian and full-time research associate operate this facility. Services are available on a fee basis.

For more information go to http://www.sh.lsuhsc.edu/oor/rcf/index.html