CHAPTER NINE: Research Regulations

Listed below are important policies that help to ensure University compliance with federal regulations governing research.

9.1 Human Subjects Protection Program Office (IRB)

The University’s Institutional Review Boards (IRB) are a part of the University Human Subjects Protection Program. An IRB is a group of individuals with varying backgrounds, charged with reviewing proposed research involving human subjects to ensure the protections of those subjects and compliance with federal human subject’s regulations. The University of Louisville has two such review boards, each consisting of faculty, staff, and representatives from our affiliated institutions, as well as members of the Louisville community.

The University of Louisville Institutional Review Boards and the Human Subjects Protection Program were accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2005. The University of Louisville IRBs operate in compliance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research.

The charge of the Institutional Review Board is:

· To protect human subjects involved in research at the University and its affiliated institutions
· To ensure that human subjects voluntarily consent to their involvement in research
· To protect the investigators involved in research at the University and its affiliated institutions by providing guidance
· To protect the University and its affiliated institutions by providing guidance to the signatory institutions named herein and following the federal, state and local standards for human subject protections
· To protect the volunteer members of the IRB involved in the review of human research studies.

All paid and gratis faculty of the University of Louisville, who conduct human subject’s research associated with their appointment, must utilize the University's IRBs for review, approval and continued oversight of the research. In certain circumstances, individual or institutional conflicts of interest may require the utilization of an independent IRB. Requests for use of an independent IRB must be made to the University IRB and approved by the EVPRI.

Prior to implementation of any research involving human subjects, one of the IRBs, one of the IRB chairs or vice-chairs or one of the experienced committee members designated by the IRB chair must review the proposed research and approve it or exempt it from IRB review.

The IRB is guided by three basic ethical principles regarding all research involving human subjects, regardless of whether the research is subject to federal regulation, with whom it is conducted, or the source of support. Those principles, enumerated in The Belmont Report, are:

· Respect for persons
· Beneficence: The obligation to do no harm, maximize benefits and minimize risks
· Justice, equal opportunity for subjects to receive the benefits and bear the risks of research, regardless of gender, race and socioeconomic status.

All faculty and staff involved in human subjects research are expected to be familiar with The Belmont Report.

As noted above, there are two IRB's at the University of Louisville.

IRB Medical

IRB Medical meets three times per month - the first, third and fourth Thursday of the month at 12:15 p.m. in Room 230 of MedCenter One, 501 E. Broadway, Health Sciences Center campus.

IRB Behavioral/Social Science/Education

IRB Behavioral/Social Science meets the first Wednesday of every month at 12:30 p.m. Room 230 of MedCenter One, 501 E. Broadway, Health Sciences Center campus.

Protocols are assigned to primary reviewers and are pre-reviewed by board members or Human Subjects Protection Program Office staff to identify items that need the investigator's attention prior to full board review. The investigator should work with the reviewers and staff to address any concerns identified prior to the protocol going to the full board.

Definition of Research and What Types of Research Must be Reviewed

Research is defined in the “Common Rule” (45 CFR 46.102(d) as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Clinical investigation, as defined in FDA regulations (21 CFR 50.3(c) means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Human subjects are defined in the “Common Rule” as “living individuals about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” The FDA regulations define human subjects as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. The appropriate definition depending on the type of human research will generally apply to all human research conducted by investigators at the University of Louisville.

If there is any doubt as to whether IRB review for specific research is required, one of the IRB chairs makes the determination for the University of Louisville and its affiliated institutions. Every prospective investigator considering submitting a proposal including human subject research should become familiar with the issues related to human research and with the process by which IRB approval is obtained.

Federal-wide Assurances

The University of Louisville, University of Louisville Hospital, Norton Healthcare and Jewish Hospital Healthcare Services all have Federal-wide Assurances with the Department of Health and Human Services. An FWA is a binding written document that commits these institutions to comply with federal regulations concerning federally-funded human research conducted at the institutions listed below. The Federal-wide Assurance numbers for each of the named institutions are:

The Human Subjects Protection Program Office

The Human Subjects Protection Program Office (HSPPO) helps to ensure that all University of Louisville research involving human participants is conducted in accordance with Federal and State regulations and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants. HSPPO upholds this commitment to the protection of human participants involved in research regardless of the funding source and regardless of the location of the research. HSPPO supports two duly established and independent Institutional Review Boards (hereby referred to as IRBs), which review and approve protocols for all research involving human participants.

The HSPPO staff is the first point of contact in the human research review process. They will answer questions and provide assistance about the appropriate review path for the particular research protocol.  The IRB chairs and vice-chairs work out of the Human Subjects Protection Program Office when conducting IRB business.

The Human Subjects Protection Program Office on the Health Sciences Campus is located in Suite 200 of MedCenter One, 501 E. Broadway. The office is open from 8:00 a.m. to 5:00 p.m. Investigators are encouraged to call 852-5188 with questions.

IRB Policies and/or Procedures

Comments or suggestions regarding IRB policies or procedures are welcome and should be addressed to the Executive Vice President for Research and Innovation, Room 200, Jouett Hall, or to the Director, Human Subjects Protection Program, MedCenter One, Suite 200, 501 E. Broadway, Health Sciences Center.

9.2 Animal Subjects

The Animal Care and Use Program encompasses all use of vertebrate animals by or for the University of Louisville for educational or research purposes. The designated Institutional Official, the Executive Vice President for Health Affairs, has the ultimate responsibility for the Program. Direct oversight of the Program, which has been accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), International since its inception in 1965, is delegated to the Institutional Animal Care and Use Committee (IACUC). No vertebrate animal intended for research or teaching may be purchased, bred, or otherwise acquired by or for University faculty or staff without prior approval by the IACUC. The Research Resources Facilities (RRF) manages the acquisition, husbandry, and disposition of animals. All research and teaching activities involving animal subjects in University facilities must be directed by University of Louisville faculty members or by other personnel meeting University-accepted criteria as Principal Investigators.

The IACUC is responsible for monitoring all aspects of the Animal Care and Use Program and for advising the Institutional Official regarding recommendations for Program requirements and/or changes. Principal IACUC responsibilities include the following:

· Ensuring the humane treatment of laboratory animals

· Establishing policy and procedures to protect personnel from occupational health and safety hazards associated with the use of research animals

· Monitoring the laboratory animal environment by periodic inspection of housing and procedural areas

· Disseminating information related to approved methods for animal care

The IACUC is composed of at least seven faculty members who are experienced scientists, at least one veterinarian experienced in laboratory animal medicine, , and at least one individual not affiliated with the University to represent community interests.

Regulatory authority for the Program, including IACUC responsibility and function, include:

• The Animal Welfare Act (AWA), 7 U.S.C. 2131-2157, 2.17, 2.51, and 371.2(g)
• U.S. Department of Agriculture (USDA) Animal Welfare Act Regulations, Title 9, Code of Federal Regulations, Chapter 1, Subchapter A – Animal Welfare, parts 1, 2, 3, and 4 (and subsequent amendments).
• Public Health Service, Policy on Humane Care and Use of Laboratory Animals
• Interagency Research Animal Committee (IRAC), “Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training

The University of Louisville Animal Care and Use Program also fully endorses the National Research Council, Guide for the Care and Use of Laboratory Animals, which is used as a basis for Program development and AAALAC accreditation.

Principal IACUC activities are as follows:

• Semi-annual review of the institutional animal care and use program and inspection animal housing and study areas
• Prepare and submit written reports of program and facility evaluations, reviewed and signed by a majority of the IACUC, and including any minority views, to the Institutional Official. Recommendations regarding any aspect of the institutional animal care and use program or facilities may be included in these reports
• Review and approve, require changes to secure approval, or withhold approval of “Proposals to Use Laboratory Animals in Research and Teaching” (Proposals) prior to the initiation of related research or teaching activities. Re-review is required every three years, or more frequently as determined by the IACUC or regulatory agencies, and prior to modifications of ongoing activities.
• Provide PIs/PDs with written notice of decisions regarding Proposal review
• Suspend previously approved Proposals if activities are determined to be contrary to federal, state, local, and University regulations
• Investigate, review, and, if warranted, report public or institutional concerns of animal care and use program noncompliance

Prior to IACUC review, a Proposal t is pre-reviewed by IACUC staff, a member of the Research Resources Facilities Veterinary Care faculty, and representative from pertinent safety offices/committees. This pre-review not only satisfies regulatory requirements for veterinary involvement in project design but also helps ensure that personnel and facilities are available to support the proposed work and that any special safety concerns are met. Following pre-review, the Proposal is submitted to a Designated Reviewer and 0-2 Review Consultants, depending on the nature of the project. Summaries of Proposals under review are sent to all IACUC members, which may elect to request full committee deliberation prior to approval. Otherwise, approval is granted after assigned reviewers’ concerns are met. Decisions involving Proposal disposition are made only after consideration of non-animal models and other research methods that reduce animal number and/or any anticipated pain or distress. Committee objectives are accomplished while preserving the freedom of scientific inquiry...

All research faculty and staff members are required to attend a training seminar that addresses humane methods of animal maintenance and research experimentation. Also discussed in mandatory training are the availability and use of research or testing methods that limit the use of animals and minimize potential animal pain and distress. This includes the proper use of anesthetics and analgesics. Procedures whereby personnel may report perceived deficiencies in the Animal Care and Use Program are also defined. Issues pertaining to the hazards associated with animals and mandatory enrollment in the Occupational Health and Safety Program for personnel exposed to research animals are also presented. Because of such issues, the IACUC also serves as a liaison for research staff and other important oversight bodies within the University, including the Department of Environmental Health and Safety, Radiation Safety, and the Institutional Biosafety Committee.

Once approval for the use of animals is secured, the faculty and staff of the RRF are responsible for maintaining research animals in a clean and distress-free environment. In maintaining centralized animal holding facilities, the RRF strives to provide investigative staff with physiologically and psychologically healthy research subjects. The University Animal Care and Use Program views the relationship of the IACUC, RRF, and research staff as a partnership in providing the highest quality animal model possible to support the highest quality research data.

For more information regarding the University’s policies, see https://louisville.edu/research/iacuc/policies, and/or contact the Health Sciences Center Office of Research Services.

9.3 Institutional Biosafety Committee

In compliance with NIH Guidelines and University policies, an Institutional Biosafety Committee (IBC) has been established at the University of Louisville. UofL’s Institutional Biosafety Committee (IBC) reviews all institutional activities involving the use of biohazardous agents, and recombinant and synthetic nucleic acid molecules that require approval for "biosafety activities" as described in current governmental regulatory requirements. These regulatory requirements include, but are not limited to, the National Institutes of Health (NIH) Recombinant DNA Guidelines, the Centers for Disease Control and Prevention (CDC) Guidelines, and the Occupational Safety and Health Administration (OSHA) regulations and compliance directives as adopted and adhered to by KY OSHA.

All principal investigators that want to use one of the following biological agents must complete and submit at IBC application/registration form:

• Biological agents as specified in the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories web site.
• Recombinant DNA and human gene therapy, as outlined in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) web site.
• Human blood, body fluids, tissues, other clinical specimens are regulated through the OSHA Bloodborne pathogen standard: See information on the Department of Environmental Health and Safety (DEHS) web site for all the regulatory requirements that principal investigators and clinical supervisors must meet.
• The possession, transport and acquisition of Select Agent and other than permissible quantities of toxins requires registration with Health and Human Services (HHS) Centers for Disease Control (CDC) and USDA Animal and Plant Health Inspection Service (APHIS) prior to possession. If you possess Select Agents or any amount of Select Toxins OR intend to perform future research or work involving any Select Agent or Toxins, you must immediately inform the Biological Safety Officer, or call 852-6670, so that appropriate arrangements can be made
• When laboratories are to be relocated, renovated, vacated or closed, all chemical, radioactive, biological or other hazardous materials must be removed and disposed, in accordance with applicable EPA, OSHA, NIH, CDC and other regulations. Equipment and items that may pose a potential danger to people or the environment must be removed and properly disposed. Failure to comply with the policy below may result in sanctions. Policy For Laboratory Decommissioning

The IBC application/registration form is available on-line at the iRIS web site. Completed application/registration forms must be submitted by the principal investigator. In general, approval from the IBC is needed for work with Risk Group 2 and 3 biological agents; recombinant and synthetic nucleic acids (unless it is specifically exempt per the NIH guidelines); and human and primate materials; biological Toxins.

The IBC's charge is to ensure that all procedures and facilities involving the use of biological agents, recombinant DNA and large scale activities meet the best interests of laboratory safety, effective research, as well as the environment and general public. The IBC is appointed by and reports to the Executive Vice President of Research and Innovation. The composition of the committee meets the requirements as specified in the NIH Guidelines which includes two community members that are not affiliated with the University of Louisville. The IBC has standing monthly meetings, which are generally scheduled the first week of each month. The Department of Environmental Health and Safety provides the administrative support for the functions and business of the IBC.

9.4 Radiation Safety

The University of Louisville’s radiation safety program encompasses approval of Authorized Users and uses of radioactive materials, worker training, laboratory surveys, purchasing and inventory control of radioactive materials, bioassay, personal dosimetry, radioactive waste disposal, survey instrument calibration and emergency response. The Radioactive Materials User Guide is the policy and procedure manual for all authorized users of radioactive materials and the personnel under their direction that handle radioactive materials. The Department of Environmental Health and Safety’s (DEHS) Radiation Safety Office writes and maintains the University’s radioactive materials licenses. These licenses are issued by the Kentucky Radiation Control Branch of the Cabinet for Human Resources under the authority of the Nuclear Regulatory Commission. Additionally, DEHS’s Radiation Safety Office coordinates the activities of the Radiation Safety Committee, which meets quarterly. Under UofL’s radioactive materials licenses, the Radiation Safety Committee has full authority to govern radioactive materials usage within the university. In accordance with our licenses and state regulation, the Committee is charged with the following duties and responsibilities:

• Reviewing the training and experience of a proposed Authorized User to determine their qualifications to use radioactive material and approving all requests to use radioactive material.
• Prescribing special conditions and monitoring techniques for all proposed uses of radioactive material to insure safety.
• Reviewing the Radiation Safety Officer’s summary reports on radioactive material uses including training records, lab surveys, incidents, misadministrations, occupational radiation exposure records that are submitted to the committee on a quarterly and annual basis.
• Establishing a program to insure that all individuals working with radioactive material are properly trained prior to commencing work and annually thereafter.
• Recommending remedial actions to correct any deficiencies in the radiation safety program.

In order to obtain authorization to procure and use radioactive material at UofL, an individual must: be a full-time faculty member; have prior training and experience in the types of radioactive material and uses requested; and complete an "Application for Authorization to Use Radioactive Material" form. The first point of contact in the application process is the Radiation Safety Office, which is located in Room 102 of the Library/Commons Building. Applications are available on-line or by calling 852-5231. Once the application is completed, it should be submitted to the Radiation Safety Office so that the Radiation Safety Officer can perform a preliminary review. The application will then be routed to appropriate members of the Radiation Safety Committee for ultimate approval or disapproval.

All authorized users of radioactive materials must comply with the conditions and possession limits of their authorization and UofL’s radioactive materials license as follows:

• Assuming responsibility for their own safety and the safety of all personnel under their direction working with radioactive material.
• Notifying the Radiation Safety Officer of newly hired or transferred personnel who will be working with radioactive material.
• Ensuring that all individuals requiring radiation dosimetry to monitor exposure are assigned film badges which must be ordered through the Radiation Safety Office.
• Ensuring the security of radioactive material in the laboratory and clinical areas to prevent accidental loss or theft.
• Ensuring that all radioactive waste is properly disposed of through the Radiation Safety Office.
• When laboratories are to be relocated, renovated, vacated or closed, all chemical, radioactive, biological or other hazardous materials must be removed and disposed, in accordance with applicable EPA, OSHA, NIH, CDC and other regulations. Equipment and items that may pose a potential danger to people or the environment must be removed and properly disposed. Failure to comply with the policy below may result in sanctions. Policy For Laboratory Decommissioning

Additionally, the Authorized User is responsible for assuring that all individuals under his/her direction that handle radioactive materials have received adequate instruction in radiation safety principles applicable to specific practices of that particular laboratory. It should be noted that many handling and radiation safety procedures pertain to circumstances in a particular lab or institution; therefore, it may not be assumed that instruction has necessarily been adequately provided by prior occupational training, board certification, etc.

Completion of the initial orientation radiation safety training course offered by the Radiation Safety Office is mandatory for all individuals using radioactive materials. This course is generally offered the second Thursday from 11 AM – 12PM.  Locations are specific on the DEHS web site. Group or individualized training can be arranged on a case-by-case basis. All users and workers that require this training must contact the Radiation Safety Office at 852-5231 to register. Annual refresher training is also mandatory for all users of radioactive material. This training is now available on-line on the Department of Environmental Health and Safety web site.

X- Ray Units and Other Radiation Producing Machines

Machines that produce ionizing radiation, such as x-rays from fluoroscopes, analytical x-ray units, must be registered with the Kentucky Radiation Control Branch as required by state law. Department Chairs are responsible for review and approval of proposed uses of all ionizing radiation producing machines within their jurisdiction. Such approval signifies that the department will provide the resources including facilities and equipment necessary to control hazards. Prior to departmental approval, the Radiation Safety Office must be notified of any new ionizing radiation producing equipment in the event that revisions to UofL’s licenses and permits are required. All individuals working with x-ray units or machines that produce ionizing radiation must be trained by the Principal Investigator or Clinical Supervisor in the appropriate safety practices and must wear dosimetry. Compliance surveys of radiation producing machines are conducted by the Radiation Safety Office on a pre-set time frame consistent with the license issued by the Kentucky Cabinet for Human Resources’ Radiation Control Branch.

9.5 Laser Safety

Lasers are utilized in research and clinical applications throughout the university. The laser’s high degree of coherence of the light beam makes it an ideal tool for many different applications. However, this coherence also makes the light beam (direct or reflected) a serious threat for damage to the human eye. For that reason, the American National Standards Institute has developed a guideline entitled "Standards for the Safe Use of Lasers" (ANSI z136.1) which is the laser industry’s standard for all persons who operate Class II, Class III, or Class IV laser products.  The Radiation Safety Office has produced a Laser Safety manual that can be found online on the DEHS website.  Adhering to this manual will satisfy the recommended requirements for laser safety.  Additionally, the Occupational Safety and Health Administration (OSHA) issued a directive to its compliance officers entitled "Guidelines for Laser Safety and Hazard Assessment" since citations for safety problems with lasers can be issued under OSHA’s general duty clause. This directive provides detailed information on laser types, hazards, classifications, control measures, and personal protective equipment. In addition to the operations and maintenance manual for each laser, this directive contains useful information that can serve as the basis of training for users of lasers.

All Principal Investigators and Clinical Supervisors that have lasers are responsible for the training and safety of personnel under their direction that may use the laser.  Laser Safety training can also be found online at the DEHS website.  This includes ensuring that protective eyewear is available and utilized and that beam stops or other engineering safety features are not defeated or removed. Principal Investigators and Clinical Supervisors must notify the Radiation Safety Office of any existing class IIIB or IV lasers as well as any purchased in the future. All injuries involving lasers must be reported to the Radiation Safety Office as well as UofL’s Worker’s Compensation representative in the Risk Management department.

OSHA Directive Publication 8-1.7 "Guidelines for Laser Safety and Hazard Assessment" is available at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=1705

When laboratories are to be relocated, renovated, vacated or closed, all chemical, radioactive, biological or other hazardous materials must be removed and disposed, in accordance with applicable EPA, OSHA, NIH, CDC and other regulations. Equipment and items that may pose a potential danger to people or the environment must be removed and properly disposed. Failure to comply with the policy below may result in sanctions. Policy For Laboratory Decommissioning

9.6 Chemical Agents

The use and storage of hazardous chemicals are highly regulated by federal, state and local agencies such as the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the National Fire Protection Association (NFPA), and the Metropolitan Sewer District (MSD). An overview of environmental, health and safety regulations applicable to laboratories is available on the DEHS web site. This information source, Regulatory Requirements and Standards of Care for Laboratories, provides compliance basics on various aspects of chemical safety, including keys to compliance, training information, common problems to avoid, as well as University contacts for additional support and resources.

This section of the Research Handbook will not attempt to duplicate that web-based resource, but will instead emphasize one of the major regulations impacting research laboratories using hazardous chemicals: the OSHA Laboratory Standard. This standard regulates laboratory use of hazardous chemicals. Compliance with this standard centers on each laboratory having its own written Chemical Hygiene Plan with the following major elements:

• Standard operating procedures.
• Control measures such as fume hoods, special work practices, and personal protective equipment.
• Training of laboratory personnel, including access to Safety Data Sheets.
• Circumstances under which prior approval of a laboratory operation is required.
• Provisions for medical consultations and examinations in case of exposure to hazardous chemicals.
• Designation of persons responsible for implementing the Plan.
• Designation of a Chemical Hygiene Officer/Committee to provide technical guidance.
• Additional precautions for working with select carcinogens, reproductive toxins, and substances with a high degree of acute toxicity.
• Measures to ensure fume hoods function properly.

Policies and procedures for chemical safety are incorporated in the University Laboratory Safety Manual and the Laboratory Chemical Hygiene Plan.

• Lab personnel interested in performing self-inspections of labs should contact the DEHS Laboratory Safety Coordinator for guidance.  DEHS also conducts periodic laboratory safety inspections.  Faculty or laboratory managers are also encouraged to request a DEHS lab safety inspection, particularly if a highly hazardous chemical or procedure has been introduced to the lab.

In addition to inspections of laboratories, DEHS also provides review of research proposals requiring institutional health and safety approval. IACUC policy requires health and safety review of animal research proposals involving hazardous chemicals. If the hazard assessment indicates the need for hazard controls, DEHS determines that appropriate procedures and equipment are in place prior to approving the proposal. Granting agencies such as the American Heart Association and the Department of Defense also require this institutional review and approval. Researchers should be aware they will be required to have approved, written safety procedures for use of select carcinogens, reproductive toxins, and substances with a high degree of acute toxicity, such as cytotoxic drugs, in place prior to grant application deadlines.

Other responsibilities of the Principal Investigator related to the use of chemical agents are:

• Maintaining an accurate and current chemical inventory of all chemicals used and/or stored in areas under his/her responsibility (i.e. labs and cold rooms).
• Maintaining current copies of Safety Data Sheets (SDS) for each hazardous chemical used in the laboratory. If SDS are accessed on-line, all laboratory staff must be informed regarding the procedures to obtain them.
• Assuring that the proper personal protective equipment is provided to all laboratory staff which includes but is not limited to lab coats, aprons, eye protection, face protection, gloves, etc. The DEHS web site contains useful information on the selection of personal protection equipment in labs.
• Assuring that training is provided for hazards and procedures specific to their laboratory, the DEHS web site contains a Laboratory Safety and Hazardous Waste classroom training schedule.   All new laboratory staff must attend a Laboratory Safety and Hazardous Waste classroom training session.  Online refresher training must also be completed every 3 years.

Finally, if principal investigators use large quantities of solvents or other flammable liquids, storage requirements and the allowed volumes are specified by the National Fire Protection Association (NFPA) standards and the Occupational Safety and Health Administration (OSHA) regulations. Also, there are carcinogens and other chemicals that are regulated by OSHA through substance specific standards so that additional requirements may apply. Refer to the DEHS Laboratory Safety Manual for information.

When laboratories are to be relocated, renovated, vacated or closed, all chemical, radioactive, biological or other hazardous materials must be removed and disposed, in accordance with applicable EPA, OSHA, NIH, CDC and other regulations. Equipment and items that may pose a potential danger to people or the environment must be removed and properly disposed. Failure to comply with the policy below may result in sanctions. Policy For Laboratory Decommissioning

9.7 Hazardous Chemical and Infectious Waste

The disposal of hazardous chemical waste, as well as infectious, waste, are both highly regulated activities due to the potential for environmental harm if not properly handled. The University has a very restrictive policy regarding the sink disposal and regular trash disposal of chemically hazardous and infectious waste. As such, DEHS has developed a Disposal Guide to provide assistance to faculty and staff on the required procedures to handle and dispose of these types of waste. This manual is available on-line.  In addition to providing the requirements for proper disposal of chemical and infectious waste, it also includes information on disposal requirements of gas cylinders; empty containers; used batteries and lamps, controlled drugs and used oils since these are all potential issues that principal investigators in labs may encounter.

Completion of the hazardous waste training course offered by DEHS is mandatory for all persons who manage hazardous waste in laboratories. It offers information about the basics of complying with hazardous waste regulations and instructs university personnel in the procedures for having hazardous waste picked up by DEHS. University personnel can view the DEHS training schedule located on the DEHS web site for session dates.  Most all chemical wastes from laboratories are presumed to be a regulated hazardous waste. If the chemical waste exhibits one or more of the following EPA four hazardous characteristics or is listed, the waste is determined to be a regulated hazardous waste.

• Ignitability - Ignitable wastes can create fires under certain conditions, are spontaneously combustible, have oxidizing potential, or have a flash point less than 60 °C (140 °F). Examples include ethanol and acetone wash solutions, hexane, diesel fuel, used solvents, nitrates, perchlorates, and chromates.
• Corrosivity - Corrosive wastes are liquid wastes, such as acids or bases (pH less than or equal to 2, or greater than or equal to 12.5) that are capable of corroding metal containers, such as storage tanks and drums.
• Reactivity - Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes, gases, or vapors when heated, compressed, or mixed with water. Examples include n-butyl lithium, silane, lithium-sulfur batteries, and explosives.
• Toxicity - Toxic wastes are harmful or fatal when ingested or absorbed (e.g. contains heavy metals such mercury, lead, cadmium, chromium, barium, silver, selenium, arsenic, pesticides, carcinogenic organics, etc.). When toxic wastes are land disposed, contaminated liquid may leach from the waste and pollute ground water. Toxicity is defined through a laboratory procedure called the. The TCLP helps identify wastes likely to leach concentrations of contaminants that may be harmful to human health or the environment.

Additionally, by definition, EPA determined that some specific wastes are hazardous. These wastes are incorporated into lists published by the Agency. These lists are organized into three categories:

• The F-list (non-specific source wastes). This list identifies wastes from common manufacturing and industrial processes, such as solvents that have been used in cleaning or degreasing operations. This includes common used waste solvents such as xylene, toluene, acetone, ethyl acetate, methylene chloride, trichloroethane.
• The K-list (source-specific wastes). This list includes certain wastes from specific industries, such as petroleum refining or pesticide manufacturing. Certain sludges and wastewaters from treatment and production processes in these industries are examples of source-specific wastes.
• The P-list and the U-list (discarded commercial chemical products). These lists include specific commercial chemical products in an unused form. Some pesticides and some pharmaceutical products become hazardous waste when discarded.

Although the chemical may not be determined to be a regulated hazardous waste, it could still be toxic to human health, animal health, and the environment if not disposed properly.  These include chemicals that have acute or chronic carcinogenicity, mutagenicity, and teratogenicity.  Moreover, some chemicals could be deemed hazardous or a nuisance to our city’s waste water treatment plants. These include chemicals that contain concentrated dyes, emanates a strong, offensive odor, any oxygen demanding pollutant, detergents, surface active agents, or other substances which might cause excessive foaming to the POTW.

All laboratories that generate hazardous chemical waste are considered "satellite accumulation areas" by the EPA. Colleges and universities across the country are not immune from EPA inspections, it is essentially important that all principal investigators and research personnel that generate hazardous chemical waste comply with the following Satellite Accumulation Area Requirements:

• Hazardous chemical waste container(s) must be kept at or near the process generating the waste and under the control of the operator.  An inspector typically interprets this as the same room the hazardous chemical waste is generated.
• Any container used to collect hazardous or chemical waste must be marked with the words "Hazardous Waste" or “Chemical Waste”.
• Any container holding hazardous chemical waste must be in good condition. This means no cracks, no rust, and no leaks.
• Any container holding hazardous chemical waste must be compatible with the waste and any waste mixtures in that container must also be compatible.
• Any container holding hazardous chemical waste must be closed at ALL TIMES. The only exception to this is when waste is being added to or removed from the waste container.
• Accumulation of hazardous waste in any satellite accumulation area cannot exceed 50 gallons or 200 pounds at any time. If the area accumulates acutely hazardous waste (EPA P-Listed Waste), one quart (1 kg) is the maximum amount allowed to be accumulated. A list of EPA acutely hazardous wastes is available in Chapter 3 of the Disposal Guide.

NOTE:

Laboratories may be subject to unannounced hazardous waste inspection by State and/or Federal regulatory agencies.  These inspections routinely include ensuring that chemical hazardous waste containers are prominently marked as “Hazardous Waste”, chemical hazardous waste containers are closed, and chemical waste is kept in the same room the waste is generated.  Any fines assessed against UofL laboratories will be paid by the home department or lab itself.

Regulations imposed by local, state, and federal agencies dictate that infectious (medical, biological waste) must be segregated, packaged, and disposed of in a specific manner. The primary purpose of the regulations is to limit on-the job exposure to blood and other potentially infectious materials. It is the responsibility of every unit, or laboratory generating infectious waste to ensure that all wastes listed in this section are segregated from other wastes, packaged, and disposed of in accordance with University policy, following packaging and disposal guidelines. These wastes include the following:

• Microbiological waste - i.e., stocks and/or cultures of etiological or infectious agents, including culture plates, test tubes, swabs, etc. contaminated with these agents.

• Human Pathological Waste - i.e. all human, tissues, muscles, parts, organs, etc.

• Animal Pathological Waste – i.e. animal carcasses, tissues, parts, etc.

• Transgenic Plant Material - plant’s genetic material that has been altered by the introduction of genes from another organism.

• Sharps - i.e., syringes, needles, and scalpel blades, glass and plastic pipettes, plastic pipette tips, and vials All needles and syringes regardless of their use are to be handled in accordance with this guide. Approved sharps containers are hard-sided, biohazard labeled and puncture resistant. Sharps containers should be sealed when ¾ full and discarded in a red biohazard bag-lined burn box.

Contaminated protective gloves and disposable lab coats should also be disposed of as biohazardous waste. Laboratories and other areas that generate infectious waste must use the medical waste red bag liners and containers provided by University custodial services. Infectious waste must be packaged and prepared for disposal by laboratory or clinical staff. Full securely closed, marked, and labelled medical waste containers should remain in the laboratory or clinical space. When U of L laboratories are housed in a non-University facility, disposal of infectious waste must follow the policies of the organization where the laboratory is located. Policy conflicts or questions about safety should be directed to DEHS.

The detailed requirements for pickup of hazardous chemical waste and infectious waste are available on the DEHS Waste Disposal web site.  (Chapters 3 and 5, respectively, of the Disposal Guide).  For further information regarding the University’s chemical waste and infectious waste management programs, contact the DEHS Hazardous Waste Coordinator at 852-2956 or Cathy Price.

When laboratories are to be relocated, renovated, vacated or closed, all chemical, radioactive, biological, or other hazardous materials must be removed and disposed, in accordance with applicable EPA, OSHA, NIH, CDC and other regulations. Equipment and items that may pose a potential danger to human health or the environment must be removed and properly disposed. Failure to comply with the policy below may result in sanctions. Policy For Laboratory Decommissioning

9.8 Conflict of Interest in Research

A conflict of interest is any situation that may compromise or appear to compromise a covered individual’s (employee’s) professional judgment in carrying out their institutional activities because of an external relationship/interest of the employee or their immediate family.  The University of Louisville has developed policies and procedures for promoting objectivity and responsible conduct of research by managing, reducing, or eliminating conflicts of interest.

The Attestation and Disclosure Form (ADF), available in iRIS must be completed, at least annually by:

1. All University of Louisville Employees.
2. All individuals participating in research under the auspices of U of L, regardless of compensation. This includes all individuals with a research appointment.

Effective August 24, 2012, a current ADF must be on file for each named researcher at the time of proposal submission. The ADF is located on the iRIS web site.  Directions for completing the ADF are located on the COI web site (under the COI requirements link).  Additional information regarding conflicts of interest can also be found at this site.

If you have a question or concern regarding research misconduct, feel free to email Research Integrity.

9.10 Research Activities Performed by Outside Organizations

The University of Louisville recognizes that from time to time it may be appropriate for an outside organization to perform research activities, including human subject research, at the University. The University will consider requests for such activities based on the following guidelines:

• University faculty research must have priority over all private-sector research with respect to all resources including facilities, equipment, services, and personnel.
• The services that are to be provided to the outside company should be for stated periods of time rather than permanent.
• The research being conducted in University facilities must be within the research mission of at least one of the University’s departments.
• If the research involves human subjects, then the guidance subscribed to by the university must be followed. This includes review by the appropriate University of Louisville IRB and continued oversight by the IRB for the length of the project.
• The University will receive reimbursement for all costs associated with each individual project. Such reimbursement shall include incremental costs incurred by the University as a result of the use plus the appropriate indirect cost for sponsored projects.
• The University will not make its facilities available for services that are available from the private sector in the Louisville area. This guideline would apply to the basic purpose for which facilities are used and not to all ancillary services.
• All companies must have a sponsoring department that is willing to certify to at least the following:

1. The department has the space available for the outside company to perform the project.
2. The project will not take away from any of the department's functions or activities.
3. The department will be responsible for all administrative details relating to the proposed company's use of the facilities, such as obtaining temporary parking permits through University Police, arranging for keys, etc.
4. If University resources for which it has an obligation to a third party are to be used, the sponsoring department will appoint a faculty member who will be responsible for the conduct of the outside company relating to those resources.
5. All such arrangements should be subject to a business agreement to be negotiated by the Office of the Executive Vice President for Research and Innovation upon the recommendation of the sponsoring department and the appropriate dean, with final approval by the President.

9.11 Responding to Instances of Non-Compliance

The University has taken steps to manage compliance risk, but in the event that an instance of non-compliance occurs, the University has policies and procedures through which instances of non-compliance with federal, sponsor, or University regulations will be investigated.  Findings of such investigations will be reported, as required by regulation and contractual requirements.

9.12 Committee Information

Application deadlines, meeting schedules, procedures and forms for each of the University of Louisville's research regulation committees can be found at the following points of contact:

11/25/2020