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Regulations, Policy & Procedures

Biological Hazards (BioHazards):
A biohazard is any potentially disease-causing organism or any tissue, body fluid, or waste specimen that might contain such organism(s). This includes all organisms with the potential for causing disease in healthy humans or animals, whether these organisms occur commonly in the environment or not. Biomolecules with disease-causing potential, tissues that might contain these, or tissues from organisms with transmissible disease of unknown etiology are also biohazards. Due to the complex and variable nature of our population, any agent categorized as CDC Biosafety Level 2 or higher is a biohazard requiring approval by the IBC. Agents categorized as CDC Biosafety Level 1 may qualify for Exempt status.

The Center for Disease Control-NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) (5th Edition) manual should be used for guidelines in completing the Biohazards Protocol section. It is a requirement that all personnel be offered appropriate inoculations for occupational health purposes before they can be involved in any lab work. If inoculations are not received, a waiver must be signed.

Guidance Document for Research Work with Nanomaterials:
Research with 1) recombinant DNA, 2) biological hazards, including but not limited to, a BSL2 agent or above, toxins, human blood and cell lines, and/or 3) chemicals that are defined as highly toxic, mutagenic, teratogenic, carcinogenic (confirmed or suspected), explosive or involving Schedule I or II drugs requires that an IBC application be submitted to the Office of Research Compliance for review by the Institutional Biosafety Committee (IBC).

For employees and students conducting research involving the creation, manipulation, or use of nanomaterials or devices not involving the materials listed in the previous paragraph, Clemson University recommends that researchers submit an IBC application because of the potential exposure to ultrafine nanostructures, devices, and systems whose toxicity and health risks associated with nanoparticle exposure have not been defined. The definition of “nanomaterials” includes, but is not limited to, ultrafine structures (engineered or extracted from natural components), devices and systems that have a length scale of roughly 1 to 100 nanometers in one dimension such as fullerenes, quantum dots, carbon nanotubes, nanowires, etc.

A Guidance Document has been adopted by the CU IBC which describes: 1) a definition of nanomaterials,2) work practices, 3) safety concerns, 4) knowledge gaps, 5) reasonable control strategies for working with nanomaterials and 6) control of exposure by inhalation, dermal exposure and ingestion.

Human Cell Line Policy:
All cell cultures and body fluids of human origin, including established cell lines, must be handled in accordance with the OSHA Bloodborne Pathogens Standard and under Biosafety Level 2 (BSL2) containment.  Click here for more information.

Selected EPA-registered Disinfectants:
EPA has provided on its website EPA's Registered Disinfectants (Sterilizers, Tuberculocides and Antimicrobial Products against HIV-1, and Hepatitis B and Hepatitis C viruses) updated January 4, 2006. The use of EPA registered products effective against human blood borne pathogens listed is in compliance with OSHA's (Occupational Safety and Health Administration) occupational blood born pathogen exposure standards (29 CFR 1910-1030).

Minors working on IBC approved research projects:
The Clemson University IBC has adopted the following policy regarding minors. Individuals under the age of 18 are considered minors and must assent to participation in IBC approved research and must have the written permission of their parent or guardian. This policy applies to all persons under the age of 18 whether students, employees or volunteers. The Minor Registration Form should be completed and kept by the PI.

Guidance Document on Research Work with Animal Specimens:
The purpose of this guidance document is to provide information to minimize occupational exposure to zoonotic diseases focusing on contact with animal tissue or products obtained from uninspected sources (not USDA inspected) or specimens not approved by the Clemson University Veterinarian.

Clemson University is currently recommending that researchers working with non-USDA inspected animal specimens, culturing of specimens, or specimens not approved by the University Veterinarian submit an IBC application. Those researchers not working with the areas noted above should review and submit to the IBC office a “Clemson University Acknowledgement form for Working with Animal Specimens in Research”, acknowledging that they are aware of the risk of working with animal specimens.

Chemical Hazards:
Any chemical listed as highly toxic, carcinogenic (confirmed or suspected), mutagenic, teratogenic or explosive on its MSDS must be covered by an approved IBC protocol; if unqualified undergraduates are involved in the research then any chemical listed as toxic, highly toxic, carcinogenic (confirmed or suspected), teratogenic or explosive on its MSDS must be covered and the protocol. Unqualified undergraduates are those that lack at least a year of college level chemistry and biological science (e.g. general biology, microbiology, inorganic, organic biochemistry) or are under the age of 18.

Highly toxic agent is defined as:

  1. A chemical that has a median lethal dose (LD50) of 50 milligrams or less per kilogram of body weight when administered orally to albino rats weighing between 200 and 300 grams each.
  2. A chemical that has a median lethal dose (LD50) of 200 milligrams or less per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each.
  3. A chemical that has a median lethal concentration (LC50) in air of 200 parts per million by volume or less of gas or vapor, or 2 milligrams per liter or less of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 grams each.

Toxic agent is defined as:

  1. A chemical that has a median lethal dose (LD50) of more than 50 milligrams per kilogram but not more than 500 milligrams per kilogram of body weight when administered orally to albino rats weighing between 200 and 300 grams each.
  2. A chemical that has a median lethal dose (LD50) of more than 200 milligrams per kilogram but not more than 1,000 milligrams per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each.
  3. A chemical that has a median lethal concentration (LC50) in air of more than 200 parts per million but not more than 2,000 parts per million by volume of gas or vapor, or more than two milligrams per liter but not more than 20 milligrams per liter of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 grams each.

Explosives: If the project involves the use of explosive material for their explosive property, the PI must contact EHS (Naomi Kelly at 656-1806).

Copies of Manufacturer’s Material Safety Data Sheets (MSDS) for each chemical listed in the protocol must be included in the IBC applications either as a PDF or WORD electronic document or an attached paper copy.

See the EHS website for links to MSDSdatabases.

See the EHS website for the current Chemical Hygiene Plan dated September 11, 2007 at http://ehs.clemson.edu/cehsp/2007%20Chemical%20Waste%20Manage%20Manual/ChemicalHygienePlan2007.htm.

Recombinant DNA (rDNA):
By definition (Federal Register 51 (88) page 16959 I-D-2), the IBC reviews and oversees projects that deal with rDNA technologies. Clemson University must have such an oversight committee made up of faculty, staff, and people from the community, for review of protocols and compliance in rDNA matters. While the most scrutinized protocols are those dealing with the environmental release of genetically engineered organisms, all protocols including those using only laboratory or classroom contained experiments are also closely examined. While certain types of experiments are ultimately considered exempt, Clemson has the policy of requesting that all investigators file a protocol when using rDNA organisms. This guarantees our compliance with federal regulations and allows us to assure the public that we are safeguarding their interests. If you use rDNA, a component of the protocol form will require you to identify the section(s) and appendices of the NIH Guidelines appropriate for your experiments. A copy of the Guidelines for Research Involving Recombinant DNA Molecules is available on the Internet at http://www.nih.gov/od/oba/. A hard copy is available at the Office of Research Compliance.

The following document "The NIH rDNA Guidelines Explained" was written to extract the essence of the NIH guideline requirements and put them in user friendly easy to read format. As noted in the document, the actual guidelines should be consulted since many of the details are not included in this shorter version.

If you plan at any time to introduce genetically engineered organisms into the environment, additional information must be filed. For this component, you will need to complete Steps 1-4 in Part D of the protocol. You will also need to reference the USDA publication entitled Guidelines for Research Involving Planned Introduction into the Environment of Genetically Modified Organisms (December 3-4, 1991). This guide is located at http://www.aphis.usda.gov/brs/pdf/abrac%201991.pdf.

Working with Viral Vectors:
Stanford University has shared with the list-serve of the America Biological Safety Association (ABSAA) the following document that may be helpful for researchers working with viral vectors.

www.stanford.edu/dept/EHS/prod/researchlab/bio/docs/Working_with_Viral_Vectors.pdf

Trapping or Handling Small Mammals in Field Studies (Hantavirus Policy):
Clemson University Institutional Biosafety Committee (IBC) and the Medical Surveillance Program have approved a Policy for Individuals Participating in the Trapping or Handling of Small Mammals in Field Studies. This is referred to as the Hantavirus Policy. The purpose of this policy is to minimize faculty, students and staff occupational exposure to zoonotic diseases.

Persons handling small mammals while conducting fieldwork are at an increased risk for many zoonotic infections. Given the high case-fatality rate (38%) among individuals who develop Hantavirus Pulmonary Syndrome (HPS), hantaviruses in the US are of significant public health importance. Because of the virulent natures of the agents of HPS and because animal-to-human transmission may occur is <5 minutes, persons trapping, handling or performing necropsies on wild rodents in known affects areas or potentially affected areas are required to abide by the following precautions outlined in the Clemson University Hanta Virus Policy. The southeastern United States (including North and South Carolina) are considered potentially affected area.

Faculty, students and staff with occupational exposure to small mammals, which includes but is not limited to, wild rodents, must enroll in the Medical Surveillance Program and take hantavirus specific training. Sue Pedrick is the Occupational Health Nurse and can be reached at (864) 656-5529 or spedric@clemson.edu for enrollment in the Medical Surveillance Program and for training. Please call the receptionist at the Joseph Sullivan Center (864) 656-3076 for an appointment. Please review the Hantavirus Policy in advance of your appointment.

The following procedures are followed for field studies under this policy:

  1. The Animal Research Committee reviews AUP field studies.
  2. If the Principal Investigator (PI) is going to collect tissue, blood samples, body fluids samples that are to be brought back to Clemson University facilities, this requires a separate IBC protocol.
  3. If carcasses are handled in accord with the Hantavirus Policy and only returned to campus for disposal, a separate IBC protocol is not needed.
  4. Maintaining trapped live animals from the field in Clemson University facilities or laboratories is not allowed under the present policy.
  5. ARC approval is withheld pending completion of required forms and documentation of hantavirus training.
  6. Principal Investigator must complete and sign the front page of “Clemson University Policy for Individuals in the Trapping or Handling of Small Animals in Field Studies” and forward to the ARC Coordinator.
  7. The Acknowledgment Signature Sheet must be presented with original signatures for all research staff involved in the trapping or handling of small animals in field studies and forwarded to ARC Coordinator.
  8. When all documentation is completed, the ARC issues an approval letter to the PI.
  9. All required documentation is kept in the AUP research protocol file.

Select Agents:
Certain biological organisms and toxins are defined as “Select Agents” by the U.S. Government and have special restrictions on their use; the current list can be accessed by the above link. Anyone desiring to work with these materials must have security clearance to do so and have special security procedures in place for their labs. Investigators wishing to work with any of these agents MUST contact Robin Newberry (the duly authorized Responsible Official) prior to doing so, and all security clearances and procedures must be in place prior to requesting the Select Agents (note that requests for Select Agents MUST be placed by the Responsible Official). Failure to abide by Select Agent regulations can be a Federal felony, punishable by prison sentences and fines. Contact Robin Newberry (wnewber@clemson.edu or at 864-656-1806) for assistance with Select Agent requirements.

Nanotechnology:
Nanotechnology has potential applications in many sectors of the American economy including consumer products, health care, transportation, energy and agriculture. In addition, nanotechnology presents new opportunities to improve how we measure, monitor, manage, and minimize contaminants in the environment. The EPA "white paper" contains information that describes nanotechnology, overview of existing information on nanomaterials regarding components needed to conduct a risk assessment, review of research needs for both environmental applications and implications for nanotechnology, and recommendations for science issues and research needs. Information in the white paper related to human health effects of nanomaterials can be found here (see pages 52-58).

To learn about Nanotechnology at NIOSH, visit the CDC/NIOSH Nanoparticle Information Library at www.cdc.gov/niosh/topics/nanotech/.

Use of UV Light in Biosafety Cabinets:
Use of UV Light in Biosafety Cabinets: The first document which appeared in Applied Biosafety (2006) reviews information available on the use, risks and benefits of using Ultraviolet (UV) lights in Biological Safety Cabinets (BSC) and reports that the CDC, NIH and NSF agree that UV lamps are neither recommended not required in BSCs. The second document which also appeared in Applied Biosafety (2006) presents a contrarian view and suggests as a reasonable compromise limited use of UV in BSCs with required safety features such as interlocks and timers.

Review Process:
All documents submitted for review are routed to the appropriate committee member(s). After questions are resolved between the reviewers, committee and principal investigator, the documents are recommended for approval to the IBC Chair. Once approval is granted, the PI can proceed with the study. The length of this process depends on the complexity of the protocol. Responses are typically returned from the reviewers within approximately 10 business days. However, it can take longer if the protocol is complicated or involves multiple hazardous agents.

Changes to the Protocol (Updates):
Any proposed changes in the protocol for the use of hazardous agents must be submitted and approved as an update prior to initiation. You may use the Hazardous Agent (IBC) Protocol Application for an amendment which makes significant changes to the existing protocol. For minor changes to an existing protocol the Minor Amendment Form may be used. It is always important to ensure that the committee is informed of changes in study personnel.

Continuing Review Process:
An annual review of the hazardous agent(s) used must be completed and approved at least every twelve (12) months for the study to continue. You will be notified approximately six weeks prior to the current expiration. If you wish to review this form or complete it in advance, please see the Continuing Review Form.

Training that may be required:
You may be required to enroll in the Medical Surveillance Program, take certain classes or attend seminars prior to receiving full approval from the IBC. This training may include the following:

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