Before you call us, we might be able to answer some of your questions here:
Establishment of IBC
3. What is meant by “exempt review” for recombinant DNA research?
4. How do I enroll in the Medical Surveillance Program?
5. Who needs to have a Hazardous Material Inventory completed and sent to EHS?
6. Will IBC approval be granted if the Hazardous Material Inventory is not completed and sent to EHS?
7. What is the current version of the Chemical Hygiene Plan and the Research Safety - Safety Plan that I should be using?
8. Are there any other changes to the EHS Comprehensive Manual?
9. If I a using human cell line either from a commercial or non-commercial source do I need an IBC approval?
10. If I am using animal cell lines, do I need an IBC application?
11. What do I do if I want to transport hazardous materials?
12. How frequently must the eyewash and shower be inspected?
13. Who should sign the Hazard Acknowledgment Sheet?
14. If I need to change personnel working on a project what should I do?
15. If I am working with human blood, can the IBC application be exempt?
16. What if I have student/individuals under the age of 18 working on a protocol?
17. Do teaching activities (including but not limited to courses) that involves the use of hazardous agents need to be submitted to the IBC for review and approval?
18. What types of training do I need for biological, chemical and recombinant DNA protocols?
19. What types of training/preparation is required for the trapping of small wild animals?
20. If I am trapping small animals in field studies do I need an IBC protocol?
21. How do I know how to respond to a chemical spill?
22. How can I determine what type of product to use for disinfection and sterilization of biohazards in my protocol?
23. When are respirators necessary?
24. What is required before using a respirator?
25. Where can I obtain information on signs and labeling for my research area?
26. Where can I obtain information of the glove selection for certain chemicals?
1. What do I do if I have questions about policies and regulations governing the use of hazardous agents? Visit the Clemson University IBC website for information on policies and regulations. If you still need assistance contact Hope Smith-Sielicki in the Office of Research Compliance at (864) 656-0118.
2. How are the members of the IBC selected?
Section IV-B-2-a-(1) of the NIH Guidelines. The Institutional Biosafety Committee must be comprised of no fewer than five members so selected that they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment (e.g., officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health or environmental concerns in the community).
The Institutional Biosafety Committee shall include at least one individual with expertise in plant, plant pathogen or plant pest containment principles when experiments utilizing Appendix P, Physical and Biological Containment for Recombinant DNA Research Involving Plants, require prior approval by the Institutional Biosafety Committee. The Institutional Biosafety Committee shall include at least one scientist with expertise in animal containment principles when experiments utilizing Appendix Q, Physical and Biological Containment for Recombinant DNA Research Involving Animals, require Institutional Biosafety Committee prior approval. When the institution conducts recombinant DNA research at BL3, BL4, or Large Scale (greater than 10 liters), a Biological Safety Officer is mandatory and shall be a member of the Institutional Biosafety Committee (see Section IV-B-3, Biological Safety Officer).
When the institution participates in or sponsors recombinant DNA research involving human research participants, the institution must ensure that: (i) the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants as deemed necessary); (ii) all aspects of Appendix M have been appropriately addressed by the Principal Investigator; (iii) no research participant shall be enrolled (see definition of enrollment in Section I-E-7) in a human gene transfer experiment until the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements); and (iv) final IBC approval is granted only after the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements). Institutional Biosafety Committee approval must be obtained from the institution at which recombinant DNA material will be administered to human research participants (rather than the site involved in manufacturing gene transfer products).
Section IV-B-2-a-(2). In order to ensure the competence necessary to review and approve recombinant DNA activities, it is recommended that the Institutional Biosafety Committee: (i) include persons with expertise in recombinant DNA technology, biological safety, and physical containment; (ii) include or have available as consultants persons knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice, community attitudes, and the environment, and (iii) include at least one member representing the laboratory technical staff.
3. What is meant by exempt review for recombinant DNA research? Research activities that involve the use of biological, chemical or recombinant DNA agents that present only minor hazards with very low risk (BSL 1) may be addressed by completing section A of the IBC application and usually are reviewed by only the Chair of the IBC and Biosafety Officer (BSO).
Note: Exempt criteria as outlined in the NIH Guidelines are in Section III-F, Appendix A, and Appendix C. The following link is set to the FAQs for NIH Guidelines where the Number 8 question references the “exempt criteria.” http://oba.od.nih.gov/oba/faqs/Synthetic_FAQs_April_2013.pdf
Exempt protocols still require annual review. Exempt review does not mean that the PI can make a determination that the research/teaching activity is exempt and not submit an IBC application to the IBC. The IBC makes the determination of exempt status.
4. How do I enroll in the Medical Surveillance Program? Please visit http://www.clemson.edu/centers-institutes/sullivan/ourservices/msp/ for more information.
5. Who needs to have a Hazardous Material Inventory completed and sent to Research Safety? A Hazardous Material Inventory must be developed and sent to Research Safety every 12 months when hazardous materials are used. This includes chemicals and biological agents. Up-to-date inventories are due by February 15th of each calendar year and they should be sent to firstname.lastname@example.org. The inventory must be submitted on the form that is found on the Research Safety website. This requirement is for all Clemson University operations, regardless of location and any non-Clemson employee working on University property. Contact the Chemical Safety Officer at 656-7554 for more information.
6. Will IBC approval be granted if the Hazardous Material Inventory is not completed and sent to Research Safety? No. IBC approval will not be granted if the inventory has not been sent to Research Safety.
7. What is the current version of the Chemical Hygiene Plan and the Environmental Health and Safety Plan that I should be using? The current versions of the Comprehensive Environmental Health and Safety Plan and the Chemical Hygiene Plan may be found on the Research Safety website.
9. If I am using human cell lines either from a commercial or non-commercial source do I need an IBC approval? Yes, human blood, tissue or waste specimen, human cell lines and non-human primate cell lines need an IBC application and are handled at the BSL-2 level even though a company may suggest a BSL-1 level. Some companies have disclaimer regarding their BSL suggested level of containment. In some cases, the use of human blood, tissue, waste specimen and human cell lines may also need IRB approval. For further information about the use of human subject or blood, and tissue from human subjects, please contact the IRB Administrator in the Office of Research Compliance at (864) 656-6460. If it is cell line that the PI and research team create and is of a species that could harbor a zoonotic agent then an IBC application is needed.
10. If I am using animal cell lines, do I need an IBC application? If it is a non-human/non primate line from a public-commercial company (e.g. one that certifies reasonably healthy lines), a protocol may not be necessary. If it is a cell line that the PI and research team create and is of a species that “could” harbor a zoonotic agent then an IBC protocol would be needed. Some products may be “specific pathogen free” and some companies “suggest” a BSL level but have a disclaimer. Contact the IBC Administrator at (864) 656-0118 or email@example.com for more information.
11. What do I do if I want to transport hazardous materials? If the hazardous materials are to be shipped, someone who is trained in HM 181 has to package and prepare the manifest or be trained in receiving the package if it is being shipped by others. Check in your department to see who is trained in HM 181 and who could do it for you if you have not had this training yourself. This training is given once or twice a year. EHS has a CD Rom for the training that can be checked out from their office. For specific information contact firstname.lastname@example.org. Hazardous Materials may not be transported in personal vehicles. If you chose to take them yourself in a state vehicle, triple packaging is recommended — the cultures inside a vial or Petri dish, the vials or petri’s inside a leakproof container (Ziploc bag works) and that inside another package like a box or cooler.
12. How frequently must the eyewash and shower be inspected? As per the Clemson University policy, the eyewash must be inspected and flushed weekly and the shower monthly. Records are kept of the inspection. This routine must be followed throughout the year. Complete information on flushing/inspection procedures can be found in Appendix N of the Chemical Hygiene Plan and must be followed.
13. Who should sign the Hazard Acknowledgment Sheet? All faculty, staff or students working on the protocol must read the protocol and any associated materials such as MSD sheets and sign the Hazard Acknowledgment Sheet, which is then sent by the PI to the Office of Research Compliance.
14. If I need to change personnel working on a project what should I do? File a Minor Amendment Form and send a new Hazard Acknowledgement Sheet listing all the current personnel associated with the project to the IBC office in the Office of Research Compliance.
15. If I am working with human blood, can the IBC application be exempt? No, protocols requiring containment levels of BSL2 or above will not qualify as exempt. If using human or non-human primate tissue or body fluid(s) an IBC application is required.
16. What if I have students/individuals under the age of 18 working on a protocol? Individuals not over the age of 18 working on IBC protocols with hazardous agents need written parental/guardian approval to participate in the project. On the IBC forms page is a registration form for minors. A Hazard Acknowledgement form needs to be signed by the minor working on an approved IBC protocol.
17. Do teaching activities (including but not limited to courses) that involve the use of hazardous agents (biological, chemical and recombinant DNA) need to be submitted to the IBC for review and approval? At the present time it not required, but the IBC will review those submitted.
18. What types of training do I need for biological, chemical and recombinant DNA protocols? Individuals handling these hazardous agents must be fully informed regarding the hazards of the materials and safe handling methods. This information is provided by the principal investigator. See Appendix J of the Research Safety Chemical Hygiene Plan for required training.
For biological agents: Individuals working with biological agents should have training in Biological Safety and Biological Safety Cabinets. This training is available on the Research Safety on-line training website (http://www.clemson.edu/research/safety/index.html) and the online 3rd edition WHO Laboratory Biosafety Manual at (http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/)For human blood, blood products and other potentially infectious materials: OSHA Bloodborne Pathogen Standard (BBP) training is required as well as enrollment in the Medical Surveillance Program. Individuals will be offered appropriate immunizations through the MSP. If these are declined, a waiver must be signed. OSHA requires annual training for personnel with occupational exposure to BBP. Online training is available on the Research Safety website or this requirement can be met with other OSHA compliant sources that provide documentation. At the end of the online training submit your name so that it will be entered into the Research Safety BBP training database. The Office of Research Compliance will query the database for documentation that training has been completed.
For chemical agents: Chemical Hygiene Training and Hazardous Waste Management training is required for the use of chemicals. Online training in these areas is available on the Research Safety website. The Chemical Hygiene training has a quiz at the end that needs to be sent to Research Safety. Follow the instructions at the end of the Chemical Hygiene Training and Hazardous Waste Management Training modules for registration of training.
In the event that someone is working with chemicals, but not in a laboratory (farms etc.), the required training is Hazard Communication and Hazardous Waste Management. It is recommended that all laboratory workers also read the Chemical Hood Policy and anyone working with chemicals take MSDS training.
For recombinant DNA agents: Recombinant DNA Guidelines (NIH)
For animal work: Clemson employees, students and volunteers with exposure to animals, animal tissue or animal waste must take zoonotic training and enroll in the Medical Surveillance Program (MSP). Zoonotic training and enrollment material is online but the forms must be faxed or mailed to the MSP office. Directions are on the MSP/zoonotic training Web site: http://www.hehd.clemson.edu/msp/
19. What type of training/preparation is required for the trapping of small wild mammals? Depending on the species and degree of contact, Hantavirus training, medical clearance for respirator use, respirator fitting by EHS and special training by the Office of Research Services personnel may be required. Rabies immunization may also be appropriate. Consult the Clemson University “Policy for Individuals Participating in the Trapping or Handling of Small Animals in Field Studies,” which is available on the IBC Web site. Contact the Occupational Health Nurse (Sue Pedrick) to arrange for Hantavirus training and respiratory clearance. Contact Don Worthy regarding respirator fitting and the Office of Research Services for additional training.
20. If I am trapping small mammals in field studies do I need an IBC protocol? If tissue, blood or fluid samples are to be brought back to Clemson University facilities, then a separate IBC protocol is needed. If carcasses are handled in accord with the Clemson Hantavirus Policy and only brought to campus for disposal, a separate IBC protocol is not needed. Maintaining trapped live animals from the field in Clemson University facilities or laboratories is not allowed under the present policy.
21. How do I know how to respond to a chemical spill? Research personnel need to refer to Appendix D of the Chemical Hygiene Plan for determining how to respond to a chemical spill and to a specific MSD sheet.
22. How can I determine what type of product to use for disinfection and sterilization of biohazards in my protocol? The EPA has several lists of approved disinfectants. The WHO Biosafety Laboratory Manual has a section (Chapter 13 pp. 82-93) on disinfectants.
23. When are respirators necessary? Respirators (which includes supplied air, full and half face cartridge respirators, as well as dust/mist respirators) should be worn only when respiratory hazards cannot be removed by engineering controls (i.e. chemical hoods, canopy or snorkel devices etc.).
24. What is required before using a respirator? Before a respirator can be used, you must enroll in the University’s Medical Surveillance and Respiratory Protection Programs. The appropriate respirator will be selected for you, fit tested on you by a member of EHS to ensure proper fit ad seal, and you will be trained on the proper use and maintenance. The Occupational Health Nurse conducts screening and evaluations to determine medical fitness for wearing a respirator.