IBC Procedures and Requirements

Investigator's Responsibilities

The Principal Investigator is responsible for reviewing this policy and complying with its requirements. Specifically, he/she will:

File the appropriate Registration Document and an Annual Renewal form for each project and meet all the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules, the CDC Biosafety in Microbiological and Biomedical Laboratories, and the university's Bloodborne Pathogens Exposure Control Plan.
Make available to laboratory staff and students copies of the registration documents and other protocols that describe potential biohazards and the specific precautions to be taken;
Provide appropriate instruction and training in practices and techniques necessary to ensure laboratory safety, as well as maintain training records for all personnel associated with protocol;
Supervise the laboratory staff to ensure that appropriate safety techniques and procedures are employed;
Report in writing to the IBC any significant problems pertaining to the operation and implementation of containment practices and procedures;
Take prompt corrective actions on all issues during periodic inspections and/or incident reports

Required Components for Protocols

A protocol should include the names of ALL persons (including students and staff) who are to be approved to work with all aspects of infectious/biohazardous material.

A continuing review must submitted annually for each approved registration. Protocols must be renewed or expired every three years via De Novo Review. In addition, any substantive changes in procedures or type of recombinant DNA molecules/etiologic agents should be submitted via an amendment to be reviewed by IBC. This includes changes in key personnel, laboratories, or other modifications to the protocols.

Each investigator/instructor using recombinant DNA molecules or biological agents as defined previous is required to submit the appropriate IBC form as described below. You must submit these forms using the Hazard Safety Module in SPARCS.

Registration Document for Research/Teaching Involving Recombinant DNA: investigators/instructors employing recombinant DNA molecules and technology, including the construction and use of transgenic animals, and transfection of mammalian cell lines.
- Investigators conducting "exempt experiments" must still submit a registration form to the IBC. However, investigators completing this registration document need not complete an additional registration document for infectious agents for the same project.
Registration Document for Research/Teaching Involving Etiologic Agents: investigators/instructors employing biological agents in their research and teaching, but not involving recombinant DNA technology
Registration Document for Research/Teaching Involving Human Tissue or Body Fluids: investigators/instructors employing human tissue or body fluids, including saliva, urine, blood, or primary human cell cultures.
Registration Document for Research/Teaching Involving Wild-Caught or Random Source Animals or Animal Tissues: investigators/instructors employing animals that may carry zoonotic disease, or for those investigators/instructors employing biologically-derived chemicals.

Guidelines for Disposal of IBC-Regulated Materials

The current College Institutional Biosafety Guidelines requires each investigator/instructor using recombinant DNA molecules or biological agents to submit an IBC protocol for the safe and appropriate handling of these biological materials from receipt of the materials at the start of the research activity through to disposal of biological waste at the end of the activity. Description of the means of disposal is an essential part of the IBC protocol. Investigators are required to define when their biological materials shall be discarded as well as the decontamination and disposal protocols they will follow for handling these materials.

There are several key principles that aid Investigators in making a determination for their disposal practices.

First, the act of discarding determines when a material becomes a waste; any material being handled under an approved IBC protocol is not a waste until the investigator decides to discard the material.
Second, because work performed under William & Mary’s Institutional Biosafety Committee-approved protocols contributes to the university’s general waste stream, IBC protocols must be compatible with the waste handling requirements defined in William & Mary's Regulated Medical Waste Management procedure.

It is clear from the university’s Regulated Medical Waste definitions that defining “discarded” items as "Regulated Medical Waste" is determined by whether such discarded items are also "contaminated" by organisms likely to be pathogenic to healthy humans at the time of disposal. Such contamination is obviously dependent upon whether in the course of normal laboratory processing of research materials there is a total inactivation of all such organisms. If "organisms likely to be pathogenic to healthy humans" are discarded without total inactivation then these items are correctly termed "Regulated Medical Waste." However, if total inactivation occurs as part of the normal laboratory protocol then such items are not RMW.

Therefore, investigators may opt to discard laboratory biological materials in one of two ways:

Infectious and/or potentially biohazardous materials may be discarded as RMW to obviate the additional effort of inactivating such materials before disposal in the common waste stream. Investigators shall follow the waste handling guidelines prescribed in the university’s Regulated Medical Waste Management procedure.
- Investigators must restrict the use of the term "RMW" to indicate the materials that will be contained in specially marked plastic bags (orange or red) and held in specially marked boxes until removal from the laboratory by the VIMS or College EH&S Office for disposal by a licensed vendor of such services.
- If red or orange colored bags are employed for any purpose then the bag contents will always be considered RMW; once loaded these bags must be disposed of by a licensed RMW contractor.
- All autoclave bags must be labeled with an initial and a date.
Investigators may establish an IBC-approved protocol to work at either Biosafety Level (BSL) 1 or 2, and inactivate all materials to be discarded, with exception of sharps, in a manner that renders the materials non-infectious & non-biohazardous prior to disposal. [For a definition of “sharps” refer to Section 3, item 6 of the RMW Management procedure] Electing this option requires the submission of a protocol that will specify all chemical and/or heat inactivation methods to be employed. These methods shall be consistent with accepted practices and/or the product’s Material Safety Data Sheet for inactivation by means of chemical and/or steam sterilization.
- Investigators selecting this option must specifically detail how any infectious and/or potentially biohazardous materials will be inactivated before they are discarded.
- All research materials to be inactivated under an IBC-approved protocol specific to the project must be discarded only in clear bags and without any identification that could be confused with RMW. Each bag must be labeled with initials and a date.

Additional Guidelines:

As part of any BSL 1 or 2 protocol, all potentially infectious/biohazardous material should be so identified within the laboratory by some form of recognized hazard label that includes the name or initials of the investigator. This label must remain affixed to all material that is discarded as RMW. However, all biohazard labels affixed to infectious materials while in use in the laboratory must be removed or fully defaced before autoclaving and the subsequent discarding of these autoclaved materials as common waste.
Persons named on a specific IBC-approved protocol will be responsible for taking research materials to the autoclave room and then autoclaving in clear plastic bags prior to final disposal. No materials may be left unattended in the autoclave room except while the autoclave is cycling. Autoclaved materials must be promptly removed when the cycle is completed. It is strongly recommended that all investigators review the operation manual for the autoclave used in their specific protocol.
Biosafety Personal Protective Equipment Matrix