Download Higher Biological Materials Research Registration BMR

Michigan State University
BSL-2 or Higher
Biological Materials Research (BMR) Registration
This registration is for IBC review of research involving:
 Risk Group 2 or Higher, Infectious Agents, Unfixed Human Material such as HUMAN CELL LINES (Bacteria, Virus, Yeast,
Fungi, Prions, Rickettsias, & Parasites)
 Risk Group 1 agents are exempt from this review
 Registration of Recombinant DNA or Synthetic Nucleic Acid Molecule research is located at the following link:
http://www.oeos.msu.edu/PI/search.htm . Contact our office for access code to register.
INSTRUCTIONS:
E-mail your completed form to [email protected]. Contact the Biosafety Office at 355-0153. Keep a copy of this
application for your records.
SECTION 1: GENERAL BSL-2 or HIGHER PROJECT INFORMATION
APPLICATION STATUS:
New
Renewal (every 3 yrs), previous BMR #:
Amendment, BMR#:
IF AMENDMENT, mark amended section(s). Check all that apply
1 - Contact Information
4 - Research Description
7 – Infectious Materials
2 - Summary of Project
5 – Personnel
3 -Ancillary Committee
6 - Hazard communication, entry and occupational health requirements
Principal Investigator’s Name (last, first):
Degree:
Department:
Campus Address:
Office Phone:
Lab Phone:
Emergency Phone:
Fax:
Email:
Co-Principal Investigator’s Name (last, first):
Degree:
Department:
Campus Address:
Office Phone:
Lab Phone:
Emergency Phone:
Fax:
Email:
Alternate Contact Name (e.g., lab supervisor, etc):
Email of Alternate Lab Contact:
Title:
Lab Phone :
Office Phone:
IBC ADMINISTRATIVE USE ONLY
OFFICIAL EH&S RECEIPT DATE
IBC BMR #:
IBC Meeting Date:
Status:
Approved
MSU EHS Biosafety
I
Inactivated
Date:
Page 1
SECTION 2: GENERAL SUMMARY OF BSL-2 or HIGHER PROJECT
YES
Mark the materials below that will be used in this BSL-2 or higher project:
NO
Use of Infectious Agents to Human, Plant or Animal (Bacteria, Virus, Yeast, Fungus, Prions, & Parasitic Agents)
If ‘Yes’ check the risk group(s) which apply.
Agent Summary Statements at Centers for Disease Control BMBL 5th Edition:
http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_VIII.pdf
Or Risk Groups at: http://www.absa.org/riskgroups/index.html
Risk Group 3.....(BSL-3) must receive approval from IBC before initiation of experiments.
Risk Group 2.....(BSL-2) must receive approval from IBC before initiation of experiments.
If you do not work with these materials or you are not sure contact the Biosafety Office.
Use of Recombinant DNA, gene transfer, host vector systems. If “YES” then make sure it is registered. If it is
not then register it using the Recombinant and Synthetic Nucleic Acid Molecule Registration available at:
http://www.oeos.msu.edu/PI/search.htm
Use of Human subjects
Use of unfixed Nonhuman Primate Material (including all fluids, tissues, excretions, secretions, or cell lines)
Use of unfixed Human Material (including all fluids, tissues, excretions, secretions, or cell lines)
Use of transgenic or other genetically modified whole plants
Use of transgenic or other genetically modified whole animals
Use of animals or unfixed animal specimens
Use of Biological Toxins or CDC Select Agents
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusions.html
Other (specify):
SECTION 3: ANCILLARY COMMITTEE
Committee
Yes
No
N/A
Pending
(date submitted)
IRB (Institutional Review Board)
ISCRC (Institutional Stem Cell
Research Committee)
IACUC (Institutional Animal Care and
Use Committee)
IBC for Recombinant or Synthetic
Nucleic Acid Molecule research
Other or comments regarding status
(specify):
MSU EHS Biosafety
IBC Biosafety Application 0414
Page 2
Protocol Number
Most Recent
Approval Date
SECTION 4: BSL-2 or HIGHER RESEARCH DESCRIPTION/STANDARD OPERATING PROCEDURES
The IBC is made up of a diverse group of members. Use language useful for a scientific evaluation as well as general
language to be understood by members with non-scientific backgrounds. Provide sufficient information to evaluate the
work for the purposes of determining an appropriate biohazard risk assessment for your BSL-2 or Higher research. Grant
applications or abstracts will not be accepted. This section meets the CDC BMBL requirement for site specific standard
operating procedures (SOP).
1. List all BSL-2 or Higher Project/Grant Title(s) (if more than one label with a number and carry number throughout rest of section 4):
2. Provide a brief non-technical description and objectives of the BSL-2 or Higher research project, include goals/hypothesis. If this is
a renewal or amendment, provide updated information here.
3. Describe in detail the procedures and techniques to be used in the BSL-2 or higher research project. If applicable, incorporate a
description of any work being done outside of typical BSL-2 engineering controls or that involves other hazards. For example: open
bench work, use of stereotaxic instruments for animal injection of hazardous materials outside of the biosafety cabinet, etc.
4. Engineering Controls for your BSL-2 or higher research project (biosafety cabinet, centrifuge with safety lids, etc.)
5. Personnel Protective Equipment for your BSL-2 or higher research (gloves, lab coat, shoe covers, etc.)
6. List disinfectant(s) used for cleaning work surfaces and after spills of biological materials from your BSL-2 or higher research,
including concentration and contact time. (10% bleach made fresh, contact time 10 minutes)
7. Describe liquid and solid waste disposal procedure for your BSL-2 or higher research (autoclave then dispose, other)
8. Describe how your BSL-2 or higher biological materials will be transported, if you will not be transporting then skip this question
9. List sharps that will be used with these BSL-2 or higher materials (scalpels, needles, glass pipettes, etc) and if they are safety sharps
or Luer Lock devices
MSU EHS Biosafety
IBC Biosafety Application 0414
Page 3
SECTION 5: BSL-2 or HIGHER PERSONNEL
In addition to taking the required EHS safety training, each person working on the project is required to receive formal
(agent specific) training in the handling of biohazardous materials prior to beginning of the project from the PI or lab
supervisor. Site specific training can be performed using the checklist available on our website under manuals and forms
at www.ehs.msu.edu. This must be made available during inspections.
Training records are available by using your access code at http://www.oeos.msu.edu/wts/search.htm and also during
inspections.
1.
Personnel Additions
Name (last, first)
Position Title
e.g. staff researcher
2.
Biological materials working with (human cell lines,
animals, toxins, Adeno-virus)
Site Specific Training Completed
Personnel Removal
Name (last, first)
Position Title
Location Now(left MSU, left lab still at MSU, unknown)
e.g. staff researcher
MSU EHS Biosafety
IBC Biosafety Application 0414
Page 4
SECTION 6: HAZARD COMMUNICATION, ENTRY AND OCCUPATIONAL HEALTH REQUIREMENTS
In accordance to the NIH Guidelines and CDC Biosafety in Microbiological and Biomedical Laboratories (5th ed):


All persons entering the laboratory must be advised of the potential hazards and meet specific entry/exit
requirements.
Laboratory personnel must be provided medical surveillance and offered appropriate immunizations for agents
handled or potentially present in the laboratory.
1. Prospective workers/current workers must be educated about the biohazard(s) listed in this protocol.
YES
NO
Mark if these items are implemented in the laboratory.
All personnel must complete the appropriate EHS safety training prior to start of experiments.
All personnel must read and adhere to the MSU Biosafety Manual.
All personnel must read and adhere to the standard operating procedures (Task Procedure) related to this
protocol.
All personnel must receive a laboratory orientation from the PI or lab supervisor prior to start of
experiments to be knowledgeable with, but not limited to the following, entry/exit procedure, contact
information in case of an emergency, and location of life safety equipment (e.g., eye wash, shower, fire
extinguisher, spill kit, etc.).
All personnel must demonstrate to PI or lab supervisor, proficiency in standard and special microbiological
practices before start of experiments.
Other Educational Training (specify):
2. If any, describe additional medical surveillance for personnel who are more vulnerable to infection with the agents
listed in this protocol (e.g., non-vaccinated individuals, immunodeficient workers or non-immune pregnant female
workers).
3. List applicable health surveillance/immunization programs that will be recommended or implemented for this
protocol. The IBC upon review may change any of these items based on currently available federal, state, and local
Occupational Health recommendations.
None
Hepatitis B Vaccination (declination must be documented)
Annual Respirator Fit Testing
Serological Testing (Contact EH&S Biosafety Division for serum sample banking information/research
applicability)
Other (specify):
4. In case of an exposure incident, check the procedure that will be implemented for personnel to obtain consultation
and treatment (check all that apply) beyond contacting the Supervisor/Principal Investigator:
Undergraduate students go to MSU Student Health Services at Olin or after hours Sparrow Emergency.
Graduate students and other staff will take go to Primary Care at Olin or after hours Sparrow Emergency.
Grand Rapids College of Human Medicine faculty/staff will report to Van Andel Institute Security.
Other (specify):
MSU EHS Biosafety
IBC Biosafety Application 0414
Page 5
SECTION 7: INFECTIOUS MATERIALS/BSL-2 or HIGHER RISK GROUP, UNFIXED
List all BSL-2 or higher materials including specific strain information
1. In Storage, include origin (i.e.: from commercial vendor, PI collaborator)
2. In Use, include origin (i.e.: from commercial vendor, PI collaborator)
3. Used in large scale experiments, >10 liters per vessel (i.e.: a bioreactor)
4. Used in Animal Experiment, include animal species and containment
MSU EHS Biosafety
IBC Biosafety Application 0414
Page 6
SECTION 8: PRINCIPAL INVESTIGATOR’S ASSURANCE
1. I attest that the information contained in the attached application is accurate and complete to the best of
my knowledge.
2. I agree to comply with the requirements pertaining to the possession, use, transfer, and disposal of all
regulated biologically hazardous materials in accordance to all applicable federal, state, and local laws and
regulations and MSU policies and procedures.
3. I attest that prior to the start of this project, all persons involved (including my collaborators):

are adequately trained in good microbiological techniques and practices,

have received instruction on any specific hazards associated with the project and worksite,

are aware of any specific safety equipment, practices, and behaviors required for the procedures and
use of the facilities, and

are familiar with appropriate emergency procedure response (e.g., spills, accidental exposure,
environmental release) to ensure safety will be followed.
4. I hereby adopt the current edition of the MSU Biosafety Manual in accordance with the CDC/NIH Biosafety
in Microbiological and Biomedical Laboratories as the principal biosafety manual for my laboratory with
laboratory specific standard operating procedures. I understand that the laboratory specific standard
operating procedures must be approved by the IBC before research can commence.
5. I will abide by the reporting requirements and submit a report to the IBC for activities that may include, but
not limited to the following:

All accidents that result in exposure to the infectious agents or recombinant DNA or danger of
environmental contamination.

All spills outside a physical containment equipment (e.g., outside biosafety cabinet, outside centrifuge,
etc).

All problems pertaining to operation, implementation of containment safety procedures or equipment,
facility failure, or breach in security (facility and/or biological agent).

Any new information bearing on the Guidelines such as technical information relating to hazards and
safety procedures or innovations.
6. I understand my responsibility with regard to laboratory safety and certify that the protocol as approved by
the IBC will be followed during the period covered by this research project. I certify that no work will be
initiated or modified until approval has been issued by the IBC, other appropriate oversight committees and
all sponsoring agency requirements have been met.
7. I understand that my sending this registration via my email program will be considered the same as a
penned signature on a hard copy of this document.
Signature of Principal Investigator (submit form via PI’s email address to be recorded as signature)
MSU EHS Biosafety
IBC Biosafety Application 0414
Page 7
Date: