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This document outlines the policies and procedures for conducting research involving recombinant DNA, infectious agents, and biohazardous materials at Upstate Medical University, including the role
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How to fill out policy and procedures for

How to fill out Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents
01
Begin by obtaining the policy template from your institution or regulatory body.
02
Review the relevant local, national, and international regulations regarding recombinant DNA and bio-hazardous agents.
03
Identify the specific type of research projects that fall under this policy.
04
Include sections on definitions of key terms used in the policy.
05
Outline the objectives of the policy, emphasizing safety, compliance, and ethical considerations.
06
Describe the roles and responsibilities of all personnel involved in the research.
07
Establish guidelines for risk assessment and management related to the use of recombinant DNA and infectious agents.
08
Detail the procedures for obtaining necessary approvals before commencing research.
09
Specify training requirements for researchers and laboratory personnel.
10
Include sections on monitoring and reporting incidents or breaches of policy.
11
Review and revise the document periodically to ensure it remains current.
Who needs Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents?
01
Researchers conducting studies involving recombinant DNA and bio-hazardous agents.
02
Institutional biosafety committees responsible for oversight of research compliance.
03
Laboratory personnel who handle or work with recombinant DNA and infectious agents.
04
Regulatory bodies ensuring research adheres to safety and ethical standards.
05
Administrators overseeing research programs and institutional compliance.
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People Also Ask about
What is Section 4 B 2 A of the NIH guidelines?
Section IV-B-2-a-(1) of the NIH Guidelines states that at least two members of the IBC shall not be affiliated with the institution. These individuals are supposed to represent the interests of the surrounding community with respect to the environment and public health.
What is the protocol for recombinant DNA?
The steps in recombinant DNA technology include: isolating DNA from the donor and host organisms, cutting the DNA using restriction enzymes, joining the fragments with DNA ligase, introducing the recombinant DNA into the host organism, and selecting and screening transformed cells.
Who is responsible for the NIH system of oversight of rDNA in research?
The IBC is responsible for reviewing rDNA research activities and for approving those which are in conformity with the intent and specifics of the NIH Guidelines. Furthermore, the IBC is authorized by the IRO to enforce the NIH Guidelines and to ensure that investigators/staff adhere to approved protocol conditions.
What experiments are exempt from the NIH?
How do I know if I am working with host-vector system that is exempt from the NIH Guidelines? Only certain experiments that use E. coli K-12, Saccharomyces, Bacillus subtilis or Bacillus licheniformis host-vector systems are specifically exempted from the NIH Guidelines (see Appendix C- II).
Which entity is designated to review research activities involving recombinant DNA per the NIH guidelines for research involving recombinant DNA molecules?
The UT Health Science Center Institutional Biosafety Committee (IBC) reviews research involving recombinant DNA (rDNA) and other biohazardous materials to ensure principal investigators and lab personnel use best practices.
Which of the following incidents involving rDNA should be reported to NIH?
Researchers are responsible for immediately reporting any spill and/or accident involving recombinant or synthetic nucleic acid molecules research resulting in an overt or possible exposure, or that otherwise could lead to personal injury or illness, or to a breach of containment to their PI, the Biosafety Officer (BSO
What incidents must be reported to NIH?
These kinds of events might include skin punctures with needles containing recombinant DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant materials occurring outside of a biosafety cabinet.
How do NIH guidelines define recombinant and synthetic nucleic acids?
ing to NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as (1) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means synthesized or
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What is Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents?
It is a set of guidelines and regulations that govern the safe use, handling, and disposal of recombinant DNA and infectious or bio-hazardous agents in research settings to ensure safety for researchers, the environment, and the public.
Who is required to file Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents?
Researchers, laboratories, and institutions conducting studies or experiments that involve recombinant DNA and/or infectious or bio-hazardous agents are required to file these policies and procedures.
How to fill out Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents?
To fill out the policy and procedures, the researcher must provide detailed information about the research project, including the types of agents being used, containment measures, safety protocols, and any relevant compliance with federal, state, and institutional regulations.
What is the purpose of Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents?
The purpose is to ensure that all research involving recombinant DNA and infectious agents is conducted safely and ethically, minimizing risks to the researchers, the environment, and the general public while complying with legal and regulatory requirements.
What information must be reported on Policy and Procedures for Research Involving Recombinant DNA and Infectious or Bio-Hazardous Agents?
The report must include details on the nature of the research, the specific recombinant DNA or bio-hazardous agents used, risk assessments, safety and containment measures, training of personnel, and emergency response protocols.
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