Researchers

Researcher Roles & Responsibilities

Principal investigators or project directors at U-M are responsible for:

  1. Understanding the requirements governing research involving potentially hazardous biologics, including recombinant DNA and SNA, infectious agents, and biological toxins.
  2. Understand that their research is not used as a dual research.
  3. Submitting an IBC application using the IBC/AP/13/ANNEX 2 to secure required approval from the IBBC and NBB, NRE for all research involving recombinant DNA or SNA before beginning the project.
  4. Amending the approved IBC application prior to implementing changes to the research.
  5. Fulfilling any additional PI/PD responsibilities as detailed in Biosafety Act Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
  6. (i) Ensuring that all laboratory personnel have received the required training for the work they will perform and that their type of work and their suitability is approved by the supervisor.  Such training include:
  7. The use of proper microbiological practices and laboratory techniques at the approved biosafety level
  8. If working at BSL2, downloading and compiling a BSL2 Biosafety Manual for use by lab personnel
  9. (ii) If working at BSL2, scheduling and completing an annual BSL2 laboratory inspection with MUM biosafety panel and approved  (for details  :MUM IBBC BSL2 Inspection Checklist
  10. (iii) If working with infectious agents to identify that organisms belong to the RG1 or RG2: Check the type of work that can be conducted if using RG3 or 4 organisms, where they are not permissible as MUM do not have a BSL-3 and BSL4 facility.

Under the biosafety law, it is mandatory for anyone who is conducting modern biotechnology activity to get an approval from the National Biosafety Board (NBB). This is stated under the Biosafety Act under s12(1) as well as s22(1).

If the researcher is conducting modern biotechnology activity, the relevant form must be filled up (Form E if it is contained use) and it has to be assessed by the Institutional Biosafety Committee (IBC).

For your reference, kindly find attached a flow chart with an explanation how application process involved where MOSTI involved.

Also attached a link to the Biosasety Act 2007 for your reference:

http://www.biosafety.nre.gov.my/act_regulations/biosafety-act2007.pdf

Working with recombinant DNA or synthetic nucleic acid molecules at BSL1 or BSL2? Register with the IBC.

Proposing a human gene transfer project? Obtain NMRR/MREC approval as well as review and approval by IBBC and NBB.

(i) IBC/AP/13/ANNEX 2 form : IBC ASSESSMENT OF PROJECT PROPOSAL INVOLVING MODERN BIOTECHNOLOGY ACTIVITIES:

(ii) Training schedule: Induction courses and specific training by supervisors

(iii) BSL2-Biosafety manual for working with RG2 infectious agents and other `modern biotechnology’ techniques

(iv) MUM IBBC BSL2 Inspection Checklist

(v) Risk Group organisms and containment levels (BSL-1 to BSL-4)  for LMO/rDNA and infectious microbes research

(vi) Work and Safety procedures in a BSL-2 laboratory for LMO/rDNA of Plant work

(vii) Work and Safety procedures in a BSL-2 laboratory for LMO/rDNA of retroviral vector work

(viii) Work and Safety procedures in a BSL-2 laboratory for transgenic animal work

(ix) Work and Safety procedures in a BSL-2 laboratory for General LMO/rDNA

(x) Work and Safety procedures in a BSL-2 laboratory for Infectious microbes of RG2

References and Resources

Dual Use Research of Concern Policy

University of Michigan policy that outlines U-M's oversight requirements for life science research that may be considered to be "dual use research of concern" (DURC) and subject to the federal DURC policy.

References and Resources

NIH/OBA Investigator Responsibilities under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid

Molecules(link is external) NIH/OBA brochure summarizing PI responsibilities for rDNA or SNA research. IBC RESOURCES

University of Michigan Vector Core

LABORATORY & RESEARCH SAFETY

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