NATIONAL GUIDELINES FOR INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

Biosafety Information Manual
August 26, 2018
BIOSAFETY LABORATORY MANUAL
August 27, 2018
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FEDERAL REPUBLIC OF NIGERIA

 

 

NATIONAL GUIDELINES FOR

INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

 

 

 

August, 2018

 

 

 

Contents

Guidelines on Institutional Biosafety Committee (IBC) 2

1     Introduction. 2

2     Actions and Responsibilities of Institutions: 2

3     Composition of the IBC.. 3

4     Functions of the IBC.. 3

5     Biosafety Officer (BO) 4

5.1      Responsibilities of the Biosafety Officer: 4

6     Principal Investigator (PI) 5

6.1      Functions of the PI. 5

7     Institutional Biosafety Committee (IBC) Recommendation. 5

Original:  File. 6

 

 

 

Guidelines on Institutional Biosafety Committee (IBC)

 

1          Introduction

All institutions in Nigeria, both private and public (e.g. research institutes, universities and polytechnics, international research centres, industrial research and development units which plan to undertake modern biotechnology research and/or development), shall each establish an Institutional Biosafety Committee (IBC), which will be responsible to, and co-operate with the National Biosafety Management Agency (NBMA).  Institution/organization may elect to use the IBC of another Institution/Organization. The Institutions must also seek accreditation of the Institute to deal in modern biotechnology and certification of their Biosafety Containment from the NBMA.

 

2          Actions and Responsibilities of Institutions:

Responsibilities of the institution will include:

(a)     Formulation of policies and guidelines for modern biotechnology research in the respective institutions consistent with the National Biosafety Management Agency Act 2015, Regulations and Guidelines;

(b)     Establishment of an IBC. Where a critical mass of scientists to constitute the IBC is not available, the institution may jointly form one committee with other institutions, or rely on the IBC of another institution;

(c)      Assistance to Principal Investigators (PIs), responsible for research to make sure that the research is conducted in accordance with established guidelines;

(d)     Appointment of a Biosafety Officer (BO) as Chairman of the IBC who will monitor and advise on biosafety issues on day-to-day basis;

(e)      Establishment of provisions to make available to the public information on experiments conducted at the institution, subject to established guidelines, unless it contains confidential business information or its disclosure is prohibited by law, and to make available a general description of information withheld;

(f)      Assurance that the IBC reports promptly to the NBMA any significant problems with implementation of established guidelines;

(g)     Establish and oversee the work of scientific subcommittees, whose roles and functions include research performed under contained laboratory conditions.

 

3          Composition of the IBC

The IBC should include:

(a)     Five members from the respective institution, including the BO (Who is the Chairman of the IBC);

(b)     Two other members not affiliated with the institution but knowledgeable in biotechnology or related fields, and representing the interests of the community, such as:

(i)      Members of governments’ public health, food safety or      environmental agencies;

(ii)     Persons active in human, plant, food or animal health safety concerns and,

(iii)    Persons or industries active in environmental concerns.

(c)      The IBC may invite any PI or representative of NBC or any other person to its meetings.

 

4          Functions of the IBC

The IBC shall perform the following functions:

(a)     Consult with the NBMA;

(b)     Implement the recommendations of the NBMA;

(c)      Review and give recommendation to PI if satisfied with his/her application;

(d)     Create and maintain a central reference file and library of catalogues, books, articles, news letters and other communications as a source of advice and reference, including such items as the availability of safety equipment, the availability and level of biological containment for various hosts: vector systems, suitable training of personnel and data on the potential biohazards associated with certain technologies;

(e)      Facilitate the exchange of scientific, technical, environmental and legal information on, and experience with Living Modified Organisms (LMOs)/Genetically Modified Organisms (GMOs);

(f)      Collaborate with and develop a safety and operation manual and assist PIs in the required staff training;

(g)     Ensure the safety of facilities, procedures, and practices as well as the level of training and expertise of the personnel;

(h)     Review and monitor all modern biotechnology research conducted and sponsored by the institution to ensure compliance with established national guidelines;

(i)      Maintain a list of PIs, project supervisors, approved by the IBC as competent to perform supervisory duties for particular projects;

(j)      Maintain records and files of each modern biotechnology research project;

(k)     Investigate and report promptly to the NBMA all accidents and unexplained absence due to illness;

(l)      Submit an annual report to the NBMA.

 

5          Biosafety Officer (BO)

The institution’s authority will appoint the BO.  It is expected that the BO will be familiar with biosafety requirements for rDNA work.  In addition, the BO should be sufficiently independent to exercise some authority as related to responsibilities of this office.

5.1               Responsibilities of the Biosafety Officer:

  1. Make checks and advise on biosafety issues on a day-to-day basis;
  2. Ensure that biosafety is not compromised by any other considerations;
  3. Serve as Chairman of the IBC;
  4. Prepare a report, which should form part of the IBC’s annual report to the NBMA;
  5. Ensure that the IBC meets as when necessary.

6          Principal Investigator (PI)

The PI who is responsible for conducting modern biotechnology research is the agent of an institution.  The PI is accountable to the IBC and leads the efforts in a safe manner and in compliance with the appropriate research guidelines and all applicable regulations.

6.1                     Functions of the PI

The PI shall perform the following functions:

  1. Ensure that experiments, for which the PI is responsible, are carried out in strict compliance with institutional and national guidelines,
  2. Ensure that safety procedures and practices are complied with;
  3. Report promptly to the IBC on any significant problems with respect to the implementation of relevant guidelines and regulations;
  4. Immediately notify the IBC and the NBMA on any research-related accidents that have resulted or could result in human illness, in unanticipated plant or animal disease, or in the escape of organisms under study from the containment/confinement;
  5. Obtain approval of the IBC before embarking on modern biotechnology research requiring prior approval of the NBMA.
  6. Ensure compliance with applicable shipping requirements regarding human, plant, food and animal health safety policies, Permit requirements and containment conditions for possession of certain organisms.

7          Institutional Biosafety Committee (IBC) Recommendation

The IBC recommendation must be submitted after decision is taken on any application and in the following format:

 

  1. Name of Institution:
  2. Address of Institution:
  3. Summary of Request:

 

  1. Applicant Information:
    • Name and Address/Dept. of Applicant:
    • Nature of Request/Research:
    • Description of Organism and Proposed Activity:
    • Rationale for Development of the GMO
  2. Safety Assessment:
  • Identified Risks;
  1. Characterization of Identified Risks;
  2. Characterization of Non-safety Issues i.e. Socio-Economic impact;
  3. Consequences and Implications of event;
  • Proposed Management Measures;
  • Appropriateness and Adequacy of Management Measures.

 

  1. Measures to Address Safety Concerns;
  2. Measures to Address Non-Safety Issues: i.e. socio-economic impact;
  3. Decision and Justification;
  4. Terms and Conditions of Decision: Are based on risk associated with the modification, mitigation plan and procedures, contingency plan, and the terms and conditions that may be imposed by the IBC.

 

 

Name and Signature of Institutional Biosafety Officer

 Signature: _________________________________

Name: _____________________________________

Date:

 

 

 

Original:  File

Copy:

  • Head of Institution/CEO
  • Applicant
  • National Biosafety Management Agency

 

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