The Evolution and Impact of the NHLS National Biobank

The Evolution and Impact of the NHLS National Biobank

A Crucial Resource for Research and Collaboration

The National Health Laboratory Service (NHLS) National Biobank, founded in 2012, was established in response to a growing need for accessible and ethically managed biological samples to support research within South Africa (SA). Prior to its formation, NHLS researchers often relied on international and private biorepositories for the storage of research samples. The establishment of the National Biobank has been a transformative development for the country, providing a local solution that has helped limit the transfer of samples across borders and, crucially, maintain control over their ethical use. 

The primary aim of the NHLS National Biobank is to support research related to disease prevention, diagnostics, and management, particularly in the context of SA’s unique health challenges. From its inception, the Biobank has steadily expanded its collections, accommodating both public and private entities. It has also attracted international attention, particularly from institutions in the United Kingdom conducting clinical trials in SA. This evolution has allowed the Biobank to grow into a vital resource, not only for the country but also for global research endeavours.

Unique Features and Capabilities

The NHLS National Biobank is a population-based biobank, with a broad biobanking scope that serves a diverse pool of researchers. The Biobank operates under a quality management system that aligns with both ISO 9001:2015 and the new biobank-specific ISO 20387 standard. This focus on quality assurance ensures that the Biobank offers a comprehensive service throughout the biobanking cycle.

Moreover, the Biobank’s personnel bring a wealth of expertise to their roles. The team includes professionals with advanced qualifications that are not commonly found in other biobanking institutions. Among them are South Africa’s first MSc in Biobanking graduate, a PhD in bioethics and health law with a specialisation in ethico-legal biobank research, and various national and international committee members contributing to the development of best practices and standards in biobanking.

Specimen Collection and Usage

The NHLS National Biobank houses an extensive range of biological specimens. These include serum, plasma, buffy coat, urine samples, genomic material, tuberculosis (TB) microbank samples, dried blood spot (DBS) samples, and histology and cytology slides. These specimens play a critical role in supporting research in both communicable and non-communicable diseases, aligning with the national health research priorities of South Africa. The variety and quality of the collections ensure that researchers have access to the essential resources needed to conduct studies that advance understanding in these critical areas.

Contributing to Medical Breakthroughs

One of the most notable achievements of the NHLS National Biobank is its ISO 9001:2015 certification, the first of its kind for an African biobank. This certification, obtained in 2019, underscores the Biobank’s commitment to maintaining a high standard of quality across its operations. The robustness of its quality management system ensures that the materials it provides for research are of the highest standard, contributing to downstream medical advances.

Additionally, the Biobank played a crucial role during the COVID-19 pandemic. It stored samples that were instrumental in the analysis leading to the discovery of a novel COVID virus strain, highlighting its importance in responding to emerging global health threats.

Collaboration and Ethical Governance

Collaboration is at the heart of the NHLS National Biobank’s operations. Its inclusion in the MBirSA network, a collaboration of biorepositories, enhances its ability to work with key stakeholders both within and outside South Africa. These collaborations are governed by a robust regulatory and ethical framework that ensures all engagements adhere to national and international standards. This includes the use of material transfer agreements (MTAs), service level agreements (SLAs), and compliance with relevant regulatory instruments.

This commitment to ethical governance is paramount, ensuring that all sample usage is conducted in a manner that respects the integrity of the research and the participants.

Future Growth and the Role of MBirSA

Looking to the future, the NHLS National Biobank is committed to continued expansion and innovation. It aims to increase its collaboration with researchers, both locally and internationally, through the MBirSA network. This expansion will allow the Biobank to raise awareness of its resources among researchers, which could lead to new partnerships and collaborative research efforts. 

Additionally, the NHLS National Biobank plans to increase its publication output, helping to showcase the valuable research being conducted using its samples. Through its participation in MBirSA, the Biobank will also have access to a network of resources that can support disaster management, ensuring the long-term stability and success of its operations.

The NHLS National Biobank has emerged as a key player in the biobanking landscape of South Africa and beyond. With its strong foundations in quality management, ethical compliance, and collaboration, it is well-positioned to continue playing a pivotal role in advancing medical research for the benefit of all.

MBirSA Membership

1. Introduction

This document sets out the governance framework for membership to the Medical Biorepositories of South Africa (MBirSA). It defines membership categories, eligibility criteria, the application process, rights and responsibilities, and terms of membership. This governance structure aims to ensure inclusive, equitable, and transparent participation in MBirSA’s activities, in alignment with its mission to support ethical, effective, and sustainable biorepositories in South Africa.

2. Categories of Membership

MBirSA offers four categories of membership:

  1. Biorepository membership
  2. Institutional membership
  3. Individual membership
  4. Associate members
  5. Observer status

2.1 Biorepository Membership

Biorepository membership is open to any biorepository operating within South Africa that supports and aligns with MBirSA’s principles and objectives.

Rights of membership

  • Eligibility to nominate representatives to MBirSA working groups and committees.
  • Opportunity to comment on and vote on any MBirSA consensus statements or other MBirSA policies developed.
  • Access to MBirSA resources, training, and capacity-building activities.

Responsibilities:

  • Commitment to MBirSA’s Code of Conduct
  • Timely payment of membership fees (if applicable).
  • Appointing a designated representative to engage with MBirSA on behalf of the biorepository.
  • To indicate their membership of MBirSA and inclusion of the MBirSA logo on the biorepository website.

2.2 Institutional Membership

Institutional membership is open to South African institutions (e.g., universities, research councils, hospitals) that oversee or house multiple biorepositories.

Becoming a member:

  • The institution applies as a single entity and designates a primary liaison.
  • All biorepositories under the institution’s auspices automatically fall under the membership.

Rights of membership:

  • Eligibility to nominate representatives to MBirSA working groups and committees.
  • Access to MBirSA resources, training, and capacity-building activities.

Responsibilities of membership:

  • Commitment to MBirSA’s Code of Conduct.
  • Timely payment of membership fees (if applicable).
  • Oversight of affiliated biorepositories’ compliance with MBirSA principles
  • Facilitation of internal coordination and communication with MBirSA.
  • To indicate their membership of MBirSA and inclusion of the MBirSA logo on the institution’s website.

2.3 Individual Membership

Individual membership is open to professionals, researchers, ethicists, policy experts, or community advocates with a demonstrated interest in medical biorepositories in South Africa.

Rights of membership:

  • Eligibility to nominate themselves to MBirSA working groups and committees.
  • Access to MBirSA resources, training, and capacity-building activities.

Responsibilities:

  • Commitment to MBirSA’s Code of Conduct.
  • Timely payment of membership fees (if applicable).

2.4 Associate Membership

Associate membership is open to individuals or institutions located outside South Africa who support the aims of MBirSA and wish to collaborate or contribute to its work.

Rights of membership:

  • Eligibility to nominate themselves to MBirSA working groups and committees.
  • Access to MBirSA resources, training, and capacity-building activities.

Responsibilities:

  • Commitment to MBirSA’s Code of Conduct.
  • Timely payment of membership fees (if applicable).
  • To indicate their membership of MBirSA and inclusion of the MBirSA logo on the website.

2.5 Observer status

A biorepository and/or institution that may be considering membership, can join as an observer for one year only.

Rights of observer status:

  • Access to MBirSA resources, training, and capacity-building activities.

Responsibilities:

  • Commitment to MBirSA’s Code of Conduct.
  • Timely payment of observer status membership fees (if applicable).
  • To indicate their membership of MBirSA and inclusion of the MBirSA logo on the website.

3. Application and Admission Process

  1. Applicants must complete the official MBirSA membership application form and submit any supporting documentation as required.
  2. All applications are reviewed by the MBirSA Steering Committee for decision.
  3. Successful applicants will receive formal notification and a welcome package, including the MBirSA Constitution and any applicable membership fees.

4. Duration and Renewal of Membership

Membership remains valid until such time as either the member or MBirSA chooses to terminate it, subject to continued eligibility, active engagement, and payment of membership fees (if applicable).

5. Termination or Suspension of Membership

Membership may be suspended or terminated if:

  • The member is found to be in serious breach of MBirSA’s Constitution or Code of Conduct by the Steering Committee.
  • The biorepository or institution is no longer operational.
  • The member voluntarily withdraws from MBirSA in writing.

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