Operating an HVP Country Node

Once there is some form of agreement to set up the Node, the group must consider how the Node will operate.

A robust and representative organisation is required to handle operational decisions in a sustainable way.

Collecting variant data

The eventual goal is that the Country Nodes will be linked to the national health system in some way. This means that the data collected must be assessed and labelled according to its quality and suitability for use in clinical settings.

Defining your data model

Every Node needs to establish a data model that sets out:

  1. What data is stored in which database
  2. How each data element is related to each other element
  3. What format each element can be stored in
  4. Which elements are mandatory
  5. How much intervention will be made during and after submission to:
    • standardise format
    • assess data quality
    • correct errors
    • add additional information or combine records

Data sources can be identified based on the type of data being collected. For example:

  • Molecular data
    • Laboratories: either Research and/or Diagnostic
    • Clinics/Genetic Counsellors
    • Literature
  • Clinical Data
    • Laboratories
    • Clinics
    • Genetic Counsellors
    • Patients and/or Patient Registries

Remember

Specific data elements that must be shared are to be specified by the International Confederation of Countries Advisory Council.

As outlined in the definition of an HVP Country Node, Nodes require a set of agreed and implemented policies in three areas:

  1. Data Collection policy and Data Collection Agreement/s
    • What is collected
    • Privacy/identification issues
    • Clinical data
    • How is it collected
    • How is it stored
    • When is it collected
    • Why is it collected
  2. Data Access policy
    • Who can access data locally and for what purpose?
    • Controlled Access?
    • Classes of use
    • Who can access data internationally?
    • What data can be shared and with whom. This is very important as the Human Variome Project is an international organization
  3. Data ownership/IP policy: this is particularly important where both public/private laboratories coexist as private/commercial laboratories may have different requirements.
    • Who ‘owns’ the data ‘submitted’ to a Node?
    • The laboratory, or
    • The Node
    • License terms
    • Withdrawal from the agreement
    • What happens to the data already shared internationally?

Tip

Experience tells us that it is important not to duplicate the effort of others; data needs to be made available and viewed through various technical interfaces. The Node should act as a navigator to where good data and information can be found; it does not need to ‘own’ the data itself.

The International Coordinating Office can help Nodes navigate issues relating to data ownership and IP policy.

Sharing data internationally

International data sharing has additional complexities:

  • Ethical and legal frameworks and expectations might be different but need to be resolved in advance
  • Data sharing policies need to be harmonized
  • Consents and conflicts of interest need to be handled openly.

Tip

Nodes often find it helpful to identify a disease-based entry point to build the case for establishing a Node. The Human Variome Project participates in several projects that aim to involve countries in international consortia that are collaborating to resolve issues of systematic data collection and sharing on variants leading to known health outcomes.

Staffing the Node

Country Nodes generally start small, often with limited resources.

There are two important roles or functions that need to be considered when first setting up:

  1. A Spokesperson: speaks on behalf of the Country Node, leads fund raising, raises the profile of the node, persuades other to join
  2. A Node co-ordinator/administrator: responsible for administration for the Node, organizing meetings, keeping records, implementing policies, point of contact for enquiries

Tip

Experience tell us that it is important to consider these responsibilities and pay attention to how they will be carried out. It is important to start small. These roles do not need to be full-time at the beginning. Nodes often start with volunteers with people working a few hours per week, then as their case develops and the network widens, different mixes of skills are required.

Funding and sustainability

The funding requirements of the Node generally fall in to three categories:

  1. Supporting the functioning of the organisation and its administration
  2. Maintaining the operations of the technical systems and infrastructure, and
  3. Developing new technical systems and infrastructure in response to user needs.

The organisational component is most likely to be the highest recurring cost (including salaries, travel etc.) while recurring technical costs are generally low.

Likely sources of funds to support organisational framework include:

  1. Government: Ministries of Science, Health, Development; Research bodies; Academies of Science, Medicine
  2. Universities
  3. Professional societies
  4. Philanthropic sources

In kind resources can have a role—voluntary work, server hosting, office co-location, subsidies etc.

Operating the Node in a responsible and accountable manner requires:

  • Ensuring the data is collected, stored and used in a manner that complies with all local ethical, cultural, legal and social concerns
  • Protecting the rights of all involved: patients, practitioners, researchers and families
  • Being aware of changing policy landscape at national and international levels
  • More than privacy and consent: conflicts of interest, free and open access, adherence to Human Variome Project Standards, Guidelines and policies

Local organisations are best placed to determine how to do this. Many countries have laws and regulations that cover the use of human samples, genetic and genomic materials, patients’ rights, protection of children and so on.

All HVP Country Nodes need to ensure that:

  • They have appropriate policies in place to protect all involved. This may include policies dealing specifically with:
    • Consent/privacy
    • Conflicts of interest
    • Ethics
  • These policies are implemented, monitored and reviewed regularly in the context of the Node’s operations
  • Have strong relationships with national bodies responsible for ethical health service delivery, conduct of research as appropriate.

Tip

Experience tells us that it is better to ensure that any problems are foreseen and prevented before they occur as the reputation of the Node will be very difficult to rebuild if it is called into question, or perceived to be in question.