HVP Australian Node - Data Access Policy

Statement of General Principles Regarding Data Access
1. Overall Policy Goal
2. This policy provides information and guidelines for individuals wishing to request access to data stored within the Australian Human Variome Database ("the Database") for diagnostic, clinical or research use. The Human Variome Project Australian Node ("the Node") is committed to providing diagnostic, clinical and research investigators the opportunity to access data for purposes that are consistent with the missions of both the Node and the International Human Variome Project.
3. The following policy is drafted to provide reasonable access to data while allowing the Node to meet its obligation of ensuring the data is used in a legal and ethically compliant manner.
Purpose of the Human Variome Project Australian Node
1. The Human Variome Project Australian Node is a repository of genetic test results and interpretations as reported by diagnostic laboratories within Australia.
2. Access to the data is provided through the Australian Node Portal to diagnostic laboratory workers and clinicians for direct diagnostic/clinical use: determining the classification and consequences of a variant discovered in the genetic sequence of an individual patient.
3. Access to the data for research use is provided through the BioGrid system (http://www.biogrid.org.au) where it can be linked in a de-identified manner with records from other data sources accessible by BioGrid.
Management Overview
1. The Human Variome Project Australian Node is a project maintained by the Department of Pathology of the University of Melbourne.
2. The management structure of the Human Variome Project Australian Node is outlined in full on the Node website (http://www.hvpaustralia.org.au/).
  1. The day-to-day operations are of the Node are managed by the Project Director, advised by the Management Advisory Committee.
  2. The views of the users of the Node are communicated to the Project Director by the Users Committee, a representative body of the end users of data held by the Node.
  3. The Australian Node Access Committee manages and reviews access requests for the data within the Database.
Identified User and Use Types
1. In this document, Users are defined as those individuals who have been granted access to the Database either through the Portal for clinical and diagnostic use, or through the BioGrid service for research use.
2. Diagnostic/Clinical Use
3. As stated in Paragraph 2.2 above, access to the Database for direct diagnostic or clinical use is possible through the Australian Node Portal.
4. The Australian Node Portal has three user types: Registered, Laboratory Admin and Node Admin users. Guest access to the Portal (i.e. access without registration) is not possible.
5. Members of the Registered Users category can be:
  1. Individuals who are employees of laboratories located in Australia that are recognised by the Royal College of Pathologists of Australasia and/or the National Association of Testing Authorities as conducting genetic testing;
  2. Individual medical practitioners who are registered with the Medical Board of Australia who can demonstrate a need to access information stored within the Database in order to manage one or more of their current patients; or
  3. Individuals who have received Board certification or higher from the Human Genetics Society of Australia in the area of genetic counselling.
6. Members of the Laboratory Admin category are those individuals who satisfy the requirements of Paragraph 4.5.1 and who have been appointed by their laboratory to manage the list of Registered Users for that laboratory.
7. Members of the Node Admin category are restricted to members of staff of the Human Variome Project Australian Node.
8. All applications for registration are reviewed and approved by the Australian Node Access Committee.
9. Other individuals with a demonstrable need for access for diagnostic/clinical use may apply to the Australian Node Access Committee for consideration.
10. Research Use
11. Access to the data contained in the Database for use in research projects is possible via the BioGrid service ( http://www.biogrid.org.au), subject to the terms and conditions imposed by BioGrid and a full scientific and ethical review of the proposed research.
12. As per the BioGrid Data Access Process, requests for access to the Database for research use will be referred to the Data Access Committee who will engage data submitters in the process of determining access.
13. All publications containing data or analyses consisting of, or derived from, information obtained from the Database must provide acknowledgement of the source of that information.
General Conditions of Access
1. Access to the Database is only available for demonstrable clinical, diagnostic or research purposes.
2. Users must comply with all applicable privacy legislation, both Federal and State (see http://www.privacy.gov.au/law) in relation to the use, disclosure and storage of the data obtained from the Database.
3. Users must not distribute data to third parties.
4. Users must ensure their user name and password is secure and is not shared.
5. Diagnostic/Clinical Use
6. Users must keep their contact details up to date at all times. Contact details can be changed at any time via the Portal.
7. Users must notify the Australian Node Access Committee upon any change of institution. Upon notification, the user's account will be temporarily suspended pending authentication of their new employment arrangements. The Access Committee can be notified of an institutional change via the Australian Node Portal.
8. Users in the Laboratory Admin category must regularly review and update the list of Registered Users from their Institution. Once a Registered User leaves the Institution, the Laboratory Admin User for that Institution should notify the Access Committee via the Portal.
9. The Portal provides access to all records stored within the Database; there are no restrictions on access to individual records.
10. Restrictions do apply to specific fields within each record. The Portal will not display:
  1. identifying details of patients, including, but not limited to, hashed linkage keys for linking to clinical data via BioGrid; or
  2. identifying details of the laboratory submitting a particular record (although users will be able to contact the submitting laboratory via the Portal).
11. Research Use
12. In addition to Paragraphs 5.1 to 5.4 above, access to the Database for research purposes shall be governed by the BioGrid Terms and Conditions (see http://www.biogrid.org.au).
Application Process
1. Any potential user can apply for access via the Australian Node Portal.
2. Potential users will be asked to submit the following to the Access Committee:
  1. full name;
  2. institution to which they belong;
  3. contact details, including address and telephone numbers;
  4. a valid institutional email address; and
  5. supporting documentation as requested by the Access Committee.
3. All requests for access will be reviewed by the Access Committee.
4. The Access Committee reserves the right to contact the potential users and/or their institution for the purposes of determining their employment status and confirming their stated need for access.
5. Upon successful review by the Access Committee, an account will be generated and the user name and password forwarded to the new user.
6. Unsuccessful applicants will be informed in writing of the reasoning behind their application being rejected.
7. Review of Decisions
8. Applicants who have been denied access who respond to the Access Committee's concerns in writing within 14 days will have their application reassessed.

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