Privacy Policy - Trial Participants

Updated 1 February 2024

Genesis Research Services Pty Ltd (“Genesis Research Services”, “we”, “us”, “our”) respects and upholds the rights of all of our participants & customers to privacy protection under the Australian Privacy Principles (APP) of the Privacy Amendment (Enhancing Privacy Protection) Act 2012, which amends the Privacy Act 1988. The APP commenced 14th March 2014. The Health Records and Information Privacy Act 2002 (HRIPA NSW) was updated on January 2014.

This policy sets out how we collect and treat your personal information .

1. Definitions

Personal information is defined by the Australian Privacy Principles guidelines as:

Information or an opinion about an identified individual, or an individual who is reasonably identifiable:

  • whether the information or opinion is true or not; and
  • whether the information or opinion is recorded in a material form or not.

Personal information includes health information, which is also considered ‘sensitive information’.

Sensitive information is defined as:

  • Information or an opinion (that is also personal information) about an individual’s:
    • racial or ethnic origin
    • political opinions
    • membership of a political association
    • religious beliefs or affiliations
    • philosophical beliefs
    • membership of a professional or trade association
    • membership of a trade union
    • sexual orientation or practices, or
    • criminal record
  • health information about an individual
  • genetic information
  • biometric information that is to be used for the purpose of automated biometric verification or biometric identification, or
  • biometric templates.

De-identification is the process of removing personal identifiers, such as name, address, date of birth, or removing or altering other information that may allow an individual to be identified. De-identified information is no longer considered personal information.

2. Personal Information Collected and Held

Genesis Research Services may collect and store personal information that you provide to us, including, but not limited to:

  • name
  • date of birth
  • sex/gender
  • address
  • contact details – telephone number(s), email address
  • bank account details
  • details of family, next of kin, and emergency contact details
  • race or ethnic origin (sensitive)
  • name of general practitioner, referring doctors (if other), and any other doctors, past or present, involved in your care
  • medical history, including:
    • relevant family medical history
    • past surgical history
    • current and previous medications and other treatments
    • allergies, sensitivities, and adverse reactions to drugs
  • details of any physical examinations
  • body measurements (height, weight)
  • details of any relevant lifestyle factors
  • details of relevant health investigations and results.

3. How Personal Information is Collected

Genesis Research Services may collect personal information by means such as:

  • via telephone call or email
  • our website contact forms or application forms for current or future clinical trials
  • online questionnaires or surveys, including those advertised on social media
  • during a study visit after providing your informed consent
  • paper-based study forms, questionnaires, and other study assessments
  • from external healthcare providers as part of your clinical trial participation.

Any unsolicited personal information that we receive will be de-identified or destroyed.

At or before the time, or if that is unreasonable or impractical, after personal information is collected, you will be made aware of this privacy policy and relevant privacy notices (APP5).

4. Use of Personal Information

Genesis Research Services implements processes to obtain freely given consent to the use and disclosure of personal information. We use personal information for purposes related to our clinical trial operations, including:

  • to provide you with information about clinical trials
  • to make appointments
  • to assess your suitability (eligibility) to participate in a clinical trial
  • to process your clinical trial participation
  • for the specific purposes of the clinical trial being conducted
  • to provide medical care and treatment as part of your clinical trial participation
  • to assist with any calls from our clinical trial participants
  • to maintain a database of potential candidates who have expressed interest in clinical trial participation
  • for our internal administrative requirements
  • to comply with our reporting requirements and any legal and regulatory obligations.

Before personal information is used for the specific purposes of a clinical trial, a process of informed consent is followed to obtain confirmation that a person understands the clinical trial, including its purpose, procedures, foreseeable risks, and potential benefits, before confirming their willingness to participate. This information will be detailed in the participant information and consent form (PICF) received prior to the clinical trial screening visit.

Where personal information is used for the purpose of direct marketing, a simple means of opting-out from such communications will be provided.

5. Disclosure of Personal Information

Genesis Research Services will never disclose personal information to unauthorised personnel. We may disclose personal information to third parties bound by us in agreement for purposes related to our clinical trial operations, and where the Privacy Act permits so. These include:

  • other medical, nursing, research, and allied health professionals who provide necessary follow-up treatment and ongoing medical care
  • external healthcare providers, including affiliated hospitals, day surgery centre, and imaging and pathology providers
  • the ethics committee that approved the clinical trial, to fulfil safety reporting requirements
  • representatives of the clinical trial sponsor, such as trial monitors and auditors
  • the regulatory authority(ies) that audit or inspect our facility for compliance with Australian Standards, Codes and Legislation
  • third-party bodies that audit our facility for the purposes of accreditation of our Quality Management System
  • specialist sub-contractors and consultants who assist us in the management of our facility
  • government bodies, where disclosure is required or authorised by law, including:
    • the Commonwealth Ombudsman
    • the Office of the Australian Information Commissioner
    • the Australian Taxation Office; and
    • the Australian Federal Police.

Any information provided to external organisations is de-identified, unless there is reason for which de-identified data will not serve the purpose of disclosure.

6. Overseas Disclosure

It is unlikely that any personal information will be provided to an overseas recipient. Oversees recipients that may receive personal information include clinical trial sponsors located in North America, Europe, or Asia. Any information that is provided to an overseas clinical trial sponsor will be de-identified, unless there is reason for which de-identified data will not serve the purpose of disclosure. If personal information is to be disclosed to an overseas recipient, reasonable steps will be taken to ensure there will be no breach of the Australian Privacy Principles.

7. Access to and Correction of Personal Information

Australian privacy law gives you the right to request access to and correction of the personal information that Genesis Research Services holds about you.

Participants may request access to their personal information by writing to the Research Manager via email ( or the website Contact Us form. A response will be generated within 30 days. Only the participant, or a person they have authorised, can request access to personal information. Information is released at the discretion of the Medical Director by copying, summarising, or through consultation. Documents may be collected in person or sent via registered post. There will be a small fee.

Under certain conditions, refusal may be an option, and this will be in writing. Any complaint should be directed to the Research Manager.

Australian privacy law also gives you the right to correct or request removal of the personal information that we hold about you if it is inaccurate, out of date, incomplete, irrelevant, or misleading. Genesis Research Services is committed to maintaining the accuracy, currency, and completeness of the personal information we collect, use, and disclose. To assist us, please notify us of any updates or changes to your personal details by writing to the Research Manager.

Please note, if you consent to participate in a clinical trial, Australian clinical trial regulations require Genesis Research Services to maintain and store clinical trial records, including personal information related to the clinical trial, for a minimum of 15 years.

8. Storage and Security of Personal Information

Genesis Research Services is committed to ensuring that the personal information you provide to us is kept private and secure. Personal information is maintained in the strictest confidence in accordance with this Policy and our Quality Management System.

The personal details and health information of our participants is contained in both paper-based (hard copy) documents and electronically. Access to records is restricted by:

  • storing hard copies in secure, locked facilities
  • storing electronic copies on secure servers
  • restricted access to hard copy and electronic documents
  • electronic password protection
  • electronic backups attended daily and remotely
  • signed confidentiality agreements.

9. Complaints Pathway

If you feel we have breached any of the Australian Privacy Principles, please contact the Research Manager on (02) 4985 1860 or send an email to Alternatively, you may send a message using the Contact Us form.