Privacy Notice for Study Participants

1.  About this Privacy Notice

This Privacy Notice tells you how we, Scientia Clinical Research Ltd. (Scientia) will collect and use your personal information. We will use your information to contact you in the future about clinical trials. If you take part in a clinical trial, we will keep your records for as long as required by law and international guidelines for clinical trials.

You should read this Privacy Notice in conjunction with Scientia’s Privacy Policy.

2.  Why does Scientia need to collect and store your personal data?

We will hold the information that you submit to Scientia for the sole purpose of checking your suitability for future clinical trials, and contacting you to tell you about those clinical trials. We will ensure that the information we collect and use is appropriate for this purpose, and does not constitute an invasion of your privacy. We will not contact you for any other marketing purposes, without first obtaining your consent.

You are under no obligation to give your personal information to Scientia. However, we will need your personal details, including medical information about you, if you want to take part in clinical trials at Scientia.

We will use your personal information to meet the aims of the clinical trial if you take part in a clinical trial with us.

3.  Collection and processing of personal information?

1. If you complete the registration form and/or any of our assessments, but don’t take part in a clinical trial, then we process and control your personal information because we are company that does clinical trials and needs to be able to identify suitable trial participants from a group of people who are interested in taking part in clinical trials.
2. If you take part in a clinical trial, then we process your information because the sponsor (the company or organisation paying for the clinical trial) needs the information to develop new medicines or do other health-related scientific research. The sponsor is the data controller for clinical trial information (which will be de-identified by Scientia before sharing – refer to section 5).  To contact the data controller, please refer to the information and consent form for the trial, the data privacy statement on the sponsor’s website, or talk to your study doctor.
3. If you take part in a clinical trial, Scientia will collect and control some information that does not form part of the clinical trial records. For example:

• details of your next of kin – in case of emergency or in case we need to contact you in the future because we have important new information about the study medicine
• your bank details – so we can pay you for taking part in the trial
• your photograph and identification (such as your passport or driving licence) – so we can check that no-one else uses your name, and make sure you don’t take part in clinical trials too often
• we will ask you to fill in optional questionnaires about your experience in the trial – we use the feedback in the questionnaires to monitor our performance and find ways to improve our service to participants

4.  If I take part in a clinical trial, how will Scientia collect additional information about me?

In addition to information that you give to us, Scientia will process the results of your medical tests and procedures (such as blood tests, blood pressure and x-rays).  We may also ask you GP or another doctor responsible for your care, to give us additional medical information about you e.g. when you are screened to see if you are suitable to take part in a clinical trial or at any time during the study if required.

5.  Will SCR share my personal information with anyone else?

Scientia will store your information, including personal and medical details. We may keep your personal information on paper and in a computer database that is confidential and access controlled.

Scientia also uses third party databases and services for e.g. our study participant recruitment campaigns. This includes, but is not limited to MailChimp where some of your personal data may be stored.

MailChimp have their servers in the USA.  To learn more about their privacy statements, please refer the section titled “Members located in Australia” on their website https://mailchimp.com/legal/privacy/

Once you consent to take part in a clinical trial, however, your information will form part of the clinical trial records and will be processed in line with the applicable laws that control clinical trials.

If you take part in a clinical trial, your personal identifiable information might be seen at Scientia by:

• Scientia staff
• Health care professionals who work on the study or help with your care
• the authorities that control medicines, such as the Australian Therapeutic Goods Administration (TGA)
• representatives of the sponsor (the company paying for the study), who check that the study procedures are being done correctly

As part of a clinical trial, we might share your personal information with other parties (such as a specialist doctor or scanning unit who work on the trial). Those parties must keep your information confidential and use it only for the clinical trial. However, unless required by law, we will not send your name, address or any other information that identifies you, to anyone else outside Scientia except for medical professionals responsible for your care (such as your GP or specialist if required).

When Scientia sends your personal information to anyone else, we will replace your name with a code, so the recipient will not know that it came from you. Scientia will keep the key that links your results to you; we will not share that key with anyone else. When you decide to take part in a specific clinical trial or research project, detailed information will be provided to you including what personal data will be collected, what will happen with your personal data and with whom we will share your (de-identified) before you agree and consent in writing to participate.

We will never allow third parties access to your personal information for their own marketing purposes, and we will never sell personally identifiable information to third parties.

6.  How long will Scientia keep my personal data?

If you have never been screened for and/or participated in a clinical trial at Scientia, then we will keep your personal information for approximately 5 years after you have last been in contact with us.

Once, you have taken part in a clinical trial, we can’t delete your personal information from our records because we need to keep clinical trials information for at least 15 years, in line with the regulations, and because we might need to contact you if there is any new information about the study medicine.

Scientia is collecting your bank details only for the purpose of paying you.  Scientia is using a third party, the University of New South Wales (“UNSW”) to facilitate and process all payments.  SCR is a wholly-owned entity of UNSW.  As a result, bank details you provide will be processed by UNSW Finance.  SCR is required by law to retain your bank details for 7 years.  SCR will not disclose your bank details to any entity, except to UNSW Finance and our bank, unless required to do so by law.

7.  Under what circumstances will Scientia contact me?

If you are an existing volunteer, we will ask your consent to contact you in future by email, social media account, text, phone or other common means of communication to tell you about forthcoming studies. We will stop contacting you about clinical trials if you inform us at any time that you no longer wish to be contacted. We will keep your name on our database as ‘active’ for at least 5 years if we don’t hear from you. We aim not to be intrusive, and not to ask irrelevant or unnecessary questions.

8.  Cookies

Cookies are small files sent from websites like Scientia’s (or through a service from a third party such as Google via Google Analytics) and stored in your internet browser. They allow a website’s systems to recognise your internet browser and remember certain information. The Scientia website uses ‘cookies’ for maintaining contact with a user through a website session. All cookies will immediately lost when you end your internet session and shut down your computer. Scientia’s record of your information will be automatically deleted twenty minutes after you last use out website. We cannot collect your personal information (like name, date of birth, contact details, etc.) via cookies on our website.

You can reject receiving cookies from websites through the settings on your internet browser. If you would like to reject cookies from Google Analytics, please refer to the link below in Section 12.

9.  Google Analytics and other tools

Scientia uses a range of tools provided by third parties, such as Google Analytics, to collect or view website traffic information, and to manage, secure and improve our website. These sites have their own privacy policies and SCR is not responsible for the privacy practices of other business – or the content of websites that may be linked to our website.

Google may set up cookies or read current cookies on your internet browser to collect data. Google use this information to evaluate your use of our website, and to prepare reports on website activity. Google will not link your computer’s IP address with any other data held by Google.  Obtain for further information about managing your settings, opt-out options and Google’s privacy policy on https://policies.google.com .

No attempt will be made to identify anonymous users of their browser activities unless Scientia is legally compelled to do so.

10.  How can I find out about personal information that Scientia holds about me?

Scientia upon your request can confirm what personal information we hold about you and how it is used and processed. Please refer to Scientia’s Privacy Policy on how to do that, what information we can provide and what sort of proof of identification we require from you.

11.  What rights do I have over my personal information once I take part in a clinical trial?

If you take part in a clinical trial, the personal information we hold about you will form part of the clinical trial records, and will be processed as described in the Participant Information and Consent Form (PICF) for the trial. Because the information is used for a clinical trial that has been approved by a research ethics committee, your rights to access, change, delete or move your information are limited, as follows:

• You can’t make us delete study information and results we’ve already collected, or object to or limit our processing them
• We might not have to make corrections to your study results and information if you ask us to
• You can ask to see your study results and information once they are available, but you don’t have an automatic right to have a copy; however, the study doctor will share any important medical information with you and other doctors responsible for your care.

12.  How secure is the personal information I provide?

Scientia places an importance on the security of all personal information that it holds.  We have security measures in place to protect personal information that we hold against loss, misuse and interference, and from unauthorised access, modification or disclosure.

No data transmission over the internet can be guaranteed to be 100 per cent secure.  As a result, while we strive to protect user’s personal information, Scientia cannot ensure or warrant the security of any information transmitted to it or from its website, and users do so at their own risk.

Once Scientia receives your transmission, it makes every effort to ensure its security on its systems.

13.  Who should I contact if I need more information or I have any concerns or complaints?

If you have any queries, concerns or complaints about this Privacy Notice or our Privacy Policy or the way in which we handle your personal information, please contact us via our email at privacy@scientiaclinicalresearch.com.au or you may wish to call us.

If you would like access to the personal information we hold about you, or to have your name removed from our database, please contact us by phone or by email.

Document code: PN-Participants-v01Nov2018