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Contact Information
- Camden Medical Centre, 1 Orchard Boulevard #13-07, Singapore 248649
- +65 9828 1910
- info@ivisionresearch.com
Privacy Policy
1. Confidentiality
Your or your child’s/ward’s identity and personal health data will be kept confidential.
Without your and/or your child’s/ward’s consent, your or your child’s/ward’s data cannot be used. Therefore you or your child/ward will not be able to take part in the study if you do not give your consent to use your or your child’s /ward’s personal data.
During the course of the study, the study investigator will collect personal data, including personal health data about you or your child/ward, which will be used for the purpose of the study as described in this form and may help develop new tests, procedures, and commercial products.
You and/or your child/ward must give your and/or your child’s/ward’s authorization before the study investigator can use or share your or your child’s/ward’s personal data with others. This section will describe how your or your child’s/ward’s personal data will be collected and used and explain your and/or your child’s/ward’s rights.
By signing this form, you consent to the study investigator and the study staff collecting and using personal data about you or your child/ward for the study (“Study Data”) as permitted by the applicable laws and regulations.
Your and/or your child’s/ward’s consent to the use of your or your child’s/ward’s Study Data for the purposes of the Study does not have a specific expiration date. However, you or your child/ward may withdraw your or your child’s/ward’s consent at any time. If you or your child/ward do take away your and/or your child’s/ward’s consent, no new information will be taken about you or your child/ward.
2. Data Collected
“Personal Data” means data about you or your child/ward which makes you or your child/ward identifiable (i) from such data or (ii) from that data and other information which an organization has or likely to have access. This includes medical conditions, medications, investigations, and treatment history.
Research arising in the future, based on this Personal Data, will be subject to review by the relevant institutional review board.
The Study Data that will be collected are:
- Personal data
- Your or your child’s/ward’s name, address, telephone number, email address, national identification number.
- Your or your child’s/ward’s age, gender, ethnicity, and race
- information about your or your child’s/ward’s lifestyle, health, medical history, and medications your child takes
- Information about your or your child’s/ward’s use and response to study contact lenses
- Information about side effects and medical history and tests while you or your child/ward is taking part in the study
By signing the Informed Consent Form, you and/or your child/ward is authorizing such access to your or your child’s/ward’s study and medical records.
3. Data Protection
Your or your child’s/ward’s full identity will not be on any of the study documents or kept by the sponsor for their studies. The institutions will remove personal data, including personal health data, relating to you or your child/ward from Study Data before these are transferred or otherwise made available to the sponsor.
The Study Data given to and used by the sponsor is protected using a subject identification number, which is a number specific to you or your child/ward. Only a unique subject identification number for the study will link the data to you or your child/ward. These data may contain your or your child’s/ward’s gender and race, as well as any medical and scientific data required by the study. The study investigator maintains a confidential list that links the subject identification number to you or your child/ward. Only the study investigator will be able to connect the subject identification number to your or your child’s/ward’s personal data. He/she will not share this information except as explained in this consent form. The institution will also establish the necessary technical and organizational measures to prevent your or your child’s/ward’s re-identification by sponsor.
The sponsor, the sponsor’s representatives, regulatory authorities, the auditors, the health authorities (FDA, HSA), the ethics committee, the Ministry of Health or other supervisory bodies may review any encoded Study Data held by the study investigators and the institutions. The reason these people may look at your or your child’s/ward’s encoded Study Data is to make sure the study has been done the right way and that the Study Data are accurate and for regulatory purposes. The only circumstances in which the sponsor, the sponsor’s representatives, regulatory authorities, or other supervisory bodies may review un-encoded Study Data (Study data that identifies you or your child/ward) would be where this is necessary to comply with the national law of Singapore or is necessary for the performance of a task carried out in the public interest. In particular, the only circumstances in which
sponsor’s representatives may review un-encoded Study Data would be where the national
law of Singapore requires this review such as for verification of clinical trial procedures and/or data, and as part of an investigation of an adverse event that occurred during the study, without violating your or your child’s/ward’s confidentiality. These people and organizations are all obligated to maintain confidentiality by the nature of their work or are bound by confidentiality agreements.
The sponsor may share the encoded Study Data with its representatives, including authorized study monitors, with other companies within its group, with its service providers, its contractors and business collaborators, and with research institutions and researchbased commercial organizations who will use the encoded Study Data for the purposes described above.
The sponsor and those who work for or with the sponsor, th IRB/IEC and national and international Regulatory Authorities will be able to see your or your child’s/ward’s personal medical files at the institution or electronically, which contain your or your child’s/ward’s full name. All people involved in the study have the duty of confidentiality.
Despite these steps taken to limit access to your or your child’s/ward’s personal data, including the use of the subject identification number as described above, people may develop ways in the future that would allow someone to link your or your child’s/ward’s health information in study databases back to you or your child/ward. For example, someone could compare information in the databases with information from you or your child/ward in another database and be able to identify you or your child/ward. It also is possible that there could be security breaches of the computer systems used to store the codes linking your or your child’s/ward’s medical information to you or your child/ward. There may also be other privacy risks that are not yet foreseen. All reasonable steps will be undertaken to ensure the confidentiality of the Study Data.
Your or your child’s/ward’s personal data will be stored for at least 10 years or according to sponsor’s requirement after the end of the study, whichever longer.
4. Publication
On completion of the study, results and data from the study that will not include any personal identifiers may be published in accordance with
regulatory requirements.
Although information about this study, including the results, may be published for scientific purposes, presented, or posted electronically (for example, in a clinical trials registry database) or presented to scientific groups, your or your child’s/ward’s name and personal information will not be used and your or your child’s/ward’s identity will not otherwise be revealed.
5. Rights Concerning the Processing of Your or Your child’s/ward’s Personal Data
The data recorded at the time of this study may be held on computer or as paper records by the sponsor or by someone else for the sponsor. You or your child/ward have a right of access to, and, if needed, to have your or your child’s/ward’s data corrected. You or your child/ward have the right to request from sponsor erasure of your or your child’s/ward’s personal data, to obtain from the sponsor restriction of processing to object to processing, and to receive
personal data provided to sponsor for transfer to a third party (i.e., right to data portability). However, certain personal data collected before you or your child/ward make such a request may need to be processed by the sponsor to comply with regulations governing clinical research in your or your child’s/ward’s country and cannot, therefore, be erased. You and/or your child/ward have the right to withdraw your and/or your child’s/ward’s consent to the processing of your or your child’s/ward’s personal data at any time. However, if you and/or your child/ward withdraw your and/or your child’s/ward’s consent to the processing of your or your child’s/ward’s personal data after you or your child/ward has started participation in
the study this will result in your or your child’s/ward’s withdrawal from the study.
If you and/or your child/ward has any questions about the collection and use of information about your or your child/ward or would like to exercise rights that you or your child/ward may have regarding this information, you and/or your child/ward should ask the study investigator.
