You or your child/ward’s identity and personal health data will be kept confidential. Without your consent, your or your child/ward’s data cannot be used. This is why 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/ward’s personal data. During the course of the study, the study doctor 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 must give your authorization before the study doctor can use or share your or your child/ward’s personal data with others. This section will describe how your or your child/ward’s personal data will be collected and used and explain your and/or your child’s rights.
By signing this form, you consent to the study doctor and his or her 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 consent to the use of your or your child/ward’s Study Data for the purposes of the Study does not have a specific expiration date. However, you may withdraw your consent at any time. If you do take away your consent, no new information will be taken about you or your child/ward.
“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
You or your child/ward’s name, address, telephone number, email address, national identification number (last 4 alphanumerical digits).
You or your child/ward’s age, gender, ethnicity and race
information about you or your child/ward’s life style, health, medical history and medications you or your child/ward takes
Information about your or your child/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 are authorizing such access to you or your child/ward’s study and medical records.
You or your child/ward’s full identity will not be on any of the study documents and kept by the sponsor for their studies. The institution will remove personal data, including personal health data, relating to your 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 by the use of 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/ward’s gender and race, as well as any medical and scientific data required by the study. The study doctor maintains a confidential list that links the subject identification number to you or your child/ward. Only the study doctor will be able to connect the subject identification number to you or your child/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 you or your child’s re-identification by sponsor.
The sponsor, the sponsor’s representatives, The Ethics Committee / Institutional Review Board, FDA, regulatory authorities, the Ministry of Health and representatives of the pharmaceutical company or other supervisory bodies may review any encoded Study Data held by the study doctor and the institution. The reason these people may look at your or your child/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 you or your child/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 research-based 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, the IRB/IEC and national and international Regulatory Authorities will be able to see your or your child/ward’s personal medical files at the institution or electronically, which contain your child’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/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/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/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/ward’s personal data will be stored for at least 10 years after the end of the study.
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/ward’s name and personal information will not be used and your or your child/ward’s identity will not otherwise be revealed.
Rights Concerning the Processing of Your or Your child/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 have a right of access to, and, if needed, to have your or your child/ward’s data corrected. You have the right to request from sponsor erasure of your or your child/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 make such a request may need to be processed by the sponsor in order to comply with regulations governing clinical research in your country and cannot, therefore, be erased. You have the right to withdraw your consent to the processing of your or your child/ward’s personal data at any time. However, if you withdraw your consent to the processing of your or your child/ward’s personal data after you
or your child/ward has started participation in the study this will result in your or your child/ward’s withdrawal from the study.
You or your child/ward’s study data collected for this study will not be used or distributed for future research.
If you have any questions about the collection and use of information about you or your child/ward, or would like to exercise rights that you or your child/ward may have regarding this information, you should ask the study doctor.
During the course of the study, there is a possibility that we might unintentionally come to know of new information about your or your child/ward’s health condition from the data collected for this study. These are called “incidental findings”.
“Incidental findings” are findings that have potential health or reproductive importance to research participants like you or your child/ward and are discovered in the course of conducting the study, but are unrelated to the purposes, objectives or variables of the study. There will not be any incidental findings arising in this research.
During the study, new information about the risks and benefits of the project may become known. The study doctor will talk with you and/or your child/ward about any important new information that is learned during the course of the study that may affect your or your child/ward’s willingness to continue to take part in the study. This new information may also mean that you or your child/ward can no longer take part in this study. In all cases, you or your child/ward will be offered all available care to suit your or your child/ward’s needs.
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