- The Use of Health Data and Biospecimens Including Information Generated from the Biospecimens for the Research and Academic Purposes
The collection, use, and disclosure (“
process” or “
processing”) of health data (e.g., information about your health status, medical test results, and what medical conditions you have) and biospecimens (e.g., blood or other body tissues) including information generated from the biospecimens (collectively referred to as “
health data and biospecimens”), which are considered to be sensitive data, for the research and academic purposes have been promoting significant developments and enhancing personnel in the medical industry, scientific industry, and the other industries.
Esperance Clinic and its affiliated companies (“
we” or “
Clinic”) hope to make it easier for the researchers and the academicians to use your health data and biospecimens in the future as explained further in this Explanation of Consent for the Processing of Health Data and Biospecimens including Information Generated from the Biospecimens for the Research and Academic Purposes (“
Explanation”).
When all of the details that could reasonably be used to identify you (e.g., name, surname, address, medical record number) have been removed from the health data and biospecimens, we say they are “
de-identified health data and biospecimens” which are not considered as personal data. The applicable laws allow the researchers and the academicians to process such de-identified health data and biospecimens without consent from the data subject
.
When your health data and biospecimens can still be linked to you, we say they are “
identifiable health data and biospecimens”. Research and academic use of identifiable health data and biospecimens can be even more helpful to science and medicine, because it allows researchers and academicians to put together a lot of information about a person and understand even more about medical conditions and if and how treatments work. However, data processing of identifiable health data and biospecimens for research and academic purposes bears more risk to people’s privacy, and therefore, there are strict rules for those kinds of processing.
Furthermore, identifiable health data and biospecimens may be de-identified and become de-identified health data and biospecimens which we are allowed to process such de-identified health data and biospecimens for research and academic purposes, however, with your prior consent.
- What are we asking you to do?
This Explanation asks you to make an important choice about the use of your identifiable health data and biospecimens for research and academic purposes.
If you consent, the researchers and the academicians will be allowed to
- Implement the de-identification procedure on your identifiable health data and biospecimens for the research and academic purposes; and
- process your identifiable health data and biospecimens for research and academic purposes;
over a long period of time, without asking your permission again for any specific researches and academic activities covered by this Explanation.
If you do not consent, the researchers and the academicians in most cases will have to ask your permission to de-identify or process your identifiable health data and biospecimens in any future research and academic activities. As this may be difficult or impossible, it could make scientific studies and academic activities harder to do.
Remember, this consent granted hereunder applies only to research and academic activities with identifiable health data and biospecimens. The researchers and the academicians can always use de-identified health data and biospecimens for research and academic activities without getting any your consent. However, we will ask for your consent before implementing the de-identification on your identifiable health data and biospecimens.
Please ask us about anything in this Explanation that you do not understand, and only make a decision if you have had all your questions answered and have had enough time and opportunity to consider whether to agree to give this consent.
- What is the Purpose of this Consent?
If you consent, we will de-identify and process your identifiable health data and biospecimens for the purposes of medical, academic, scientific and other research, now and into the future, for as long as they are needed for this purpose. We may share your de-identifiable health data and biospecimens with any third party as set forth in clause 4. and our Privacy Notice for the aforementioned purposes.
What Types of Research May be Done?
If you consent, we will process your identifiable health data and biospecimens for the researches that include but not limited to:
- Studying the causes and progression of different diseases and conditions;
- Developing and testing methods to diagnose and treat different diseases and conditions;
- Whole genome sequencing (meaning that your entire personal genetic code will be identified);
- Specific genetic research looking at diseases and medical conditions that are passed on in families and among populations larger than families;
- Research that creates cell lines by growing cells from your biospecimens in a laboratory – including cells that can be used to create different types of tissue;
- Research that includes changing the genes in cells or putting human cells into animals;
- Research about drug abuse and alcoholism diagnosis and treatment;
- Research about mental health diagnosis and treatment;
- Research about developmental disabilities;
- Research about HIV and sexually transmitted diseases;
- Research about induced termination of pregnancy and abortion; and
- Family planning and reproductive health research.
The results of research done on your health data and biospecimens will not be put into your medical records. It is possible, but unlikely, that such research could show that you have a medical condition (like tuberculosis), that the law requires reporting to public health departments along with your personal data, which such disclosure is our obligation to comply with the laws.
What Types of Academic Activities May be Done?
If you consent, we will process your identifiable health data and biospecimens for the academic activities that include but not limited to:
- Publication;
- Teaching medical personnel;
- Standardization of methods to diagnose and treat different diseases and conditions;
- The Disclosure of your Health Data and Biospecimens
If you consent, we may disclose
, transmit or transfer your de-identifiable health data and biospecimens with researchers and academicians, e.g., researchers of different projects, academia, other medical facilities, other researchers, pharmaceutical companies, medical equipment companies, and biotechnology companies, or the governmental authorities and regulators, e.g., the Food and Drug Administration (FDA), the Institutional Review Board, and other agencies whose job is to review and oversee research, or other third parties from inside or outside the country. However, the disclosure of your identifiable health data and biospecimens will be made only when it is necessary to achieve the purposes specified herein and those in the Privacy Notice.
If publication resulting from use of your identifiable health data and biospecimens, your name will not be used in those publications.
- Are There Risks of Harm?
The main risk in giving consent herein is that your privacy could be violated. We will do our best to protect your information from going to people who should not have it, including by removing information that could be used easily to identify you. The risk that your identifiable health data and biospecimens will go to someone who should not get it is very small. Another risk is that your identifiable health data and biospecimens could be used in a research or academic activity which cannot specify the title at the time; furthermore, in most cases, we are unable inform you the future procedures of research or academic activities in details. However, the examples listed above should give you a good idea of the kinds of researches and academic activities that might be done. Also, a research ethics committee will make sure the researches and academic activities are conducted in accordance with the ethics in medical research.
- Are There Any Benefits, Compensations, or Expenses?
You will not personally benefit from giving consent herein. Research and academic use of your identifiable health data and biospecimens may help others by improving our understanding of health and disease, improving health care and making safer or more effective medical therapies, and developing new scientific knowledge.
If you consent, your health data and biospecimens may be used to create products or to deliver services, including some that may be sold and/or make money for others. If this happens, there are no plans to tell you, or to pay you, or to give any compensation to you or your family.
Whether you give consent or not, there are no costs to you.
- Are There Alternatives to this Broad Consent? Is There a Choice?
You are free to not consent to the processing of your identifiable health data and biospecimens which will not cause you any denial in access to health care or benefits to which you are entitled and will not change your relationship with your health care providers. No matter what you decide, your decision will not affect your rights to obtain medical care or other services.
- Can You Change Your Mind and Reverse Your Decision to Give this Consent?
You can withdraw your granted consent by contacting Data Protection Officer at
[email protected]. We will not begin new research or academic uses of your identifiable health data and biospecimens, however, without prejudice to the researches and academic activities already conducted.
- If You Say “Yes,” Will You Learn More about Your Health?
There are no plans to tell you about any specific research or academic activities that might be done with your health data and biospecimens, and there are no plans to give you any results from these studies. Most tests done are only for research and have no clear meaning for health care. If future research with your health data and biospecimens gives results that do have meaning for your health, the researchers may – but are not required to – contact you to let you know what they have found. If the researchers return genetic test results to you, it may be because they think you could have a health risk and want to recommend that the test should be re-done by a certified clinical laboratory to check the results. If this happens, then you may want to get a second test from a certified clinical laboratory, consult your own doctor, or get professional genetic counseling, which you may have to pay for those additional services yourself.
- Options for Responding to this Request for Broad Consent: What Will Happen?
As explained above, this form is asking for your consent to 1) the de-identification and 2) the processing of your identifiable health data and biospecimens for research and academic purposes. You are free to give your consent, and your decisions will result as follows:
If you consent,
If you do not consent (including the case you do not reply to this form)
- Your identifiable health data and biospecimens will not be stored, de-identified, or processed for the kinds of future research and academic activities described herein and those in the Privacy Notice, however, your identifiable health data and biospecimens can be de-identified and processed for research and academic purposes.
- Researchers could come to you again later and ask to de-identify and process your identifiable health data and biospecimens for research and academic purposes.
- Researchers may contact you in the future for your consent.
- Contact Information
If you have any questions about the consent or your rights hereunder, please contact Data Protection Officer at
[email protected]. Please ask us to explain anything in this form that you do not clearly understand and and/or discuss it with family or friends before making a decision
.