Vigil Neuroscience, Inc. Privacy Notice for Clinical Trials
Effective on: August 30, 2022
Vigil Neuroscience, Inc. (“Vigil”, “we”, “us”, “our”) sponsors ethically approved clinical trials (“Trial” or “Trials”). We take the protection of personally identifiable information (“Personal Data”) very seriously. This Privacy Notice (the “Notice”) addresses individual patients and medical staff assisting with Trials (“Data Subjects”) whose Personal Data we may receive in connection with the Trials. Please read this Notice to learn what we are doing with your Personal Data, how we protect it, and how you can exercise your privacy rights.
2. Identity and Contact Information
If you are an individual patient and you have any questions about this Notice or our processing of your Personal Data, or you would like to exercise your data protection rights, please first speak with your study doctor. Vigil generally only has access to pseudonymized or “key-coded” data (as defined in Section 5 below), and we will be unable to identify you if we receive a request from you directly.
If you are not an individual patient, please contact us using one of the contact methods below. Please allow up to one month for us to reply.
Clinical Trial Sponsor
Legal entity name: Vigil Neuroscience, Inc.
Address: 100 Forge Road, Suite 700, Watertown, MA 02472
Email Address: firstname.lastname@example.org
Sponsor’s Data Protection Officer
Address: 100 M Street S.E., Suite 600, Washington, D.C. 20003 USA
Email address: email@example.com
Sponsor’s Data Protection Representative in the EU
VeraSafe Netherlands BV
Keizersgracht 391 A
1016 EJ Amsterdam
Phone: +420 228 881 031
Sponsor’s Data Protection Representative in the UK
VeraSafe United Kingdom Ltd.
37 Albert Embankment, London SE1 7TL, United Kingdom
Phone: +44 (20) 4532 2003
3. Scope of this Notice
What Is Covered by this Notice?
This Notice specifically addresses and applies to:
- individual patients and potential Trial participants in connection with our Trials and use of our experimental pharmaceutical products and/or future commercialized pharmaceutical products (if any);
- health care providers and other study site personnel, in connection with our Trials.
What Is Not Covered by this Notice?
- Human Resources Personal Data
This Notice does not apply to Personal Data collected by any other means or in different contexts, such as the Personal Data of our employees, job applicants, contractors, business owners, officers, directors, or staff of Vigil.
- Website Visitors
- Information Which Does Not Constitute Personal Data
If we maintain information in a manner that cannot reasonably identify, relate to, describe, be capable of being associated with, or be linked, directly or indirectly, with a particular individual or household, such information is not considered Personal Data and this Notice will not apply to our processing of that information. For clarity, this does not apply to pseudonymized data of Trial participants, which is considered Personal Data and will be treated as such.
Within the scope of this Notice, Vigil generally acts as a data controller for the Personal Data processed in the context of the Trials we sponsor. This means that we alone determine the purposes and means of the processing of your Personal Data.
In some jurisdictions, we may be considered a “joint controller” with another organization, such as the study site (for example, a hospital or medical office) where the Trial is being conducted. This means that we jointly, together with the other organization, determine the purposes and means of the processing of your Personal Data. If you would like to know more about any other data controllers who might be joint controllers together with Vigil, you may ask your study doctor or the study site for further details specifically relating to the Trial that you are participating in.
5. Categories of Personal Data
Personal Data of Individual Trial Participants
Personal Data is collected by the clinic or other healthcare facilities where the Trial is being conducted or other third parties, such as your general medical practitioner. The personal data that is collected may include your name, phone number, physical address, email address and information about your Trial location (i.e., study site). However, even though Vigil is a data controller for the Personal Data processed in the context of our Trials, Vigil itself does not collect directly identifiable Personal Data, meaning that we are unable to directly identify you personally from the information we are collecting.
When any information relating to you is shared with us, it will first be key-coded (also known as “pseudonymized”) so that it is only linked to a study patient number and not to any direct personal identifier (such as your name). The key necessary to decode your information is stored securely at the Trial location and is not shared with Vigil.
To comply with legislation governing the Trial, Vigil may appoint a site monitor or inspector to review your identifiable information at the site or remotely via a secure online portal. The site monitor and/or inspector will not collect nor remove your information from the site and will not disclose your identity to Vigil.
The following types of information listed below are also collected by the healthcare providers at the site and will be shared with Vigil and our service providers. This information is key-coded and neither Vigil nor our service providers can identify you from this information:
- basic identifying information, such as your unique Trial ID, age, sex, ethnicity, and race; and
- health information, such as your medical history, current health status and reaction to the Trial drug or treatment.
The Informed Consent Form you signed when you joined the Trial will detail which information is collected from you, how it will be processed and analysed, and for how long it will be stored. You can ask your study doctor if you are unsure whether any specific information that you are being asked to provide is required as part of your participation in the Trial.
Personal Data of Healthcare Providers Participating in a Trial
We may collect the following types of Personal Data about healthcare providers in the context of our Trials:
- basic identifying information, such as your first and last name;
- contact information, such as your phone number, physical address and email address;
- professional and employment-related information, such as your qualifications and job titles; and/or
- location information, such as the location of your testing site and Trial location (i.e., study site).
6. How We Receive Personal Data
We receive your Personal Data when:
- you provide it directly to us (including when you provide your Personal Data to one of our service providers acting on our behalf);
- a study doctor (also known as an “investigator”) or other healthcare personnel at the study site provides it to us, or your healthcare provider provides it to us;
- we receive it from the clinical research organization that conducts the Trial on our behalf;
- you visit one of the Trial-specific websites or online portals; and
- you provide it to us, the clinical research organization, or a study doctor when you complete a pre-screening questionnaire to confirm your eligibility to participate in the Trial.
7. Purposes of Processing
Personal Data of Individual Trial Participants
We process the Personal Data of individual Trial participants for the purposes of:
- enabling your participation in the Trial;
- managing and facilitating the Trial;
- developing new medicinal drugs or health treatments;
- complying with legislation governing Trials;
- communicating with you on the status of the Trial;
- monitoring and reporting on any adverse events, such as negative side effects; • answering the research questions for the Trial and aggregating data to generate statistics relating to the Trial and/or study drug or health treatment;
- disclosing your Personal Data to the appropriate regulatory authorities, auditors, and ethics committees, if required by law; and/or
- processing your requests to exercise your data protection rights.
We also process your Personal Data for the specific purposes described in the Informed Consent Form provided to you by Trial personnel.
Personal Data of Healthcare Providers Participating in a Trial
We process the Personal Data of healthcare providers in the context of our Trials for the purposes of:
- confirming your qualifications and experience in order to comply with the suitability requirements for individuals conducting Trials in terms of clinical trials legislation;
- managing and facilitating the Trial;
- communicating with you on matters regarding the Trial;
- complying with legislation governing the Trial; and
- processing your requests to exercise your data protection rights.
8. Basis of Processing
We may process your Personal Data on the basis of:
- Consent: We may rely on your consent to collect and process your Personal Data, including special categories of Personal Data, such as your health status and medical history.
- Contract: We may process your Personal Data to fulfill a contract we have with you.
- Legitimate Interests: We may process your Personal Data based on our legitimate interests in facilitating and managing our Trials.
- Compliance with Legal Obligations: We may need to process your Personal Data for us to comply with applicable laws or regulations, such as the laws regulating the safety and reliability of our Trials.
- Public Interest: We may process your Personal Data for reasons of public health interests to ensure adequate standards of quality and safety of the drugs or treatments we are developing.
Where we process your Personal Data, based on your consent, you may withdraw your consent at any time. However, this will not affect the lawfulness of our processing before you withdrew your consent. It will also not affect processing performed on other lawful grounds. If you withdraw your consent, you may be ineligible to participate in the Trial.
Where we receive your Personal Data as part of a contract we may have with you, we require such Personal Data to be able to carry out the contract. Without that necessary Personal Data, we will not be able to fulfill our contractual obligation towards you.
Where we process Personal Data on the basis of our legitimate interests, we will always do so after a careful assessment which requires balancing your right to privacy and our legitimate interests. You have the right to ask us more about how we decided to choose this legal basis. To do so, please use the contact details provided in the Identity and Contact Information section above.
Since we process special categories of Personal Data, such as your health status, medical history, race and ethnicity, the EU General Data Protection Regulation (“GDPR”) and the United Kingdom General Data Protection Regulation (“UK GDPR”) requires that we must have an additional legal ground to process this type of information. Vigil may process your special categories of Personal Data on the basis of your explicit consent, where the processing is necessary for reasons of public interest in the area of public health or where the processing is necessary for archiving purposes in the public interest, scientific or historical research purposes, or statistical purposes. Where we rely on your explicit consent, you may withdraw your consent at any time.
The specific grounds on which we process your Personal Data, including special categories of data, may vary somewhat from the above in order to comply with the requirements of local laws in jurisdictions where we sponsor Trials. If you are a participant in a Trial, please refer to the Informed Consent Form you signed when you joined the Trial for more information about the legal grounds on which we process your Personal Data.
9. Automated Individual Decision-Making
If you participate in a Trial we sponsor, you will be assigned a unique patient identification number. For a given Trial, this number may be used as part of an automatic process that randomly determines if you will receive the experimental drug product or treatment that is being evaluated in the Trial, or if you will receive a different treatment. This type of automated decision-making is required in order to ensure that the Trial is conducted in an ethical way, and in accordance with the pharmaceutical industry’s standards.
For decisions that may seriously impact you, you have the “right not to be subject to automatic decision-making, including profiling". But in those cases, we will always explain to you when we might do this, why it is happening, and the potential effect on you.
10. Data Retention
We will retain your Personal Data for as long as is necessary to fulfill the purpose for which we collected your Personal Data (listed above) and any other permitted linked purpose, and in compliance with our data retention policies as applicable from time to time. For example, we will retain and use your Personal Data to the extent necessary to comply with our legal obligations (for example, if we are required to retain your data to comply with applicable laws), resolve disputes, and enforce our legal agreements and policies.
Once your information has been entered into the Trial records, we cannot remove it without affecting the accuracy of the Trial and the test results. Some laws require us to keep Trial records for at least 25 years after the conclusion of the Trial. We will ensure that your Personal Data is safeguarded at all times.
11. Sharing Personal Data With Third Parties
We may share Personal Data with our service providers who process Personal Data on our behalf, and who agree to use the Personal Data only to assist us in fulfilling the purposes of processing as described in Section 7 above, or as required by law. Our service providers may include parties providing the following, either currently or in the future:
- contract/clinical research organization services;
- patient recruitment services;
- electronic data capture software and hardware;
- laboratory services;
- trial oversight, imaging and digital patient services;
- quality assurance, safety and pharmacovigilance software and related services; • data storage and archiving software and related services;
- data analytics and reporting software and services;
- services related to the collection, storage, testing, and transportation of biological material;
- software that randomly decides which dose level or treatment you will receive during the Trial;
- file management and security; and
- logistics and transport service providers.
12. Transfers of Personal Data from the EU/EEA
The GDPR only allows us to transfer Personal Data outside of the European Union (“EU”) or the European Economic Area (“EEA”) if the country that the data is being transferred to offers an adequate level of protection for the Personal Data which is equivalent to EU law.
Vigil is located in the United States. Some of our third-party service providers described above may also be located in countries outside of the EU/EEA. In some cases, the European Commission may have determined that the laws of certain countries provide a level of protection to Personal Data. You can see here the list of countries that the European Commission has recognized as providing an adequate level of protection to Personal Data.
For transfers of Personal Data to third countries which are not recognized as providing an adequate level of protection, we will only transfer EU Personal Data to third parties in those countries when there are appropriate safeguards in place. These safeguards may include the Standard Contractual Clauses as approved by the European Commission under Article 46.2 of the GDPR.
13. Transfer of Personal Data from the UK
The UK GDPR only allows us to transfer Personal Data outside of the United Kingdom (“UK”) if the country that the data is being transferred to offers an adequate level of protection for the Personal Data which is equivalent to UK law.
Some of our third-party service providers described above may also be located in countries outside of the UK. In some cases, the UK Information Commissioner’s Office (the “ICO”) may have determined that the laws of certain countries provide a level of protection to Personal Data.
For transfers of Personal Data to third countries which are not recognized as providing an adequate level of protection, we will only transfer UK Personal Data to third parties in those countries when there are appropriate safeguards in place. These safeguards may include Standard Contractual Clauses or other applicable transfer agreements, such as the International Data Transfer Agreement, as approved by the ICO.
14. Other Disclosure of Your Personal Data
We may disclose your Personal Data:
- with regulators or competent authorities, to the extent necessary to comply with applicable laws, regulations and rules (including, without limitation, federal, state or local laws);
- to the extent required by law, or if we have a good-faith belief that we need to disclose it in order to comply with official investigations or legal proceedings (whether initiated by governmental/law enforcement officials, or private parties);
- if, in the future, we sell or transfer, or consider selling or transferring, part or all of our company, business, shares or assets to a third party, and we disclose your Personal Data to such third party in connection with the sale or transfer; or
- in the event that we are acquired by, or merged with, a third party entity, or in the event of bankruptcy or a comparable event, we reserve the right to transfer, disclose or assign your Personal Data in connection with the foregoing events.
If we have to disclose your Personal Data to governmental/law enforcement officials, we may not be able to ensure that those officials will maintain the privacy and security of your Personal Data.
15. Data Integrity and Security
We have implemented and will maintain technical, administrative, and physical measures that are reasonably designed to help protect Personal Data from unauthorized processing. This includes unauthorized access, disclosure, alteration, or destruction.
16. Your Data Protection Rights
You have specific rights regarding your Personal Data that we collect and process.
For individual patients: to exercise the rights we explain below, please first speak with your study doctor instead of contacting us directly.
To exercise your data protection rights, please email us at firstname.lastname@example.org. Provide as much information that you consider fit to help us identify you and swiftly treat your request.
Right to Know What Happens to Your Personal Data
This is called the “right to be informed”. It means that you have the right to obtain from us all information regarding our data processing activities that concern you (or your child), such as how we collect and use your Personal Data, how long we will keep it, and who it will be shared with, among other things.
We are informing you of how we process your Personal Data with this Notice.
Right to Know What Personal Data Vigil Has About You
This is called the “right of access”. This right allows you to ask for full details of the Personal Data we hold about you.
Once we receive and confirm that the request came from you or your authorized agent, we will disclose to you:
- the categories of your Personal Data that we process;
- the categories of sources for your Personal Data;
- our purposes for processing your Personal Data;
- where possible, the retention period for your Personal Data, or, if not possible, the criteria used to determine the retention period;
- the categories of third parties with whom we share your Personal Data; • if we carry out automated decision-making, including profiling, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for you;
- the specific pieces of Personal Data we process about you in an easily sharable format; • the categories of parties that received your Personal Data from us;
- if we rely on legitimate interests as a lawful basis to process your Personal Data, the specific legitimate interests; and
- the appropriate safeguards used to transfer Personal Data from the EEA to a third country, if applicable.
Under some circumstances, we may deny your access request. In that event, we will respond to you with the reason for the denial.
Right to Correct Your Personal Data
This is called the “right to rectification”. It gives you the right to ask us to correct anything that you think is wrong with the Personal Data we have on file about you (or your child), and to complete any incomplete Personal Data.
Right to Delete Your Personal Data
This is called the “right to erasure”, “right to deletion”, or the “right to be forgotten”. This right means you can ask for your Personal Data to be deleted.
Sometimes we can delete your information, but other times it is not possible for either technical or legal reasons. If that is the case, we will consider if we can limit how we use it. We will also inform you of our reason for denying your deletion request.
Right to Ask Us to Limit How We Process Your Personal Data
This is called the “right to restrict processing”. It is the right to ask us to only use or store your Personal Data for certain purposes. You have this right in certain instances, such as where you believe the data is inaccurate or the processing activity is unlawful.
Right to Ask Us to Stop Using Your Personal Data
This is called the “right to object”. This is your right to tell us to stop using your Personal Data. You have this right where we rely on a legitimate interest of ours (or of a third party). You may also object at any time to the processing of your Personal Data for direct marketing purposes.
We will stop processing the relevant Personal Data unless: (i) we have compelling legitimate grounds for the processing that override your interests, rights, or freedoms; or (ii) we need to continue processing your Personal Data to establish, exercise, or defend a legal claim.
Right to Port or Move Your Personal Data
This is called the “right to data portability”. It is the right to ask for and receive a portable copy of your Personal Data that you have given us, so that you can:
- move it;
- copy it;
- keep it for yourself; and/or
- transfer it to another organization.
We will provide your Personal Data in a structured, commonly used, and machine-readable format. When you request this information electronically, we will give you a copy in electronic format.
Right Related to Automated Decision Making
We sometimes use computers to study your Personal Data. For decisions that may seriously impact you, you have the right not to be subject to automatic decision-making, including profiling. But in those cases, we will always explain to you when we might do this, why it is happening and the effect.
Right to Withdraw Your Consent
Where we rely on your consent as the legal basis for processing your Personal Data, you may withdraw your consent at any time. If you withdraw your consent, our use of your Personal Data before you withdraw is still lawful.
As discussed above, if we requested your consent to process your Personal Data, you have the right to withdraw your consent at any time. However, this will not affect the lawfulness of our processing before you withdrew your consent. It will also not affect processing performed on other lawful grounds. If you withdraw your consent, you may be ineligible to participate in the Trial.
Right to Lodge a Complaint with a Supervisory Authority
If the GDPR applies to our processing of your Personal Data, you have the right to lodge a complaint with a supervisory authority if you are not satisfied with how we process your Personal Data.
Specifically, you can lodge a complaint with the competent supervisory authority in the Member State of the European Union of your habitual residence, place of work, or the alleged violation of the GDPR, or in the United Kingdom, with the UK Information Commissioner’s Office, in case of violation of the UK GDPR.
17. Changes to this Notice
If we change this Notice, we will publish the revised Notice on our website. We will also update the “Effective” date.