Alnylam is committed to protecting the privacy and security of your personal information. This privacy notice describes how we collect and use personal information about you. It applies to all visitors to our participant website www.HELIOS-AStudy.com and anyone who takes part in our recruitment process to be a participant in a clinical trial at our EU sites. If you go on to participate in a clinical trial, we will provide you with further privacy information at the time.
Alnylam is a “data controller”. This means that we are responsible for deciding how we hold and use personal information about you. We are required under data protection legislation to notify you of the information contained in this privacy notice. Often, if you go on to take part in a clinical trial then the data controller of your data in relation to that trial will be someone else, usually the organizer or sponsor of the trial. If this happens, we will let you know the identity of the new data controller at that time.
We may update this notice at any time and we will inform you of any substantial updates which may affect you.
It is important that you read this notice, together with any other privacy notice we may provide on specific occasions when we are collecting or processing personal information about you, so that you are aware of how and why we are using such information.
We will comply with data protection law. This says that the personal information we hold about you must be:
- Used lawfully, fairly and in a transparent way.
- Collected only for valid purposes that we have clearly explained to you and not used in any way that is incompatible with those purposes.
- Relevant to the purposes we have told you about and limited only to those purposes.
- Accurate and kept up to date.
- Kept only as long as necessary for the purposes we have told you about.
- Kept securely.
Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data).
There are “special categories” of more sensitive personal data which require a higher level of protection.
We will collect, store, and use the following categories of personal information about you:
Personal contact details such as name, title, addresses, telephone numbers, and personal email addresses
- Date of birth
- Next of kin and emergency contact information
- National Insurance number
- Bank account details
- Copy of driving license/passport or other national identity document
We may also collect, store and use the following “special categories” of more sensitive personal information:
- Information about your health, including any medical condition, health and sickness records
- Genetic information and biometric data
- Race and ethnicity information
We collect personal information about you when you visit our website and directly from you if you choose to apply to become a participant. We may sometimes collect additional information from third parties such as your GP or other health professional.
We will collect additional personal information in the course of activities throughout the period in which you participant with us, including as part of any interactions with you on social media.
We will only use your personal information when the law allows us to. Most commonly, we will use your personal information in the following circumstances:
- Where we need to perform the agreement we have entered into with you
- Where we need to comply with a legal obligation
- Where it is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests
- Where you consent to its use
We may also use your personal information in the following situations, which are likely to be rare:
- Where we need to protect your interests (or someone else’s interests), such as for safety reasons
- Where it is needed in the public interest or for official purposes
Situations in which we will use your personal information
We need all the categories of information in the list above primarily for our legitimate interests in providing a participant website to provide information about clinical trials to you, to maintain a database of potential participants for clinical trials, to conduct any screening or health checks to assess your suitability for clinical trials and to contact you about trials you may be interested in. In some cases, we may use your personal information to pursue legitimate interests of our own or those of third parties, provided your interests and fundamental rights do not override those interests. The situations in which we will process your personal information are listed below.
- Providing a participant website to provide information about clinical trials to you.
- To maintain a database of potential participants for clinical trials.
- To conduct any screening or health checks to assess your suitability for clinical trials.
- To contact you about trials you may be interested in.
- To conduct clinical trials, including medical assessments and testing of bodily samples (such as blood or urine).
- To make payments to you which you may be entitled as part of your role as a participant or application to be a participant or if you have recommended someone to take part in our trials.
- Complying with health and safety obligations.
- To prevent fraud.
- To monitor your use of our information and communication systems to ensure compliance with our IT policies.
- To conduct data analytics studies to review and better understand participant engagement.
- To conduct surveys.
Some of the above grounds for processing will overlap and there may be several grounds which justify our use of your personal information.
If You Fail to Provide Personal Information
If you fail to provide certain information when requested, we may not be able to perform any agreement we have entered into with you (such as paying you or providing a benefit), keeping your details on our participant database, letting you know about trials for which you may be suitable, or letting you participate in a trial.
We will only use your personal information for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose. If we need to use your personal information for an unrelated purpose, we will notify you and we will explain the legal basis which allows us to do so.
Please note that we may process your personal information without your knowledge or consent, in compliance with the above rules, where this is required or permitted by law.
“Special categories” of particularly sensitive personal information require higher levels of protection. We need to have further justification for collecting, storing and using this type of personal information. We may process special categories of personal information in the following circumstances:
- With your explicit consent.
- Where we need to carry out our legal obligations.
- Where it is needed in the public interest.
- Where it is needed to assess your health or safety, subject to appropriate confidentiality safeguards.
Less commonly, we may process this type of information where it is needed in relation to legal claims or where it is needed to protect your interests (or someone else’s interests) and you are not capable of giving your consent, or where you have already made the information public.
Our Obligations as Data Controller
We will use your sensitive personal information in the following ways:
We will use information about your physical or mental health, or disability status, to assess your suitability to take part in a clinical trial, to identify trials for which you might be suitable, to conduct testing and medical procedures if you go on to take part in a clinical trial and to liaise with your GP if needed.
We need your consent to use your special categories of information, such as health information.
We do not envisage that any decisions will be taken about you using automated means, however we will notify you in writing if this position changes.
We may have to share your data with third parties, including third-party service providers and other entities in the group. We require third parties to respect the security of your data and to treat it in accordance with the law.
We may transfer your personal information outside the EU.
If we do, you can expect a similar degree of protection in respect of your personal information.
Why might you share my personal information with third parties?
We will share your personal information with third parties where required by law, or where we have another legitimate interest in doing so, such as to enable us to maintain our participant database or let you know about a clinical trial.
Which third-party service providers process my personal information?
”Third parties” includes third-party service providers and other entities within our group. The following activities are carried out by third-party service providers:
Payment of monies due to you; administration and technical support services provided to help us manage our participant database or market our clinical trials; checking whether you have participated in another clinical trial recently, to make sure you are not taking part in trials too frequently which can be harmful to you and may affect the validity of the trial; and testing of samples given by you, such as blood samples.
The main service providers we use are:
How secure is my information with third-party service providers?
All our third-party service providers are required to take appropriate security measures to protect your personal information in line with our policies. We do not allow our third-party service providers to use your personal data for their own purposes. We only permit them to process your personal data for specified purposes and in accordance with our instructions.
Transferring information outside the EU
We may transfer the personal information we collect about you outside of the EU, including to the USA (where some of our group companies are based), in order to provide our services to you. There is not an adequacy decision by the European Commission in respect of the USA, which means that the country to which we transfer your data are not deemed to automatically provide an adequate level of protection for your personal information. However, to ensure that your personal information does receive an adequate level of protection we have put in place the following appropriate measures to ensure that your personal information is treated by those third parties in a way that is consistent with and which respects the EU and UK laws on data protection: ensuring the third party subscribes to the US Privacy Shield, utilizes Binding Corporate Rules or enters into EU standard contractual clauses. If you require further information about these protective measures, you can request it from our Data Protection Officer.
We have put in place measures to protect the security of your information, some of which are shown below. Further details of these measures are available upon request.
Third parties will only process your personal information on our instructions and where they have agreed to treat the information confidentially and to keep it secure.
We have put in place appropriate security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. In addition, we limit access to your personal information to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal information on our instructions and they are subject to a duty of confidentiality.
Some of our existing technical and organizational measures include: Technical measures:
- User roles, groups and permissions are in place to limit access to personal data. Antivirus software is installed on all computers.
SSL, TLS, encryption, pseudonymisation, restricted access, two factor authentication, Industry grade firewalls protect/surround the network, malware and Off-site access to networked computers is limited to certain users, who can then only access the network through VPN.
Organizational security measures:
- Key-card access is required to enter all buildings. Data security and/or confidentiality provisions are utilized in agreements with third parties. Documented Back-up and disaster recovery procedures are in place. Internal audit and compliance functions provide regulatory oversight. We have put in place procedures to deal with any suspected data security breach and will notify you and any applicable regulator of a suspected breach where we are legally required to do so.
How long will you use my information for?
We will only retain your personal information for as long as necessary to fulfil the purposes we collected it for, including for the purposes of satisfying any legal, accounting, or reporting requirements.
If you take part in a clinical trial, we are required to keep it in line with legislation which can mean it is kept for up to 30 years or more.
In some circumstances we may anonymize your personal information so that it can no longer be associated with you, in which case we keep using such information as it is no longer considered personal to you.
RIGHTS OF ACCESS, CORRECTION, ERASURE, AND RESTRICTION
Your Duty to Inform Us of Changes
It is important that the personal information we hold about you is accurate and current. Please keep us informed if your personal information changes during your relationship with us by contacting us.
Your Rights in Connection with Personal Information
Under certain circumstances, by law you have the right to:
- Request access to your personal information (commonly known as a “data subject access request”). This enables you to receive a copy of the personal information we hold about you and to check that we are lawfully processing it.
- Request correction of the personal information that we hold about you. This enables you to have any incomplete or inaccurate information we hold about you corrected.
- Request erasure of your personal information. This enables you to ask us to delete or remove personal information where there is no good reason for us continuing to process it. You also have the right to ask us to delete or remove your personal information where you have exercised your right to object to processing (see below).
- Object to processing of your personal information where we are relying on a legitimate interest (or those of a third party) and there is something about your particular situation which makes you want to object to processing on this ground.
- Request the restriction of processing of your personal information. This enables you to ask us to suspend the processing of personal information about you, for example if you want us to establish its accuracy or the reason for processing it.
- Request the transfer of your personal information to another party.
These request can be made online: https://clin-edge.com/data-subject-requests-gdpr/ Or by mail: 108 Myrtle St, Quincy, MA, 02171 Attention: DPO
You will not have to pay a fee to access your personal information (or to exercise any of the other rights). However, we may charge a reasonable fee if your request for access is clearly unfounded or excessive. Alternatively, we may refuse to comply with the request in such circumstances.
What We May Need From You
We may need to request specific information from you to help us confirm your identity and ensure your right to access the information (or to exercise any of your other rights). This is another appropriate security measure to ensure that personal information is not disclosed to any person who has no right to receive it.
RIGHT TO WITHDRAW CONSENT
In any circumstances where you may have provided your consent to the collection, processing and transfer of your personal information for a specific purpose, you have the right to withdraw your consent for that specific processing at any time. To withdraw your consent, visit https://clin-edge.com/data-subject-requests-gdpr/ Or by mail: 108 Myrtle St, Quincy, MA, 02171 Attention: DPO. Once we have received notification that you have withdrawn your consent, we will no longer process your information for the purpose or purposes you originally agreed to, unless we have another legitimate basis for doing so in law.
We have appointed a data protection officer (DPO) to oversee compliance with this privacy notice. If you have any questions about this privacy notice or how we handle your personal information, please contact the DPO via the participant management department. You have the right to make a complaint at any time to the Information Commissioner’s Office (ICO), the UK supervisory authority for data protection issues.
ClinEdge’s registered office is at 108 Myrtle Street, Quincy MA 02171 and registered in England and Wales under company number CSN3311528. ClinEdge is registered on the Information Commissioner’s Office Register; registration number ZA445878.
CHANGES TO THIS PRIVACY NOTICE
We reserve the right to update this privacy notice at any time, and we will provide you with a new privacy notice when we make any substantial updates. We may also notify you in other ways from time to time about the processing of your personal information.
If you have any questions about this privacy notice, please contact us, via email at GDPR@clin-edge.com.