This Privacy Statement tells you how Gen1 Research protects the privacy of personal information that you may provide to us. Our website, our database, and our mobile application, Helix®, are built with all of the latest privacy and security features that are required to keep patient information safe. We follow all of the guidelines of both healthcare technology and research technology security features without compromising beautiful design, and keeping your data secure is our highest priority.
Gen1 Research may collect anonymous computer information from you on our website. We collect personally identifiable information from you—with your consent– when you complete an interest form or eligibility questionnaire for specific trials. In all cases, your personally identifiable information is kept confidential. We only share this information with our partners and sponsors who are working with us on a specific clinical trial. All other information collected from you may be used and shared with third parties on an anonymous or aggregated basis only. Your personal information is stored in our databases, and if you participate in a trial using Helix®, your data will be stored there as required by the trial, and we will contact you as required by the trial and in the manner you agreed to upon enrollment. In addition to participation in a specific trial, we may contact you from time to time about other clinical trials that may be of interest to you. You can opt out from this communication at any time.
Purpose of Privacy Notice
The purpose of this privacy statement is to explain what Gen1 Research does with personally identifiable information that you provide to us, such as your name, address, age, and information relating to your medical conditions. We want you to know how this information will be protected, under what circumstances we may share it and with whom and for what purposes.
Reason for Collection of Your Information
There is no requirement to register to view the Gen1 Research website. You can freely visit many of our web pages without telling us who you are. However, other activities possible through our site, such as completing an interest form for specific clinical trials, require that you provide your personal details, including but not limited to information about your medical history, demographics, email address, name, and other information. This allows us to process and/or send you information that you request about specific clinical trials. If selected to participate in a clinical trial, further registration is required to use Helix®, the Clinical Trial Management System. If you are selected to participate in a Gen1 Research trial, you will receive an invitation to enroll in Helix® as a user by setting an email address and a password, and you may be asked to enter additional information specific to the clinical trial in which you are enrolling.
Personal Information Collected from You
The type of information collected from you will depend on whether you are registering for a general interest list, or are indicating interest in a specific trial. The information that we may ask you to provide may include your first and last name, your mailing address, your age, birth date, gender, e-mail address, photos, and information about your medical history. Gen1 Research seeks to limit the collection and processing of personal and medical information to the minimum for what is necessary to fulfill the purposes for which it is to be used.
Consolidation of Information Collected from You
If you indicate interest in more than one study, or sign up on multiple pages, we may combine your personally identifiable information as well as any anonymous computer information collected (see below) and store it collectively. This helps us keep track of all of your information in one place, and helps us provide information to you based on a more informed review of your requests and medical conditions of interest.
Gen1 Research takes all reasonable steps to ensure that personal data collected is reliable for its intended use, accurate, complete, and current.
Collection of Anonymous Computer Information
When you visit the Gen1 Research website, we do not collect any personally identifiable information about you without your permission. However, we do collect anonymous information about you if your computer is set to allow that type of collection. (You can turn off the ability to collect some of this information on most computers.) This type of anonymous information allows us to evaluate customer interest in our websites and perform other market research activities, such as analyzing customers’ browsing habits on our site. It also allows us to track customers who may come to our websites based on website advertisements about Gen1 Research’s services. (For those who are interested in the details, some of the typical computer techniques we may use are “cookies”, “internet tags” which are also called “action tags”, “single-pixel GIFs”, clear GIFs, “invisible GIFs, and “1-by-1 GIFs). If you would like more information about web tags and cookies associated with on-line advertising or how to opt out of third-party collection of information, please visit the Network Advertising Initiative website (https://www.networkadvertising.org), an independent website not sponsored by or affiliated with Gen1 Research.
Consent to Provide Your Information to Gen1 Research
We must obtain your consent to collect your personally identifiable information when you complete an interest form regarding a specific trial, or enroll in Helix® to participate in one. In doing so, we also explain, for that trial, what you are registering to receive and how we plan to contact you and use your personal information. Enrolling in Helix® for the purpose of participating in a specific trial also includes completing an informed consent for participation that addresses the data collected and stored for that trial. Once you are enrolled for a specific trial, your data pertinent to that trial will be retained. We offer you the option of discontinuing your consent (“opting out” or “unsubscribing”) from future communication if you later decide that you no longer want to participate in the specific trial or receive additional information from us. If we wish to use this information for purposes incompatible with those for which the data was initially collected, we will inform you first and offer an opportunity to opt out of the secondary use.
Sharing Your Information with Third Parties
Gen1 Research will not share your personal information with third parties unless we have obtained your express consent to do so. You provide your consent when you click ‘submit’ at the end of the interest form or enrollment process. Your personal information may thus be shared with selected personnel and partners working on this clinical trial. Gen1 Research requires third parties to whom it discloses personal data to protect that information using substantially similar standards to those followed by Gen1 Research. We also require that they do not use your personal information for any separate use that is not specifically for the execution of the clinical trial and authorized by Gen1 Research. There may also be instances where Gen1 Research may be required to share your information with third parties who have not been retained by us (directly or indirectly), such as with health authorities, during inspections or audits, or as ordered or directed by courts or other governmental agencies. In these cases, unless otherwise required by law, the information shared is de-identified. Adverse Event reports may be forwarded to the relevant health authorities.
Security of Your Information
We use appropriate technical, administrative and physical safeguards to protect data that pertains to you from loss, misuse or alteration. In addition, we take steps to ensure that our safeguards take into account new known threats. Of course, no organization can guarantee the absolute security of personal information. You should keep in mind that Internet transmissions, particularly email transmissions, are never 100% secure or error-free. Accordingly, we also caution you to guard your own computer and password against unauthorized access by others.
Withdrawal of Your Consent to Participate in Research
If you have enrolled in Helix® in order to participate in a specific research study, you may withdraw your consent to participate at any time by emailing email@example.com. Any research involving your data that has already been performed or published prior to our receipt of your request will not be reversed, undone, or withdrawn.
Updated Gen1 Research Privacy Notices
This Privacy Statement becomes effective on September 7, 2018. Gen1 Research may update this Statement from time to time. We encourage you to review our Privacy Statement periodically.
How to Contact Us
If you have any questions about our Privacy Statement please send us your inquiry to firstname.lastname@example.org and we will get back to you shortly after.