What is the HalthaConnect Research Registry?
You are being invited to join the HalthaConnect Research.
HalthaConnect is creating a registry (a database collecting personal and health information from individuals) to:
- Identify and reach out to individuals who may qualify for HalthaConnect clinical studies.
- Gather data that can aid HalthaConnect in understanding medical conditions and related scientific areas, potentially leading to future medical advancements and discoveries.
Upon joining HalthaConnect, you’ll be asked to share certain personal and health-related information to help match you with potential clinical trials. This information will also help HalthaConnect researchers better understand medical conditions and related topics, which might contribute to scientific discoveries and advancements in healthcare.
HalthaConnect is dedicated to protecting the privacy and confidentiality of all participants. You will have control over what personal data you choose to share and can update your preferences at any time. Your personal information, including health data, will be managed and protected as outlined in this consent form.
Participation in HalthaConnect is voluntary and does not replace your standard medical care. You can choose to join or withdraw from HalthaConnect at any time without any penalty or impact on your usual healthcare or benefits. Joining HalthaConnect does not require you to give up any legal rights.
You are not obligated to join HalthaConnect to be considered for clinical trials or other research opportunities; you can discuss research options with your healthcare provider directly.
Please read this document thoroughly, take your time, and ensure you understand what participation in HalthaConnect entails. If you have questions, feel free to contact us using the provided phone number or email address listed on the first page of this consent document.
Should you choose to participate in HalthaConnect, you will first be required to sign this informed consent document. You will have the option to download a copy of this document or access it via the HalthaConnect web portal.
If there are any changes or updates to HalthaConnect in the future, you will be notified and provided with an updated consent document detailing these changes.
Please note that currently, only residents of the 50 U.S. states and the District of Columbia are eligible to join HalthaConnect.
What does participating in HalthaConnect involve?
Sharing certain personal information: If you create a HalthaConnect account and agree to participate, you will be asked to share specific personal information. This includes details at birth, race, ethnicity, language, insurance type, disability status, income bracket, education, employment status, gender identity, ancestry). Some information may be optional, and you can choose not to provide it.
Risks of Participation:
As with any online platform collecting personal data, there is a small but not nonexistent risk of a data breach. A breach could result in unauthorized access to your information, although HalthaConnect employs stringent security measures to reduce this risk. There is also a chance you might feel uncomfortable with certain questions or permissions requested by HalthaConnect, but you have the option to skip these fields and still participate.
Privacy and Confidentiality:
HalthaConnect is committed to protecting your privacy through various security measures, including limiting access to your information to only those with roles that require it, conducting research with Coded Information, and following legal, ethical, and regulatory standards. Your personal information will be stored securely, and access will be restricted to a small group of people and entities.
Who will access your information?
Certain individuals, such as HalthaConnect staff and auditors, will have access to your personal information. Other parties, including organizations collaborating with HalthaConnect, will only have access to your Information.
Benefits of Participation:
There may be no direct benefit to you from participating in HalthaConnect, but you may indirectly benefit from learning about clinical trial opportunities or contributing to scientific research that could help others in the future.
Costs and Payments:
There are no costs or payments for participating in HalthaConnect. The registry does not affect your regular medical care.
Managing Your Information:
You can view, confirm, and update the information you provide to HalthaConnect at any time through the web portal.
Information Storage:
Your information will be stored securely and retained for as long as necessary, potentially up to 10 years after HalthaConnect closes.
Use of Coded Information for Other Research:
HalthaConnect may use your Coded Information for other scientific research projects, potentially including the development of new medicines, vaccines, or digital tools.
Duration of Participation:
You may remain in HalthaConnect for as long as it remains open for enrollment, potentially up to 8 years.
Withdrawing from HalthaConnect:
You can withdraw from HalthaConnect at any time without affecting your regular medical care or other benefits. After withdrawal, your account will be deactivated, and no new information will be collected, though your Coded Information may still be used for research and regulatory purposes.
Results of HalthaConnect Research:
You can learn about the results of HalthaConnect research by visiting the web portal or receiving updates via email.outlined in the section titled “How will HalthaConnect collect my personal information, and what information will be collected?”. Approximately every 6 months, you may be asked to confirm or update the information you’ve provided.
HalthaConnect will use your personal information for the following purposes:
- Determining eligibility for clinical trials: Participation in HalthaConnect clinical trials is entirely voluntary. You will be informed about the specific requirements, as well as the potential risks and benefits, of any clinical trials for which you may be eligible. Participation in HalthaConnect is independent of your decision to participate in any clinical trials. It’s possible that you may never be contacted for a trial if you don’t meet the eligibility criteria.
- Advancing scientific knowledge: Information collected via HalthaConnect may help researchers understand more about the characteristics of individuals with specific medical conditions or those using particular medications. These insights may contribute to future scientific discoveries and healthcare advancements.
- Communication: Within the HalthaConnect web portal, you can indicate the medical conditions or types of clinical trials that interest you. If the information you provide suggests you may qualify for a clinical trial, HalthaConnect will reach out to you via email and/or telephone. Telephone contacts may be made using an automated dialing system or a prerecorded message. HalthaConnect may also send you updates or notifications related to the registry, including information about research findings or opportunities available to participants.
- Legal and regulatory compliance: This includes reporting any safety concerns related to a product you mention while participating in HalthaConnect and ensuring that the registry complies with all relevant regulations and standards.
- Other purposes: These may include verifying your eligibility for HalthaConnect, publishing findings related to the registry, and improving the quality and design of HalthaConnect and other research studies.
Information Collection Process:
You will be asked to enter personal information into the secure HalthaConnect web portal, which you will access using an email address and password. The requested information includes your name, date of birth, ZIP code, email address, telephone number, health details (e.g., medical conditions, medications, vaccination history), and demographic information (e.g., sex assigned