Informed consent is a foundational component of ethical clinical research. While formal informed consent is required before a participant can officially join a clinical trial, DecenTrialz ensures that you are also provided with clear, understandable information prior to the referral stage, during pre-screening.

This section explains how the principles of informed consent apply specifically to the DecenTrialz platform and what you can expect before any of your information is shared with a research team.

What Is informed consent in clinical research?

Informed consent is not a one-time form, it is an ongoing, transparent process through which you:

• Receive relevant and understandable information about the study
• Are given the opportunity to ask questions and evaluate the information
• Voluntarily agree (or decline) to participate, without pressure or coercion

In the context of full trial enrollment, informed consent typically involves a detailed written consent form, a discussion with clinical staff, and your documented agreement.

At the pre-screening stage, this process is more limited but still critically important to ensure your autonomy and privacy.

How Informed Consent Works at the Pre-Screening Stage

Before any personal information is shared with a clinical research site, DecenTrialz presents you with a clear consent notice. This notice:

• Describes exactly what data will be shared, such as your contact details and pre-screener responses
• Identifies the intended recipient — a specific research site conducting the matched trial
• Explains the purpose of the data sharing — to initiate contact for further eligibility screening
• Clarifies that referral is entirely optional and occurs only if you provide explicit confirmation

You will be required to actively opt in to the referral. If you choose not to proceed, no data will be transmitted. There are no penalties or consequences for declining.

What this consent does not include

The consent process at the pre-screening stage:

• Does not enroll you in any clinical trial
• Does not authorize any medical procedures, assessments, or study-related tests
• Does not replace the formal informed consent process that will occur at the research site if you move forward

Should you proceed with a referral, the clinical research site will conduct its own detailed informed consent process, in compliance with IRB, HIPAA, and FDA requirements, before any study activities begin.

Why consent still matters at the pre-screening stage

Although you are not formally joining a study at this point, the handling of your health-related and contact information still requires strong ethical safeguards. DecenTrialz ensures that:

• You are clearly informed about what will happen with your information
• You maintain full control over whether your data is shared
• You may withdraw or decline at any time without impact on future opportunities

Participation in pre-screening is fully voluntary, and your rights are respected throughout the process.

Key Note: DecenTrialz adheres to established research ethics and regulatory standards, including HIPAA, IRB oversight, and clinical consent principles. You will never be referred to a clinical research site without your explicit, informed consent, and no personal data will be shared without your direct approval.

Disclaimer: DecenTrialz does not conduct clinical trials. The platform only facilitates pre-screening to help identify potential participant eligibility. All study activities, medical evaluations, and final enrollment decisions are carried out exclusively by the independent research sites or sponsors responsible for each clinical trial.