RESOLVE™ Clinical Registry.
Regulatory Terms & Informed Consent.

1. Definition and Scope of the Clinical Registry

The RESOLVE™ Decentralized Clinical Trials (DCT) Portfolio consists of nine (9) independent, globally distributed observational disease registries. The goal of these registries is to evaluate longitudinal real-world evidence (RWE), diagnostic trajectories, and clinical outcomes for patients suffering from complex, chronic, or undiagnosed diseases.

The RESOLVE Registries are pre-registered on the Open Science Framework (DOI: 10.17605/OSF.IO/VPS9D) and registered on ClinicalTrials.gov (PRS registration in progress).

2. Zero Financial Coercion ($0 Study Participation)

DeepSensi PBC strictly adheres to the ethical guidelines established by the Declaration of Helsinki and 45 CFR § 46 (The Common Rule), which prohibit financial coercion or inducements in human subject research.

• Participation in the RESOLVE trial registries is 100% free of charge ($0.00).
• Subjects are not required to pay site fees, monitoring fees, data submission tariffs, or investigator fees.
• The Sponsor (DeepSensi PBC) does not charge subjects for evaluating their cohort eligibility or maintaining their clinical trial record.

3. Who can take part

Who can take part will be set out only in the study's public registration and in the study information approved by the ethics committee. Taking part never depends on buying anything.

4. Withdrawal

You can withdraw at any time, without giving a reason and without any consequence.

5. Informed Consent and e-ICF

Prior to any data being marked for research purposes, subjects (or their legally authorized representatives) must execute an electronic Informed Consent Form (e-ICF). This form clearly delineates:

1. The purely observational nature of the registry.
2. The data types (metabolomics, genomics, standard of care labs) that will be coded, with direct identifiers removed, and analyzed.
3. The explicit confirmation that the patient’s primary care physician or specialist remains entirely responsible for all medical decisions, diagnoses, and treatment plans. DeepSensi is an informational support tool and does not practice medicine.

6. Data privacy

Direct identifiers are removed on your device, and research data are held in coded form. The architecture removes direct identifiers on the participant's own device, and the key that links research data to a person stays there. Data transmitted for registry analysis are held in coded form; a formal de-identification determination under the HIPAA de-identification standard has not been completed and is not claimed, and research processing follows the safeguards of GDPR Article 89.

7. Comparisons

The registry is observational: it assigns no treatment and uses no placebo. Comparisons with published natural-history benchmarks are presented descriptively, and associations are not interpreted causally.