Us4Cure has an Ethical Approvals of Institutional Review Board/Independent Ethics Committee (IRB/IEC) for all clinical sites and institutes providing samples to the clients.
The Protocol and Informed consent forms(s) must be reviewed and approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC) and must comply with HHS regulatory requirements and all federal, state, and local laws as applicable.
Review is required:
Before beginning a project (initial review);
Before making any modifications to the project;
At least once each calendar year (continuing review)
Informed Consent must be approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC) before it can be signed by study subjects.
The Principal Investigator and other Clinical site staff must undergo appropriate Us4Cure training..
The informed consent process may take place anywhere from several weeks prior to biospecimen collection to immediately before sample donation.
Prior to obtaining the consent, PI and other Clinical site staff will review the consent form with the potential Candidate by discussing all elements as described in 45 CFR 46.116 and including the following: overview and purpose of the study procedures, potential risks, benefits and alternatives (not to participate).
The Principal Investigator and other Clinical site staff must allow the Candidate to read the documents and ask questions. Input from family members and other care providers, if present and appropriate, must be encouraged.
Us4Cure operates under 45 CFR section 164.514 and 45 CFR 160.103, among other Data Protection Laws.