Ethics

Our company’s senior management has the primary responsibility to ensure compliance of all employees with applicable ethical rules, law, and regulations including:

  • CFR Title 45. Public Welfare;
  • The Health Insurance Portability and Accountability Act of 1996 (HIPAA);
  • IATA / DOT Regulations;

Institutional Review Board/Independent Ethics Committee (IRB/IEC) approval.

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

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 BioCell Analytics training.

Before 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.