Ethics and Compliance
At hVIVO we place volunteers and patients at the heart of our business. We safeguard patients in clinical research. We make biomedical insights from sponsored clinical studies available as quickly as possible. And we ensure the quality and accuracy of data and information we generate and collate. We apply the highest standards for ethical research—in all hVIVO trials.
Study participants must be fully informed of the possible risks and must be free to choose whether or not to participate in a study.
Risk vs. Benefit
Before an experimental therapy or investigational medicinal product (IMP) can be tested in volunteers, it must be rigorously studied and shown to be safe enough for use in humans, and it must have sufficient medical benefit to justify expected risks in testing.
Study participants must be carefully monitored by physician Investigators. All adverse effects must be reported and use of the drug must be halted if it poses unacceptable risk.
Data Privacy Protection
We comply with the EU Data Protection Directive.
hVIVO and FluCamp take security of personal data very seriously. You may have seen articles in the press that data stored in the US is no longer secure. An EU Court ruling on 6 Oct 2015 stated that the Safe Harbour agreement was invalid and did not protect EU citizen’s personal data. hVIVO and FluCamp have taken steps to ensure that all volunteer, client and staff information held is not impacted. hVIVO can confirm that all personal data is secure. For any queries regarding this matter, please contact Sarah Howard, Head of Regulatory and Quality Governance at firstname.lastname@example.org
hVIVO working ethically day to day
Our Head of Regulatory and Quality Governance (Sarah Howard) oversees our overall quality and compliance approach and reports directly to the hVIVO CEO. This function fosters a culture of compliance and ethics throughout the company, and develops and implements the hVIVO compliance programme which assesses compliance risks, sets standards and policies, and monitors, audits and investigates compliance related issues.
Our Senior Medical Director & Responsible Officer (Dr Martin Johnson) has delegated authority from NHS England (and ultimately the General Medical Council) to ensure the systematic assessment of doctors operating at hVIVO, and to validate that they are safe and competent to operate on a continuing basis in their medical capacity.
hVIVO operates a single Quality Management System to ensure compliance with GCP regulations and guidelines –including the UK Statutory Instruments, European Directives, ICH and many more..