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
hVIVO and FluCamp take security of personal data very seriously. We comply with the EU General Data Protection Regulation 2016, the UK Data Protection Act 2018 and the Privacy and Electronic Communications Regulations 2003 and the guidance and codes of practice issued by the Information Commissioner’s Office (‘ICO’).
Please see our Privacy Notice for further information about how we process and use your data. Any queries can be directed to email@example.com.
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 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..