Patients are at the center of our three-fold promise: safeguarding patients in clinical research; making biomedical insights available as quickly as possible; and ensuring the quality of data and information we help develop.
“First do no harm.”
From the fifth century Hippocratic Oath to the 20th century Declaration of Helsinki, medical professionals have formulated codes of ethical practice aimed at protecting patients from harm and injustice. The foundational documents of ethical research include:
Guarding Patient Safety and Rights
We apply the highest standards for ethical research—in all trials, conducted everywhere in the world—according to evolving international codes of good practice, including:
These regulatory standards ensure the key provisions of ethical clinical research:
Informed Consent. 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 can be tested in patients, 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.
Safety Monitoring. 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 international laws that protect the privacy of patient medical data, including the U.S. HIPAA Privacy and Security rules, and the EU Data Protection Directive.
Clinical research organizations play an increasing role as more clinical trials are conducted in emerging nations. Quintiles meets this challenge with expanding expertise and technology:
Living Our Principles
The Ethics and Compliance Office (ECO) oversees Quintiles’ compliance program and fosters a culture of compliance and ethics throughout the company. The ECO develops and implements Quintiles’ global Ethics and Compliance Program which assesses compliance risks, sets standards and policies, and monitors, audits and investigates compliance related issues.
The Chief Compliance Officer (CCO) leads the Ethics and Compliance Office. Quintiles’ CCO is positioned high in the organization, reporting to the Chief Customer & Governance Officer, who reports to the CEO. The CCO sits on the Quintiles Executive Committee.
The Chief Medical and Scientific Officer has special oversight of medical ethics and provides leadership in the ethical conduct of clinical studies, serves as chair of Quintiles’ Early Safety Committee and as vice-chair of Quintiles’ Council on Research Ethics.
The Council on Research Ethics (CORE) monitors evolving global laws and regulations that affect all phases of research in all regions where Quintiles operates. CORE fosters ethical conduct of clinical trials, and oversees and implements practices related to ethical considerations in research, including:
The Early Clinical Development Safety Committee focuses on the protection of research subjects in early phase studies; it governs and oversees the review, implementation and monitoring of early phase trials that may be conducted in any of Quintiles Phase I units.
The Council on Data Protection establishes, disseminates, and monitors Quintiles’ data privacy and security policies and standards globally. The Privacy Incident Response Team, which is responsible to the council, develops and implements investigations and responses to privacy complaints and incidents.
 International Privacy Laws
Quintiles intends that its corporate privacy and confidentiality policies and standard practices and procedures meet or exceed the requirements of all applicable local and international privacy laws and regulations and customer contract provisions.
Though Quintiles is not a covered entity under HIPAA, the U.S. law that sets privacy and security standards for Protected Health Information, the company has put into place robust technical, organizational and security measures that, in fact, meet or exceed the HIPAA standards.
EU Data Protection Directive
With respect to “adequacy” for the transfer of personal data from the EU to Quintiles sites in countries other than the U.S., Quintiles has executed EU “Model Contracts”, that is, Data Transfer Agreements (DTAs). See more at: http://www.quintiles.com/privacy/global-data-protection