Compliance and Ethics

The Enterprise Compliance Office (ECO) oversees Quintiles’ compliance practices and helps foster a culture of compliance and ethics throughout Quintiles. It is lead by our Chief Compliance Officer.

Compliance with company standards and legal requirements is critical for our success. Compliance and ethics helps safeguard patient safety and our reputation for integrity. Maintaining our compliance and ethical standards is essential to our ability to earn and retain the trust of our stakeholders and ensuring our continued growth.

Below is information about some of the ECO resources which support our Compliance and Ethics program.

Doing the Right Thing is Quintiles’ worldwide code of conduct. It describes company expectations of acceptable behavior in a variety of areas, including healthcare regulations, conflicts of interest and data privacy protection. It also informs employees about additional resources for guidance. View or download our code of conduct: Doing the Right Thing. This document is available in twelve (12) languages. If you would like a copy, contact us.

The Quintiles Business Ethics Office is available to answer questions or offer guidance regarding the standards outlined in Doing the Right Thing.

The Quintiles Business Ethics HelpLine is available for employees to call to ask questions, seek guidance or raise concerns about Quintiles’ standards for ethical business conduct. Employees are encouraged to speak with their manager or another local resource, such as their human resources representative about such matters. However, there may be times when an employee is not comfortable approaching his or her manager or others to discuss sensitive matters. For those situations, Quintiles has established the Business Ethics HelpLine as a confidential communication alternative.

Corporate Councils

Quintiles has also established councils, e.g., the Council on Research Ethics (CORE) and the Council on Data Protection (CODP), to further support our commitment to ethics and compliance:

Research Ethics

The Council on Research Ethics (CORE) was established to monitor implementation of Quintiles’ Corporate Policy No. 003, “Ethics, Compliance and Quality,” and standard practices and procedures designed to oversee ethical issues in the conduct of research.

CORE Sources of Guidance

CORE Charter
Association of Contract Research Organizations (ACRO) Code of Ethics
PhRMA Principles
HIPAA Reviews Preparatory to Research

Information on research ethics committees is available here.

Ethics and Clinical Trials

Belmont Report
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
International Conference on Harmonisation – Good Clinical Practice Consolidated Guidance
The Nuremberg Code
The Common Rule
European Medicines Agency
EU Clinical Trials Directive

The International Compilation of Human Subject Protections is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Many of the listings embed hyperlinks to the source document. These laws, regulations, and guidelines are classified into six categories: General, Drugs and Devices, Privacy/Data Protection, Human Biological Materials, Genetic Issues, Embryos, Stem Cells, and Cloning. See http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html

Data Protection

Quintiles Global Council on Data Protection (CODP), chaired by Quintiles global Chief Privacy Officer, was established to monitor implementation of Quintiles’ Corporate Policy No. 011, “Protection of Individually Identifiable Information” and standard practices and procedures designed to oversee our global data protection program.

The CODP seeks to clarify the ever-evolving privacy laws and regulations, taking into consideration the varied activities and regions within which Quintiles works. The CODP membership includes worldwide representatives from the varied functions and lines of business as well as consultants and independent participants.

HIPAA Privacy Regulation

The Final Privacy Regulation was issued December 28, 2000 with the final Amendment on August 14, 2002 and a compliance date of April 14, 2003 and with amendments set forth in the HITECH Act.

NIH Guidance on the HIPAA Privacy Rule

Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
IRB Review Not Required for HIPAA Stand-Alone Authorizations for Research

HIPAA Document regarding Investigator Sites, HIPAA Authorizations: FDA

US-European Data Protection

Quintiles as a Harborite, Certification to the US-EU Safe Harbor effective January 5, 2005 with annual recertification.

NOTES. 1) Data Transfer Agreements are still required for transferring personal data out of Europe to Quintiles sites outside the U.S. 2) Our vendor agreements have been revised for compliance with the Safe Harbor “ongoing transfer” requirements.

This website gives information on data protection rules from around the world. Click here to view the website. For interpretation of these laws, contact Council on Data Protection.