Ethics

Business Ethics

Quintiles Values and Purpose statements reflect our fundamental beliefs about who we are as an organization and what we do. In a large global organization that operates in an evolving marketplace, our Values and Purpose statements provide constant guiding principles.

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.

The Quintiles Business Ethics Office staff 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.

Council on Research Ethics

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

OHRP Announces International Compilation of Human Subject Research Protections

Recognizing the continued growth of international research, the Office for Human Research Protections has developed an International Compilation of Human Subject Research Protections. The Compilation lists the laws, regulations and guidelines of more than 50 countries where DHHS funded or supported research is conducted. The Compilation provides direct web links to each country’s Key Organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers and others to meet regulatory requirements to assure that research studies comply with applicable law.

The Compilation can be accessed on the OHRP website.

Council on Data Protection

Charter

Quintiles Council on Data Protection (CODP) is a central organization that establishes, disseminates and monitors implementation of Quintiles' data security, privacy policies and standards designed to protect individually identifiable information. The CODP seeks to clarify the ever-evolving privacy laws and regulations, taking into consideration the varied activities and regions within which Quintiles works.

Membership The CODP membership includes worldwide representatives from Quintiles Transnational headquarters 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.

Quintiles’ Letter to Secretary Thompson, US Department of Health and Human Services – Quintiles’ Council on Data Protection has been carefully following the debate on privacy and data protection and recently sent a letter to Secretary Thompson of the US Dept. of Health and Human Services. Read the letter.

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. Quintiles Certification to the US-EU Safe Harbor:

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.