Privacy Policy

Safe Harbor Privacy Policy

This policy was last updated on October 31, 2014.

Compliance with data privacy laws is an essential business practice for Pacific Biomarkers. Pacific Biomarkers has put in place internal procedures to ensure that all clinical trial participant information is processed responsibly and in accordance with applicable data protection/privacy laws. This privacy policy sets out the privacy principles that Pacific Biomarkers follows with respect to transfers of personal data from the European Economic Area (EEA) and Switzerland to the United States.

Safe Harbor

Pacific Biomarkers complies with the US-EU Safe Harbor Framework and the US-Swiss Safe Harbor Framework as set forth by the US Department of Commerce regarding the collection, use and retention of personal information from European Union member countries and Switzerland. Pacific Biomarkers has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access and enforcement. To learn more about the Safe Harbor Program and to view Pacific Biomarkers certifications, please visit http://www.export.gov/safeharbor

Scope

This Policy applies to all personal information, either in electronic or paper format, received by Pacific Biomarkers in the United States from the EEA and Switzerland.

Definitions

For the purposes of the Policy, the following definitions shall apply:

  • “Agent” means any third party processing personal information on behalf of, and under the instructions of Pacific Biomarkers.
  • “Pacific Biomarkers” means Pacific Biomarkers laboratory (Emerald Star Holdings, LLC dba Pacific Biomarkers) which is located at one site in the United States.
  • “Personal information” means any information or set of information that identifies or could be used to identify an individual. It does not include personal information that has been anonymized, encoded or that is publicly available, unless otherwise combined with non-public personal information.
  • “Sensitive personal information” means personal information that reveals race, ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, or information that concerns health or sex life. In addition any information received from a third party, where that third party treats and identifies the information as sensitive will be treated as such.

Privacy Principles

The privacy principles contained in this Policy are based on the Safe Harbor Principles.

Notice:

Notice to clinical trial/research participants regarding the use of personal information is provided by the sponsor and/or principal investigator as part of the informed consent process. Where Pacific Biomarkers receives participant information from its clinical trial sponsors, investigators, or other sponsor contracted laboratories in the EEA and Switzerland, it will use such information as instructed by the party providing the information to Pacific Biomarkers, and in reliance on that party’s provision of the applicable notice.

Choice:

By nature of Pacific Biomarkers’ role in clinical trials, and as per regulatory, statistical, and contractual requirements, Pacific Biomarkers does not directly communicate with trial participants. Pacific Biomarkers complies with the choices the individual made regarding disclosure and use of personal information, including sensitive personal information, as per the clinical trial protocol and informed consent signed by clinical research participants.

Data Integrity:

Pacific Biomarkers will use personal information only in ways that are compatible with the purposes for which it was collected or subsequently authorized by the individual, as such information is communicated to Pacific Biomarkers by the party providing the information to Pacific Biomarkers. Pacific Biomarkers will employ reasonable steps to ensure that personal information is relevant to its intended use, accurate, complete, and up-to date.

Transfers to Agents:

Should Pacific Biomarkers transfer data to a third party that is acting as an agent, it will ascertain that this third party safeguards personally identifiable data consistent with this policy and the requirements of the US-EU Safe Harbor Framework and the US-Swiss Safe Harbor Framework. Where Pacific Biomarkers has knowledge that an agent is using or disclosing personally identifiable data contrary to this policy, Pacific Biomarkers will take reasonable steps to prevent or stop the use or disclosure.

Access and Correction:

Upon request, individuals will be provided with personally identifiable data in which Pacific Biomarkers holds about them through the applicable sponsor or laboratory. Pacific Biomarkers will also take reasonable steps to provide the means to correct, amend, or delete information found to be inaccurate or incomplete. Due to regulatory, statistical, and contractual requirements, we are not able to provide direct access to research data to participants or clinical investigators

Security:

Pacific Biomarkers will employ reasonable precautions to protect personal information in its possession from loss, misuse, unauthorized access, alteration and destruction. Electronic records are received, stored and transmitted from its internal secure network that is protected from malware and monitored for unauthorized use. All records, both electronic and paper based, are maintained in access controlled facilities.

Enforcement:

Pacific Biomarkers will conduct internal compliance audits of its relevant privacy practices to verify adherence to this Policy. Pacific Biomarkers provides its employees with training regarding the handling and protection of personal information. Any employee in violation of applicable privacy policies/procedures will be subject to disciplinary action.

Dispute Resolution:

Any questions or concerns regarding Pacific Biomarkers’ use or disclosure of personally identifiable data under this policy should be directed its Corporate Contact. We will investigate and attempt to resolve complaints and disputes in accordance with the principles contained in this policy. If we are unable to mutually resolve such a complaint, we agree to submit the complaint to binding arbitration, with arbitrators selected in accordance with, and in accordance with, the rules of the American Arbitration Association.

Contact Information

Questions or comments related to this policy should be submitted to:

Quality Assurance Manager
Pacific Biomarkers
645 Elliott Ave W, Suite 300
Seattle, WA 98119

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