Notice of Patient Privacy Practices

Your Personal Health Information
A federal government rule has been issued to protect the privacy rights of patients. This rule was issued under a law called the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This rule is designed to protect the confidentiality of your personal health information. Your personal health information is information about you that could be used to find out who you are. For a research study, this includes information in your existing medical records needed for the study and new information created or collected during the study.

This Privacy Practices Notice explains how your personal health information will be used and who it will be given to for a specific research study. It also describes your privacy rights, including your right to see your personal health information.

Using Your Personal Health Information
If you agree to participate in the research study, your personal health information will be used and disclosed in the following ways:

¨        A study doctor and staff will use your medical records and information created or collected during the study to conduct the study.

¨        The study doctor and staff will send your study-related health information (“study data”) to the sponsor of the study and its representatives (“sponsor”). Because the sponsor conducts business related to clinical research in many countries around the world, this may involve sending your study data outside of the United States. Other countries may have privacy laws that do not provide the same protections as the laws in this country. However, the sponsor will respect the terms of this Privacy Practices Notice in all countries.

¨        The study data sent by the study doctor to the sponsor does not include your name, address, social security number, or other information that directly identifies you. Instead, the study doctor assigns a code number to the study data and may use your initials. Some study data sent to the sponsor may contain information that could be used (perhaps in combination with other information) to identify you (eg. Date of birth). If you have questions about the specific health information that will be sent to the sponsor, you should ask the study coordinator.

¨        The sponsor will use the study data for research purposes to support the scientific objectives described in the consent document and the process of getting regulatory approvals for its drugs.

¨        The sponsor may add your study data to date from other studies in research databases so that it can study better measures of safety and effectiveness, study other therapies for patients, develop a better understanding of diseases, or improve the design of future clinical trials.

¨        Your study data, either alone or combined with data from other studies, may be shared with regulatory authorities in the United States and other countries, doctors at other institutions participating in the study, and the ethical review board overseeing this study.

¨        Study data that does not directly identify you may be published in medical journals or shared with others as part of scientific discussions.

¨        Your original medical records, which may contain information that directly identifies you, may be reviewed by the sponsor, the ethical review board overseeing this study, and regulatory authorities in the United States and other countries. The purpose of these revisions is to assure the quality of the study conduct and the study data, or for other uses authorized by law.

¨        The sponsor works with business partners in drug development. The sponsor may share your study data with these business partners, but only if the business partners need the information as part of this work with the sponsor, and only if the business partners sign a contract that requires it to protect your study data in the same way as the sponsor.

¨        The sponsor will not disclose personal health information to insurance companies unless required to do so by law, or unless you provide separate written consent to do so.

¨        We may also use your health information when we call you for appointments or to advise you about future research study opportunities.

¨        Your medical records and study data may be held and processed on computers.

Using Your Personal Health Information Without Your Consent

We are legally required to use or disclose identifiable health information about you without your consent to meet special reporting requirements, to facilitate continuity of care, or for public health and other purposes.  For example, we provide:

¨        Reports to the Food and Drug Administration

¨        Data for health oversight activities such as auditing or licensure

¨        Reports on communicable diseases

¨        Reports to employers for work-related illnesses or injuries such as in Workers’ Compensation

¨        Reports on abuse, neglect or domestic violence

¨        Reports to avert a serious threat to health or safety or to prevent serious harm to an individual

¨        Communication with designated family members or other individuals who you select as your personal representative about your care.

We must provide information when required by law, such as for law enforcement or judicial activities in specific circumstances. 

Special AuthorizationCertain federal and state laws that provide special protections for certain kinds of personal health information call for specific authorizations from you to use or disclose information.  When your personal health information falls under these special protections, we will contact you to secure the required authorizations to comply with federal and state laws such as:



¨        Uniform Health Care Information Act (RCW 70.02)

¨        Sexually Transmitted Diseases (RCW 70.24.105)

¨        Drug and Alcohol Abuse Treatment Records (RCW 70.96A.150)

¨        Mental Health Services for Minors (RCW 71.05.390-690)

¨        Communicable and Certain Other Diseases Confidentiality (WAC 246-100-016)

¨        Confidentiality of Alcohol and Drug Abuse Patients (42 CFR Part 2)

If we need your health information for any other reason that has not been described in this notice, we will ask you for your written authorization before using or disclosing any identifiable health information about you.  Most important, if you choose to sign an authorization to disclose information, you can revoke that authorization at a later time to stop any future use and disclosure.

Your Individual Rights

You have individual rights over the use and disclosure of your personal health information. 

Limit use: You may request in writing that we not use or disclose your information for treatment, payments, and administrative purposes except when specifically authorized by you, when required by law, or in emergency circumstances.  We will consider your request but are not legally required to accept it.  You will have the opportunity to do this when you sign the Consent for Use and Disclosure of Personal Health Information.

Receive confidential communications:  We may call you to confirm an appointment, and leave a message on your voice mail or with another person. You have the right to receive confidential communication by alternative means or locations.  This includes an alternative mailing address or an email address.  If this is necessary, please let us know.

Inspect and copy:  You have the right to look at your health information and review your record of healthcare. Please submit your request to view your record to us in writing.  You may request a copy of your health information.  Standard copy fees will be assessed.

Request amendments: If you believe that information in your record is incorrect or if important information is missing, you have the right to request in writing that the existing information be amended.

Know about disclosures: You have the right to receive a list of instances where we have disclosed information for reasons other than treatment, payment or health care operations.

Receipt of this notice: You have the right to receive this notice either on paper or electronically.  Please let us know if you would like a copy of this notice in another format.

Complaints: If you are concerned that we have violated your privacy, or you disagree with a decision we made about access to your records, you may discuss this with your study coordinator or the Privacy Compliance Officer either in person or by calling our office at 425-251-1720. 

If you are not satisfied with the protection your personal health information, you may contact the Secretary of Health and Human Services if you feel your privacy rights have been violated. Rainier Clinical Research Center will not retaliate against a patient for filing a complaint.

When New Uses Are Required
Our Legal Duty: We are required by law to protect the privacy of your information, provide this notice about our information practices, and to follow the information practices that are described in this notice.

Rainier Clinical Research Center reserves the right to change the terms of this notice and to make the new notice provisions effective for all the personal health information that it maintains.  We may change our policies at any time but with any significant policy change the new notice will be changed, posted, and distributed to our patients.  Also, this notice will be promptly revised and distributed whenever there is a material change to the uses or disclosures, your rights, our legal duties or other privacy practices changes.  Any such changes will become effective on the date the revised notice is issued.  You may request a copy of this notice from Rainier Clinical Research Center at any time.

This notice is effective as of: April 14, 2003