(This policy was last updated on February 16, 2012)
Spaulding Clinical is committed to respecting the privacy of individuals. Spaulding Clinical has established internal procedures to repeatedly review and monitor the use of Personal Information and to ensure it is used responsibly and that we comply with internationally recognized standards of privacy protection.
By Personal Information, we mean information that either identifies or is capable of identifying an individual, including our clients, volunteers or patients in clinical studies (research subjects), employees, vendors and clinical investigators with whom we work. Personal Information may include, but is not limited to:
- First and last name
- Date of birth
- Social security or Federal EIN number
- Company information
- Home or other physical address
- Email address
- Phone number or other contact information
- Medical information
If you become a volunteer, we will (with your consent) collect Personal Information in relation to your medical history. We will retain and/or dispose of or transfer this Personal Information in accordance with both the pertinent protocol for the clinical study for which it was collected and applicable law. During a clinical study, we will also collect and disclose certain Personal Information (such as blood test results). This data will be maintained in a unique format from which the individual cannot be recognized.
Means of Collecting & Processing Data
The United States Food and Drug Administration requires that potential volunteers of a clinical study be given complete information about the study. This process is known as “informed consent” and is given to the potential volunteer in writing prior the commencement of the study. This informed consent will include information and permissions related to Personal Information protection, as well as details regarding access to your medical records by appropriate authorized personnel.
When Personal Information is collected from individuals, they will be informed of the purpose for which the Personal Information is collected and how the Personal Information will be used. The third parties, to whom any Personal Information may be disclosed, will be disclosed to the individual. Notice will be provided in clear and conspicuous language when individuals are first asked toprovide Personal Information.
We may automatically collect certain data and receive Personal Information about you where you provide such Personal Information through our website or other communications and interactions with Spaulding Clinical. We may also receive Personal Information from service providers that refer you to the Spaulding Clinical site, and from customer/volunteer lists lawfully acquired from third-party vendors. This Personal Information may be disclosed only to our staff and to third parties involved in any clinical studies.
We do NOT collect Personal Information about you without your knowledge. All data collected will only be collected with your expressed consent.
Information Use & Data Integrity
Spaulding Clinical will use Personal Information in ways that are compatible with the purpose for which the data was collected. Spaulding Clinical will take reasonable steps to ensure that Personal Information is relevant to its intended use, accurate, complete and current.
Sometimes, we may need to share your Personal Information with other third parties. This may happen, for example, where it is necessary for the purposes of our own legitimate interests or for those of a third party. Spaulding Clinical may make the data we hold available to the following:
- Sponsor of the clinical study
- Regulatory agencies (as required by law)
- Health authorities (as required by law)
- Spaulding Clinical affiliate companies (which may be involved in the clinical study)
Except where local laws entitle the Sponsor of the study or Regulatory authorities to view patient records, all data is released in the coded form that will not identify volunteers.
Keeping Information Up to Date
Access & Correction
Spaulding Clinical will take reasonable steps to permit individuals to correct, amend, or delete Personal Information that is demonstrated to be inaccurate or incomplete.
You may contact us (see our site (www.spauldingclinical.com) for contact information) if you:
- Want to confirm the accuracy of the Personal Information we have collected about you
- Would like to update your Personal Information or delete your Personal Information
- Have any complaint regarding our use of your Personal Information
If requested, we will change any Personal Information that you have provided to us or mark any Personal Information to prohibit future use, provided that you provide evidence as we may reasonably require for such changes and sufficient Personal Information to enable us to locate your Personal Information.
If you choose to withdraw your consent for either your participation in the study or for your Personal Information to be processed, no further data that includes any of your Personal Information will be collected or processed by the Research Institution or Spaulding Clinical. However, Personal Information collected to date may continue to be processed in order to protect the integrity of the study and your safety.
Spaulding Clinical maintains a high level of security, especially in relation to data. At Spaulding Clinical, our computer equipment, networks, programs, data and documentation are maintained to a high standard. Precautions are in place to protect Personal Information from loss, misuse, unauthorized access, disclosure, alteration, and/or destruction.
Spaulding Clinical maintains the following measures of security in protecting data:
- Employees adhere to the Network Utilization Policy
- This makes employees aware of their responsibilities in protecting Spaulding Clinical data integrity
- This disallows employees from sharing information pertaining to research activities outside of Spaulding Clinical
- All Spaulding Clinical employees must be aware of and keep up to date with industry “best practices” on network security standards
- A structured process for controlling physical access to individual computers
- A managed approach to network access
- A regimented approach to maintaining network security (encryption)
- Regular testing to ensure integrity and security of network
- Utilization of potential threat and risk analysis
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Spaulding Clinical has provided its employees with appropriate training to ensure that all individuals who process Personal Information are fully aware of the responsibility with respect to data protection.
At Spaulding Clinical, all employees who deal with research data and other Personal Information of volunteers will be required to comply with Spaulding Clinical’s policies and procedures. Breaches of security are properly investigated and remedied. If an employee knowingly or recklessly discloses Personal Information of volunteers outside Spaulding Clinical’s policies and procedures, he or she will be subjected to disciplinary action and may also be held criminally liable.
Internet Privacy / Links to Third Party Websites