Medical research frequently requires the storage, collection, storing, sharing and analysis of sensitive information about the health characteristics of individuals. Hereditary Cancer Institute (HCI) participants are assured that security measures are in place to keep their identifying data private and protected from unauthorized use. All clinical and research data and specimens will be held in confidence. HCI staff are constantly mindful of the sensitive information with which they work and are committed to safeguarding the confidentiality of family and individual information.
- The family study process routinely involves sharing information about biological relationships of family members and medical history of family members, among members of the family. For example, one person may be asked to confirm, or provide further detail, about the cancer diagnosis of a deceased family member reported by a third family member. Participants are cautioned about this possibility and may choose not to participate because of it. They may also limit sharing of specific pieces of information. We do honor such requests.
- We will not disclose genetic test results to any family members, or to the physicians of any family members, except at the request of the tested individual (or if deceased, the next of kin). A written release is required in all such cases (unless the tested individual is present for the disclosure and provides verbal consent).
- Information about individual family members will be provided to collaborators only after removal of all personal identifiers (i.e., names and all other publicly known identifiers). Release of personally identifiable information to a collaborator is rare, and only done when strictly necessary to the completion of the project. In all cases, collaborators must agree to hold all information we provide them in confidence.
- No personally identifiable information will be provided to other centers for uses outside those specified in the informed consent for the project. Data may be shared with other research centers for other purposes after it has been stripped of all linkable information (e.g., ID numbers which could be linked to personal identifying information in our database).
- Published data is usually in the aggregate form with no individual findings. When individual findings are published (for example as a case history, a pedigree drawing or tabulated individual results), all personal identifiers will be removed and other information may be encrypted to prevent identification of individuals themselves or by any other reader of the publication.
- No other data or specimen releases are authorized.
- Unauthorized release of information and specimens is prevented by storage of data in file cabinets and computers within the locked premises of the Department of Preventive Medicine and storage of specimens in locked and secure laboratories and offices of the department.
Electronic record security is protected via authentication of users by password, user access restricted based on need to know, a locked server room, audit trails that logs when the database has been accessed and by whom, and regular system assessments to insure the integrity of the database. No database activities are performed on home computers. - The confidentiality of electronic records is maintained through identification codes to separate participant identifiers from research data. Paper records have a form stamped CONFIDENTIAL to cover all genetic test result documents and shredding is required for document disposal after use.
- Certificates of Confidentiality are available for federally funded projects, which are of a sensitive nature, where protection is judged necessary to achieve the research objectives. All applicable HCI projects have obtained a Certificate of Confidentiality which protects the researchers from being compelled to reveal participants identities in the research study in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings.
