Questions and Concerns

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. 

1. 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.
2. 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). 
3. 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.
4. 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).
5. 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.
6. No other data or specimen releases are authorized.
7. 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.
8. 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. 
9. 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.

Fear of genetic discrimination is one of the most common reasons high-risk individuals decline genetic testing. However, the evidence remains unclear as to whether genetic discrimination actually occurs. Yet this perception is enough for some individuals to forgo genetic testing and the health benefits associated with knowing one’s genetic status such as tailored preventive care.

Some of the concerns associated with genetic discrimination include the fear of being unable to obtain or losing insurance coverage, and the fear of losing a job. To help protect against the potential for insurance and employment discrimination many states have enacted genetic nondiscrimination laws. However, these laws differ from state to state, vary in comprehensiveness, and may not apply to all types of insurance plans. As of last year, 44 states addressed discrimination based on genetic information for health insurance and 17 of these states extended their prohibitions to include life, disability, and/or long-term care insurance. Also, 28 states enacted laws against use of genetic information in the workplace, and 24 states enacted genetic privacy laws.

The following sites contain listings of enacted genetic nondiscrimination laws at the state level:

National Human Genome Research Institute

Enacted insurance legislation
Enacted employment legislation
National Conference of State Legislatures

Genetic Technologies Project (if the link takes you to the NCSL homepage, click on Public User to continue)

A federal law that directly addresses the issue of insurance discrimination is the Health Insurance Portability and Accountability Act (HIPAA). However, it only applies to employer-based and commercially issued health insurance plans, and does not apply to private health insurance plans.

HIPAA prohibits group health plans from using any health status-related factor, including genetic information as a basis for

• denying coverage
• limiting eligibility for coverage, or
• charging an individual or their family members higher premiums for coverage.

HIPAA also states that genetic information in the absence of a current diagnosis of illness shall not be considered a preexisting condition.

More information on HIPAA can be found on the Health Care Financing Administration website.

A family study is performed to discover and assess the family history of cancer and related conditions. The aim of the family study is to identify the hereditary cancer syndrome, if any, to identify family members at elevated risk for cancer, to develop recommendations for cancer control for family members, and to gather information about the occurrence of cancer in families for the improvement of medical knowledge. During the family study process, individuals who have been affected with cancer and their first-, second- and third-degree relatives may be asked to participate.

There are no restrictions to participation in the study based on gender, race, or ethnic origin. All family members 18 years of age or older may participate. If an individual affected with cancer is deceased we may ask a spouse or close relative for information about that person; if under age 18, we ask a parent for information.

The family study begins with the identification of an individual who is concerned about their cancer history or cancer risk. This person is called the proband. He or she is mailed an initial questionnaire which asks for names, vital status, date of birth and death, gender, and history of malignancy (all types) for themselves and all first-, second-, and third-degree relatives, as well as contact information for living adult relatives. These data are used to create an initial pedigree which will be modified as additional information is gathered. We ask the proband to sign informed consent forms allowing CU staff to contact other family members. We ask the proband to sign release forms to which allow us to retrieve medical records, pathology reports, and diagnostic specimens. This information is needed to verify and specify diagnoses. When this permission has been granted, a similar questionnaire will be mailed to other family members to expand the pedigree and to obtain signed release forms needed to retrieve medical records on other affected family members.

As the family study progresses, clinicians and research associates meet to discuss the pedigree, classify it, and plan further action. At these meetings, syndrome diagnoses are made and cancer control recommendations are decided upon.

Participating in a family study is not without risk. The main risk is the disclosure of confidential personal or family data. To minimize this risk, all data collected from individuals is held in confidence by the Department of Preventive Medicine. Procedures which we have developed in our many years of performing family studies, to protect this confidentiality, will be applied in this study. Our procedures are monitored by the Creighton University Institutional Review Board.