Advanced Colorectal Cancer of Serrated Subtype (ACCESS) Study

A: To preserve confidentiality, all participant data and biospecimens are assigned a unique ID number. Identifying information will be kept separate from the data and samples in locked and/or password-protected files at Fred Hutch. Only ACCESS Study staff have access to these files. Every staff member has taken a confidentiality pledge and Fred Hutch has several physical, technological, and administrative safeguards in place to protect the information.

A federal law called the Genetic Information Nondiscrimination Act (GINA) restricts access to genetic information. GINA won't allow health insurance companies or group health plans to ask for genetic information provided in research studies or use genetic information when making decisions regarding eligibility or premiums.

In addition, information shared with the study is covered by a Certificate of Confidentiality issued by the National Cancer Institute.

• The Certificate protects from involuntary release of information collected during the course of this study
• The researchers and staff involved in this project cannot be forced to disclose the identity or any information about participants collected in this study in any legal proceedings at the Federal, State, or local level, regardless of whether they are civil, administrative, legislative or criminal proceedings

The Certificate does not prevent the review of research records under some circumstances. For example, the National Institutes of Health, the National Cancer Institute, the Office of Human Research Protections and the Fred Hutch Institutional Review Board may need to look at the information to make sure participant rights are protected.

A: The ACCESS Study uses participant information to advance knowledge of colorectal cancer — what causes it and how best to treat and prevent it. Interview data, medical records and pathology reports related to cancer diagnoses and treatment will be analyzed at Fred Hutch. The goal of these analyses is to observe patterns of behaviors, medical information, and treatment options. Some of the tests on saliva and tissue will include analyses of DNA. DNA comes from cells in the body and contains genetic information specific to an individual.

All information will be stored in a data repository. This information may be shared with investigators with other IRB-approved projects. Before any information is shared with collaborators or placed in a repository, all identifiers are removed. Some of these repositories are controlled-access internet repositories maintained by the National Institutes of Health.

If we want to use data or biospecimens for a research purpose not described in the consent forms, we will send our request to the Fred Hutch Institutional Review Board (IRB). The IRB protects the rights and welfare of participants and they will determine if we need to re-contact participants and ask for consent before proceeding with the additional research.

A: We may contact participants in the future to ask about other research studies. They can decide whether to participate at that time.

We plan to conduct genetic and other testing on the saliva and tissue samples donated by participants. While unlikely, it is possible the test results could be important for healthcare decisions. We may contact participants if the study finds genetic information useful to them and their family. Because we are working within the constraints of resources intended for research results, we may not test everyone’s sample. If we do notify participants, it will simply be an opportunity to talk about the option of discussing the genetic information with a genetic counselor. They may decide at that time whether or not they want to pursue this option.

We may also link information to other public databases (for example, Medicare) to update our records. We will always obtain IRB approval before performing any of these links.

For additional questions about blood or saliva sample donation, consent forms or confidentiality, please contact us directly.