2. Patients may, in addition to the automatic testing now done for diagnosis, ask for genomic tests that reveal if inherited mutations (BRACA1,2) are present. Or they may request biomarker or genomic tests (such as Oncotype DX) that may provide more detailed information about their cancer. This information will be in each patient's medical records and linked to them.
Research
- As part of their cancer surgery, patients may be asked to donate additional
tissue for biomarker research. Sometimes this “ask’ is buried in the surgery
consent document and not specifically discussed. So be sure to either read the
document or ask if your tissue will be used in cancer research. This data may or
may not go in a patient’s, medical record so it may or may not be linked to
them – patients must ask.
- Patients may be asked and agree to participate in a clinical trial to test new
therapeutics’. Usually tissue donations that will be used to look for biomarkers
will be part of the clinical trial. This data may or may not go in a patient’s
medical records so it may or may not be linked to them – patients must ask.
Patients who are considering participating in genetic research should fully
understand the purpose of such research and the expected outcomes. This
information should be provided during the informed consent process.
A “Patient Friendly” Informed Consent
Personalized medicine depends on tissue (biospecimen) research to identify new
biomarkers. Patients may be asked to consider participating in a clinical trial and
to donate tissue for the purposes of the study. Or they may be asked to donate
tissue as part of providing their consent for surgery. In the latter scenario, it is
important to note that the consent for tissue donation may be buried in the
surgery consent form. Patients may also ask their doctors directly whether they
can donate tissue.
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Many agree that the consent process is generally not “user friendly” for patients. Informed consent
documents often include lengthy and complex
terminology written in scientific, medical, and legal
language.
People are often unfamiliar with and may be easily
intimidated by such terminology. |
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Image provided by CISN archives.
All rights reserved. |
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The consent process may therefore be overwhelming and confusing for some
patients, particularly following a cancer diagnosis when emotions may run high,
thoughts may be scattered, and a person’s ability to think logically may be clouded
by the need to make many challenging and life-altering decisions.
What Patients Need to Understand
If patients consent to donate their tissue, they should have a full understanding of
how their genetic biospecimen and data will be used, including:
- What research will be conducted for the present study and in future studies
- What benefits may result from the research
- How the information will be used and what information may be revealed
about participants who donated their tissue for this research
- Which entity owns the donated tissue
It’s crucial for patients to ensure that they receive a clear, thorough explanation
during the consent process and that they ask the questions listed above.
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Doing so will help to achieve truly “informed
consent” and to prevent inappropriate use of genetic
specimens and related data. |
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Image provided by CISN archives.
All rights reserved. |
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For more detailed information on the topic of tissue donation, please go to
our section on tissue donation.
“Content Developed September 1, 2012” |
