Genetic information is biologically linked to individual identity, making personalized medicine an intimate and serious process. Although the promise of improved outcomes is real, there will be much more information about each person’s genomic makeup in their medical records.

1. As part of every cancer patient’s diagnosis, genomic testing is already being done on their cancer tissue and documented in their pathology report.

Many more of these tests will become routine as the field progresses. Individuals will not be asked for permission to test, as the information will be seen as necessary for correct diagnosis and staging. This information will be in their medical record and linked to them.

For example:

• Hormone status of tumors: i.e., ER + or -
• Genomic mutations present, i.e., KRAS, Her2-neu

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

1. 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.
2. 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.

		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.
Image provided by CISN archives. All rights reserved.

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.

		Doing so will help to achieve truly “informed consent” and to prevent inappropriate use of genetic specimens and related data.
Image provided by CISN archives. All rights reserved.

For more detailed information on the topic of tissue donation, please go to our section on tissue donation.

“Content Developed September 1, 2012”