As part of my volunteer activities as a patient research advocate in MD Anderson's head and neck SPORE (Specialized Programs of Research Excellence) program, I've observed multiple patients going through the tumor tissue biopsy consent process.
These sessions were generally held a day or two before major surgery, thus competing with the patients' already extreme stress, strong emotions and very trying circumstances.
The clinician asking for the biopsy consent was well skilled in communicating with each patient/caregiver the process of donating their cancer tumor tissue for research purposes. Yet, there were still questions, some explicit, others implicit, asked by patients and caregivers in those consent sessions.
Witnessing these interactions makes it clear to me that increased patient awareness and information beforehand could make this an easier process for the patient, clinician and doctor, ultimately improving the science of curing cancer.
What you need to know
At some point during your cancer journey at MD Anderson (or at your own cancer center) your doctor may ask for your consent, or permission, to use your tumor tissue for research purposes. If you consent, you will be asked to sign a form to that effect.
There are three distinct purposes for evaluating a tumor sample:
A clinical biopsy -- this tumor sample is used for the direct benefit of the patient (i.e., yourself) and the results will be used to guide the care of the patient from whom the biopsy was extracted.
A research biopsy for integral biomarker studies -- this tumor biopsy is used to determine biomarkers in the tumor and may be used to guide the treatment of a patient during a clinical trial.
A research biopsy for correlative studies -- the tumor biopsy will be used to assess the correlation between the molecular features of the tissue and a patient's disease and outcome. There is no direct benefit to the patient who donates this tissue sample.
Frequently asked questions
Will my surgeon take more tissue than he/she would otherwise take during the normal course of the surgery?
No. The objective during surgery is to remove all detectable cancer cells and obtain clean margins, or normal tissue, around the tumor site. The research tissue biopsies will come from the tissue that is already extracted. No extra tissue will be taken.
Will my tissue sample be used for purposes other than those stated during the consent process?
No. Your consent form will spell out specific objectives for the use of your tumor sample. There is a rigorous process surrounding the development of tissue collection protocols, which includes sign-off by an internal review board (IRB).
Any deviation from this process requires that the protocol go back to the IRB for approval and that the hospital contact you to gain an updated consent.
If I refuse to consent, will this delay my treatment? Will my doctor hold this against me?
In cases of a clinical biopsy, where treatment is dependent on knowing the molecular profile of your tumor, yes, your treatment may be delayed. A doctor can't treat what he doesn't know.
In cases where the sample is for research purposes and not for your direct benefit, rest assured, your doctor will not hold a tumor tissue denial against you and treatment will proceed as planned.
What if my tumor sample turns up other health issues that I'm not ready to know?
Although it's possible your tumor may turn up other health issues, this is unlikely. The tumor analyses being performed are generally looking for specific biomarkers and are not evaluating the tissue for a broad range of diseases.
Can the results of my tumor sample analysis be used by my insurance company to deny coverage?
Actually, the opposite is more likely. Your biopsy results may support your case in obtaining reimbursement from your insurance company, as your treatment will be based on the standard of care for your particular cancer.
In addition, thanks to HIPAA (Health Insurance Portability and Accountability Act) regulations, many tissue-collection protocols specifically address who has access to your tumor biopsy analysis. Typically, unless you explicitly grant access during the consent process, MD Anderson will not share the results of your biopsy with a third party such as your insurance company.
Will my cancer center communicate with me the results of my tumor biopsy analysis?
If the biopsy is for clinical analysis, the answer is generally yes. If it's a research biopsy, it depends on the type of research and the institution. Biomarker studies may or may not be shared; correlative studies are generally not shared.
So, here we come full circle. This entry began with the question of whether you should consent to a research biopsy. Now that you have more information, I'd like to turn that question around.
If given the opportunity to help science and yourself, why wouldn't you consent to donating a tumor biopsy for research purposes?
Note: For more information on this subject, the Research Advocacy Network (RAN) publishes many patient education and advocacy documents.