Biospecimen Issues:
For Patients and Advocates - continued

Dealing with results

Ordinarily you will not be given results of studies conducted with tissue donated for research. This is because the information may be preliminary and needs to be combined with that from other research studies to produce a sample size large enough to be representative; or the information needs to verified; or because there are no validated/standardized tests with normal values to compare with for patient use.

Researchers may offer to tell you your individual results or information if the work is no longer preliminary and it has been validated. Before agreeing to obtain your results you may want to discuss some of the following issues:

	What can the results tell you (i.e. can they be useful)? Could the results show that you or your family is at risk of developing a particular disease? If you are at risk, is there anything you can do to minimize your chances of developing the disease

Even if your genes show that you have a higher risk of developing a certain disease it does not necessarily follow that you will develop the disease. You may decide that it is less stressful not knowing the results. Gene research is still at an early stage, so it is also possible that the information you are given does not tell the whole story. In this case you could end up worrying about your health for no reason.

 

Ownership

When properly preserved, tissue can be used far into the future to study questions that may not even be thought of today, or that use technologies that have not yet been invented. However, issues of who owns stored tissue (patients, researchers, hospitals, or storage facilities) have sometimes gotten in the way of being able to take advantage of stored tissue.

Thus far, although hospitals and pathologists generally feel that patients own their samples the courts have ruled against patient ownership. However, this question will continue to evolve.

Internationally, Iceland has had three different laws concerning ownership of the physical samples and the information they may contain. Current Icelandic law holds that the Icelandic government has custodial rights of the physical samples themselves but the donors retain ownership rights. In contrast, Tonga and Estonia cede ownership of biobank samples to the governments, but their laws include strong protections of donor rights.

Why tissue donation is so important

When people are diagnosed with cancer, they probably aren't thinking of ways to help prevent or treat the disease for future patients. However, a tissue donation to their hospital tissue bank could help researchers do just that.

The purpose of the bank, and others like it is to collect, process and store tissue samples for research. The more researchers learn about cancer, the more they realize that each patient's disease progresses differently. Researchers hope to advance treatment of the disease and help patients live longer.

By using donated tissue to study how cancer develops and how new drugs affect samples before testing them in people, drugs that seem most likely to have the best chance of success in humans can be moved rapidly from the laboratory to the clinic resulting in benefit for patients.

Types of tissue needed

Important information about the biology of cancer, biomarker discoveries, new targets and sub groups within each type of cancer can result from studies using donated biospecimens. This information can then lead to use of new prevention, diagnostic and treatment strategies, which are the promise of, personalized medicine. To implement this promise researches need both normal and cancer biospecimens.

Patients can donate:

• Left over samples obtained from surgical procedures or biopsies.
• Samples collected as part of a research clinical trial

Healthy individuals can donate:

• Normal samples when they have routine surgery or blood drawn.

CISN Summary:

Current research strategies are greatly enhanced by the contribution of tissue by patients - those with cancer and those without. This is the only way science can make advances in "personalized" medicines so doctors can treat tumors based upon specific targets.

Consent forms need to be fully explained to all possible donors. Advocates play many roles in translational research - get involved, be part of the solution!!