Providing Specimens For Research: What You Need to Know
What are research biospecimens?
“Biospecimen” refers to any type of human sample, specimen or tissue and the associated clinical data that could be used for research. This includes such things as tissue, blood, saliva and hair. The term “biospecimen” also refers to all the things that make up these specimens that you cannot readily see, such as proteins, nucleic acids and carbohydrates.
What does the term remnant biospecimen mean?
“Remnant biospecimen” refers to the part of the sample left over after the specimen, tissue, etc., was used by a doctor in your diagnosis or treatment, whether you have cancer or not. The sample is no longer needed to help make a diagnosis or for treatment decisions. These samples can be used for research that may help future patients with cancer and/or other diseases. Where do remnant biospecimens come from? There are many sources of remnant biospecimens, but most commonly they come from people having surgery, biopsies or blood drawn. Whenever a procedure such as surgery or a biopsy is performed, the tissue or specimen that is removed is examined under the microscope by a doctor to determine the nature of the disease and assist with the diagnosis and plan of care/treatment. Your tissue will always be used first to help make decisions about your care. After all tests have been done, there is usually some of the sample left over. Usually this is not kept (it is discarded), because it is not needed for patient care. However, a person can choose to let us keep the sample/tissue for future research. People who are trained to handle tissue and to protect your rights make sure that the highest standards are followed in collecting, storing and using the tissue for research in RPCI’s tissue procurement facility (TPF). Your doctor does not work for the TPF, but has agreed to help collect tissue if you have agreed. If you agree, only the tissue/specimen left over from what is taken for your diagnosis and care will be saved for research. Whether you did or did not agree to have the excess tissue used for research, your doctor will collect the same amount of tissue needed for diagnosis and/or treatment. The doctor will not take any extra tissue or specimens just for research purposes.
Why do people do research with these biospecimens?
Research with human samples can help find out more about what causes cancer, how to prevent it, and how to treat it. Research using human samples can also answer other health questions. Some of these include finding the causes of diabetes and heart disease, or finding genetic links to Alzheimer’s disease.
What type of research will be done with my samples?
Many different kinds of studies use human samples. Some researchers may develop new tests to diagnose diseases. Others may develop new ways to treat or even cure a disease. Still others may look at the genetic material contained in the tissue to study diseases at the genetic level. Some research looks at diseases that are passed on in families (genetic research). Research done with your tissue may look for genetic causes and signs of cancer or other disease. In the future, some of the research may help to develop new products, such as tests and drugs. You are providing your sample to RPCI for these purposes.
How do researchers get these human samples?
If you sign the consent form, samples left over from your procedure, biopsy or test will be sent to and stored in the RPCI TPF. Scientists who do research at RPCI will contact RPCI’s TP facility and request samples for their studies. The TPF will release the samples only after the Institutional Review Board (IRB) that protects participants’ rights has reviewed and approved the study. Based on what the IRB has approved, the RPCI TPF will send the samples and limited clinical information about you to the researcher. The TPF will not send your name, address, phone number, Social Security number, or other information that could identify you personally to the researcher. Will I find out the results of the research using my samples? No, you will not receive the results of research done with your remnant biospecimens. That is because research involves the use of samples from many people, and results from research using left over sample/tissue may not be ready for many years. While the research on left over samples will not affect your care right now, the results may be helpful to other people like you in the future. Though research involves the test results of many different people, your biopsy/surgery/test result involves only you. That is the reason the biopsy, surgery or blood test was done in the first place. Your doctor will give you the results of your biopsy or results of your surgery when these are known. These results are ready in a short time and are used to make decisions about your care.
Will I benefit from the research using my samples?
There will be no direct benefit to you, financially or otherwise, because your samples may not be used for some time after you donate, and because research can take a long time. However, it is hoped that the results of research on your tissue and tissues from other patients will provide information that will help others in the future. Your tissue/specimen will be helpful whether you have cancer or not.
Why do you need information from my health records?
In order to do research with your samples, researchers may need to know some things about you. (For example: Are you male or female? What is your race or ethnic group? How old are you? Have you ever smoked?) That helps researchers answer questions about diseases. The researcher may be given information about your age, sex, race, diagnosis, treatments, and possibly some family history (although no names or addresses will be used). That information is collected by RPCI and is contained in your records. The TPF will obtain only what is needed and give it to the researcher, but without your name or other identifying information.
Will my name be attached to the records that are given to the researcher?
No. Your name, address, phone number and anything else that could identify you personally will be removed before the specimen/tissue is given to the researcher.