The University of California’s mission includes teaching, research and public service. To carry out our research mission, UC Davis conducts many research studies. Some of those studies involve human beings.
The federal government has regulations to protect people who are in research studies. One regulation says that if an institution performs research studies that involve people, it must create an “institutional review board” (IRB). The board approves all research before it begins. The board also periodically reviews ongoing research.
The IRB at UC Davis is made up of three committees. The committees carry out their mandate through a review process to make sure that the risks to people involved in research studies are as small as can be and the risks should be justified by the anticipated benefits to the subject or society.
The IRB’s assessment of risks and anticipated benefits involves a series of steps. The IRB must:
- Identify the risks associated with the research, compared with the risks of therapies the subjects would receive even if not participating in research
- Determine that the risks will be minimized as much as possible
- Identify the probable benefits from the research
- Determine that the risks are reasonable considering the benefits to the subjects, if any, and the importance of the knowledge to be gained
- Assure that potential subjects will be given a fair, accurate description of the risks or discomforts and the anticipated benefits of the research
- Determine intervals of periodic review of the study
The IRB also reviews the provisions to protect the privacy of subjects and maintain the confidentiality of the research data, and, where the subjects are likely to be members of a vulnerable population (for instance children, pregnant women, fetuses, mentally disabled people, or prisoners) determine that appropriate additional safeguards are in place to protect the rights and welfare of these subjects. The main document used to describe the research to potential subjects is the Informed Consent form.
Use of Specimens for Future Research Purposes
During the course of the research, the research investigator may ask for your consent to remove some specimens (tissue, blood, urine, or other body materials) for future research purposes. Before you make a decision, here is some information to consider:
Things to Think About:
- The decision to let the researcher keep the specimen(s) for future research purposes is up to you. No matter what you decide to do, it will not affect your care.
- Even if you have already consented to let the researcher use your specimens, you can change your mind at any time. Just let the researcher know that you do not want him/her to use your specimen(s) and it will no longer be used.
- Sometimes tissue/blood/urine are used for genetic research (about diseases that are passed on in families). Even if your tissue or blood is used for this kind of research, the results will not be put in your health records.
- Specimen(s) will only be used for research purposes. The research done with your specimen(s) may help to develop new products in the future. Please be aware that you will not have any property rights or ownership interests in products or data which may be derived from the use of your specimen(s).
Where Do Specimens Come From?
A specimen may be from a blood sample, urine, or from bone marrow, skin, toenails or other body materials. People who are trained to handle specimens and protect donors’ rights make sure that the highest standards of quality control are followed.
Why Do People Do Research With Specimens?
Research with specimens can help to find out more about diseases, how to prevent them, how to treat them, and how to cure them.
What Type of Research Will Be Done With My Specimen?
Many different kinds of studies use specimens. Some researchers may develop new tests to find diseases. Others may develop new ways to treat or even cure diseases. In the future, some of the research may help to develop new products, such as tests and drugs. Some research looks at diseases that are passed on in families (called genetic research). Research done with your specimen may look for genetic causes and signs of disease.
Will I Find Out the Results of the Research Using My Specimen?
You will not receive the results of research done with your specimen. This is because research can take a long time and must use specimen samples from many people before results are known. Results from research using your specimen may not be ready for many years and will not affect your care right now, but they may be helpful to people like you in the future.
Why Do You Need Information From My Health Records?
In order to do research with your specimen, 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?) This helps researchers answer questions about diseases. The information that will be given to the researcher may include your age, sex, race, diagnosis, treatments, and family history. This information is collected by your hospital from your health record.
Will My Name Be Attached to the Records That Are Given to the Researcher?
No, you will remain anonymous. Your name, address, phone number and anything else that could identify you will be removed before they go to the researcher. The researcher will not know who you are.
How Could the Records Be Used in Ways That Might Be Harmful to Me?
Sometimes, health records have been used against patients and their families. For example, insurance companies may deny a patient insurance or employers may not hire someone with a certain illness (such as AIDS or cancer). The results of genetic research may not apply only to you, but to your family members too. For disease caused by gene changes, the information in one person’s health record could be used against family members.
What If I Have More Questions?
If you have any questions, please talk to the research investigator.