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Clinical Trials Q&A

Questions and answers on clinical trials at UAMS

What is a clinical trial?

A clinical trial is one of the final stages of a long and careful research process. For example, a scientist first thoroughly studies a potential new drug in the laboratory and then makes sure it is safe and effective on animals. But, even if this new medicine helps sick animals, it may not always be effective for humans. Scientists use clinical trials to make sure that new treatments and procedures work reliably for the humans they were designed to help.

Why should I participate in medical research?

Many advances in health care would not be possible if people did not volunteer to take part in research. If you participate in a medical research study, you might help doctors find a cure for a disease or discover a new drug to treat disease. You could also help make an advance in science that will help researchers make more medical breakthroughs. Thousands of people have participated in medical research studies at UAMS. Some of them were patients here and participated in studies related to their illnesses. Whether you are or ever have been treated at UAMS, you may decide to advance science and medical care by participating in one of the hundreds of medical research projects conducted here every day.

But, no matter what you choose to do, if you have come to UAMS for medical treatment, your doctor will continue to give you the best care available. Participating in a medical study is an option you have in addition to your care; it is never required. You must decide what is right for you, and UAMS wants you to have the information to make the best possible decision.

What should I expect if I join a research study?

Research studies, especially clinical trials, often compare a standard treatment with a potential new treatment. Researchers hope that the new treatment will be better than the old one, but there is always the chance that it will not work as expected. No one can predict how a research study will affect you. It may not help you directly, but your participation may provide valuable information that will help others in the future. If you have a disease that the doctors are studying, you may notice that the new treatment makes you feel better. While the treatment may help, it may cause unpleasant side effects. Side effects can make you feel nauseated, dizzy or depressed. There can be other side effects, as well, depending on the treatment. You should always discuss possible side effects with your doctor, but keep in mind that when doctors give you a new drug, all the side effects may not yet be known.

If you participate in a research study, your doctor may require more visits and tests than you would otherwise need. You may also have to keep a log, fill out forms about your health or do other tasks that will help doctors with their research. In addition, some studies continue to follow up with patients even after the study ends. Sometimes, subjects are granted stipends to help pay for out-of-pocket costs associated with the study, such as added travel.

What is informed consent?

Federal law says that all research involving humans requires informed consent. What this means is that the researcher must thoroughly explain the study and how it affects you – especially risks or discomforts – before you agree to participate. The researcher must also tell you about any changes during the course of the study, such as newly discovered risks or side effects. Informed consent applies to the whole study, no matter how long it takes to complete. So, you are always assured that you are kept informed.

If you do agree to participate in a study, you can always decide to withdraw from the study at any time, for any reason. Do not be afraid to ask any question if you do not understand. Feel free to discuss your participation in the research study with family and friends to get their advice. Sign the informed consent only if you are comfortable with what you have read.

Are there any risks involved in participating in a research study?

UAMS approves all research carried out by its doctors and researchers according to rigorous federal regulations and guidelines. The UAMS Institutional Review Board (IRB) is a board made up of physicians, scientists, experts and community members who review plans for medical research and must approve those plans before the researcher can begin the study. The IRB makes sure that the planned research is accurate, safe and useful and that each step in the study meets or exceeds UAMS standards and federal laws. The IRB continues to monitor the study, too, to make sure the study maintains safety standards over time.

Will my privacy be protected if I take part in a clinical trial?

If you are asked to participate in a research study, you should always ask if it has been approved by the IRB. If a study has not been approved by the IRB, always refuse to participate. UAMS guarantees the safety and privacy of your records. Our doctors, nurses and scientists who conduct human research studies have received training on keeping medical information confidential, especially in a research study.

In addition, new federal laws, like HIPAA (the Health Insurance Portability and Accountability Act of 1996), require that your records be kept confidential. The only people who need to see your records are the study team; those responsible for monitoring the study, which includes the UAMS Institutional Review Board (IRB); and the agency funding the study, such as the National Institutes of Health (NIH).

If you have general questions, concerns, complaints or suggestions about being a current or potential research participant, call the Review Board office at (501) 686-5667 or the IRB Hotline at (501) 526-7134.

For more information about clinical trials, use the links listed below.

For general information:
http://www.clinicaltrials.gov
http://www.cc.nih.gov/
http://www.fda.gov/
http://www.centerwatch.com/
http://ohrp.osophs.dhhs.gov/

For cancer trials:
http://www.nci.nih.gov/
http://www.cancer.gov/clinical_trials/
http://oesi.nci.nih.gov/series/cted/
http://www.va.gov/cancer/

http://www.fda.gov/oashi/cancer/cancer.html
http://www.cancer.org/
http://cancernet.nci.nih.gov/
http://www.cancerguide.org/

For vision trials:
http://www.nei.nih.gov/resources/

For mental health trials:
http://www.nimh.nih.gov/studies/clinres.cfm

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