An Invitation to Participate in Clinical Research Trials
Choosing to participate in a research study involving clinical research trials is an important personal decision. The following frequently asked questions provide general information about research studies.
If you have more questions, please contact the office of Clinical Research Education and Support Services (CRESS) or 412-641-1427.
Clinical Research Trials FAQs
What is a clinical research trial?
A clinical research trial is a study conducted to improve health care or to develop new methods of health care. Each study is designed to answer scientific questions on ways to prevent, diagnose, or treat diseases. Clinical research trials are not meant to take the place of your usual medical care, nor are they meant to conflict with any care you may currently be receiving. All clinical research trials are coordinated with your health care team.
Why are clinical research trials conducted?
A clinical research trial is one of the final stages of a long research process. Studies are conducted with patients to find safe and effective approaches to the diagnosis and treatment of diseases. Without studying a treatment correctly, we can never be certain whether it is effective or better than an older treatment and new treatments could never be used to help others.
Why join a clinical research trial?
There are many reasons why people volunteer to become part of clinical research trials. Some people volunteer because they may be helped by a new treatment or procedure. Others join because they want to help in the discovery of new treatments, procedures, or medications that may benefit patients in the future.
Who is eligible to participate in a clinical research trial?
Almost everyone can participate in some type of research study. Even healthy people are needed for some studies. Each clinical research trial has its own eligibility criteria outlining who can participate. The criteria may include age, risk of the disease being studied, and any medications that you are currently taking. You should talk to your doctor or the person in charge of enrolling patients for the study to find out if you are eligible for a particular study.
What happens during a clinical research trial?
Some clinical research trials may require that you complete a questionnaire, while others may require that you have a blood test or take a certain medication. Some research studies may involve more extensive treatment. You will be given complete information about the type of clinical research trial, what will be required of you, and what the potential risks and benefits might be.
If you decide to participate in a study, you will work with a research group that may consist of doctors, nurses, social workers, dieticians, and other health care professionals. They will provide your care, monitor your health, and give you specific instructions about the study. To make the trial results as reliable as possible, it is important for you to follow the instructions, attend all doctor visits, take all tests and medicines on time, and complete logs or answer questionnaires.
What are the possible risks and benefits of research studies?
The risks and benefits of each study are dependent on the study itself. All the risks and benefits will be listed in an informed consent document and will be explained to you in detail by the researcher who is conducting the study.
Some potential benefits of participating in a clinical research trial may include:
- Expert health care provided by leading physicians during the study
- Access to new drugs and treatments before they are widely available
- A more active role in your own health care
- An opportunity to benefit from being one of the first to use an approach if it is found to be helpful
- An opportunity to make valuable contributions to medical research
Some potential risks of participating in clinical research trials may include:
- New drugs and procedures may have side effects or risks unknown to the doctors
- Side effects and results may be worse than current standard interventions
- The experimental treatment may not work for you
- Health insurers and managed care providers do not always cover all the costs of care in research studies
What is informed consent?
Informed consent is a process in which you learn the key facts about a clinical research trial before you decide whether to participate. In addition to discussing these facts with the researcher, they will be included in a written consent form that you can take home to read and discuss with family and friends. The consent form includes information such as what is being researched, the length of the study, possible risks and benefits, and the tests you may have to undergo. Once you decide to participate, the researchers will ask you to sign an informed consent document.
Who has access to my information?
Any information about you obtained from the research, including answers to questionnaires, medical history information, laboratory data, or findings from physical examination, biopsy, or surgery, will be kept confidential. You will not be identified by name in any report or publication unless you sign a release. Just like they can review hospital medical records, federal regulatory authorities may review your records.
Can I withdraw from the study?
You can refuse to participate in any study or withdraw at any time. Your decision will not adversely affect your care at Magee-Womens Hospital of UPMC or cause any loss of benefits to which you would otherwise be entitled.
How do I become part of a study or learn more?
You can sign up or get more information about our clinical research trials in a number of ways.
- Visit our current list of clinical research trials.
- Call the contact number listed in the information for each clinical research trial.
- Call us directly at 412-641-1427.
- Ask your health care provider about our studies.
General Research Registry Information
What is the research registry?
The research registry is a way for women who are or have been patients at Magee-Womens Hospital of UPMC to give their approval to participate in research. The registry was developed by the hospital to allow researchers to look at medical charts to learn about diseases that particularly affect women and infants. It is also used to find patients who may want to take part in research studies.
How does the registry benefit me?
Being part of the research registry is beneficial to you in a number of ways. If you are asked to participate in a research study, you may be helped by a new treatment or procedure. You also may be part of a discovery that may lead to new treatments, procedures, or medications that may help future patients.
How is the registry beneficial to research?
Without the registry, researchers cannot review your chart information or contact you to participate in research studies or clinical research studies. Without you, research would not move forward, and valuable contributions to the future of health and medicine would be compromised.
Do I have to participate in a research study because I am part of the registry?
No. If you sign up for the research registry, you still can refuse to take part in any research study that you are contacted for. Some studies, known as chart reviews, look at your medical records. You will not be contacted nor do you have to do anything for these types of studies if you have signed up for the registry.
How do I become part of the registry?
You can download the Consent Form for the Magee-Womens Hospital of UPMC Research Registry for Women and Infants Health. Please read the entire document carefully and review with your clinical care provider.
Can I withdraw from the registry?
If you change your mind, you can withdraw from the research registry at any time. We will no longer use your medical record information for research purposes; however, any research that involved use of your medical record information before the date that you withdraw permission will not be destroyed.