Choosing to participate in a clinical trial is an important personal decision. The following questions provide detailed information about participating in clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact our Help us Discover team to find out more about what trials are occurring at Yale and to contact the study research staff and ask questions about specific trials. Email us at firstname.lastname@example.org or call 1-877-978-8343.
- Some volunteers have a condition that is being treated effectively but want to help doctors find out more about it in order to develop new treatments.
- Sometimes volunteers have a friend or loved one with an illness or injury and they want to participate in a research study as a way of helping that person and others who may suffer from the same condition.
- It may be that there is no effective treatment for an illness or injury or the existing treatment has harsh side effects. Participating in a clinical trial may offer potential treatment options that might otherwise be unavailable.
- Many people choose to participate in a study even though it might not be able to help them directly. Knowing that others may be able to benefit from their efforts is a rewarding experience.
- Sometimes people volunteer because they are compensated for their time and effort.
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research
As with most medical treatments, there may be some risks to participating in a clinical trial. Possible risks include the following:
- Your participation may require more time and attention than routine clinical care. This may involve visits to the study site, phone calls from the study doctor or staff, frequent treatments or procedures, answering questions, a hospital stay or a more complicated drug regimen.
- The treatment or procedure may not be effective for every individual.
- There may be unpleasant, serious or even life-threatening side effects when undergoing experimental treatments.
You should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for you to discuss with the health care team.
Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What drugs, devices, procedures, tests, examinations and visits are required in order to participate?
- What are the potential risks of this trial?
- What are the expected benefits to me if I participate?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- Will I have to change my daily activities or diet if I participate?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I incur any costs?
- Will I be reimbursed for expenses or paid for my participation?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
- Whom should I contact if I have questions about the trial?
- Are there other clinical trials for which I might be eligible?
Some of the ways to determine if a clinical trial is right for you include:
- Comparing the reason why you're interested in participating to the question the trial hopes to answer. You should think about whether the trial has the potential to fulfill your hopes and expectations. You should also weigh the potential risks and benefits of participating in the trial.
- Informing yourself about the questions the trial is trying to answer by researching on your own through reputable websites and the library and by asking questions. You may also want to talk to your family, friends or your personal physician.
YCCI staff members, study doctors, nurses and coordinators are available to answer your questions so that you can make an informed decision
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
The ethical and legal codes that govern medical practice also apply to clinical trials. Most clinical research is federally regulated with built in safeguards to protect the participants. For example, every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. In addition, all trials follow a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA).
The sponsor of the research usually pays for all research-related costs. If a study involves routine tests, treatments or procedures that you would normally undergo as part of the standard course of treatment for your condition, then you or your insurance company may be asked to cover these fees. Before the trial begins, be sure to ask the trial staff which fees may be billable to you or your insurance company.
To read more about financial responsibilities associated with participation in a research study click here.
There are no benefits to your treatment from the research done on your medical records, left-over blood or tissue or genetic testing. The research may benefit patients like you in the future and contribute to advances in medical care and treatment.
You will not receive any payment for the use of left-over blood or body tissues or for the use of medical record information. Your information will not be sold to anyone. There may be a chance that your blood, tissue and information could indirectly lead to new discoveries. The researchers who make these discoveries could make money from them. You will not receive any money from these discoveries.
You can know that even while you are a patient, you are contributing to an effort to improve the health of patients and to find ways to cure and prevent disease in the future.
There are a number of ways that all patients contribute to improving health care. As a patient, you may be asked to participate in a clinical trial that investigates a new drug or procedure for your particular illness. If so, you will be provided with information so that you can decide what is best for you. If you decide to participate in a clinical trial, you must give your written permission to be involved after all of your questions are answered.
There are other ways that you and all patients participate in medical research. Researchers may use the information in your medical record to study diseases in general and the effect of treatment. In addition, when you have blood tests and have body tissue removed for diagnosis and treatment, left over blood and tissue is not discarded but is saved for research. Investigators use these materials to investigate how disease develops and progresses in order to find new treatments.
When the information from the medical record is combined with the research on the left-over blood and tissue, much can be learned about different diseases and how to treat them.
Genetic studies will not affect your treatment in any way. Neither you nor your doctor will be given results of genetic tests on your tissue or blood when these tests are done strictly for research purposes. If you need genetic testing as part of your treatment, your doctor will order those tests and will share the results with you.
Your genetic information from research is not included in your medical record and it is protected so that it does not affect your access to insurance coverage or potential employment.
For research involving your medical records, leftover blood or tissue, or genetic testing, all of the samples and information collected do not disturb or change your care in any way. You will not undergo extra tests for research purposes, no extra blood is drawn, and no extra tissue is removed. There is no physical or medical risk to you.
We also take precautions to safeguard your privacy. Whenever possible, researchers use your information, blood and/or tissue without knowing your name and identifying information. If they need to use some identifying information about you for their research, they must undergo an approval process by Yale’s Human Research Protection Program. This program is responsible for making certain that Yale research adheres to the highest ethical standards for protecting research participants.
Click here to create a research profile in MyChart, Yale’s electronic medical record portal for patients.
1) Email: email@example.com
2) Call: 1-877-978-8343, option #3
3) Write: Office of Research Services
Attn: Opt-Out Recruitment
Yale School of Medicine
PO Box 208054
New Haven, CT 06520-8054
Click in the Forgot Password section of the MyChart login. You will need your MyChart User Name and date of birth. If you do not remember any of this information, you will have to contact your MyChart help desk at MyChartSupport@YNHH.org to help you regain access to your MyChart account.
Yes. Your profile includes an area where you can specify a preferred method of contact. You can choose between being contacted by phone or email.
Questions about Privacy
Who will be able to see my profile information? Will google be able to see my profile?
The Yale doctor and research staff affiliated with specific studies in which you expressed interest or those who are conducting studies in categories that interest you will be able to see your profile information. Just as when you visit your doctor, all health care providers and research staff at Yale are subject to HIPAA (Health Insurance Portability and Accountability Act) and are therefore required to protect the privacy and confidentiality of your information.
Internet search engines such as Google, Bing and Yahoo will not be able to see or index your information.
How will my privacy be protected?We will keep your information confidential and secure as required by state and federal law. We will keep the information that you provide indefinitely until and if you delete it. If you decide that you do not wish to participate in the database any more, you can delete your information any time by contacting the Office of Research Services at 1-877-978-8343, option #3 or my e-mailing firstname.lastname@example.org or by writing to the Office of Research Services, Attn: Opt-Out Recruitment; PO Box 208054; New Haven, CT 06410. Please provide your full name, date of birth and address.
1) Email: email@example.com
2) Call 1-877-978-8348, option #3
3) Write: Office of Research Services
Attn: Opt-Out Recruitment
Yale School of Medicine
P.O. Box 208054
New Haven, CT 06520- 8054
Please feel free to ask about anything you don't understand and to consider participation in the research database and the consent form carefully - as long as you feel is necessary - before you make a decision. Questions about the database should be made by calling 1-877-YSTUDIES (97883437).
If you have any questions concerning your rights as a research volunteer, you may contact the Human Investigation Committee at (203) 785-4688.
If you have any questions about your privacy rights, please contact the Yale Privacy Officer at (203) 436-3650. If you have any questions about participating in clinical trials, you may also wish to read our Clinical Trials FAQ.