Questions About Trials and Profiles

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 helpusdiscover@yale.edu or call 1-877-978-8343.


Trials

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined procedure.
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of each participant at the beginning of the trial, give specific instructions for participating in the trial, monitor each participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than you would normally have for an illness or condition. For all types of trials, you will work with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, including its risks and how well it may or may not work.
There are many reasons why people volunteer to take part in a clinical trial:
  • 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.
All clinical trials have guidelines about who can participate. The use of these guidelines is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that prevent someone from participating are called "exclusion criteria". These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
While some research studies seek participants with illnesses or conditions to be studied in the clinical trial, it is not always necessary to have a specific illness or condition to participate. In fact, there are many trials that need healthy volunteers. Participants who are healthy are often needed to provide information that can be compared with people who have a particular disease.
Benefits

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
Risks

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.
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

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.


Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Yes, you can leave a clinical trial, at any time. When withdrawing from the trial, you should let the research team know about it, and the reasons for leaving the study. Some of this information is copyright of the U.S. National Library of Medicine

Research

Your medical records, leftover blood and/or tissue may be used for medical research to study diseases and find ways of curing, treating and preventing them. The researchers who do this work are qualified scientists and physicians.
There is a chance that your medical information, blood and/or tissue may indirectly lead to new discoveries that may benefit you in the future and contribute to advances in medical care. The researchers who make these discoveries could profit from them, but you will not receive any money from these discoveries.

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. 

Many diseases are related to people’s genes – the cell material that determines individual differences in each person. Medical science is using genetic information to determine which people are at risk for certain disorders, to individualize care, and to prevent disease. To study how genes work together in causing and preventing disease, researchers also study genetic sequencing which means that they map out parts or the complete set of human genes. Researchers may be using some of your left-over blood and tissue for genetic studies and to complete whole genome sequencing. They may also choose certain cells from your tissue to create a cell line for future research.  Creating cell lines is not cloning. In a cell line, cells are all identical, grow in small amounts, and are used for medical research in the laboratory.
Under some circumstances, it could be risky for someone to find out about your genetic information.  Variation in some genes is known to be directly related to risk of certain illnesses. In some cases, knowledge of genetic information could be upsetting. If other people find out about your genes, that could affect your access to or retention of certain benefits or entitlements. For example, genetic information about certain diseases could potentially be used against you if it were revealed to insurance companies or potential employers. At Yale, we make sure that your genetic information from research is not available to any of your caregivers and is not included in your medical record. This helps make sure that outsiders do not discover anything about your genes.

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. 

Researchers may use some of your leftover blood and tissue for genetic studies and to map out some or all of your genes. They may also choose certain cells from your tissue to create a cell line for future research. In a cell line, identical cells are grown in small amounts in the laboratory for use in research.

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. 

Creating A Profile

Click here to create a research profile in MyChart, Yale’s electronic medical record portal for patients.

You may be contacted for clinical trials at Yale unless you opt out. To opt out of being included in research studies, you may choose one of three ways. Please provide your full name, date of birth and address:

1) Email: optout@yale.edu
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.

How will my information be used? / How does the system work?

When you express interest in a specific study, the information from your profile will be sent to the doctor conducting that study. If you're eligible to participate, you may be contacted by a nurse or study coordinator. If you select a health category rather than a specific study, our recruitment team may contact you for further information to determine the study that's right for you. Doctors who have active studies in that area may contact you to ask if you would like to participate. In both cases, you will be contacted by the preferred method (e-mail or phone) that you specified in your profile.
Every trial has eligibility criteria that are used to make sure participants are suited to the study. We have provided a basic list of eligibility criteria, but there may be other factors to consider. The doctor, nurse, or study coordinator may ask you additional questions to make sure the study is right for you. Even if it's not, you may be eligible for other studies.
We may send you information about research findings, new studies, or other items related to clinical research at Yale. Your address is also provided to the doctor or study coordinator.
We ask about race or ethnicity because some trials are looking for specific characteristics in participants. This is because some conditions may be more common in those with a particular ethnic background or may affect them differently. Also, in order to receive funding from the federal government, we are required to make sure that research studies include a variety of groups, such as women and minorities, where appropriate.
A member of the Help us Discover or study coordination team will contact you.
Once you have created a profile, a member of our recruitment team will contact you to try to match you to a study that is right for you. There is also the possibility that you will not qualify for any studies at this time. Therefore, a period of time may pass before you are matched to a trial and contacted by a member of a particular study team.
Participating in a clinical trial is always your decision. You can change your mind about participating at any time. If you decide to withdraw in the middle of a trial, you should let the research team know about it and the reasons why, because it is important for them to know about any side effects you may have experienced. Also, it may be necessary to gradually stop taking any medications you have been given.

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 optout@yale.edu 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.

Opt Out and Additional Questions

When you receive medical care at any site in the Yale New Haven Health System, your medical records, leftover blood and/or tissue may be used for research purposes unless you opt out. You will be asked if you would like to opt out of having your records, blood and tissue included in research studies when you visit a Yale physician or undergo tests or treatments.
To opt out of being included in research studies, you may choose one of three ways. Please provide your full name, address, and date of birth.

1) Email: optout@yale.edu
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.

Need help? Contact us.

Call us at 1-877-978-8343 or email