Clinical Trials

Information for Volunteers and Study Participants

So, you’re considering becoming a volunteer. If you are visiting this website, it’s likely that you already have an interest in volunteering. Maybe someone who has been a volunteer in the past has encouraged you to volunteer. Or perhaps you have a health problem that’s related to one of the studies currently being conducted at the UConn Health Center.

There are probably as many reasons to volunteer as there are volunteers for our research studies. We welcome your interest and we encourage you to apply to become a volunteer.

You’ve probably got some questions. Here are some of the things many potential volunteers want to know about.

What is clinical research and why should I volunteer to participate in it?

We conduct clinical research to evaluate health risks and to test new ways to treat and prevent specific diseases and disorders. Clinical research can improve the quality of healthcare. Often it involves gathering information about health risks. In both cases, clinical research knowledge is of significant value to society. Without it, healthcare in our nation would almost certainly be different than it is today.

By volunteering as a participant in one of our research studies, you’ll have the satisfaction of knowing that you are making a contribution to the improvement of healthcare for our society. Moreover, many volunteers report additional personal benefits from participating in our studies. Sometimes, for instance, participants in a study are able to receive experimental treatments that have a beneficial effect on diseases or disorders from which they are suffering.

Is it safe?

The studies conducted at the Health Center – like those conducted at other research facilities – are approved according to federal, state and UConn Health Center guidelines. In fact, no study can even begin before it has been approved by the Institutional Review Board (IRB), which carefully considers the potential risks and benefits of the study before authorizing it. The safety and protection of volunteers participating in the studies are of paramount concern.

Whenever anyone applies to become a volunteer participant, (s)he is given an informed consent form that spells out the nature of the study and any risks that are involved and clarifies his/her rights as a participant. If any kind of intervention will be involved – such as obtaining blood samples or documenting the participant’s health history – a careful consent process is conducted before the person actually becomes involved in the study. This ensures that the volunteer knows what is expected and any possible risks. Completing and returning the consent form means the person agrees to volunteer. But if the volunteer then has second thoughts, (s)he can simply withdraw from the study. There is no penalty for withdrawing.

Additionally, the Health Center has a research subject advocate (RSA) , whose job is to represent the interests of the volunteers who participate in our studies. The RSA has a number of responsibilities. She/he must provide information to patients and volunteers who are participating in any clinical trial and research where there is a greater than minimal risk. Other responsibilities of the RSA include:

• Assisting investigators to develop data and safety monitoring plans, and helping research advisory committees review those plans;
• assuring that the Health Center’s studies adhere to the IRB-approved protocol and monitoring procedures;
• ensuring the reporting of any significant problems or conflicts of interest to appropriate local committees and federal agencies; and
• assuring that Health Center investigators are appropriately trained and remain current on their regulatory and patient safety responsibilities.

Who participates in clinical research studies?

Because clinical studies focus on a wide range of diseases and disorders, all kinds of people are needed as volunteers. Volunteers can include both healthy people and people with an illness. Every study has its own unique criteria for who is eligible to participate.

Are you eligible to participate?

That depends upon a variety of factors, such as the nature of the study and whether you meet the screening requirements. You will know more about the study and whether you qualify when you receive the informed consent form, which will provide you with a thorough description of the project and any risks to participants.

If you decide that you would like to volunteer for a study, the study staff will determine if you meet the study’s requirements. Those requirements may involve your age, physical condition, race or gender.

Who will conduct the study?

Each study conducted at the Health Center has a principal investigator (PI) who is the person in charge of the study. The PI may be one of a number of different kinds of healthcare professionals. He or she will assemble a team of research professionals who will also be involved in managing the study.

What should you consider before deciding to be a participant?

Even if you are eligible to participate in a study, you should give it careful thought before deciding to become a participant. While you may benefit in a host of ways from participation, you should also be aware that participating could impact your life in many ways, as well.

It’s important for you to make an informed decision. So, you will probably want to consult with your personal physician and members of your family before making a commitment. If you have any concerns about the project, you should also discuss them with the research team working on the project. Here are some questions you’ll want to obtain answers to before making a decision:

• What are the goals of the study?
• What will I be required to do as a participant?
• Are there any risks? How likely are they to occur and what is done to reduce the likelihood of their occurring?
• What role will I play in the study?
• Am I likely to benefit directly from participating in the study?
• What are the study’s potential benefits to other people and to society as a whole?
• How long will my participation in the study be required?
• What discomforts, inconveniences or costs will I experience as a participant?

What are my rights as a participant?

All volunteers who participate in studies at the Health Center are guaranteed rights that ensure they are treated professionally and respectfully. When you take part in one of our studies you have the right to:

• Be treated with respect.
• Know the risks of participation in the study.
• Know what alternatives are available.
• Withdraw from the study without penalty.
• Make your decision without feeling any pressure from the research staff.
• Know the name, credentials and contact information of the study’s principal investigator.
• Know the purpose of the study.
• Know who will have access to your information.
• Know what procedures may be performed and what drugs or medicines may be used.
• Seek additional help or clarification during the informed consent process and at any time during the study.

What are your responsibilities as a participant?

All volunteers who participate in studies at the Health Center are expected to comply with the specific requirements of the study. In addition, study participants are expected to adhere to a general set of requirements that apply to all participants. They include:

• Arriving for all scheduled appointments or calling ahead if you are unable to keep an appointment.
• Arranging your own transportation to and from the study site(s).
• Following the directions of the researchers.
• Making sure your contact information is up to date.
• Providing – to the best of your ability – accurate information about your medical history if it is relevant to the study.
• Seeking healthcare for any medical conditions unrelated to the study.
• Asking the researchers to completely answer any questions you may have at any time during the study.
• Informing the research staff of any negative experiences you have while participating in the study.
• Informing the research subject advocate and, if necessary, the Institutional Review Board if you feel your rights as a study subject have been violated.

Can you learn the results of a study?

Many study participants wish to review the results of studies in which they have participated. Once a study is complete, participants are informed of their results and given advice concerning their future medical care. You should be aware that this may not occur for some time after a study is complete, while all research data are being analyzed.