So, you’re considering becoming a research volunteer …
Clinical research contributes to medical and scientific advances in human health and well-being. All clinical research depends upon volunteer participants who take part in research studies and, through their participation, help to advance health discoveries.
You could be one of those volunteers. If you are visiting this website, it’s likely that you already have an interest in participating in research. Maybe someone who volunteered in the past has encouraged you to volunteer. Or, perhaps you have a health problem related to one of the studies currently being conducted at the Clinical Research Center (CRC).
There are probably as many reasons to volunteer as there are volunteers for research studies. We welcome your interest and we encourage you to apply to become a volunteer. For a list of studies currently supported by the CRC, see the Current Research listing.
You probably have 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?
Clinical research is conducted to evaluate health risks and to test new ways to treat and prevent specific diseases and disorders. Clinical research can improve the quality of health care. Often it involves gathering information about health risks. The knowledge resulting from clinical research is of significant value to society. Without it, health care in our nation would almost certainly be different than it is today.
By volunteering as a participant in a CRC study, you’ll have the satisfaction of knowing that you are making a contribution to the future improvement of human health and well-being. Moreover, some volunteers report a personal benefit from participating in a study. Sometimes, for instance, a participant in a study receives an experimental treatment that has a beneficial effect on a disease or disorder from which they are suffering.
Is it safe?
The safety and protection of research volunteers is of paramount concern. Studies conducted at the CRC are reviewed and approved according to federal, state, and institutional requirements. In fact, no study can even begin until it has been approved by the Institutional Review Board (IRB), which carefully scrutinizes the potential risks and benefits of the study.
When you apply to be a volunteer participant, you will be given an informed consent form that spells out the nature of the study, any risks that are involved, and your rights as a participant. Study staff will carefully review the form with you and discuss your questions or concerns. Any study procedures – such as obtaining blood samples or documenting your health history – will be explained to you before you actually become involved in the study. This ensures that you know what is expected of you and any possible risks. Once you feel comfortable with what your participation in the study requires, you will be asked to sign the consent form.
Signing the consent form means you agree to volunteer. But, if you later have second thoughts, you are free to withdraw from the study at any time. There is no penalty for withdrawing.
As an added safety measure, the CRC includes a research subject advocate, whose job is to represent the interests of research volunteers. The research subject advocate is available to talk with patients and volunteers who are participating in any studies in the CRC.
Other responsibilities of the research subject advocate include:
- Advising principal investigators in the development and implementation of Data and Safety Monitoring Plans (DSMPs).
- Reviewing research plans to identify safety and/or ethical concerns prior to implementation within the CRC.
- Serving as an unbiased observer and counsel to potential subjects and research study staff on the informed consent process, as requested
- Facilitating principal investigator’s reporting of adverse events and protocol deviations.
- Review protocols and consent forms of ongoing CRC projects to confirm IRB-approval and communicate any changes to the CRC Scientific Advisory Committee (SAC).
- Serve as a resource to research participants, study coordinators, principal investigators, and nurses for consultation, education, and research subject advocacy.
Who participates in clinical research studies?
Because clinical research focuses 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.
Am I 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 research staff will determine if you meet the study’s requirements. Those requirements may include, for example: your age, physical condition, and gender.
Who will conduct the study?
Each study conducted at the CRC has a principal investigator (PI), who is the person in charge of the study. The PI may be any one of a number of different kinds of health care professionals, such as an MD or Ph.D. He or she assembles a team of research professionals who are involved in conducting the study.
What should I 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 may want to consult with your personal physician or members of your family before making a commitment. If you have any concerns about the research study, you should also discuss them with the research staff.
Here are some questions you will want answered 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 CRC are guaranteed rights that ensure they are treated professionally and respectfully. When you take part in one of the CRC’s 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 my responsibilities as a participant?
All volunteers who participate in studies at the CRC 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 health care 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 (at 860.679.3276) and, if necessary, the Institutional Review Board (at 860.679.1019 or 860.679.4851) if you feel your rights as a study subject have been violated.
Can I learn the results of the study?
Many study participants wish to review the results of the study in which they participated. Depending on the nature of the research, once a study is complete it may be possible for you to learn your individual results and receive advice from the PI concerning your future medical care. You should be aware that this may not occur until after a study is complete, while all research data are being analyzed.
Overall results of the study, which are typically published in medical journals for the public and health care professionals, may also be available to you in the future.