For Patients & Families

Volunteering for a Research Study

What is a research study?

Research involves asking and answering questions in a systematic way in order to learn and expand knowledge about important topics. In a healthcare setting, research studies focus on people, their health and the care they receive in clinical or community settings. Research has led to many new and beneficial discoveries related to medical treatment, issues that impact health, and quality of care.

Healthcare research covers a broad range of topics. Some studies test new medications, devices, or procedures. Other studies look at why people become ill or how they stay healthy. Research may also focus on improving the safety and quality of healthcare. Not all studies are experimental. Research may include describing people and their health, observing changes in health or behavior, preventing disease, diagnosing or screening for health conditions, or improving quality of life.

Who may participate?

Every research study has specific guidelines about who is eligible to participate. Eligibility may be based on age, gender, race or ethnicity, type of disease, health risks, medical history, or health status. To help determine if you qualify for a research study, study staff may ask questions about your medical history or have you complete a questionnaire.

What are the benefits of volunteering for a research study?

Some studies may benefit participants directly. Others may not benefit participants directly, but could benefit society. Possible benefits include:

Taking an active role in your own health care
Gaining access to new treatments before they are available to the public
Receiving study specific medical care at leading health care facilities
Improving the quality of care people receive
Helping further knowledge about medicine and health

What are the risks?

Studies may involve risks. Studies may involve risks. The level of risk depends on the type of study. For instance, experimental studies testing new medications involve more risks than studies involving surveys or questionnaires. Possible risks related to experimental clinical studies testing a new medication, device or procedure include:

Uncomfortable, serious, or even life-threatening side-effects
The treatment you receive in the study may not be effective
The study may require more visits or a longer stay at the health care facility
If the study is a randomized experimental trial, you may be in either the new treatment group, or a control group that receives the current standard of care. In this type of study, you cannot choose. There is always a chance that the treatment will work. However, there is also a chance that the treatment won’t work or will be worse.

Non-experimental or observational studies usually do not impact your physical health. However, they may involve other types of risk. These risks also apply to experimental studies:

Even though researchers take steps to protect privacy and confidentiality, others may learn about your participation in the study, or some of the information you provide.
You may feel uncomfortable answering certain questions or providing sensitive information about yourself
You may need to travel to appointments, or set aside time for the research

Speak with the study doctor or the study staff about the benefits and risks before deciding to participate. Your doctor or the study staff will explain all of the risks involved in the study to help you decide if you want to participate.

How am I protected?

Research participants have rights. Research studies follow strict rules to ensure that good information is collected, the research is ethical, and study participants are safe.

All research must be reviewed and approved by an Institutional Review Board (IRB). The IRB is a group of people who review research to protect your rights. The IRB looks at all of the procedures, risks and benefits before approving a study. The IRB also monitors studies to make sure that the rules are followed and participants are safe.

Will I be compensated?

Some studies may compensate you for expenses such as transportation, meals, child care, or your time. Others studies may not compensate you at all. Speak with the study team about any compensation.

Is compensation reported to the Internal Revenue Service (IRS)?

It depends. Study sites are required to report compensation to the IRS if you receive $600 or more in one calendar year. If so, your compensation will be reported to the IRS and you will receive a Form 1099 – Other Income. As an example, if you receive $500 for participating in an experimental study, and $100 for taking part in an observational study, the site will report the total amount of $600 to the IRS and you will receive Form 1099.

What do I need to know before I join a research study?

Research participants, not the researchers, are the most important people involved in a study. Keep in mind that participation in a research study is voluntary. You may choose not to participate or leave the study at any time, without penalty, for any reason. For instance, you may simply not want to take part in research, or you may drop out of a study because of side-effects, inconvenience, or because you changed your mind. Leaving the study will not impact the care you receive from your doctor or healthcare facility. We encourage you to talk to the researcher and your doctor first, particularly if the study involves an experimental medication, device or procedure. Often, knowing why participants choose to leave a study helps researchers identify problems such as side-effects, preferences, or problems with the design of the study itself.

What questions should I ask before choosing to participate?

If you are thinking about participating in a research study, you should talk to your doctor or other healthcare provider. Questions you should ask include:

Why is this study being done?
What is involved or expected of participants?
Who is sponsoring or paying for the study?
How many people will take part in the study?
What are the researcher’s qualifications?
Where is the study being conducted?
How long will I be in the study?
What are the risks of the study?
What are the possible benefits?
What other options are available?
Are there any costs associated with my participation?
How is confidentiality handled?
Who should I contact if I have questions or problems?
Is there an option to remain on the treatment, even after the study is over?

Your doctor or the research staff will give you information to read and think about before you decide to participate. If the information is difficult to understand, ask your doctor or the study staff to explain it. You should understand what is involved and what the study is about before you make a decision. You may want to speak to your family or another person you trust. Take as much time as you need. You should never feel pressured into participating.

How can I volunteer for a research study?

Speak with your doctor; your doctor may be able to suggest a research study that is right for you.