Frequently Asked Questions

Below are answers to frequently asked questions about clinical research and clinical trials at UMMC.

What type of research studies are conducted at UMMC?

The word “research” has many different meanings. Researchers study a wide range of topics, and each research study is different. Some studies involve medical procedures or treatments while others may involve a survey. As a UMMC Research Partner, we may ask you to complete a task, take an experimental medication, or provide information that may lead to new medical discoveries.

There are a wide variety of research studies conducted at UMMC:

• Interventional research studies: Participants receive specific interventions, such as an investigational medication, procedure, and/or device done according to a research plan or protocol. The research team then seeks to determine if the intervention provides a better treatment option.
• Observational research studies: Researchers assess health outcomes in participants according to a research plan or protocol. Researchers may observe participants’ health for days, weeks, months, or even years. During this time, participants may receive interventions or procedures as part of their routine medical care, but participants do not receive interventions directly from the study.
• Behavioral research studies: Researchers seek to predict, prevent, and manage illness by attempting to understand how certain behaviors are related to those illnesses.
• Diagnostic and screening studies: Researchers evaluate and seek to improve ways in which we screen for and diagnose diseases.

What are the benefits and risks of participating in clinical trials?

Each clinical trial has its own benefits and risks which will be explained thoroughly by the study team.

You may benefit from joining a clinical study in one of the following ways:

• Gaining access to investigational treatments. If a new treatment works, you may be one of the first people to benefit.
• You may increase your knowledge about your own health.
• You may be able to help your own community and future generations through the advancement of medicine and science.

Some possible risks include:

• Side effects may be worse than those of standard treatments and you may experience side effects your doctor does not expect.
• New treatments do not always turn out to be better than, or as good as, standard treatments.
• As with standard treatments, the new treatment may not work for you even if it works for other patients.

Who can participate?

UMMC’s clinical research programs require both healthy and patient volunteers.

Healthy volunteers

Healthy volunteers play an important role in research because they help define “normal” ranges. While they may receive no direct benefit, healthy volunteers may choose to participate in clinical research because they want to help others and contribute to advancing science.

Patient volunteers

People with a health condition or disease may take part in a research study to gain access to a new therapy; take a more active role in their health; or contribute to better understanding, diagnosing, or treating that disease or condition. While some patient volunteers may receive a direct benefit from participating, the overall goal of the clinical trial may be to understand the risks and benefits of a treatment and to scientifically prove whether it is effective.

How do researchers determine eligibility?

Researchers use a list of rules called "eligibility criteria" to decide who is eligible to be in the study. These criteria ensure it is safe for you to participate. They also ensure the study results are due to the treatment being studied and not other factors or chance.

“Inclusion criteria” are factors that allow someone to be included in the study. “Exclusion criteria” are factors that disqualify someone from being in a study. These factors can include:

• Age
• Gender
• Type and stage of a disease
• Previous treatment history
• Other medical conditions

What is informed consent?

• Informed consent is the process of learning key information about a research study before deciding whether to participate. The informed consent process involves talking to a doctor, nurse, or other research team member about the study and reviewing the consent documents.

• During the consent process, you will learn about the study’s purpose, the things you will be asked to do, how long the study will take, potential benefits and risks you may experience and other aspects of the study.
• You are encouraged to ask any questions you may have about the study and if you decide to participate, you will be asked to sign the consent form. However, the informed consent process does not stop once you sign the form. The researchers must alert you when changes occur, when new risks are identified, or when new knowledge is gained that may change the risk-benefit ratio and allow you to decide to continue your participation.
• Questions to ask when deciding whether to volunteer for research - External link

Who pays for the clinical trial?

All trials are different. The clinical trial sponsor may pay for the new treatment, extra tests, and extra doctor visits as needed for the trial. Funding for clinical trials can come from various sources, including:

• University of Mississippi Medical Center
• The National Institutes of Health and other governmental agencies
• A pharmaceutical company
• Non-profit foundations and other medical centers

Where do UMMC clinical trials and research studies take place?

UMMC clinical trials and research studies take place at various UMMC locations across the state, with the majority of trials occurring at the main campus in Jackson.

Can I leave a clinical trial once it has begun?

All participants in clinical trials are volunteers and have the right to withdraw from a study at any time. You can withdraw, or decide to not participate at all, without affecting your access to health care at UMMC.