Mayo Clinic

 

Research studies and diverse participation

 

 

What you need to know

Before you enroll in a clinical trial, it is a good idea to learn as much as you can about it. You may be interested to know that there are different kinds of clinical trials. Some need healthy volunteers while other clinical trials seek volunteers needing treatment.

A clinical trial is conducted according to a plan called a protocol, which describes

  • What types of volunteers may enter the study
  • The schedules of tests and procedures, study medications and dosages
  • Length of the study
  • Number of study visits

If you qualify for the clinical trial, you will be asked to agree in writing to follow the protocol. This is called giving informed consent.

  • Watch this video to learn what happens in the lab before clinical trials begin. This video is also available in Spanish

 

What are clinical trials and how do they work?

Clinical trials, also known as “clinical research studies”, or “clinical studies”, are studies conducted with people, designed to answer specific questions about medical devices, behaviors, or the safety and effectiveness of new drug, treatment or test. Participation is always voluntary—you can leave a study whenever you want. Your safety is a priority. Researchers must follow detailed protocols and the FDA’s safety requirements to make each trial as safe as possible. The study will be explained to you in an informed consent process before you agree to join. Participants in clinical trials should represent the patients that will benefit from the treatment.

  • Watch this video to learn more on how clinical trials work. This video is also available in Spanish

 

Possible costs and risks of participation

  • You may require additional time, additional procedures, paperwork and travel.
  • You may require a new health care team and facility that is trained on the clinical trial. Your regular health care practitioner team will still remain a part of your care outside the clinical trial and can receive your health care information.
  • You will be receiving experimental treatments that may include additional risks which will be shared with you.

Why are clinical trials important?

The more people who participate in clinical trials, the faster the drugs, treatments, and lifestyle changes can be tested, and the quicker people can get better care. You will make a difference.

Are clinical trials safe?

All clinical research at Mayo Clinic is reviewed and approved by our Institutional Review Board (IRB). The IRB is a committee of experts with various backgrounds who review every part of the clinical trial to ensure the protection of your rights, privacy, and welfare. Federal rules help ensure clinical research is done safely and ethically. Mayo Clinic is committed to protect you and your safety. Each study requires an informed consent to make the key facts about the research clear be-fore you get involved. Ask as many questions as you need to. You should know as much as possible before agreeing to participate. Discuss it with your health care providers, family, and friends.

Should I consider enrolling in a research study?

Research helps experts to understand more about health and disease and to develop new strategies that improve people’s health and the communities they live in. By participating in research, people like you may hold the key to better health outcomes for all. Like other important medical decisions, many factors should be considered when deciding whether or not to participate in research. This is a very personal decision with no right or wrong answer.

How are you protected if you participate?

Federal guidelines and codes of ethics are in place to protect clinical research volunteers from harm. In addition, an Institutional Review Board, a panel of professionals and community members, is responsible for monitoring study safety and protecting volunteer rights in every clinical trial.

Things to consider before volunteering

Possible benefits of participation:

Find Clinical Trials

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Non-Cancer Clinical Studies Questions

Cancer-Related Clinical Studies Questions

International Patient Clinical Studies Questions

Mayo Clinic provides language interpreter services at no cost to clinical trial participants to support diversity and inclusion in research.

If you would like to be notified about potential clinical trials for which you may qualify by enrolling in Mayo Clinic Florida’s Community Research Registry, please fill out this Mayo Clinic Community Research Registry Prescreening/ Interest Form

 

The following websites are recognized for providing reliable information on volunteering for clinical trials:

Health and Human Services (HHS)

Food and Drug Administration (FDA)