Clemson Rural Health Clinical Research

Frequently Asked Questions

• What is clinical research?

  Research is the way we discover new things about the world we live in.

  At Clemson Rural Health, our patients get the chance to take part in clinical research studies. These studies test out new medicines and treatments to find better ways of stopping, finding, and treating sicknesses. People can choose to join these studies to help scientists and doctors figure out if something is helpful, harmful, or neither.

  Even though medical care and clinical research might seem alike, they have different goals. Medical care aims to make you healthier in some way, while clinical research asks questions and tries to find answers about health care.

  Research questions in these studies usually focus on finding solutions to these kinds of questions:

  • How can we make health care better?
  • How can we give health care to more people?
  • Is there a more affordable way to provide health care?
  • When can we expect or predict a certain health result?

  What is Medical Research

  ¿Qué es la investigación médica?

• How does clinical research work?

  How does clinical research work?

  Clinical research goes through various stages or phases before it's tested on people. First, ideas are checked in labs and must be successfully proven before moving on to animal testing. Most studies involving humans are first carried out on animals to find any possible risks or safety issues.

  Once the idea is ready to be tested on humans, it goes through four more phases of clinical research and approvals before reaching final FDA approval.

  Phase I
  Phase one is the initial step where a treatment or medicine is used in humans for the first time. Usually, it involves a small group of 1 to 10 people. This phase mainly focuses on safety and understanding how the body reacts to the new thing.

  Phase II
  Phase two research comes after phase one. This phase includes a larger number of participants, usually between 10 to 100. Here, the research concentrates on figuring out if the new treatment or medicine really works.

  Phase III
  Phase three research follows phase two. This time, it involves more than 100 participants. The aim of this stage is to see if the new treatment or medicine is better than what's already available.

  Phase IV
  Phase four research is the final stage. It happens after the new treatment or medicine is accessible to everyone. This phase collects information from participants to keep learning about the advantages and the best ways to use the new treatment or medicine.

  What Are Clinical Trial Phases?

  ¿Qué son las fases de los ensayos clínicos?

• What will I be required to do?

  The first step of participating in a research study is to discuss the consent form.

  The consent form outlines everything the researchers will do and any responsibilities you will have during the research study. It is important that you fully understand this document.

  You are not committed to participate in the research until you have signed the consent form. It's your choice to sign it or not; you won't be treated differently by your doctors if you decide not to join. If you ever feel uncomfortable or don't want to continue, you can leave the study at any time.

  At Clemson Rural Health, we want our participants to fully understand what they're agreeing to when they join a research study.

  Informed Concent for Research: Requirements

  Concentración Informada para la Investigación: Requisitos

• Are there any risks?

  Every study has some risks. Your provider will tell you about any known risks based on the research done so far. They'll also talk to you about all other treatment choices available to you. Ultimately, you get to decide whether the benefits of participating in the research study outweigh the potential risks.

  At Clemson Rural Health, we want you to ask questions and talk about these risks with your doctors, family, and supporters before you agree to be in a research study.

  Informed Concent for Research: Risks

  Concento informado para la investigación: riesgos

• What are the benefits of participating in clinical research?

  Personal Benefit
  Certain research opportunities offer incentives to participants to thank them for taking part in the study or to cover their study-related expenses. Examples of incentives could include cash, gift-cards, free medical tests, free medication, free imaging, etc.  It is important to talk with the research team about what is provided as an incentive. Each research study is different and could provide one, some, or none of what was listed.

  Societal Benefit
  When you take part in a research study, you are helping scientists understand how new treatments or medical devices work for different people. Your involvement can improve health care for you, your family, and future generations.

  At Clemson Rural Health, we encourage our patients to think about whether the benefits of participating in a research study are right for them. Our staff is here to answer any questions or concerns about joining a clinical research study.

  Informed Concent for Research: Benefits

  Concentración informada para la investigación: Beneficios

• What are the costs?

  Often patients assume that by participating in research, their treatment will be free. This is not true.  Each research study is unique in what medical services are provided at no-cost by the study and which services are billed to patients. Typically, the patient is responsible for paying or billing insurance for any care that you would typically receive outside of the research study.

  At Clemson Rural Health, we know that health care payments can be confusing and complicated. We will try our best to give patients timely and accurate estimates of expected out-of-pocket costs. If you have any questions, contact your research team or call 864-656-3076.

  Questions to Ask Before Volunteering in Clinical Trials

  Preguntas que debe hacerse antes de ser voluntario en ensayos clínicos

• Will I still receive medical care during the research study?

  In some research studies, they use a method called randomization. This means they divide people into two groups by chance, like flipping a coin to decide. One group gets a new treatment or medicine, while the other doesn’t get the new treatment but might receive something similar. You won't always know which group you're in, but you'll know there's a chance you might not get the new treatment.

  At Clemson Rural Health, we always provide medical care. If there's a way to treat your condition or pain, your doctor will do so. If there's no treatment available and you're thinking about joining a research study, we'll let you know if the study involves randomization.

  Explaining Randomization in Clinical Trials

  Explicación de la aleatorización en los ensayos clínicos

• Will I be required to participate in research?

  You can always choose whether to join a research study. Your doctor might offer the chance to participate, but it is never required for your care at Clemson Rural Health.

  Sometimes, research is the only way to get a specific medical test, medicine, or device. However, your doctor should tell you about other available treatments for your condition that are not part of research. You can decide if you want to join the research or stick with the treatments used normally.

  If you decide to join, you will be an important part of the research project, like being on a team. At Clemson Rural Health, we support our patients considering research opportunities. It's a good idea to talk about it with your doctor, family, and people who support you.

  Informed Consent for Research: Participation

  Consentimiento informado para investigación: Participación

• Where can I get more information about clinical research?

  It's okay to ask lots of questions. You can find a list of possible questions to ask your doctor or research team by using the link in 'Additional Resource.' There's also a button that leads to the Office of Human Research Protection. They have helpful information to help you decide.

  At Clemson Rural Health, our main concern is your well-being. The decision that's best for you is yours to make.

  Questions to Ask Before Volunteering in Clinical Trials

  Preguntas que debe hacerse antes de ser voluntario en ensayos clínicos

• Additional Resources

  Printable List: Questions to Ask when deciding whether to volunteer for research

  Questions to Ask when deciding whether to volunteer for research

  Preguntas que debe hacerse al decidir si desea ofrecerse como voluntario para una investigación

  How to find a research study:

  • ClinicalTrials.gov 
  • South Carolina Research Studies Directory
  • Center for Information and Study on Clinical Research Participation