The Clinical and Translational Research Unit is proud to support research studies with the goal of advancing health, but we couldn’t do any of these studies without volunteers! Volunteers are the most important part of any clinical research study, and many promising treatments never make it to patients who need them because there weren’t enough volunteers to complete the study. If you are considering volunteering for a research study, please read on for some common questions that can help with your decision.
What is Clinical and Translational Research?
Clinical research typically refers to studies that use human subjects in order to answer a question, with the goal of improving patient care, knowledge of a particular disease or risk factor for disease, or prevention or treatment of a medical condition. A research study that involves testing the effectiveness and safety of a drug, procedure, treatment or medical device is called a clinical trial. Translational research refers to studies that are aiming to translate biomedical discoveries made in the lab into treatments for human patients.
Why should I volunteer?
There are many different reasons to participate in a research study. Many people volunteer to help find treatments for themselves or for others who are suffering from a disease, others volunteer to contribute to the science and understanding of a certain disease, while still others volunteer to learn more about and potentially improve their own health. Whatever the reason, volunteers make a huge impact on improving prevention, diagnoses and treatments for diseases in their communities and all across the world.
Is it safe?
All studies conducted at the CTRU are reviewed by an Institutional Review Board (IRB), which reviews all studies for participant safety, risks and benefits before the study can begin. Participant safety is of utmost concern, and studies must have appropriate safeguards in place and demonstrate the level of risk is low enough in relation to the benefits of the study before it is approved. Study participants are always first given a consent form to review before their participation in the study can begin. This consent form outlines the goals and components of the study, as well as the risks and benefits. Volunteers are encouraged to carefully review the consent form and ask questions during the consent process- our goal is to make sure all volunteers know what to expect and be comfortable participating in the study. Participation in a study is always completely voluntary. If at any time a volunteer wishes to stop participating, they can withdraw from the study with no penalty.
What should I consider before making my decision to participate?
Clinical research studies have varying degrees of risk and engagement, so it is very important to give study participation careful thought before deciding to participate. During the consenting process, you will review the study process as well as risks and benefits with a researcher. Some of the things to consider and ask questions about are:
- What are the goals of the study?
- What will I have to do as a study participant?
- How long will my participation in the study last?
- What inconveniences or discomfort will I experience as a participant?
- What are the risks of participating in the study, and how likely are they to occur?
- What benefits can the study provide to myself or to others?
Volunteers are encouraged to ask questions to fully understand what to expect from study participation. Study participation is always voluntary, and participants can withdraw from the study at any time if they are not comfortable with participating in that study.
What are my rights and responsibilities as a study participant?
Volunteers participating in studies at the CTRU have the right to:
- Be treated with respect and professionalism
- Know the purpose of and procedures involved in the study, as well as the risks and benefits of participating in the study
- Make a fully informed decision about whether to participate in the study without any pressure from the research team
- Withdraw from the study at any time without penalty
- Know the name and contact information of the study’s lead investigator
- Be able to ask questions or seek help from the research team during the consent process and at any time during the study
In order for us to carry out successful studies, we also ask study participants to adhere to the following responsibilities:
- Comply with the specific requirements and procedures of the study you are involved with
- Provide accurate information to the research team as it relates to your involvement in the study
- Ask questions to make a fully informed decision whether to participate in the study, and ask questions if you are not sure about anything during the study
- Be on time for study visits or call ahead if you cannot make the appointment
- Inform the research team of any negative experiences as a result of being involved in the study
What studies am I eligible for?
Every study has its own criteria for who is eligible- some require healthy volunteers, or those with a specific medical condition, or those at risk of a medical condition. To see the eligibility criteria for our current studies, please visit our Participate in a Study page.