A clinical study is a research study to help answer specific health questions. Clinical studies can range from vaccine trials to new drug trials to exercise studies. These studies help discover new treatments for health-related issues and whether these treatments are both safe and effective.
There are many reasons why individuals should participate in a clinical trial. Being involved is one way that you can play a more active role in your healthcare. Ultimately, being a research participant is a way for you to contribute to medical science and help researchers find better ways to help others.
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Scientific research is conducted to obtain information needed in order to answer a question or learn more about a subject matter. Clinical research is conducted to test the effects of a treatment (or intervention) on a certain health condition. For example, The Cooper Institute often conducts exercise studies that test whether carefully controlled levels of physical activity lead to changes in weight, body fat, and other clinical outcomes. Often research studies use different tools or measurements to document any changes that occur throughout the study such as questionnaires and physical measurements like blood pressure and weight.
Research is conducted by trained professionals in many areas of investigation, such as medicine, psychology, sociology, education, government, business, epidemiology, marketing, and many others. Research studies are usually led by the principal investigator (PI). The PI trains others to assist him/her on the study and they are usually called research study coordinators and research assistants. Sometimes, research participants will not see the PI since he/she has trained the staff to conduct the study procedures.
Each research study will have its own requirements that are outlined in a document called the “informed consent form.” Some studies are short and may only require participants to complete one visit or one questionnaire. Other studies are longer and may require participants to complete multiple visits and numerous tests like blood draws, questionnaires, and physical measurements. Participation in a study can be time consuming; however it can provide benefits to the participants and others in the future.
ICF is a document that interested participants must read and sign before agreeing to participate in any research study. Participants have as much time as they need to read this form and ask questions to ensure they understand the study. Only after all questions are answered, should a participant sign the ICF and agree to participate in a study. The ICF will outline all of the requirements of the study: total number of participants needed, number of visits, procedures done at each visit, study length, compensation amount (if any), potential benefits and risks, plan for data collection and use, and contact information for the researchers. It will also describe your rights as a research participant.
Each research study is different in terms of the types of compensation offered to participants. Some provide monetary compensation to help cover transportation and time. Others may provide gift cards or incentives related to the research such as pedometers, water bottles, etc.
The data collected during the study is used by the researchers to inform their participants and the scientific community. The information is analyzed by the research team using scientific methods. The results of the research study are often presented to the public in various forms, including formal presentations and published articles. All information presented is de-identified meaning it cannot be traced back to a particular research participant. Findings are reported in aggregate, or group form.
Informed consent is not a contract. You may leave the study for any reason, or at any time you choose by speaking with the investigator, coordinator, or other study staff. Your decision to leave a study will not involve any pressure to remain involved. However, participants are encouraged to think very carefully about study involvement, and to ask any questions they may have before signing the informed consent.
"My experience here at Cooper has been quite rewarding. As I've gotten older and older, fewer and fewer of my friends have remained as physically active as I have, consequently, Cooper has given me a brand new set of women to relate to and exercise with."
"Making that first phone call to come in and exercise was very hard because usually Mexican-American women are so busy usually with children and family that our wants or needs come last. But taking that first step helped make me talk to people, the other women in the study group were very friendly."
"Well, to describe my experience here The Cooper Institute in Oak Cliff is very easy. First came the awakening that there are women just like me. I had absolutely no motivation to exercise. Cooper has provided me the tools to motivate me to exercise and eat well."