Carolinas HealthCare System has an array of research programs spanning clinical research (including outcomes research) and translational research (including bench and population-based research).
What is Clinical Research?
Clinical research is the “examination of biomedical or clinical” questions where human subjects participate in a study and it can take on many forms.
Early phase I studies test the safety and tolerability of potential new drugs. Phase II studies establish optimal doses and effectiveness. Phase III studies are designed to lead to FDA approval for new drugs and devices. Phase IV studies provide continual monitoring of new drugs or devices after their initial approval.
Not all clinical research studies involve medical treatments or experimental therapies. Some include observational studies, in which people are followed over a period of time to determine health outcomes. It may also be used to determine the usefulness or safety of a new diagnostic procedure or drug treatment in the form of a clinical trial. Clinical research studies follow a defined protocol plan.
NIH defines human clinical research as research with human subjects that is: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. (Source: NIH PHS 398 Instructions on Human Subjects Research)
How to Participate in Clinical Research
In order to participate in research, a person must give informed consent. This allows one to be a part of the clinical trial after having learned about the study (the purpose, risks, benefits, alternatives and expectations) and had the chance to ask questions before agreeing to participate. When you give informed consent, you sign a document that describes the rights of the participants as well as details of the study, the names of the investigators who are conducting the study and contact information.
Please note even if you decide to participate in a study, you may stop your participation at any time.
How Are Research Subjects Protected?
Clinical trials are required to maintain strict patient privacy. Your name will not be published with the study data nor will it be included in any publicly available information. In addition, researchers follow human subject protection regulations designed to protect you. Each study is reviewed by the Carolinas HealthCare System Institutional Review Board (IRB) or designee. The IRB ensures subjects are protected.
If you have questions about your rights as a research participant, please contact Carolinas HealthCare System IRB at 704-355-3158.
Important questions to ask before deciding to participate in a clinical study:
- What is the purpose of the trial?
- How does this differ from current standard therapy for my condition?
- Has the drug or treatment ever been tested before?
- How much time will I need to commit to this study?
- What are the risks and possible side effects of the treatment?
- Who will pay for the treatments?
- Will I receive travel reimbursement or any type of compensation for my time or expenses?
- How long is the trial expected to last?
- What will happen to my medical care if I opt not to participate?
- Will my insurance cover any part of this study?
What is translational research?
Translational research includes:
- the process of making discoveries in the research laboratory or in preclinical studies that will have an impact on human health and may lead to the development of studies in humans,
- the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans and
- research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.
Source: Based on Institutional Clinical and Translational Science Award (U54) RFA-RM-07-007 CTSA RFA