What is biomedical research?

Biomedical scientists study human physiology and the treatment or understanding of disease. Biomedical research applies the principles of the physical sciences to medicine. Most biomedical research is conducted by physicians or biological scientists, but many studies are conducted by biologists, chemists, physicists, and other medical and scientific professionals.

Most biomedical research involves clinical trials, which are phased studies involving human volunteers designed to answer questions about the safety and effectiveness of biologics, devices, pharmaceuticals, new treatments, or new ways to use known treatments. Initially, trials are often conducted in a small group, but in subsequent stages are expanded when safety and efficacy are demonstrated. Most clinical trials are regulated by the FDA, but there are some exceptions.

 

Types and methods

 

Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention:
Studies of treatments (e.g., medications, exercise, surgery, or medical devices)
Diagnostic procedures (e.g., CT scans, prenatal diagnosis through amniocentesis)
preventive measures (e.g. vaccines, diet or fluoridated toothpaste)
The study of normal human functioning and development:
Studies of the human body during exercise, fasting, feeding, sleeping or learning
how it responds to things like stress or sensory stimulation
Research that compares the functioning of a particular physiological system at different stages of development (e.g., infancy, childhood, adolescence, maturity, or old age)
Studies that determine the normal development of a child so that abnormalities can be identified
Records research – often used to develop and refine hypotheses
Research on specific disease processes is often required before developing improved methods of prevention, diagnosis and treatment, e.g:
research on biochemical changes associated with AIDS
Research on neurological changes associated with senile dementia
Research of the human genome and genetic markers – to create new ways to understand disease processes and their ultimate control

 

Other biomedical research that does not involve human subjects or is not subject to regulations on human subjects and therefore does not require IRB review:

 

research with animals
research on preliminary samples of materials (tissue, blood, or urine) collected for other purposes where the information is recorded by the investigator in such a way that subjects cannot be identified directly or through identifiers associated with the subjects
Record-based research, where data are recorded in such a way that the individuals to whom the records relate cannot be identified directly or through identifiers associated with the subjects

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