BIOMEDICAL RESEARCH. Is research related to the study of human subjects, which must be in accordance with the generally accepted scientific principles and should be based on laboratory and animal experiments, as well as in-depth knowledge of the relevant scientific literature. VI.20.
BIOMEDICAL RESEARCH. Studies that are designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis, chorionic villi testing, and fetoscopy), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). It can also include normal human functioning and development, compare the functioning of a particular physiological system at different stages of development (e.g., infancy, childhood, adolescence, adulthood, or old age), or define normal childhood development. It includes records research used to develop and refine hypotheses. Research on specific disease (e.g., research on the biochemical changes associated with AIDS or schizophrenia, or the neurological changes associated with senile dementia of the Alzheimer type) and the human genome and genetic markers fall under biomedical research. Biomedical research is focused on: specific diseases and health conditions (mental or physical), including: detection, cause, treatment, prevention, and rehabilitation evaluation and testing of the safety, effectiveness, or usefulness of an intervention, treatment, or therapy normal and abnormal physiology, human functioning, and development cognitive, emotional, and behavioral responses to real or potential health problems the human genome and genetic markers the incidence and prevalence of illness and injury among populations, and strategies for prevention and health promotion CERTIFICATE OF CONFIDENTIALITY: A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. Any research project that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a Certificate. Federal funding is not a prerequisite for Certificate. For more information: xxxx://xxxxxx.xxx.xxx/grants/policy/coc/index.htm CERTIFICATION: Official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by...
