The IRB Process

Design Issues

Health Research

Health research employs many methods and research designs. Studies 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). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Some studies compare the functioning of a particular physiological system at different stages of development (e.g., infancy, childhood, adolescence, adulthood, or old age). Others are directed at defining normal childhood development so that deviations from normal can be identified. Sometimes research, particularly records research, is used to develop and refine hypotheses. Research on specific disease processes is often needed before improved methods of prevention, diagnoses, and treatment can be developed (e.g., research on the biochemical changes associated with AIDS or schizophrenia, or the neurological changes associated with senile dementia of the Alzheimer type). Research on the human genome and genetic markers is expected to create new avenues for understanding disease processes and their eventual control.

Subjects of some health studies engage in ordinary tasks (e.g., exercise, learn a series of words, or respond to various sensory stimuli) while measurements of physiological and bodily functions are made. Although many procedures used in health research are similar to those used in routine physical examinations, at times more invasive procedures (e.g., "spinal taps," skin or muscle biopsies, or X-rays used in conjunction with contrast dyes) must be used if a desired measurement is to be made. Although research designed to generate information about normal physiology or a disease process is not concerned with evaluating a medical intervention, it may still require the use of invasive procedures. When the research deals with subjects whose condition is not normal, the research can have either therapeutic or nontherapeutic purposes.

The IRB shall assess the risks and benefits of health research to determine whether the research protcol adequately protects the participants. To assist the IRB in this endeavor, the researcher should complete IRB form 1040 and the Medical Appendix. Researchers will also need to seek off site approval if they are conducting health research at another institution.

Other health studies that do not involve human subjects (e.g., animal research) are exempt from the human subjects regulations. Researchers conducting non-human health research should contact the Chair of the Webster University IRB to obtain the proper approval. The Webster IRB will also need to see a copy of the off-campus Animal Review Board approval (there are currently no approved animal research facilities at Webster University).