Human Research Protection Program

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Biomedical Research

What is Biomedical Research

Biomedical research is the study of human physiology and the treatment or understanding of disease.

Types and Methods

  1. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention:
    • research on therapies (g., drugs, surgical interventions, or medical devices)
    • diagnostic procedures (g., imaging biomarkers)
    • preventive measures (g., vaccines or diet)
  2. Research on normal human functioning and development:
    • studies of the human body while exercising, fasting, eating, sleeping, or learning
    • responding to such things as stress or sensory stimulation
  3. Studies comparing the functioning of a particular physiological system at different stages of development
  4. Studies defining normal childhood development so that deviations from normal can be identified
  5. Medical records and biospecimens research
  6. Research on specific disease processes to establish and improve methods of prevention, diagnoses, and treatment
  7. Research on the human genome and genetic markers

Risks/Harm

Risk is the probability of harm or injury (physical, psychological, social, or economic) occurring as the result of participation in a research study.  Biomedical researchers must consider the following risks when conducting their study:

  1. Social, psychological, or economic harm
  2. Physical harm
    • possible side effects of drugs, biologics, or medical devices
    • injury from medical procedures

The IRB is responsible for conducting a risk/benefit assessment and will want to know how such risks will be minimized or addressed.

iStar

When submitting an application in iStar you will see the following in section 1.5.

Genomic Data Sharing (GDS)/Stem Cell Research