Exploring Bioethics - NIH Office of Science Education - National ...

Issues Explored• Why is it important to involve humans as participants in research?• What ethical challenges arise when humans are participants in medical research?• What issues should you consider if you are invited to serve as aresearch participant?At a GlancePurpose and RationaleBiomedical research has contributed greatly to human health, providingtreatments and cures for a wide range of conditions and diseases andimproving quality of life. Students and their families benefit from theseresearch advances yet often have little knowledge of how drugs, medicaldevices, new types of surgery, and vaccines are developed. Although testingnew treatments through human clinical trials is a vital part of research, thepublic poorly understands this process.Researchers have, at times, inflicted great harms on participants in clinicaltrials. Students should be aware of the risks that human research entails, aswell as its benefits. The research community, in collaboration with ethicists andregulatory agencies, has developed guidelines to help ensure the appropriateand responsible conduct of human clinical trials. Committees called institutionalreview boards (IRBs) review study protocols—plans for research thatinclude proposed protections for participants—to carefully consider the ethicalimplications of using humans in that research. Knowledge of the scientificdesign of the research and the safeguards in place to protect human participantsis vital to ensuring public understanding of the research enterprise.This module can be used in conjunction with units on the scientific methodand experimental design, disease, or microbiology (bacteria and viruses). Ifintegrated into an existing unit, the first day of the module could introducethe unit as a whole. The module can be expanded to include student-designedexperiments with human subjects or integrated into lessons about hownonhuman animal experiments are also used for research.OverviewThis module focuses on the ethical considerations of doing biomedical researchon humans. An asthma study simulation illustrates how researchers design clinicaltrials and highlights some common ethical considerations, with a particularemphasis on respect for persons and minimizing harms while maximizing benefits.Students contemplate whether they would enroll in the study. Then, theybrainstorm the wide range of benefits that have resulted from human research.As they examine a case study in which a participant died (the Ellen Roche case),5-2 Exploring Bioethics