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

• The Belmont Report has served as a guide to the oversight ofresearch with humans in the United States. The report clearlyarticulates three ethical considerations (principles): respect forpersons, beneficence (“do good”), and justice (“ensure that the risksand the benefits of research are fairly shared”) as they relate toresearch with human participants.• The Declaration of Helsinki, developed by the World MedicalAssociation, provides guidelines for medical researchers about theuse of human subjects. It was first ratified in 1964 and has beenrevised five times, most recently in 2000.See Teacher Support MaterialsA Nuremberg Code excerpt, the Belmont Report, and theDeclaration of Helsinki are available online at http://science.education.nih.gov/bioethics/teacher.8. Point out that these documents reflect how research guidelines forhuman subjects have evolved over time.For example, in its mandate for informed consent, the NurembergCode states that using children in research is problematic. Also, theNuremberg Code and the Declaration of Helsinki guidelines treatresearch that has no benefits in different ways. While the Declarationof Helsinki provides guidelines for “non-therapeutic research,” it is notclear that such research would be allowed under the Nuremberg Code.The Declaration of Helsinki, first published in 1964, has undergonemultiple revisions.9. Tell students that in addition to these guidelines, review boardsat research institutions (institutional review boards, or IRBs)and the Office for Human Research Protections (of the federalgovernment) also monitor research.ClosureRemind students that they have explored both the benefits ofresearch in terms of improving human health in the future and someof its challenges, such as risks to participants. The next activity, whichfocuses on the Willowbrook Study, invites students to apply what theyhave learned about research to deciding whether one historically wellknownstudy was conducted ethically.5-26Exploring Bioethics