Informed Consent

Obtaining informed consent from research subjects fulfills the ethical requirements of beneficence and respect for persons described in the Belmont Report. Informed consent is an education process between the investigator and the participant that continues throughout the study. Unless waived by the IRB, consent from subjects must be obtained freely and without coercion and/or undue influence. A subject's consent is considered "informed" if he/she has a reasonable understanding of that to which he/she is consenting. 

The consent process should: 

  • Provide full disclosure of the nature of the research and the subject's participation
  • Ensure adequate comprehension on the part of potential subjects
  • Allow the subject's voluntary choice to participate

In the spirit of the the Belmont Report principle of justice, researchers are strongly encouraged to recruit and include all segments of the community in their research. Additionally, subjects should be presented with a consent document or consent script in a language that is understandable to them. If subjects do not speak or read English then consent documents must be translated into a language they can understand. Further, the consent documents should be written at the 8th-grade reading level.