Ensure Participant Rights are Adhered to

Knowingly violating a participant's rights is a serious but, fortunately, a very rare offense. If a PI or an RTM were found to have intentionally misled a patient about the risk or benefit of a study, or were to use a subject for research without his/her knowledge, in a situation that does not qualify for waiver of consent the impact on the research project would be immediate and profound. Ramifications would be significant to the PI's career, the institutional research enterprise (including legal liability) and the trust necessary for medical research with human participants to thrive in society. More commonly, if the rights of the participant are violated, it is done unintentionally and less flagrantly. There are still consequences to this, but they are typically less far-reaching.