Two Medical Legal Issues The family's allegation that the stude

The family's allegation that the student's consent was not voluntarily obtained raises several legal questions that will direct the in-house investigation into her death. A medical research facility may only perform experimental studies on subjects who have given their voluntary and informed consent to the research that will be performed upon them. However, even if the facility obtains such consent, it can still be legally liable if the subject was harmed by the facility's negligence in conducting the research or if the manner of research was illegal under state or federal law.

The investigation must first establish that the clinical trial had the necessary authorizations under state and federal law. Without such authorizations, it will not matter to what the student consented because the facility would likely be per se liable for operating outside the law. The investigation must then discover whether the student has signed a consent form to participate in the trial. The consent form should describe the trial with particularity and should inform the student that the invasive anesthetic and intubation procedures could have been one facet of the trial. Here, it is not important that the consent form advised the student that these procedures would be performed, but rather that it advised the student that these procedures were a possibility during the trial and the student agreed to their being performed if deemed appropriate.

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