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Case 3b :

Human Subjects Compliance: Adverse Events and Serious Adverse Events

The International Council on Harmonisation—Good Clinical Practice (ICH-GCP) guidelines, defines an adverse event as one that possibly threatens the health of a subject enrolled in a clinical trial, but does not pose a threat to the mortality of enrollee or is not conducive to an irreversible disability. This might include an abnormal laboratory value, for example. A serious adverse event, on the other hand, includes irreversible disabilities, death, dismemberment, critical care stay, or other irreversible change to the enrollee's health status or the health status of their unborn child. Although the criteria for adverse events (AEs) and serious adverse events (SAEs) are reasonably clear, there is still interpretive room.

This evening, Mr Chau, a patient enrolled in an inpatient, but fully observational, behavioral health study collapsed while shopping in Causeway Bay. Witnesses at the scene described him as being disoriented, bumping into store displays and speaking to himself rapidly before he collapsed. He was taken to a local hospital where the attending physician noted he held your contact card in his wallet. Upon admission, Mr Chau had a rapid pulse (>150), dilated pupils, shallow labored breathing, was rigid and stiff, and had lost bladder control. Four hours later, the attending reports to you that the patient is now stable with strong vital signs, is fully oriented to person, place, and time, but is unaware of the circumstances surrounding his admission.

When you come in to see Mr Chau, he says to you,

"I just wanted to go to buy some fruits to have for my dinner.... The last thing I recall was leaving the grocery store. I had a bad headache and thought to go get a milk tea. Then I woke up here".

Mr Chau's case includes collapse, loss of memory, disoriented behavior, tachycardia, tachypnea, loss of bladder function, and headaches:

• Would you report this as an adverse or a serious adverse event to your Institutional Review Board?
• Presume your trial is covered by a company party to ICH-GCP, do the requirements of ICH-GCP pertain to behavioral health studies where the patient is hospitalized for observation?
• If not, what standards ought to govern reporting of participant harms to the IRB in behavioral health or even social science studies?