The Case Of The Elusive Protocol

A customer asked us to do a chart review of patients with hypophosphatasia, an extremely rare metabolic bone disease with a live birth incidence of about one in 100,000. The perinatal variant is rapidly fatal.

A proliferation of protocols

Initially informed consent was required if local regulatory authorities and/or IRBs required it. Then the Premier Research regulatory team advised that consent was needed only for living patients.

The sponsor’s EU regulatory team said they required it for all patients outside North America.

The Canadian Research Ethics Board (REB) stated that they would not require consent from parents of deceased patients, because reminding them of their tragedy would do more harm than good. IRBs at some sites with only deceased patients said it was not a human study, and that the requirements for human studies did not apply. Which way to turn?