Access to death certificates: what should research ethics committees require for approval?

PURPOSE

To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval of a study requiring access to death certificates to identify the physicians signing the certificates and to send them a four-page questionnaire about medical decisions made at the patient's end-of-life that could possibly have hastened death.

METHODS

A simple questionnaire were sent to the responsible national investigator in an international study (Australia, Belgium, Denmark, Italy, the Netherlands, Sweden, Switzerland) asking about the interactions between the national research group and the national/regional REC(s).

RESULTS

Different laws or guidelines were used by the RECs. Denmark, the Netherlands, and Switzerland did not require an application to a REC. In Australia and Sweden, the RECs wanted changes in the research protocol, and one national research group had to refrain from publishing its results because the attrition rate became too high, probably due to the required changes in the protocol.

RECOMMENDATIONS

Generally, similar demands from all RECs in relation to one project are strongly desirable. In epidemiological research, in which voluntary completion of an anonymous questionnaire demonstrates consent, additional prior informed consent about being approached should not be required.