The effect of consent guidelines on a multiple sclerosis register.

Abstract

BACKGROUND: The 1998 Data Protection Act and guidelines from the General Medical Council on informed consent have caused concern for medical researchers and particularly those involved in the management of disease registers. OBJECTIVE: The aim of this study was to determine rates of consent for a multiple sclerosis (MS) community-based register and to investigate authorization bias by examining the characteristics of those refusing consent. METHODS: A consent letter was developed with the advice and support of an advisory group which included people with MS. All people with MS on the prevalent register (n=820) were informed about the register and its purposes and asked to indicate whether they would like their details to be removed from the register. RESULTS: Thirty-four (4.1%) people with MS asked for their details to be removed from the register. There was a significant difference in disease course in this group with more patients with benign relapsing remitting disease compared to the prevalent population. There was no significant difference in age or sex distribution. The proportion of people not giving consent was similar to a local stroke register. Prospectively all new patients have given written informed consent. CONCLUSION: Patients refusing consent may have different disease characteristics than those who consent. The potential for response bias needs to be considered in the development of a UK MS register.