Upper age limits in studies submitted to a research ethics committee

Abstract

Background and aims: Discrimination in research of new drugs for older people is frequent. We examined research protocols submitted to a research ethics committee, to ascertain whether they stipulated unjustified upper age limits, and whether these age limits are changing in time. Methods: Systematic review of protocols of studies submitted to the Research Ethics Committee of a public university hospital, in four different years, looking for unjustified upper age limits. Studies that dealt with topics or conditions that automatically excluded older people were not examined. Results: In the first three cohorts of protocols of intervention studies (1994, 1999, 2004), 36% to 40% stipulated an upper age limit. In 2007, only 19% of the protocols showed an unjustified limit. Non-intervention trials rarely had upper age limits. Age limits were arbitrarily chosen (65, 70, 75 or 80 years were chosen as cut-off points in most cases). Five to 6% of the protocols specifically concerned older persons, with no change in time. Conclusions: Unjustified age limits are frequent in the protocols of intervention studies, although the numbers have been falling recently. Ethics research committees are in a strong position to influence research practice and to reduce unethical age discrimination.