Upper age limits in studies submitted to a research ethics committee.
OBJECTIVE
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.
Cruz-Jentoft
Alfonso J
AJ
Servicio de Geriatría, Hospital Universitario Ramón y Cajal, Madrid, Spain. acruz.hrc@salud.madrid.org
Gutiérrez
Begoña
B
D000367:Age Factors; D000368:Aged; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D006801:Humans; D018579:Patient Selection; D011287:Prejudice; D016032:Randomized Controlled Trials as Topic