Upper age limits in studies submitted to a research ethics committee

Area of Science:

• Gerontology
• Clinical Trial Ethics
• Medical Research Methodology

Background:

• Discrimination against older adults in new drug research is prevalent.
• Many research protocols impose unjustified upper age limits, excluding a significant population.
• Understanding trends in age-based exclusions is crucial for equitable research participation.

Purpose of the Study:

• To investigate the prevalence of unjustified upper age limits in research protocols.
• To determine if these age limits have changed over time.
• To assess the role of research ethics committees in mitigating age discrimination.

Main Methods:

• Systematic review of research protocols submitted to a university hospital's Research Ethics Committee.
• Analysis of protocols from four distinct years to track changes in age limit stipulations.
• Exclusion of studies with conditions inherently limiting older adult participation.

Main Results:

• In 1994, 1999, and 2004, 36%-40% of intervention study protocols included unjustified upper age limits.
• By 2007, this figure decreased to 19%, indicating a positive trend.
• Non-intervention studies rarely imposed age limits; common arbitrary limits were 65, 70, 75, or 80 years.

Conclusions:

• While declining, unjustified age limits in intervention study protocols remain frequent.
• Research Ethics Committees are pivotal in influencing research practices and combating age discrimination.
• Continued vigilance and policy enforcement by ethics committees are necessary to ensure inclusive research.