Improving research to protect vulnerable populations

Protecting vulnerable populations is a common theme in medical journals. It is also an objective of the Declaration of Helsinki, which was first adopted by the World Medical Association in 1964 and sets out guidelines for research on human participants. The Declaration was last revised in 2013, strengthening protection for vulnerable populations in several important ways. Admittedly, these enhancements may be hard to identify and hence go unnoticed, but this month’s issue devotes a review article to explaining the most recent changes and explaining their evolution.¹

Aisha Malik and Charles Foster argue that the latest revision of the Declaration carefully balances the need to facilitate research while protecting the vulnerable and, importantly, recognising the practical difficulties involved in that protection. They identify four substantial changes. First, people harmed by participating in research are entitled to appropriate compensation and treatment. Second, the use of placebo-controlled trials is discouraged with emphasis on using the best proven comparator instead of placebo. Third, research in vulnerable populations is only allowed if the outcomes benefit that particular group and research in a non-vulnerable population isn't appropriate. Finally, any intervention identified as beneficial in a trial should be available to participants once the trial has finished. This last provision places responsibility upon sponsors, researchers and host governments.

The challenge for research ethics committees is to ensure that their decisions reflect the Declaration’s greater emphasis on protecting vulnerable populations. Unfortunately, trials still harm patients and compensation is difficult to win. Inappropriate placebo-controlled trials are commonplace. The business of clinical trials continues to move unnecessarily towards vulnerable populations, who may not see the benefits of the trial they risked their health to support. If these failures continue, sponsors, researchers and governments, as well as research ethics committees, must be held to account.

Protecting vulnerable populations is also a concern of health systems. Opponents of cost-cutting measures in the NHS will point to the likely harm to vulnerable populations. With junior doctors in revolt and general practitioners stretched beyond capacity, where does the NHS go from here? Margaret Turner-Warwick and Richard Thompson, past presidents of London’s Royal College of Physicians, declare their proposed solutions.²