Ethics of clinical research in patients with ALS: is there a risk of exploitation?

Amyotrophic lateral sclerosis is the most common degenerative disease of the motor neuron network. Due to its inevitably fatal outcome, numerous attempts have been made to ameliorate its course. The emergence of every new technology has spurred research to see if it might benefit patients with ALS (PALS). This paper suggests a detailed road map to be followed when performing clinical research in PALS to satisfy the ethics requirements of the Declaration of Helsinki, expressed using the terminology of Beauchamp and Childress. The ethics principles that need to be satisfied are arranged in a hierarchical manner, each having to be satisfied before the next is approached: Justice; Beneficence, Nonmaleficence, Professional-Patient Relationship, and Respect for Autonomy. Study participants' autonomy can be respected only when all other principles have been addressed before PALS are approached to participate. Five 'red flags' are identified, which, if present, might indicate a risk that PALS may be exploited. PALS who are contemplating new treatments or clinical trials and their families will be assured that their best interests are the only ones that matter whenever adherence to established ethics principles and avoidance of known pitfalls are made explicit.