Table 1

Comparison of the WMA’s Declaration of Helsinki,59 the CIOMS‘s International Ethical Guidelines for Health-related Research Involving Humans21 and Chile’s Law 20.85016

WMA, Declaration of Helsinki (2013)CIOMS, International Ethical Guidelines for Health-related Research Involving Humans (2016)Chile’s Law 20.850
(2015)
Compensation for research-related injuries
Article 15
‘Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured’.
Guideline 14
‘Sponsors and researchers must ensure that research participants who suffer physical, psychological or social harm as a result of participating in health-related research receive free treatment and rehabilitation for such harms, as well as compensation for lost wages, as appropriate. Such treatment and compensation are owed to research participants who are harmed physically, psychologically or socially, as a consequence of interventions performed solely to accomplish the purposes of research, regardless of fault’.
Article 111 E
The sponsor ‘will be liable for injuries caused by the study, even when they result from facts or circumstances that could not have been foreseen or avoided according to the technical and scientific knowledge available at the time the injuries were produced. Moreover, once the injury is confirmed, it will be presumed that it was produced by the study. The opportunity to prosecute the responsible will expire ten years after the injury manifests’.
Article 111 F
Sponsors ‘will be obliged to have civil liability insurance, in accordance with the regulations dictated by the Ministry of Health…’.
Post-trial access to treatments
Article 34
‘In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial’.
Guideline 6
‘When participants’ health needs during and after research cannot be met by the local health infrastructure or the participant’s pre-existing health insurance, the researcher and sponsor must make prior arrangements for adequate care for participants with local health authorities, members of the communities from which persons are drawn, or nongovernmental organizations such as health advocacy groups … When access is provided after the research to investigational interventions that have demonstrated significant benefit, the provision may end as soon as the study intervention is made available through the local public health-care system or after a predetermined period of time that the sponsors, researchers and community members have agreed before the start of a trial’.
Article 111 C
‘Clinical trial subjects will have the right, once the trial is over, that the [sponsor] … continues to provide the [investigational or, at a later, point, the licensed] treatment free of charge and for as long as its therapeutic utility remains, according to the respective research protocol’.
  • Excerpts from Law 20.850 have been translated by BA. To date, there are no procedural rulings on Law 20.850 that could provide further context for its interpretation.

  • CIOMS, Council for International Organizations of Medical Sciences; WMA, World Medical Association.