“The ethics of science regards the search for truth as one of the highest duties of man; it regards noble human character as the finest product of evolution; it considers the service of all mankind as the universal good; it teaches that human nature and humane nurture may be improved, that reason may replace unreason, cooperation supplement competition, and the progress of the human race through future ages be promoted by intelligence and goodwill.” were the words of the Biologist Edwin Grant Conklin as he wrote in the book “Thirteen Americans: Their Spiritual Autobiographies”. This quote stood as the cornerstone of our pursue of establishing morality as the of principles of our project and, maybe, standing up to the vision of our predecessors, as stated by Grant.
Given the nature of Hyperion as a diagnostic apparatus using samples of human origin, the team allocated significant resources in order to ensure that the project is in accordance with existing regulatory guidelines and ethical principles. Therefore, there was great interest in assessing all aspects that may matter the ethicality of our work.
Overall participants' wellbeing during the trial period were taken into consideration. It is for this reason that the team had opted to develop a trial protocol to be followed at all times before proceeding to any interventions and experiments. Additionally, this protocol had to be, as it did, approved by an independent ethics committee as such approval legitimizes the work of the team as a moral one. Points addressed in the document were the background and the purpose of our experiments, the design of the trial including population to be studied, the intervention and parameters to be taken into account, diagnostic factors, statistical analysis and evaluation of the results, assessment of the safety and risk, handling, evaluation and protection of the data and other documents, unfavourable circumstances , pause and termination of the trial as well as publication of the results and follow-ups.
For ethical and legal reasons we opted to include patients of the age of 18 years old and older with the proper mental capacity who had been fully informed about the project, its purposes and all procedures and have given their full consent to be observed and sampled. We also granted the patients the ability to be excluded and/or removed from the trial by their own free will and for any reason at any moment. Removal can be either complete with all data of the patient be deleted, not taken into further analysis and excluded from the study, under analysis with the patient being excluded only from observation, medium with the ability to be reincluded or absence during the trial. The reason and the reasoning behind any exclusion and/or removal had to be noted in order to reassess the trial's parameters and its relationship with the community, should the need occur. The trial was deemed as not a threat to the health, wellbeing and outcome of the included parties as it did not foresee any interventions to the patients or actions that include potential hazard to the health.
To ensure the integrity of the project in that matter, sampling was to be carried out by medically trained personnel in a clinical setting and under the appropriate hygienic conditions. Samples had to be handled by properly trained personnel with specialty in the field of the medical, pharmaceutical and biological sciences and privileged access to them.
Data derived from the patients and the analysis of the samples were safely stored and handled with respect and caution. The team followed all local and European regulations regarding data collection, storage and handling. Patients reserved the right to be forgotten as mentioned above.
All of the points and considerations mentioned above were extensively addressed in the trial protocol. However, in the unlikely event that any discrepancies should have occurred, the team were to handle the issue with internal mechanisms including reassessment of actions and decisions by a committee formed by high ranking members of the team, halt of all actions and briefing for our next moves and proper outside supervision and intervention by the independent ethics committee or a committee of the hospital hosting the sampling to which the researchers must immediately report in the event of a halt or any other circumstance that may threat the ethicality of the project, if necessary.