ETHIC ISSUES ACCOUNTING THE INCLUSION OF PERSONS IN THE END OF LIFE AS SUBJECT OF SCIENTIFIC INVESTIGATION

FARIAS GISELA; DRAN GRACIELA

BARCELONA

Conferencia; EUREC-ANCEI joint Conference; 2017

EUREC-ANCEI

Maximum length will be of 3.000 characters (with spaces included)Research with human subjects close to the end of their lives (EOL) represents a controversial field. We aim to point out major obstacles that we have faced when developing cancer investigation involving EOL patients in a Palliative Care (PC) Unit. Our interest is to reflect on situations that may determine the insufficient inclusion of this highly vulnerable population in research protocols and to contribute to an improvement of the work of the Research Ethics Committees (REC). The EOL patient is undoubtedly a special case of research subject, and exhibit unique characteristics. For example, they present multiplicity of symptoms of different nature and require extensive and profound interviews. It is important to create an emotional connection between the professional and the patient/ family. Information to be given often contains unfavorable prognostic elements, such as the proximity of death or non-viability of curative treatment. There is a great concern for suffering, given that devastating symptoms like dyspnea, pain and existential angst are highly frequent. They may be more inclined to create excessive or unrealistic expectations.We are currently carrying out many research protocols aimed at documenting the efficacy of PC interventions for the management of EOL patients with advanced cancer. In the development of these apparently simple, observational and descriptive studies, we found important bioethical difficulties. Due to the requirement to provide the information properly, the Informed Consent (IC) demanded a large number of pages and extension, which countered with the effective capacity of understanding of patients/caregivers at this stage. Providing the information clearly also required the inclusion of data that could affect patients' preferences about knowing their diagnosis or prognosis. The first interview is usually the moment of generating a professional/patient trust relationship, but it is also when patients are invited to participate in the research protocol, which caused a dissonance between the role of the health care provider and that of the researcher. Finally, fears or apprehension about benefits/disadvantages of treatments were frequently developed. In this context, there are certain considerations that a REC that is going to analyze a research protocol involving EOA persons should take into account.1- At the ethical level, consider developing ICs of limited length, reviewing the relevance and extent of information required, and the convenience of including expressions like "cancer", "EOL care" and "death". 2- At the methodological level, consider the inconvenience of including these subjects in first-line protocols; evaluate the feasibility of longitudinal cut studies or those requiring a large sample size. 3-The research team should be interdisciplinary, and preferably should have training in PC. 4- A singular risk-benefit balance should be done, since parameters change significantly in patients who are near death.