Concept du programme
Project coordinated by Christian Hervé
« Ethics and cancer » is a multidisciplinary program aiming to study the patient-caregiver relationship. On the one hand, we have a patient with his psychological and social representations; the patient-caregiver relationship in oncology is so complex and ambivalent that it often goes beyond simple, clear data transmission (J. T. Ptacek et al., JAMA 1996). On the other hand, in an evidence-based medical system, decision-making is almost uniquely based on clinical guidelines. There is often a need for healthcare professionals, to alleviate the violence of their own words when informing patients about their diagnosis or the progress of their disease (A. M. et al., The BMJ 2000). As most cancer-related information – at every stage of the disease- is experienced as a deadly, or lethal shock, the way information is delivered has become increasingly important as part of the treatment itself (N. Alby E. d. temps, 1995). A “therapeutic ”approach of “the ways to tell things” in the cancer field has to include an analysis of the understanding and expectations of patients.
Introducing ethics into the patient/caregiver relationship opens a pathway for better, personalized medicine. The “ethics and cancer” program explores different approaches in different locations: colorectal, head and neck, haematology, kidney, lung cancers.
This program 3 will benefit from the creation of 2 committees in the framework of the CARPEM program, “a committee of ethics and assessment practices in cancer translational research” and “a committee of patients”. These two committees will work on the ethical dimension of the research programs and will likely generate novel studies.
The debate generate through the interaction between these 2 committees, which will be described in the governance chapter, is an important part of this program allowing to integrate the ethics in the 2 others research programs. The annual report of the committee of ethics and assessment practices in cancer translational research will highlight the emergence of new questions on relations between researchers / patients and civil society on personalized medicine, that must be studied by team 19.
Three major topics will be addressed as follow:
(1) The presentation and clarification of translational research protocols to inclued patients
We need to set up and validate a method of communication and a content that can properly reflect the interest but also the limitations and risks associated with translational research. For exemple the following list of items can be debated:
- presentation of methods used in the protocols
- presentation of the expected results, which are possibly direct or indirect, immediate or delayed, Indeed, aggregation of data from different omics studies may lead to delayed results,
- presentation of the assumptions on risk and expected benefits (ie relative risk and absolute risk),
- presentation of statistics and assumptions tested.
(2) Biological collections
We need to deal with that omic studies require the collection of tissues in greater quantities than usual, justifying a higher number of biopsies.
We have to justify and explain:
- the risk associated with increase number of biopsies,
- the research assumptions in relation with expected benefit at the individual or population level, – the biological collection of data with a specific mention for genetics data (anonymisation ro pseudoanonymisation).
(3) Information Systems
They require a clarification in the management of personal and collective data. The conditions of access, operation and data transmission to national and international database should be explained and debated with patients involved in research.