The Ethics Committee
The Ethics Committee is a group of people responsible for ensuring respect for human rights, the security and well-being of patients throughout the clinical trial.
It may be specific to the institution or then independent.
Consisting of physicians, statisticians, lawyers, experts but also lay people in the field, which ensure that a trial is ethical and respects the rights of participants included in the study.
Must be present in the file submitted to the Ethics Committee:
– The detailed protocol of the study.
– A presentation of the state of current knowledge on the product studied.
– Informed consent form presented to potential participants.
– Presentation of investigator and research center skills.
– Advertising material (s) of the clinical trial (if available).
The Council of the College of Physicians
The mission of the College of Physicians is expressly defined in Article L.4121-2 of the Code of Public Health:
“The college of physicians maintains the principles of morality, integrity, competence and dedication necessary for the practice of medicine, and the observation by all its members of the professional duties and rules enacted by the code of conduct under Article L.4127-1.
It ensures the defense of the honor and independence of the medical profession.
It can organize all assistance and retirement services for the benefit of its members and their dependents.
It accomplishes its mission through the county councils, regional or interregional councils and the national council of the college. ”
It has several roles:
Moral: design and drafting of the code of medical ethics, with regular updates, given the constant evolution of the profession.
Independent, it defends the interests of patients and moral interests of the profession.
Administrative: It handles thus, the update of the table on which can be present only doctors meeting the legal requirements of morality and required skills. It controls contracts and has a monitoring function of the conditions of professional practice. It is itself controlled by the State Council.
Judicial: Doctors can indeed be tried or punished by their peers to the Disciplinary Chamber of first instance and on appeal to the National Disciplinary Chamber of Appeal, presided over by a Counselor of State, Member of the council of College. The standard rules are the provisions of the Code of Public Health under the responsibility of the State Council.
Advisory: It may be asked to give its opinion on draft laws or decrees.
National Security Agency of Medicines and Health Products (ANSM)
The National Security Agency of Medicines has been put in place in May 2012, replacing the AFSSAPS, the French Agency of Sanitary Safety of Health Products. This is a public institution under the Ministry of Health.
It has several roles:
Evaluation of the risk / benefit ratio associated with the use of health products at all stages of their life cycle.
Evaluation of the security, efficiency and quality of health products (medicines, components, medical devices, biological products …).
Monitoring of clinical trials concerning the monitoring of patients and collection of efficacy and tolerance data.
Framework of prescriptions out of AMM.
Control of advertising, information of patients and professionals.
Sanction for drug manufacturers or medical devices in case of breach of duty.
Decisions on health regulation to reconcile patient safety and access to therapeutic progress.
The National Commission for Data Protection and Liberties (CNIL-France)
The National Commission for Data Protection and Liberties must ensure that “IT is at the citizen service and that it does not affect the human identity, or human rights, or the privacy, or individual or public liberties.”
It is an independent administrative authority.
Information: informing people about their rights and obligations.
Regulation: identification of processing files and permissions depending on their characteristics.
Sanction: Sanction of structures not meeting their obligations.
Protection: Protecting the rights of citizens in different areas: work, consumption, and internet.
Control: monitoring of compliance with the Data Protection Act.
Anticipation: monitors technology evolution and future trends.
In clinical trials, the CNIL ensures compliance with patient rights and in particular that of anonymity. It thus made available to clinical trial promoters a reference methodology (RM-001), established in consultation with the Advisory Committee on Information Processing in Research in the field of Health.
CNIL provides access to simplified procedures to all promoters pledging to conduct trials respecting this methodology.
This methodology regulates the processing of personal data of the patients but also the one of the doctors investigators:
Data collected directly from patients or doctors.
Strict enumeration of treatment functions, categories of persons qualified to implement them, and those who have access to this data.
Obligation of information and consent collect of people.
Establishment of a data retention period.
Only anonymous or coded data can be transferred.
Promoters must be in accordance with this methodology at the completion of their trial.
For non-interventional studies, a complete file is required for obtaining a favorable opinion.
Advisory Committee on Information Processing in Research in the field of Health
The Advisory Committee on Information Processing in Research in the field of health is requested to give its opinion on the “relevance of personal data in relation to the objective of the research “.
It comes ahead of the consultation of the CNIL.
For non-interventional studies, a complete file is required in order to obtain a favorable opinion.
You can also visit the website of Pharmaspecific, www.pharmaspecific.fr and learn more about our activities.
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