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Instances

The Ethics of the Medical Research Internal Committee (EMRIC)

 

Missions

 

  • Within the current framework of the law, CIER issues an ethical review of research protocols that are not under the jurisdiction of a Patient Protection Committee (PPC): observational research protocols, non-interventional studies, or projects not corresponding to the clinical trials defined by law.
  • Projects must be related to the healthcare field and care of patients or emanate from the FMM,
  • To give opinions or recommendations on general issues related to ethics of medical research,
  • Dissemination of information about the regulations in the field of ethics of medical research.
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Members

 

Full members :
 

  • President of the Medical Commission of the GHICL and /or his or her representative,
  • The Dean of the Faculty of Medicine and Midwifery and/or the Vice Dean in charge of research,
  • The head of the medical research department (DRM)  and/or his or her representative,
  • The director of the Center for Medical Ethics (Ethics Department) and /or his or her representative.

 

Persons designated by other authorities :

 

  • A permanent and qualified medical expert appointed by the DRM and /or his or her representative,
  • A  midwife and /or his or her representative,
  • A GHICL psychologist and/or his or her representative,
  • A lawyer and /or his or her representative.

 

Members of the committee of relations with users and the quality of care :

 

  • A representative of users and quality of care committee and /or his/her representative.

 

People invited : Depending on the issues, experts or qualified people may be invited.

 

The Department of Medical Research has submitted 48 projects to the CIER:  27 received positive feedback, 7 received negative feedback and 14 are under review.

The National Commission for Information Technology and Liberties (NCIL)

 

Clinical studies are not only governed by the code of public health, but also must follow regulations on responsibility for carers, established by the CNIL, and must ensure the protection of personal data (data protection correspondent (DPC)). The DPC ensures the compliance with the legislation and regulations.

 

A computer science and freedom correspondent (CIL) has been appointed for those employees involved in medical research. The CIL makes it possible to guarantee compliance with the law and freedom of information regulations.

 

The use of data for medical research is allowed after compliance with the following regulations:  

 

  • The patient must be informed of the purpose of medical research;
  • A table of correlation should be created in order to safeguard the identity of the patient and the sample number used in the context of research;
  • The conditions of security and privacy must be guaranteed while processing health data.

 

For the purposes of medical research, data collected during consultation or hospitalization may be used under strict confidentiality, unless otherwise objected to, for medical research purposes. Patients may at any time oppose the use of their health data by contacting the doctor responsible for them at the GHICL.

 

In accordance with the Data Protection Act (modified January 6 1978), patients have the right to access their personal medical data by contacting our Computer and Freedom of Information Correspondent at the following email address : correspondant.recherche@ghicl.net.

 

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