Ethics Committee

Support and procedures

Chaired by Professor Pierre-Jean Weiller, the AMU Ethics Committee, composed of a societal college and a medical college, has the task of reflecting on the ethical issues raised by the research protocols presented. Its role is to offer a concrete evaluation of the ethical conformity of research projects carried out by AMU's scientific community.

The Ethics Committee gives a written opinion on the research protocol submitted for evaluation.

Research work associated with master's and doctoral theses may be submitted to the Ethics Committee. These projects must be supervised by the scientific supervisor ( PhD holder) who will be the principal investigator.

Thevarious forms to be filled in for any request for an opinion from the Committee :

1-Patient information form
2-Consent form
3-Research project sheet Attention the State of the art part must be filled in carefully.
4-Information sheet for minor children

5-The questionnaire(s) if necessary.

Ethics and national legislation:

The law n° 2012-300 of 5 March 2012 relating to research involving the human person (known as the Jardé law) and its implementingdecree(decree n° 2016-1537 of 16 November 2016) define: the 3 categories of research and the functioning of the committees for the protection of persons (CPP).

You can already check if the subject of your research does not fall under category 3 of the Jardé LAW - Order of12 April 2018 establishing the list of research mentioned in 3° of Article L. 1121-1 of the Public Health Code - therefore within the competence of a CPP:

Once the account is activated, you will receive an email with your accesses to the WEB service and you can proceed to the creation of a research file with all its attachments to be submitted for notification to a CPP.

For any research project, you will also be asked to provide the unique registration number of the research (EUDRACT number for interventional research on a drug, or ID-RCB number provided by the ANSM for all other research), as well as the title of the research.

You will submit your research dossier to the draw once you have submitted all the documents making up the dossier ( refer to the decrees setting out the content and methods of presentation of the application for an opinion).

Once you have clicked on the "draw" button, you will receive an e-mail message indicating the PPC drawn. The RIPH IS will be the interface to communicate with the designated PPC.

You can only request the designation of a PPC once per research project.

Requests for subsequent substantial modifications are addressed to the CPP having decided on the initial project always through the interface of the SI RIPH.

Requests for reconsideration of your project or requests for substantial modifications of your project by another CPP, following an unfavourable opinion from the PC will also be filed on this interface.

The European Data Protection Regulation in force since May 2018 DPMR imposes the appointment of a DPO in universities.

Mr Hervé Isar, Professor of Universities is appointed Data Protection Officer for AMU.

Please declare all your research using personal data to the DPO by email with the title of your research in the subject line.

Contact: herve.isar@univ-amu.fr