Discover Université Grenoble Alpes

How CERGA Operates

CERGA accepts applications from September through June, except during its December closure.

CERGA would like to draw your attention to the fact that if a research protocol falls under the Jardé Law (see Articles L. 1121-1 et seq. of the Public Health Code), it would require the approval of a human subjects protection committee (CPP) even before it is implemented. It is therefore the responsibility of researchers to comply with the legal provisions.

Furthermore, researchers are also responsible for complying with their legal obligations regarding data protection, the certification of research facilities, and public health measures (such as those related to COVID-19).

We would like to draw your attention once and for all to the fact that CERGA does not issue ethical approval to begin research, but only as an advisory opinion. Furthermore, if your research is likely to be affected in any way by the Jardé Act, you must obtain a favorable opinion from a CPP before beginning your research. This opinion will then serve as authorization. Under no circumstances may CERGA issue an authorization.
 
Applications should be submitted on an ongoing basis, and decisions will be made as soon as possible. Applications are processed by the CERGA office in the order in which they are received. They are then reviewed by two rapporteurs and discussed collectively by the committee during committee meetings. The committee issues its opinion by a vote. CERGA members meet seven times a year.

You may submit only one application to the committee at a time, and you must wait until you have received a decision before submitting another application to the committee. However, in exceptional cases, you may contact the CERGA office at cerga@univ-grenoble-alpes.fr to ask whether it is possible to submit a second application. The office will respond based on the number of pending applications and the waiting times.
 
Only the principal investigator (and not a doctoral student, postdoctoral fellow, etc.) may submit an application. The principal investigator may be summoned to appear before the committee to clarify any ambiguities regarding the protocol. He or she may be represented by a co-investigator (but not by a student).
 
CERGA's operations are governed by a set of regulations.
Download the CERGA Bylaws (February 2022 version)

Submit an application and request CERGA's advisory opinion on a research protocol

1. Check the following points beforehand:

• Who submits the project? The project leader, who must be a tenured staff member (researcher, faculty researcher, research engineer, etc.) at the research laboratories on the Grenoble Alpes campus, and not a doctoral or postdoctoral student or an undergraduate student. To facilitate communication, CERGA reserves the right to invite the principal investigator (or a representative holding a Ph.D.) to attend the bimonthly committee meetings.
• CERGA does not evaluate prospective non-RIPH research studies that have already begun. A research study is considered prospective when you will recruit and evaluate or follow individuals (patients or healthy participants) to conduct your research.
• Due to a lack of resources, CERGA is unable to conduct an ethical review for all non-RIPH research with an educational purpose (particularly in health education). We remind you that the law does not require ethical approval for non-RIPH research. The committee therefore encourages you not to submit your research but to use its guide and form to help you conduct your research in accordance with ethical best practices. However, if you believe that this educational research raises significant ethical issues, please do not hesitate to contact us for advice or to submit your research to CERGA.
• GDPR Compliance: CERGA is not responsible for directly assessing GDPR compliance (see the Data Protection Officer: dpo@grenet.fr), but it alerts you to your legal obligations and draws your attention to certain related issues.
• CERGA does not rule on research projects or on the portions of research projects that take place outside French borders. Consequently, when participants are physically present during the research or are recruited by a partner abroad, CERGA does not rule on that portion of the research protocol. In such cases, it is up to the partner to seek approval from the local ethics committee. However, to ensure that all research can, as far as possible, benefit from an ethical review, two exceptions may be made. In the case of research conducted entirely or partially outside French borders, CERGA may consider issuing an ethical review when:
  • The country where the research is being conducted does not have an ethics committee, and neither the partner nor the French researcher has been able to find an ethics committee familiar with the relevant field.
  • The research is conducted online and involves participants whose country of recruitment is difficult to determine.

2. Put together your application:

• Please follow the most recent submission guidelines.
  Download the submission guidelines (January 2025)
•  Please submit your application in Word format so that the experts can work directly on the document (however, if you do not want to include your signature and that of your academic unit in the Word file, you may send us that page as a PDF). 
• Do not send your applications to individual addresses! The project leader should email the application to the CERGA office atcerga@univ-grenoble-alpes.fr(this email is restricted to authorized recipients and ensures the confidentiality of the information sent).
•  Applications are processed in the order they are received. We encourage you to submit your application as they become available.
• Please note: If the project manager does not respond to a reminder email from CERGA within two months, the committee reserves the right to permanently close the case.

Possibility of amending a bill that has already received a favorable opinion

A project that has received a favorable opinion and is being implemented again may be subject to an amendment. In such cases, the CERGA Executive Board may decide to extend the favorable opinion to the new implementation.
 
The changes are divided into two categories.

Substantial/Major Changes

These are changes that may affect:

• The scientific validity of the study.
• The methodological validity of the study.
• The safety and rights of participants.
• The conditions under which the study was conducted.

These amendments are reviewed by two rapporteurs.

Non-substantial/minor changes

• Extension of the study period.
• Inclusion of more participants.
• Addition of an additional, risk-free test on the same individuals as those originally planned.

These changes are reviewed by a member of the Executive Committee.

The project sponsor should email the CERGA office at cerga@univ-grenoble-alpes.fr :

• A letter in which he explains the changes made to the project and to what extent they do not alter the nature of the protocol.
• The original document, in which he has made the changes in a way that makes them stand out (different color or highlighted).

CERGA Members

CERGA is composed of volunteer members, whose number and expertise reflect the diversity of the disciplines involved. In terms of data protection expertise, the committee is supported by data protection officers (DPOs) from the UGA. In terms of legal expertise, the committee is supported by a lawyer from the UGA’s “Law and Science” research group.