For the preparation of its opinion, the Ethics Committee shall consider the following:
- the importance of the clinical trial and the trial design;
- whether the evaluation of the anticipated benefits and risk is satisfactory and whether the conclusions are justified;
- the protocol;
- the suitability of the investigator and supporting staff;
- the investigator's brochure;
- the quality of the facilities;
- the adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent as regards the specific restrictions;
- provision for indemnity to cover the liability of the investigator and sponsor;
- the amounts and where appropriate, the arrangements for rewarding or compensating investigators and trial subjects, and the relevant aspects of any agreement between the sponsor and the site;
- the arrangements for the recruitment of subjects.
The Ethics Committee shall then have a maximum of 60 days from the date of receipt of a valid application to give its reasoned opinion to the applicant and the competent authority in the Member State concerned.
Within the period of examination of the application for an opinion, the Ethics Committee may send a single request for information supplementary to that already supplied by the applicant.
There will be no extension to the 60-day period shall be permissible except in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. In this case, an extension of a maximum of 30 days shall be permitted. For these products, this 90-day period may be extended by a further 90 days in the event of consultation of a group or a committee in accordance with the regulations and procedures of the Member States concerned. In the case of xenogenic cell therapy, there shall be no time limit to the authorization period.
For multi-center clinical trials limited to the territory of a single Member State, Member States shall establish a procedure providing, notwithstanding the number of Ethics Committees, for the adoption of a single opinion for that Member State.
In the case of multi-center clinical trials carried out in more than one Member State simultaneously, a single opinion shall be given for each Member State concerned by the clinical trial.
