However, the applied treatment protocols and procedures received ethical clearance from the national ethics committee (authorisation N°059/CNE/DNM/08) as they were submitted for a trial that was nested within the programme described in this paper (NCT00744458, unpublished).
This meant that no approval was required by the ethics committee nor any authorisation by the commissioner for data protection by the national and cantonal laws nor were these recommended by the medical-ethical guidelines for scientific integrity of the Central Ethics Committee and the Swiss Academies of Sciences.
Therefore no approval was required by the ethics committee nor any authorisation by the commissioner for data protection by the national and cantonal laws nor were these recommended by the medical-ethical guidelines for scientific integrity of the Central Ethics Committee and the Swiss Academies of Sciences.
Ethics approval was obtained for hPSCs (authorisation 09/H0306/73 and 08/H0311/201) and hESCs were imported under the guidelines of the UK Stem Cell Bank Steering Committee (authorisation SCSC10-44).
Approval was obtained from the University of Geneva "animal experimentation ethics committee" (protocol number 10 11) and formal authorisations (numbers 31.1.1027/3263/1 and 31.1.1027/3576/2) were obtained from the State and Federal authorities.
Access privileges to the EPR for scientific or any other use should, however, follow a clearly defined authorisation process approved by a local ethics committee and should require informed consent of the data subject with regard to a clearly defined purpose.
The study also has received approval from the Confidentiality Advisory Group CAGG) Ethics and Confidentiality committee (ECC 8-04(C)/2013), which provides authorisation, on behalf of the Secretary of State, to lawfully hold identifiable data on patients without their consent.
The study received ethical approval from the Oxfordshire Research Ethics Committee A, the approval is available as supporting information Ethics Approval Letter S1; and was conducted under a Clinical Trial Authorisation from the MHRA.
RSV001 has clinical trial authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) and ethics approval from NRES Berkshire (reference 13/SC/0023).
In France, authorisation is required from a judge if an ethics committee rules that the research imposes serious risks to the participants.
