Other studies

How is the responsible ethics committee determined?
The “responsible ethics committee” is the ethics committee responsible for the head of the clinical trial (overall trial management).

As the overall trial manager, the head of the clinical trial is the central figure in a multicenter trial project. He or she is responsible not only scientifically, but also ethically and legally for the conduct of the trial.
The principal investigator submits the application dossier to the competent ethics committee. The committee reviews the study and issues its vote.
 

a) Once the vote of the responsible ethics committee has been received, the localstudy centers submit their notification dossier to the local ethics committees. The submission is usually made by the local study director.

b) Possible scenarios after submission of the notification dossier:

If the local ethics committee is already able to participate in the “1 study – 1 vote” procedure, it confirms receipt of the notification dossier – the study can begin at this center.
 

If the legal requirements are not yet met at a site, the local ethics committee will ask the study physician concerned to submit the application dossier previously submitted to the responsible ethics committee instead of the notification dossier.

The principle of “one study – one vote” will also apply to amendments to studies that received their initial vote before June 2024. The change will take effect immediately, where legally possible at the local level.
The commission responsible for advising on the amendment will also check whether the content of the AKEK documents agreed upon for harmonization since June 2024 has been observed and will reprimand any deficiencies.

The first substantive amendment automatically triggers the switch to “one study – one vote.”  The switch must be made, but only when a change to a research project is submitted. In particular, the switch must be made when a study center is registered retrospectively!
It must also be made when switching from a single-center to a multicenter study if the procedure was not used for single-center studies.
If no change is made, no change is necessary.
The former initial ethics committee becomes the responsible ethics committee and issues a vote.
This vote is accepted by the local ethics committees in the context of a notification. No special measures are required on the part of the local ethics committees – amendments can be notified according to the “one study – one vote” procedure (if necessary).

Documents that did not exist prior to harmonization may need to be requested. These include:

▪ Structured synopsis (study protocol A only)
▪ List of all study centers in Germany
▪ Declaration of suitability of study centers for new trial centers only

• Study protocol
  • Does the protocol still meet the current minimum requirements according to checklists A-D?
  • Does any information on the legal basis need to be adjusted?
• Information documents
  • Do the information documents comply with current requirements (based on the eTIC tool)?
  • Is the information on data protection still up to date?
  • Are all the necessary information documents available (children, adolescents, adults, legal guardians, etc.)?

• The role of the responsible commission can only be performed by a German commission formed in accordance with state law.
• If the overall study management is based abroad, a German overall study management must be designated for the submission.
  • This must be mentioned at least in the structured synopsis.
• The commission responsible for the overall study management in Germany is the responsible commission within the meaning of the “One study - one vote” procedure.