Ethical Review Process by Ethics Committees

3. Documents To Be Reviewed By RECs

The nature of research projects varies from one project to the next. Ethics evaluation practices also evolve over time. Hence, it is difficult to establish a definitive list of documents that the REC needs to conduct a full evaluation. Given the nature of ethics evaluation, the REC may ask to be provided with any document it considers important.

The REC must review:
  • The protocol,
  • The investigator's brochure,
  • 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 laid down in Article 3, 2001/20/EC,
  • Provision for indemnity or compensation in the event of injury or death attributable to a clinical trial,
  • Any insurance or indemnity to cover the liability of the investigator and sponsor,
  • The arrangements for the recruitment of participants.
For a full list of the review process and timings please refer to Article 6, Directive EC 2001/20/EC.

The ICH-GCP provides specific guidance on the content of protocols for clinical trials. To ensure it receives information on precise aspects of research it evaluates, the REC may want to request specific information in their submission forms. For example, a submission form may ask for:
  • A summary of the protocol in non-technical language.
  • A summary of potential benefits.
  • A description of the ethical considerations.
  • A description of the recruitment process and of the consent process.
  • Actions that may be required by national law.