Submission Requirements for RNEC Review
For a thorough and complete review, research proposals must be submitted through the RNEC RhInnO Platform at least 15 working days before the scheduled meeting date.
Pre Submission Checklist
Before submitting your research protocol for RNEC review, please ensure the following:
1. Review the submission calendar
Confirm that your protocol aligns with the Review Calendar.
Submissions received after the deadline will be deferred to the next review meeting.
2. Prepare all required documents
The required documents depend on the type of submission - Clinical Trial, Nonclinical Research, Protocol Amendment, or Continued Review/ Annual Renewal. Typical documents include:
• Submission Forms - mandatory for all submissions
• Study Protocol - complete and using the correct template
• Consent and Assent Forms - all required versions
• Data Collection Tools and Questionnaires
• Translated Documents - if applicable
• CVs of Investigators - aligned with the RNEC template and signed
• Proof of Payment - as required (see Fee Structure)
The complete list of required documents is provided in the relevant SOPs and submission forms.
Initial Submission – Clinical Trial
Before submitting your Clinical Trial Protocol for Initial Ethical Review, ensure your submission aligns with the requirements in the Submission SOP (REV01), the protocol template, and the required forms:
• Clinical Trial Protocol Template (P1)
• Clinical Trial Submission Form (S1)
• Informed Consent Form Templates
• Investigator’s CV Template
The review steps are described in the Standard Full Committee Review SOP (REV03).
Initial Submission – Non Clinical Trial
Before submitting your Non Clinical Study Protocol, ensure your submission aligns with the Submission SOP (REV01), the protocol template, and the required forms:
• Non Clinical Trial Protocol Template (P2)
• Non Clinical Trial Submission Form (S2)
• Informed Consent Form Templates
• Investigator’s CV Template
The review steps are described in the Standard Full Committee Review SOP (REV03).
Protocol Amendments
Before submitting a Request for Protocol Amendments, ensure your submission complies with the Amendment SOP (PAC02) and includes:
• Amendment Request Form (S4)
Amendments are categorized as Administrative, Minor, or Major. Review timelines and applicable fees vary by amendment level and study type. Incomplete or incorrectly prepared submissions will be returned to the Principal Investigator, potentially delaying the review.
Annual Renewal – Continuing Review
Before submitting your protocol for Annual Renewal, ensure your submission aligns with the Annual Renewal SOP (PAC01) and includes:
• Annual Renewal Request Form (S5)
• Study Progress Report Template (S6)
Incomplete or incorrect submissions will be returned to the Principal Investigator.
RNEC Review Categories
RNEC offers several types of ethical review depending on the level of risk and the nature of the research. Requirements for each category are detailed in the corresponding SOPs:
• Full Board Review (REV03)
• Expedited Review (REV04)
• Exempted Review (REV05)
• Emergency Review (REV06)
• Accelerated Review (REV07)
For guidance on which review type applies to your study, consult the RNEC Eligibility Criteria or contact the RNEC Secretariat.