INSTRUCTIONS


  1. Download the file "Research protocol format" available at the following link link.
  2. Download the file "Statement of the researchers" available at the following link link.
  3. Download the file "Personal Data Sheet" available at the following link link.
  4. Edit the required fields and save the files in PDF format.
  5. Create a zipped file containing the above mentioned documents and if necessary, add some complementary elements for the review (e.g. Application Instrument, Biotherium Approval Opinion, Informed Consent, etc.). Download here an example.
  6. Attach the file generated on the Research Protocol Submission Form.

RECOMMENDATIONS FOR FILLING OUT THE FORM


  1. All research projects submitted for evaluation by the Research Ethics Committee or the Research Committee must comply with the established format.
  2. All projects must conform to the required spaces, which are designed to expedite project review.
  3. If any section does not apply to a particular study, please indicate it.
  4. It is essential that the sections on ethical considerations and the breakdown of resources required for the study are always completed.
  5. In case of research studies in humans, the letter of Informed Consent must always be attached.
  6. Any new instruments, such as questionnaires, etc., to be included in the study should be attached to this form.
  7. It is essential to note the type of risk involved in the research, which should be considered in accordance with Art. 17 of the REGULATIONS of the General Law of Health on Research for Health.
    • Research without risk.
    • Research with minimal risk.
    • Research with higher than minimal risk.