Please always send a cover letter in an editable format (mandatory requirement) to the email address: aneta.skowron@nio.gov.pl and, if possible, attach a USB drive with the recorded study documentation to the paper documentation.

Please include in the cover letter (mandatory requirement):

• study protocol number
• original opinion number assigned by our Committee
• details of the principal investigator
• details for issuing the invoice and the address to which the original opinion of the Bioethics Committee should be sent

When submitting documents, please pay special attention to:

• composition of research teams – complete, including pharmacist, radiologist, nurse, and researchers' specialisations
• attaching the head of unit's consent if the principal investigator does not hold this position
• providing detailed contraception methods in the Patient Information
• separate consents for additional studies – with space for the patient's signature
• confirmation of treatment of complications in centres without hospital facilities

When paying the invoice, please include the protocol number or the Bioethics Committee opinion number in the transfer title.

Amendments will be considered separately, and a separate fee will be charged for each.

Due to technical limitations, please send a paper version of adverse events reported by email.

The Bioethics Committee does not mediate in contacts between the Local Bioethics Committee and the Sponsor regarding payments.

Note: documents should be submitted both in paper form and electronically to the address: aneta.skowron@nio.gov.pl or komisjabioetyczna@nio.gov.pl.