The questionnaire and the informed consent (Mod 97 SL) are filled in full respect of the donor’s privacy. They are generally filled in before surgery, so to highlight non-suitability for donation or if the patient has not given consent to donation. For underaged patients, the informed consent must be signed by the parents or legal guardian.
The donor is reassured that all their details are going to be handled with the highest care and respect of privacy policies. The anonymity is guaranteed through the attribution of unique reference numbers to track the tissues after procurement. The expert in charge of the information process must guarantee the donor a thorough explanation of donation and procurement procedures:
- purpose and nature of the procurement along with the reasons for which donors are required to fill in a questionnaire and provide as much information as possible on their clinical history and the biological screening of the tissue
- explanation of the terminology: informed consent, self-exclusion and exclusion
- risk, consequences and useful information on infectious diseases transmittable via tissues, including symptoms of HIV/AIDS and hepatitis infections
- reasons for donor’s unsuitability and possible risks for the recipient
- mandatory screening and free access to the donor’s clinical history
- information on donation procedures and the therapeutic benefits for the recipients
- the donor is encouraged to ask questions
- the donor can withdraw from the decision to donate if they change their mind
- Privacy and protection of sensitive data
- Doctor-patient confidentiality
- Reassurance that in case of exclusion criteria, the donation will not be carried out
Please note that it is recommended to communicate promptly to the donor the unsuitability of the donation.
The trained expert for the informative protocol must be able to answer all the donor's questions.