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Informed Consent

Informed Consent

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Vascular indipendent research and education

Informed consent for collection and conservation of biological and genetic material

“VAS – European Biobank on Vascular Diseases (VAS-EBVD)”

Subproject: __________________________________

The undersigned ……………………. Born in …………………………….. on …. / … / …….. and resident in ……………………………. Country …………………………… Postal code ………….. address ………………………………………… tel …………………………………………………. Email: …………………………..@…………………………………….
After being properly informed of the Sub-project …………………………….………………….. by means of visit by dr. ………………………………………………….. from the centre [name of the collecting centre] and informative material from VAS that:

- the blood collection will cause no harm to my health,
- the collected biological material can be stocked at the VAS-EBVD-Biobank’s biorepository or, also, at other biorepositories according with the necessities of the research;
- the samples can be used for further investigations for a goal which must be exclusively diagnosis and research, in any case it can never be use for-profit;
- anonymity and reservation on the origin of the samples and its investigations will be granted;
- every useful action will be taken to grant the sample’s anonymity, however VAS and the EBVD-Biobank cannot be considered responsible for every damage or accident which could happen to the stocked samples;
- my consent to the sample storage and their use can be withdrawn at any time and for any reason. My samples and related data can be destroyed on request and will not be used for any investigations after the date of the receipt of my communication by the Biobank. These choices will have no negative outcome to my medical assistance;
- the results of the study will be made accessible, as scientific and statistic articles, by the scientific community even to investigate new drugs, techniques of investigation, diagnosis and therapy;
- the results of the surveys can be shared with the population and patients’ groups in anonymous form;
- My samples and the related clinical and personal information will be treated by researchers and personnel in charge respecting my privacy and can be shared in anonymous form with other researchers, based on my consent, according to the law and based on VAS’ authorisation.

In complete liberty and without any constriction declares to:

1. [ ] authorise [ ] not authorise
the conservation, according to the previously specified modalities, of the biological sample

2. [ ] authorise [ ] not authorise
the possible use of this material for studies and researches

3. [ ] authorise [ ] not authorise
that my samples and the related clinical and personal information will be treated by researchers and personnel in charge respecting my privacy and can be shared in anonymous form with other researchers, based on my consent, according to the law and based on VAS’ authorisation.

4. [ ] have been [ ] have not bee
informed about the possibility to withdraw my consent at any time and for any reason

5. [ ] have had [ ] have not had
enough time to properly read and understand the supplied information

6. [ ] have had [ ] have not had
the opportunity to ask for details and explanations regarding the project and its methodologies

7. [ ] have received [ ] have not received
detailed and exhaustive information regarding the project and its methodologies by dr. ……………

8. [ ] have been given [ ] have not been
given the opportunity to ask any questions I considered necessary

9. [ ] have received [ ] have not received
detailed and exhaustive answers to any question I have asked

10. [ ] have asked [ ] have not asked
the opinion of my GP or of any other person I trust (if answer is “have asked” skip to n. 12)

11. I did not ask for any other person’s opinion because I considered it not necessary. [ ] true [ ]false

12. [ ] have been told [ ] have not been told
that I can ask information regarding the progress of the project at any time

13. [ ] have been given [ ] have not been given
the name of dr. ……………………. as my referee for any question and/or clarification concerning the project.

14. [ ] have been given [ ] have not been given
copy of the Informative and of this Informed Consent

15. [ ] have had [ ] have not had
the time and the information to make an informed and conscious decision

Date ………………………… Signature ……………………………..

The undersigned …………………………… explicitly confirms to be taking part in the project freely, without any constriction, and having fully understood the risks and benefits that it implies.

Date ………………………… Signature ……………………………..

The undersigned …………………………… also explicitly declares to:

[ ] authorise [ ] not authorise
the researches on familiarity.

Date ………………………… Signature ……………………………..

I, undersigned dr. ……………………………, certify that Mr/Mrs ……………………………… at the moment when he/she read the here attached Informative sheet and affirmatively answered to the here above questions and accepted to take part in the project had clearly understood the information provided and was able to make an aware and fully conscious decision.

Name of the doctor collecting the consent ……………………………………………
Signature of the doctor collecting the consent ……………………………………….

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