ANNEX C.2c: Documentation of consent

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Research participant's identity

This part will be filled in by the participant or his/her proxy.

The original will be kept be the investigator; a copy will be given to the participant.

Research participant's identity and the identity and dated signatures of the participant affirming that consent was given.

The information shown below identifying the participant should be entered in the designated spaces at the time of execution of the consent document.

Participant's Name: _________________________________

Participant's Birth Date: ___________________

Participant's Reference Number:____________________

 

CONSENT FORM

This part will be filled in by the participant. The original will be kept be the investigator; a copy will be given to the participant.

Title of the study:

Place of the study:

 

 

 

Please circle

as necessary

I was informed about the effect to be expected, about possible disadvantages and about possible risks verbally and in writing by the test leader of the study.

Yes

No

I was informed about the purpose of research, the expected duration and the procedures verbally and in writing by the test leader of the study.

Yes

No

I was informed about any benefits to me or to others which may reasonably be expected from the research.

Yes

No

I was informed about the explanations on confidentiality (and limits) of the data.

Yes

No

I was informed about the right to decline to participate and to withdraw from the research once participation has begun and the foreseeable consequences of declining or withdrawing.

Yes

No

I was informed about whom to contact for questions about the research and research participants rights.

Yes

No

I have read and understood the written information handed out for the study mentioned above. My questions in connection with the study have been answered satisfactorily. I can keep the written information and receive a copy of my written declaration of consent.

Yes

No

I had sufficient time to take my decision.

Yes

No

In case an incident arises contrary to expectation, insurance consists for me in the legally specified scale. The insurance was constructed by …………… for this study.

Yes

No

I have spoken to: Dr./Mr./Ms.

…………….

I understand that I am free to withdraw from the study

  • at any time
  • without having to give a reason for withdrawing
  • and without affecting my future medical care

Yes

No

I agree to take part in the study.

Yes

No

The confidentiality of my personal data was assured to me. Personal date will used anonymised at the publication of the study’s results. I approve of the fact however under a strict compliance with the confidentiality that the responsible experts of the authorities and the ethics commission may take a look for examining and control purposes of my original data.

Yes

No

If aftereffects appear, I will contact Dr./Mr./Ms.

…………………….. with the tel. no. ……………………….

Signed:

 

Proxy Name:

 

Relationship to participant:

 

Signature:

 

Date:

 

Name (in block letters):

Investigators' confirming statement

This part will be filled in by the investigator.

The original will be given to the participant; a copy will be kept by the investigator.

I have given this research participant information on the study, which in my opinion is accurate and sufficient for the participant to understand fully the nature, risks and benefits of the study, and the rights of a research participant. There has been no coercion or undue influence. I have witnessed the signing of this document by the participant.

Investigator's Name: ___________________________

Investigator's Signature:________________________________ 

Date: ____________________________

Research participant's identity (participant unable to read the form; to be provided in an appropriate alternative media e.g. large print, audiotape, braille)

This part will be filled in by the participant or his/her proxy.

The original will be kept be the investigator; a copy will be given to the participant.

Research participant's identity and the identity and dated signatures of the participant affirming that consent was given.

The information shown below identifying the participant should be entered in the designated spaces at the time of execution of the consent document.

Participant's Name: _________________________________

Participant's Birth Date: ___________________

Participant's Reference Number:____________________

 

 


Participant Consent Form (participant unable to read the form; to be provided in an appropriate alternative media e.g. large print, audiotape, braille)

This part will be filled in by the participant or his/her proxy.

The original will be kept be the investigator; a copy will be given to the participant.

 

Title of the study:

Place of the study:

 

 

 

Please circle

as necessary

I was informed about the effect to be expected, about possible disadvantages and about possible risks verbally and in writing by the test leader of the study.

Yes

No

I was informed about the purpose of research, the expected duration and the procedures verbally and in writing by the test leader of the study.

Yes

No

I was informed about any benefits for me or for others which may reasonably be expected from the research.

Yes

No

I was informed about the explanations on confidentiality (and limits) of the data.

Yes

No

I was informed about the right to decline to participate and to withdraw from the research once participation has begun and the foreseeable consequences of declining or withdrawing.

Yes

No

I was informed about whom to contact for questions about the research and research participants rights.

Yes

No

I have read and understood the written information handed out for the study mentioned above. My questions in connection with the study have been answered satisfactorily. I can keep the written information and receive a copy of my written declaration of consent.

Yes

No

I had sufficient time to take my decision.

Yes

No

In case an incident arises contrary to expectation, insurance consists for me in the legally specified scale. The insurance was constructed by …………… for this study.

Yes

No

I have spoken to: Dr./Mr./Ms.

…………….

I understand that I am free to withdraw from the study

  • at any time
  • without having to give a reason for withdrawing
  • and without affecting my future medical care

Yes

No

I agree to take part in the study.

Yes

No

The confidentiality of my personal data was assured to me. Personal date will used anonymised at the publication of the study’s results. I approve of the fact however under a strict compliance with the confidentiality that the responsible experts of the authorities and the ethics commission may take a look for examining and control purposes of my original data.

Yes

No

If aftereffects appear, I will contact Dr./Mr./Ms.

…………………….. with the tel. no. ……………………….

 

Signed:

 

Date:

 

Name (in block letters):

 

Proxy Name:

 

Relationship to participant:

 

Signature: