ANNEX C.2d: Informed consent documentation for an illiterate participant

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This part will be filled in by the witness accepted by the LREC.

The original will be given to the witness accepted by the LREC; a copy will be kept by the investigator.

I confirm that I was present when the trial was conducted with the participant ………………………………………. The participant has given oral informed consent to the following points:

 

·         The purpose of the research, expected duration, and procedures; the possible risks, discomfort, adverse effects, and side effects (if any);

·         a description of any benefits to the subject or to others which may reasonably be expected from the research

·         confidentiality (and limits) of the data;

·         their right to decline to participate and to withdraw from the research once participation has begun and the foreseeable consequences of declining or withdrawing;

·         contact for questions about the research and research participants rights.

 

I think it is appropriate to conduct the trial with the participant …………………………………

Witness's (Proxy) Name: ___________________________

Witness’s Signature:________________________________

Relationship to participant: ____________________________

Date: ____________________________