SOCRA CCRP Practice Exam

Who must sign the short form consent and summary?

1. Just the subject/LAR

2. Both the subject/LAR and witness

3. Only the witness

4. Only the investigator

The correct answer is: Both the subject/LAR and witness

The short form consent and summary require signatures from both the subject or their legally authorized representative (LAR) and a witness. This dual-signature requirement serves multiple important purposes within clinical research. First, obtaining the signature from the subject or LAR ensures that they acknowledge understanding of the consent process and the implications of their participation. It is crucial for upholding ethical standards in obtaining informed consent. Secondly, the presence of a witness adds an additional layer of protection and validation to the consent process. The witness helps ensure that the consent was given freely and that the subject was adequately informed about the details of the trial, including risks and benefits. The witness can serve as an impartial third party who confirms that the subject had an opportunity to ask questions and receive answers before making their decision. In summary, the requirement for both parties to sign reinforces the integrity of the consent process, ensuring that all ethical guidelines are followed and that the rights of participants are safeguarded.