A waiver of the requirement for documentation of informed consent

Subject : Psychology

Question: A waiver of the requirement for documentation of informed consent may be granted when:

A) The investigator has no convenient place to store signed consent forms separate from the research data.

B) The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

C) The subjects are literate in their own language; however, they do not read, write, or speak English.

D) Potential subjects might find some of the research questions embarrassing, personal, or intrusive.

Expert Verified Solution:

The correct answer is:

B) The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

Explanation:

A waiver of the requirement for documentation of informed consent may be granted when the primary risk to participants is a breach of confidentiality, and the consent form is the only link between the participant and the study. In such cases, obtaining written consent could increase the risk to participants by creating a record that could be linked back to them. This waiver helps protect participants’ privacy while still ensuring informed consent is obtained, though possibly in an oral or implied form.