Question

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

A. Code the subjects' responses.
B. Have the subject sign the consent form under an assumed name.
C. Obtain a Certificate of Confidentiality.
D. Obtain a waiver of documentation of informed consent.

Answer 1

Answer:

D. Obtain a waiver of documentation of informed consent.

Explanation:

The most helpful approach to protect the subject identity is to obtain a waiver of documentation of informed consent, with this, the researcher does not need the subjects signature and name of the subject on the consent form hence the subjects identity is protected, or the consent form can be entirely waived, or the documentation of the subjects consent form can also be waived. It is a provision by the IRB.