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

Answer 1

Answer:

Obtain a waiver of documentation of informed consent.

Explanation:

Informed consent constitutes the right of a research participant to be informed of any and all treatment decisions that may affect their psychophysical integrity and the researcher's duty to warn of the risks and benefits of the treatments involved in the research. Once informed consent is signed, the patient agrees to all risks of the research.

However, where if the treatment used is potentially harmful to the individual, and the consent form is the only record linking the individual to the research, the best course of action is to obtain a waiver of informed consent documentation.