An adult participant receives an informed consent form to participate in a study on breast cancer in women younger than the age of 35. The study's informed consent process should include which elements? (Select all that apply.)

Question

Quizplus · Accepted Answer

The informed consent process is an essential aspect of any research study, and it is critical to ensure that participants are fully informed about the study's purpose, procedures, and any associated risks. In this case, since the study is on breast cancer in women younger than the age of 35, the informed consent process should include the following elements:
B) The participant's being informed of risks associated with the study: The participant should be informed of any potential risks associated with participating in the study, such as discomfort or side effects from any procedures involved.
C) The participant's being informed of the study protocol: The participant should be informed about the study's purpose, procedures, and any interventions that will be used.
D) The participant's being given the right to decline participation at any time: The participant should be informed that they have the right to decline participation in the study at any time and without any negative consequences.
E) The participant's being assured that her confidentiality will be maintained: The participant should be informed about the confidentiality measures that will be taken to protect their privacy and ensure that their personal information is not disclosed.
A) The participant's meeting the IRB members who approved the study: While it is important for the IRB to approve the study, there is no requirement for participants to meet the IRB members, and this is not an essential element of the informed consent process.

An Adult Participant Receives an Informed Consent Form to Participate