SOCRA CCRP Practice Exam

What is NOT listed as an additional element of informed consent per FDA guidelines?

1. Statement that treatment may involve unforseeable risks

2. Subject's right to attorney consultation

3. Circumstances in which subject participation may be terminated

4. Consequences of subject's decision to withdraw

The correct answer is: Subject's right to attorney consultation

The additional element of informed consent that is not listed per FDA guidelines is the subject's right to attorney consultation. FDA regulations do not require or recommend the subject to have an attorney present during the informed consent process. This is because an attorney may not always have the scientific or medical expertise necessary to fully understand the details of the study and may not always act in the best interest of the subject. However, subjects have the right to seek legal advice at any time during the study. The other options, A, C, and D, are listed as additional elements of informed consent according to FDA guidelines. These include informing the subject about potential unforeseeable risks, circumstances in which subject participation may be terminated, and the consequences of the subject's decision to withdraw from the study. These elements are important to ensure that the subject fully understands the potential risks and benefits of participating in the study and can make an informed