A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. In the event of any distress you may have related to this research, you will be given access to appropriate resources.

A waiver of the requirement for documentation of informed consent may be granted when: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. Potential subjects might find some of the research questions embarrassing, personal, or intrusive. The subjects are literate in their own language; however, they do not read, write, or speak English. The investigator has no convenient place to store signed consent forms separate from the research data.

Which of the following is not needed by a participant in order to give informed consent to participate in a research study? A. Knowledge of the participants in the study B. Knowledge of the purpose of the research study C. Knowledge of the risks of the study D. Knowledge of the benefits of the study

Informed consent is not required for research participation, only for medical treatment.Question 2Answera.Trueb.False

The doctrine of informed consent requires the disclosure of benefits of a treatment but not the risks of the treatment.Ask StudybuddyGroup of answer choicesTrueFalse

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. Code the subjects' responses. Obtain a waiver of documentation of informed consent. Obtain a Certificate of Confidentiality.