help what are two of them

Asubject in a clinical research trial experiences a serious, unanticipated adverse drug experience. how should the investigator proceed, with respect to the irb, after the discovery of the adverse event occurrence? a. do not report the adverse drug experience to the irb since it is a common adverse experience. b. report the adverse drug experience to the irb only if there are several other occurrences. c. report the adverse drug experience as part of the continuing review report. d. report the adverse drug experience in a timely manner, in keeping with the irb's policies and procedures, using the forms or the mechanism provided by the irb.

Which of the following powers is held only by the federal government? a. power to make a treaty b. power to set marriage laws c. power to create driving laws d. power to set the legal drinking age

Ageneral 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? a. 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. b. 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. c. 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. d. in the event of any distress you may have related to this research, you will be given access to appropriate resources.