Informed consent will be an agreement between the investigator and each subject or their Legally Authorized Representative (Healthcare Surrogate) having the capacity to understand and make an informed decision. Consent will be obtained prior to each potential subject’s participation in this clinical study.
Each subject participating in this clinical study will be made aware of the fact that his or her participation involves research and the intent of the research, the expected duration of their participation and a description of the procedures that will be followed.
Each subject will be made aware of the reasonably expected benefits he or she might receive, as well as any risks or potential discomfort that are involved.
Each subject will be made aware of alternative procedures that are available to him or her.
Each subject will be made aware that his or her records will remain confidential, but that the FDA and the Ethics Committee has the right to inspect his or her records.
Each subject will be told that his or her participation in the clinical study is voluntary, without force or influence from the investigator or sponsor.
Each subject will be given the name and method of contacting the appropriate person(s) to answer his or her questions about the research and in the event of research-related injury.
The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the
Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.
