RE:RE:RE:Where is Radar? Don't fret... we're in the midst of the IRB process and this is out of the company's control. University of Rocherster's IRB board needs to get through the paperwork. The trial is designed and just waiting to get going upon receiving IRB approval.
Appears that patients are already being pre-screened/pre-registered for the study. Once the IRB is approved the trial will start immediately. A 10 patient study should not take long to complete.
IRB Process Overview
The protection of the rights and privacy of human subjects involved in research activities is mandated by federal law. These federal regulations require that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must assure that such research is reviewed and approved by the institution's institutional review board (IRB).
Most Universities extend IRB process to protect the rights of human subjects involved in any and all research conducted. A university's IRB is responsible for determining and assuring that:
- the welfare and rights of human subjects are adequately protected and informed consent given, if necessary;
- human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of the research;
- the necessity and importance of the research outweighs the risks to the subjects; and
- the researcher(s) is/are qualified to conduct research involving human subjects.
~S
KoolaidCash1 wrote: You may be right Radar. IR said human trials next year to me. Now I am very confussed about the IRB process. WTF