![]() During this time subjects are hospitalized and monitored.īased on the protocol, informed consent documents and IRB minutes that BCM provided for this study, the IRB assessed this study as more than minimal risk and the research appeared to enroll children. The intracranial electrodes are left in place until the subject has had enough seizures to allow epileptologists to reliably localize the epileptic region(s) of the brain, usually 7-10 days. Study investigators believe that the additional electrodes add no identifiable additional risks to the subjects. According to the IRB application for this research, additional electrodes, which were designed for research purposes, are embedded in the spaces between the standard electrodes. In protocol H-18112, titled “Perceptual Thresholds for Electrical Cortical Stimulation of Human Cerebral Cortex,” subjects are scheduled to undergo surgical placement of intracranial electrodes in order to determine in what part of the brain their seizures occur. Thank you for your reports (dated March 9, 2015, and May 8, 2015) in response to those observations. On the last day of our visit, we shared with you several observations regarding the BCM’s HRPP. IRB leadership, chairs and members conveyed a sincere commitment and concern for their role in the protection of human research subjects. We are pleased to note that BCM has a robust HRPP. ![]() The site-visit team reviewed IRB records for over 45 HHS-supported research studies, IRB meeting minutes for the six months prior to the site visit and IRB written procedures. ![]() The evaluation, conducted by six OHRP staff and two expert consultants, included interviews with senior HRPP officials, institutional review board (IRB) Chairs and vice-chairs, IRB members, IRB staff and principal investigators who conduct HHS-supported research. The evaluation was conducted as part of our program to evaluate human research protection programs of institutions that receive Department of Health and Human Services (HHS) support for research in compliance with 45 CFR Part 46. ![]() The Office for Human Research Protections (OHRP) conducted an on-site evaluation of the human research protections program (HRPP) at Baylor College of Medicine (BCM) in Houston, TX from February 24-26, 2015. ![]()
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