Elements of Informed Consent Document
Informed consent is an interactive process and is one of the primary ethical requirements underpinning research between the participating human subject, parent(s) or guardian, and the medical team. Through this process everyone learns all about the research study while it reflects the basic principle of respect for persons. The Informed Consent document provides a summary of the clinical trial and explains the rights of the human subject while it includes information such as the purpose of the trial, treatment outline, schedule, potential risks, benefits, and alternatives to participation. All of this information will aid the participant and parent(s) or guardian to voluntarily decide whether or not to participate.
This Consent Form must be approved by the Driscoll Children’s Hospital (DCH) Institutional Review Board (IRB) prior to implementation. Any changes in the consent form require the approval of the DCH IRB prior to implementation. This format and its content are required for all studies approved by the DCH IRB.
DCH IRB requirements for ICD are outlined in the Model Informed Consent for Clinical Research Study.
FDA regulations regarding ICD are found at Title 21 CFR 50.25 Elements of IC and Title 21 CFR 50.27 Documentation of IC. http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00html
DHHS regulations regarding ICD are found at Title 45 CFR 46.117 Documentation of IC and Title 45 CFR 46.116 General Requirements for IC. http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
How to Reach Us
The Driscoll Children's Hospital Institutional Review Board is available to provide information and guidance to participants in clinical research studies and their families regarding their rights as Human Research Subjects. The Institutional Review Board is available to advise and inform investigators who are submitting clinical research protocols and monitor approved research activities in its jurisdiction.
Jucel Nazareno, BSN, R.N., IRB Monitor
(361) 694-4619
Fax: 361-694-5466
Institutional Review Board
Driscoll Children's Hospital
3533 South Alameda St.
Corpus Christi, TX 78411
(361) 694-5000
Statement of Compliance
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