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Nter- Norm Fost Criteria For Approval 45 CFR 46.111 25 CFR 56.111 z z z z z z z z Minimized risks Reasonable risk/benefit ratio Equitable subject selection Informed consent process Informed consent documentation Data monitored for safety Confidentiality/privacy maintained Vulnerable populations protected Review Criteria 45 CFR 46.111 21 CFR 56.111 (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the set.
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2000 FAQ
Informed consent demonstrates respect for personal autonomy (“Respect for Persons” in the Belmont Report) and is an important ethical requirement in research.
The IRB application is used to provide information to the IRB whose responsibility it is to ensure the university adheres to federal regulations in the protection of human participants in research. No recruitment or data can be collected until an application is approved by the IRB.
I participant name, agree to participate or agree to participation of my child participant name in the research project titled project title, conducted by researcher(s) name who has (have) discussed the research project with me. I have received, read and kept a copy of the information letter/plain language statement.
A short form consent document attests that the elements of informed consent, as required by DHHS and the FDA, have been presented orally to either the participant or the participant's legally authorized representative. The IRB Office has Short Form Consent Templates available in English and other languages.
The consent form is intended, in part, to provide information for the potential subject's current and future reference and to document the interaction between the subject and the investigator. However, even if a signed consent form is required, it alone does not constitute an adequate consent process.
The consent form is documentary evidence of the agreement between the healthcare professional and the patient. Written consent is employed particularly when the treatment is complex or invasive.
The consent form is intended, in part, to provide information for the potential subject's current and future reference and to document the interaction between the subject and the investigator.
The short form consent is a document, translated into the subject's native language, that contains a description of the required elements of informed consent and notes that these elements, as they pertain to the study, will be presented orally to the subject or legally authorized representative.
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