certificateof 豁免 (波特兰 v 医疗中心)( certificateof exemption( portland v a medical center)).docVIP
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certificateof 豁免 (波特兰 v 医疗中心)( certificateof exemption( portland v a medical center))
Institutional Review Board
Certification of Exemption
This form must be submitted with the Proposed Project Questionnaire (PPQ), abstract, and protocol. The Institutional Review Board Chair, qualified designee, or Lead IRB Analyst will review and make a recommendation regarding exemption from IRB oversight. The Information Security Officer and Privacy Officer will also review the submission. If you have questions, please contact the research office at x55125.
If the project involves any human subject participation or procedures not listed below or is FDA-regulated (except for category 6), this project does not qualify for exemption. When deciding if a protocol is FDA-regulated, a determination must be made whether or not research results will be submitted to or held for inspection by the FDA. If so, then the research must be considered FDA-regulated. See the “Definitions” section of the VAPORHCS IRB PP, at /Research/Committees/irb/index.asp#policies,
for the FDA’s definition of research.
If the proposed research involves children, or is focused primarily on pregnant women, human in vitro fertilization or fetuses, please consult with the Lead IRB Analyst or Research Assurance Officer to determine if the work is allowed by the VAPORHCS. Additional requirements may apply or the work may not be allowable at VAPORHCS.
Principal Investigator (PI): Extension
E-mail
Study Coordinator/Contact Person: (All Correspondence will be sent to this person)
Extension
E-mail
Submission Requirements:
Proposed Project Questionnaire (PPQ)
Abstract
Protocol; must address the purpose of the research, the subject(s)’ role (if applicable) in the research, the nature of the data to be obtained, and how the privacy and confidentiality of research data and subject information will be maintained
Certification of Exemption Request (this form)
Determining Whether Human Research is Exempt from the Regulations KEY: Solid box: All items in the box must be true.Dotted box
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