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Appendix 5 6 Evaluation Criteria APPENDIX 5

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APPENDIX 5.6
EVALUATION CRITERIA FOR PROPOSALS SUBMITTED TO THE
COMMITTEE ON THE PROTECTION OF HUMAN SUBJECTS
CALIFORNIA STATE UNIVERSITY, FRESNO
TITLE OF STUDY: ____________________________________________________________
PRINCIPAL INVESTIGATOR: ___________________________________________________
COLLABORATORS: ___________________________________________________________
DATE REVIEWED: ____________________________________________________________
LEVEL OF RISK (AS ASSESSED BY THE PI): _____ Minimal Risk _____ At Risk
Criteria for IRB Approval of Research:
Risks to subjects are minimized
Risks to subjects are reasonable in relation to anticipated benefits
Selection of subjects is equitable
Informed consent is sought from each prospective subject or the subject’s legally
authorized representative
Informed consent is appropriately documented and is adequate
Where appropriate, research plan makes adequate provision for monitoring the data
collected to insure the safety of subjects
Adequate provisions to protect the privacy of subjects and maintain the data collected to
insure the safety of subjects
Where appropriate, safeguards are included in the study to protect the rights and welfare of
vulnerable subjects
Elements of Informed Consent Present:
Information given to the subject or legal representative is in understandable language
Purpose of research (including larger social purpose, if appropriate)
Procedures (including time involved and locale)
Potential risks and discomforts
Potential benefits
Where applicable, alternative treatments contemplated (with risks and benefits)
Extent of confidentiality
Statement regarding voluntariness of participation and freedom to withdraw without
jeopardy
Assurance of investigator’s readiness to answer questions (including phone number)
Where applicable, terms of compensation
When risk is a possibility, phone number to call if injured from participation
Where applicable, provision for guardian or physician’s consent
Decision: Approved Disapproved Convene a Meeting
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Appendix 5 6 Evaluation Criteria APPENDIX 5

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Completed 18 February 2020

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