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Belmont Report
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has sub items, Regulations
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Annotated 2018 Requirements
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has sub items, Guidance
OHRP Guidance on COVID-19
OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals
OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements
Frequently Asked Questions
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has sub items, Decision Charts
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Informed Consent Posting
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has sub items, Single IRB Exception Determinations
Background
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Subpart C Certification Form
Regulations & Policy Archived Materials
Informed Consent
Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
Informed Consent Checklist (1998)
Informed Consent of Subjects Who Do Not Speak English (1995)
Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006)
Informed Consent Requirements in Emergency Research (OPRR Letter, 1996)
Informed Consent Tips (1993)
Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
IRB Review of Protocol and Informed Consent Changes for NCI/CTEP-Sponsored Clinical Trials
IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Use of Electronic Informed Consent: Questions and Answers
Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)
Related Frequently Asked Questions
Informed Consent FAQ
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