Human subjects: regulations and resources
ASU and ABOR policy and procedures
- ABOR Tribal Consultation Policy - ABOR's policy statement on government-to-government relationships with individual sovereign tribes
- ASU Procedures for the Review of Human Subjects Research - ASU IRB Procedures
- RSP 201-01, “Human Subjects in Research-General” - ASU Policy statement on human subjects in Research
- FIN 400 - "Disbursements" - ASU policy on payment to nonresident aliens
Regulations
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Office for Human Research Protections (OHRP) - HHS Office of Human Research Protections homepage
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45 CFR 46 - Protection of Human Subjects - HHS Policy for Protection of Human Research Subjects
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U.S. Food and Drug Administration (FDA) - FDA homepage
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21 CFR 50 - Protection of Human Subjects - FDA and DHHS Policy for Protection of Human Research Subjects
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21 CFR 56 - Institutional Review Boards - FDA and DHHS Policy for Institutional Review Boards
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32 CFR 219-Protection of Human Subjects - DoD Policy for Protection of Human Research Subjects
Federal guidance
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IRB Guidebook - OHRP developed IRB guidebook
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OHRP Frequently Asked Questions FAQS which provide guidance that represents OHRP guidance on particular topics
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OHRP Guidance on Research Involving Coded Private Information or Biological Specimens - DHHS guidance on research involving coded private information or human biological speciments
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OHRP International Compilation of Human Subject Research Protections a listing of over 1,000 laws, regulations and guidelines on human subjects' protections in 130 countries and many international organizations.
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OHRP Regulations and Policy - an overview of all OHRP policy and regulatory guidance
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OHRP FAQs about Research with Children - OHRP written FAQ on the regulatory requirements for including children in research
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NIH Certificates of Confidentiality Kiosk - information on Certificates of Confidentiality including how to obtain one
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A Guide to Informed Consent (FDA) - guidance on FDA informed consent requirements
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Informed Consent Checklist (OHRP) - checklists and guidance regarding OHRP informed consent requirements
Ethical codes
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Nuremburg Code - a set of research ethics principles for human experimentation
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Belmont Report - report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
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World Medical Association Declaration of Helsinki - set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA)
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Navajo Nation Human Research Code - conditions under which research activities may be performed on living human subjects within the territorial jurisdiction of Navajo Nation
ASU guidance documents
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HIPAA Research Flow Chart - flow chart for understanding HIPAA compliance
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Protecting Protected Health Information - Best practices on how to protect HIPAA Protected Health Information (PHI)
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Checklist for Research Involving Minors - ASU IRB checklist for convened review of protocols involving children
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Classroom Research - ASU IRB guidance on student research projects
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Research with Secondary Data - ASU IRB guidance for research involving secondary data
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Clinical Trials Guidance - ASU IRB guidance for research involving clinical trials
Presentations
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Tribal Consultative Review - outlines ABOR Policy and University practice to implement a consultative approach required to protect these most important relationships