ASU and Arizona Board of Regents 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 401-01 – “Disbursements”  – ASU policy on payment to nonresident aliens.

Regulations

• Office for Human Research Protections.

• 45 CFR 46 – Protection of Human Subjects – HHS Policy for Protection of Human Research Subjects.

• U.S. Food and Drug Administration.

• 21 CFR 50 – Protection of Human Subjects – FDA and DHHS Policy for Protection of Human Research Subjects.
• 21 CFR 56 – Institutional Review Boards – FDA and DHHS Policy for Institutional Review Boards.

• 32 CFR 219-Protection of Human Subjects – DoD Policy for Protection of Human Research Subjects.

Federal guidance

• IRB Guidebook  – Office for Human Research Protections developed IRB guidebook.

• OHRP Frequently Asked Questions FAQs which provide guidance that represents OHRP guidance on particular topics.

• OHRP Guidance on Research Involving Coded Private Information or Biological Specimens – DHHS guidance on research involving coded private information or human biological specimens.

• 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.

• OHRP Regulations and Policy – An overview of all OHRP policy and regulatory guidance.

• OHRP FAQs about Research with Children – OHRP written FAQ on the regulatory requirements for including children in research.

• National institutes of Health Certificates of Confidentiality Kiosk – Information on Certificates of Confidentiality including how to obtain one.

• A Guide to Informed Consent – Guidance on FDA informed consent requirements.

• Informed Consent Checklist – Checklists and guidance regarding OHRP informed consent requirements.

Ethical codes

• Nuremburg Code – A set of research ethics principles for human experimentation.

• Belmont Report – Report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

• World Medical Association Declaration of Helsinki – Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association.

• 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

• Native American Tribal Consultation. 

• HIPAA Frequently Asked Questions.

• HIPAA Research Flow Chart – Flow chart for understanding HIPAA compliance.

• Protecting Protected Health Information – Best practices on how to protect HIPAA Protected Health Information. 

• Checklist for Research Involving Minors – ASU IRB checklist for convened review of protocols involving children.

• Classroom Research – ASU IRB guidance on student research projects.

• Classroom Research Decision Tree.

• Research with Secondary Data – ASU IRB guidance for research involving secondary data.

• Clinical Trials Guidance – ASU IRB guidance for research involving clinical trials.

• IRB Guidance on Online-Based Research – Best practices for online data collection methods.

Presentations

Tribal Consultative Review – Outlines ABOR Policy and University practice to implement a consultative approach required to protect these most important relationships.