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

Office for Human Research Protections (OHRP) - HHS Office of Human Research Protections homepage
45 CFR 46 - Protection of Human Subjects - HHS Policy for Protection of Human Research Subjects
U.S. Food and Drug Administration (FDA) - FDA homepage
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

IRB Guidebook - OHRP 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 speciments
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
NIH Certificates of Confidentiality Kiosk - information on Certificates of Confidentiality including how to obtain one
A Guide to Informed Consent (FDA) - guidance on FDA informed consent requirements
Informed Consent Checklist (OHRP) - checklists and guidance regarding OHRP informed consent requirements

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 (WMA)
Navajo Nation Human Research Code - conditions under which research activities may be performed on living human subjects within the territorial jurisdiction of Navajo Nation

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 (PHI)
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

Tribal Consultative Review - outlines ABOR Policy and University practice to implement a consultative approach required to protect these most important relationships