Useful links about human subject research

Aurora Health Care is dedicated to advancing the understanding of medicine through human research. The following useful links about human subject research provide additional information, guidance and support.

Government agency websites

United States Food and Drug Administration (FDA)
FDA forms
Information sheet guidance for Institutional Review Boards (IRBs), clinical investigators and sponsors

National Institutes of Health (NIH)
Office for Civil Rights – Health Information Privacy

Office for Human Research Protections (OHRP)
HHS Office of Research Integrity

Useful links about FDA regulations

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
Guidance for industry E6 good clinical practice: Consolidated guidance (ICH GCPs)
Code of Federal Regulations (FDA) Title 21, Part 50 [21 CFR 50] – Protection of human subjects

Code of Federal Regulations (FDA) Title 21, Part 56 [21 CFR 56] – Institutional Review Boards
Code of Federal Regulations (FDA) Title 21, Part 312 [21 CFR 312] – Investigational new drug application

Code of Federal Regulations (FDA) Title 21, Part 812 [21 CFR 812] – Investigational device exemptions
Code of Federal Regulations (DHHS) Title 45, Part 46 [“Common Rule” “Subpart A”] including Subparts B, C, and D

Contact the RSPP/IRB office

We’re here to answer your research documentation questions. Contact us

IRB approval of research

Find out the steps you need to take to get IRB approval of research. IRB approval process

Resources

Download templates for IRB application, informed consent and more. IRB forms and templates

Policies

Want to know about our research policies and procedures? Learn about our policies