Human Subjects Research: Home Page

Human Subjects Research
and IRB Home Page

Questions about the IRB or human subjects research at Stanford?
Contact IRB Education or call 650-724-7141.

RCO office is moving:
Please note that the RCO office is moving off campus to California Avenue in early March. Stay tuned for more details.

Ongoing IRB Survey of the Research Community:
Since May 2009, researchers who had protocol events approved have completed a survey about the service provided by Stanford IRBs. Results through December 2009 are available.

International Research:
An updated OHRP International Compilation of Human Subject Protections has just been published. It lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in 96 countries, as well as standards from a number of international and regional organizations.

Submitting Protocols for IRB Review - getting started:
Is your project Human Subject Research? See updated information and guidance on the Medical Research and Nonmedical Research pages, and instructions for protocol submission through the eProtocol system.

Frequently Asked Questions:
See FAQs & Resources for common questions about human subjects research at Stanford.
FAQs from OHRP and the FDA (Information Sheets) and an archive of education presentations are also available.

IRB Annual Update:
May 18 2009 presentation is posted.
Updates on: Accreditation and Organization, Participant Withdrawal, Short Form Consent Process, Scientific Review, Privacy and Confidentiality, Institutional Conflict of Interest (ICOI), Reviews by Continuous Quality Improvement Group and Common Observations.

Training:
See CITI Required Tutorial for Human Subject Research training, and to see the CITI Training Status report.
See eProtocol Help for eProtocol training and technical support.

Required Study Registration:
The Stanford School of Medicine requires registration of all clinical trials conducted at Stanford and affiliated facilities.

GINA - Genetic Information Nondiscrimination Act of 2008:
This new Federal law generally makes it illegal for health insurance companies, group health plans, and employers with 15 or more employees to discriminate based on genetic information.

The STANFORD Human Research Protection Program (HRPP) affiliated organizations are:
• Stanford University
• Stanford Hospital and Clinics (SHC)
• Lucile Packard Children’s Hospital at Stanford (LPCH)
• Veterans Affairs Palo Alto Health Care System (VAPAHCS)
• Palo Alto Institute for Research and Education (PAIRE)

Stanford University has received full accreditation of its human research protection program (HRPP) through the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

IRB Registration
Stanford University maintains a Federalwide Assurance of compliance with Department of Health and Human Services (DHHS) regulations for research involving human participants:
Human Subjects Assurance No.: FWA00000935, expiration: 3/5/2012

In accordance with our Federalwide Assurance, Stanford University IRBs are registered with DHHS Office for Human Research Protections (OHRP) and FDA as required – <click here> for Assurance and IRB Registration information.

ICH/GCP: Stanford University Administrative Panels on Human Subjects in Medical
Research (IRBs) are in compliance with Good Clinical Practices as consistent with U.S.
Food and Drug Administration Code of Federal Regulations (21 CFR 50 and 56) and
DHHS (45 CFR Part 46).

Stanford University | Dean of Research | Research Compliance

Last modified: Thursday, 28-Jan-2010 07:29:29 PST

Human Subjects Research and IRB Home Page

Human Subjects Research
and IRB Home Page