Following are education and other helpful resources outside of Stanford University:
AAHRPP - Association for the Accreditation of Human Research Protection Programs
CISCRP - Stanford University is a proud member of CISCRP's Circle of Supporters. CISCRP (The Center for Information and Study on Clinical Research Participation) is a nonprofit group dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research participation.
- FAQs: Frequently Asked Questions IRB organization, membership, procedures and records, informed consent process and document content, clinical investigations and general questions.
- Consolidated Gudiance for Good Clinical Practice FDA E6 Good Clinical Practice:
Consolidated Guidance:- Checklist: Before the Clinical Phase of the Trial Commences (section 8.2) - Documents on file before the trial formally starts
- Checklist: During the Clinical Conduct of the Trial (section 8.3) - Documents added to the files during the trial
NIH (National Institutes of Health)
- The Genomic Data Sharing Policy effective 1/25/2015
- Implementation of the NIH Genomic Data Sharing Policy for NIH Grant Applications and Awards – Instructions for implementation of the GDS policy for grant applications
- Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) – 2007-2008 – GWAS policy prior to 1/25/2015
- Genome-Wide Association Studies (GWAS): Frequently Asked Questions - GWAS FAQs
- NIH Sample Data Sharing Plan
OHRP (Office of Human Research Protections)
- Educational materials
- Educational videos - topics include:
- The Research Clinic
- Research Use of Human Biological Specimens and Other Private Information
- Reviewing and Reporting Unanticipated Problems and Adverse Event
- General Informed Consent Requirements
- Institutional Review Board (IRB) Membership
- Complex Issues with Research Involving Vulnerable Populations
- IRB Records
- IRB Records II
- HHS YouTube channel
- FAQs: Frequently Asked Questions - Assurance process, IRB registration process, 45 CFR 46, research with children, investigator reponsibilities, prisoner research, informed consent, quality improvement activities
- International Compilation of Human Research Protections - Listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations
- Policy guidance and documents
- Public Outreach Page - The Office for Human Research Protections information for the general public about research participation
ORI - The Office of Research Integrity (ORI) publishes articles of interest to laboratory directors, investigators, department heads, researchers, mentors, postdocs, and graduate students.
- ORI Newsletters
- Educational items - topics include:
PRIM&R (Public Responsibility in Medicine & Research)
SRA (Society of Research Administrators)
