Related Non-Stanford Sites

Following are education and other helpful resources outside of Stanford University:

AAHRPP - Association for the Accreditation of Human Research Protection Programs

Belmont Report

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.

FDA

• FAQs: Frequently Asked Questions IRB organization, membership, procedures and records, informed consent process and document content, clinical investigations and general questions.

GCP

• 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:
  • The Research Clinic (video)
  • Case studies on the responsible conduct of research

PRIM&R (Public Responsibility in Medicine & Research)

SRA (Society of Research Administrators)