Related Non-Stanford Sites
Following are education and other helpful resources outside of Stanford University:
AAHRPP [1]- Association for the Accreditation of Human Research Protection Programs
Belmont Report [2]
CISCRP [3] - Stanford University is a proud member of CISCRP's Circle of Supporters. CISCRP [3] (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 [4]
- FAQs: Frequently Asked Questions [5] IRB organization, membership, procedures and records, informed consent process and document content, clinical investigations and general questions.
GCP [6]
- Consolidated Gudiance for Good Clinical Practice [7] FDA E6 Good Clinical Practice:
Consolidated Guidance:- Checklist: Before the Clinical Phase of the Trial Commences [8] (section 8.2) - Documents on file before the trial formally starts
- Checklist: During the Clinical Conduct of the Trial [9] (section 8.3) - Documents added to the files during the trial
NIH [10] (National Institutes of Health)
- The Genomic Data Sharing Policy [11] effective 1/25/2015
- Implementation of the NIH Genomic Data Sharing Policy for NIH Grant Applications and Awards [12] – 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 [13] – GWAS policy prior to 1/25/2015
- Genome-Wide Association Studies (GWAS): Frequently Asked Questions [14] - GWAS FAQs
- NIH Sample Data Sharing Plan [15]
OHRP [16] (Office of Human Research Protections)
- Educational materials [17]
- Educational videos [18] - topics include:
- The Research Clinic [19]
- Research Use of Human Biological Specimens and Other Private Information [20]
- Reviewing and Reporting Unanticipated Problems and Adverse Event [21]
- General Informed Consent Requirements [22]
- Institutional Review Board (IRB) Membership [23]
- Complex Issues with Research Involving Vulnerable Populations [24]
- IRB Records [25]
- IRB Records II [26]
- HHS YouTube channel [27]
- FAQs: Frequently Asked Questions [28] - 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 [29] - Listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations
- Policy guidance and documents [30]
- Public Outreach Page [31] - The Office for Human Research Protections information for the general public about research participation
ORI [32] - The Office of Research Integrity (ORI) publishes articles of interest to laboratory directors, investigators, department heads, researchers, mentors, postdocs, and graduate students.
- ORI Newsletters [33]
- Educational items [18] - topics include:
- The Research Clinic [34] (video)
- Case studies on the responsible conduct of research [35]
PRIM&R [36] (Public Responsibility in Medicine & Research)
SRA [37] (Society of Research Administrators)