Research Compliance Office
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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)


Source URL: https://researchcompliance.stanford.edu/panels/hs/links/related-non-stanford-links

Links
[1] http://aahrpp.org/
[2] http://www.hhs.gov/ohrp/policy/belmont.html
[3] http://www.ciscrp.org/
[4] http://www.fda.gov/oc/ohrt/IRBS/
[5] http://www.fda.gov/oc/ohrt/IRBS/faqs.html
[6] http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/officeofscienceandhealthcoordination/ucm2018191.htm
[7] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf
[8] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf#page=56
[9] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf#page=60
[10] https://www.nih.gov/
[11] https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/
[12] http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-111.html
[13] http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html
[14] https://osp.od.nih.gov/wp-content/uploads/Genome-Wide-Association-Studies-GWAS-Policy-Frequently-Asked-Questions.pdf
[15] https://www.niaid.nih.gov/research/sample-data-sharing-plan
[16] http://www.hhs.gov/ohrp/
[17] http://www.hhs.gov/ohrp/education/index.html#materials
[18] http://www.hhs.gov/ohrp/education/training/ded_video.html
[19] http://www.hhs.gov/ohrp/education/training/ded_video.html#clinic
[20] http://www.hhs.gov/ohrp/education/training/ded_video.html#researchuse
[21] http://www.hhs.gov/ohrp/education/training/ded_video.html#unanticipatedproblems
[22] http://www.hhs.gov/ohrp/education/training/ded_video.html#general
[23] http://www.hhs.gov/ohrp/education/training/ded_video.html#irbmembership
[24] http://www.hhs.gov/ohrp/education/training/ded_video.html#complex
[25] http://www.hhs.gov/ohrp/education/training/ded_video.html#irbrecords
[26] http://www.hhs.gov/ohrp/education/training/ded_video.html#irbrecords2
[27] http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914
[28] http://answers.hhs.gov/ohrp/categories
[29] https://www.hhs.gov/ohrp/sites/default/files/2019-International-Compilation-of-Human-Research-Standards.pdf
[30] https://www.hhs.gov/ohrp/regulations-and-policy/
[31] http://www.hhs.gov/ohrp/education/brochures/index.html
[32] http://ori.hhs.gov/
[33] http://ori.hhs.gov/publications/newsletters.shtml
[34] http://ori.hhs.gov/TheResearchClinic
[35] http://ori.hhs.gov/rcr-casebook-stories-about-researchers-worth-discussing
[36] http://www.primr.org/
[37] http://srainternational.org/