Links

Related Stanford Sites

Resources for researchers:

• Cancer Clinical Trials Office (CCTO)
  • Remote Consenting of Adults Guideline
• Clinical Trials at Stanford
• Conflicts of Interest
• Industrial Contracts Office - "Who Will Handle My Agreement?" site
• Privacy Office
  • HIPAA: Privacy Guidelines
  • Data De-identification Overview and Guidance
• Stanford Healthcare and School of Medicine Technology & Digital Solutions
• Stanford University IT
  • Protecting Sensitive Data
• School of Medicine (SOM)
  • Dean's Updates
  • Research Office Bulletin
  • Spectrum (The Stanford Center for Clinical and Translational Education and Research)
    • Clinical Laboratory
    • Clinical Research Quality
    • Policies and Procedures
    • Researcher Resources
  • Stanford Center for Clinical Research (SCCR) (An Academic Research Organization (ARO) within the Department of Medicine at the Stanford School of Medicine)

Dean of Research (DoR)

The Dean of Research (DoR) website integrates information from many sources useful for research and scholarly activities at Stanford. It provide easy access to practical information about preparing and submitting research proposals, opportunities for research funding, international activities, shared facilities and many other topics.

Research Policy Handbook

The Stanford University Research Policy Handbook is a collection of policies, guidelines and general information related to the research enterprise at Stanford University. Those pertaining to human subject research include:

RPH Chapter 1 Conduct of Research:

• RPH 1.2 - Rights and Responsibilities in the Conduct of Research
• RPH 1.7 - Research Misconduct: Policy on Allegations, Investigations, and Reporting
• RPH 1.9 - Retention of and Access to Research Data

RPH Chapter 4 Conflicts of Commitment and Interest:

• RPH 4.1 - Faculty Policy on Conflict of Commitment and Interest
• RPH 4.2 - PHS & NSF Requirements Regarding Financial Disclosures and Agency Notifications
• RPH 4.4 - Conflict of Interest and Commitment For Academic Staff  and Other Teaching  Staff
• RPH 4.7 - Institutional Conflict of Interest in Research Involving Human Subjects

RPH Chapter 5 Human Subjects and Stem Cells in Research:

• RPH 5.1 - Human Research Protection Program
• RPH 5.2 - Federal-wide Assurance for Protection of Human Subjects
• RPH 5.3 - Women as Subjects in Research
• RPH 5.4 - Use of Human Subjects in Student Projects, Pilot Studies, Oral Histories and QA/QI Projects
• RPH 5.5 - Use of Employees or Laboratory Personnel as Research Subjects
• RPH 5.6 - Guidelines for Studies Involving Human Volunteers Receiving Potentially Addicting Drugs
• RPH 5.7 - Training in the Protection of Human Subjects in Research
• RPH 5.8 - Human Stem Cell Research

RPH Chapter 18 Committees and Panels that Support Research:

• RPH 18.3 - Administrative Panels for Research Compliance
• RPH 18.4 - Confidentiality of Administrative Panel Proceedings

Administrative Offices

Several administrative offices assist researchers conducting human subjects research at Stanford University.

• Environmental Health and Safety
• Industrial Contracts Office (ICO)
  • Also see "Who Will Handle My Agreement?" ICO website 
• Information Security Office (ISO)
  • Data Classification web page
  • Computer Security Risks and Mitigations
  • Stanford Data Classifications chart
• Office of General Counsel
• Office of Sponsored Research (OSR)
• Office of Technology Licensing (OTL)
• Research Management Group (RMG)

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)