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   Presentations to the IRB

Date

Presentations Provided to IRB Members
Aug 2015   • Non-compliance
July 2015   • Component Analysis
June 2015   • Children's Findings Signature Requirements
May 2015   • Children's Findings
Apr 2015   • Recruitment
Mar 2015   • Additional Documentation Needed for Approval
Feb 2015   • Non-Significant Risk Devices
Jan 2015   • Scientific & Scholarly Validity
Dec 2014   • IRB Member Conflicting Interests
Nov 2014   • CoI: Action Reports & Management Plans
Oct 2014   • Waiver of Documentation of Consent (waiver of signature)
Sept 2014   • Waivers and Alterations of Consent
Aug 2014   • HIPAA
July 2014   • Privacy vs. Confidentiality
June 2014   • Expedited Review
May 2014   • Unanticipated Adverse Device Effect (UADE)
Apr 2014   • IRB Member Conflict of Interest (CoI)
Mar 2014   • Non-Significant Risk Devices
Feb 2014   • Conflict of Interest: Action reports & Management plans
Jan 2014   • Scientific Review & Scholarly Validity
Dec 2013   • Mobile Medical Apps
Nov 2013   • Recruitment
Oct 2013   • Waiver of Informed Consent
Sept 2013   • Waiver of Documentation (or signature) of informed consent
Aug 2013   • Preparing For AAHRPP: Criteria for Approval (Part 2)
July 2013   • Preparing For AAHRPP: Criteria for Approval (Part 1)
June 2013   • Preparing For AAHRPP: Unanticipated Problems
May 2013   • Preparing For AAHRPP: Non-Compliance
Apr 2013   • Preparing For AAHRPP: Expedited Review
Mar 2013   • Preparing For AAHRPP: the Role of the IRB Member
Feb 2013   • Preparing For AAHRPP: Introduction
Jan 2013   • Waiver of Documentation
Dec 2012   • Equitable Selection
Nov 2012

  • Criteria for IRB Approval of Research (Part 2) (video)

Oct 2012

  • Criteria for IRB Approval of Research (Part 1) (video)

Sept 2012

  • Recruitment (video)

Aug 2012

  • Expedited Review Revisited (pdf)

July 2012

  • Clinical Radiation Safety - Research with Children (video)

May 2012

  • Human Subjects Protocols: Privacy Considerations (pdf)

April 2012

  • Children's Findings – Assent and Permission (pdf)
  • Children's Findings – Assent and Permission (video)

March 2012

  • Expanded Access (pdf)
  • Expanded Access (video)

Feb 2012

  • Pregnant Women (pdf)
  • Pregnant Women (video)

Jan 2012

  • Review Types for New SCRO Protocols (pdf)

  • Phone Scripts, Questionnaires and Waivers of Documentation of Consent (pdf)
  • Phone Scripts, Questionnaires and Waivers of Documentation of Consent (video)

Dec 2011

  • Regulations for SCRO Clinical Trials and ClinicalTrials.gov (pdf)

  • Additional Element of Consent: ClinicalTrials.gov (pdf)
  • Additional Element of Consent: ClinicalTrials.gov (video)

Nov 2011

  • Informed Consent Requirements and Elements - Revisited (pdf)
  • Informed Consent Requirements and Elements - Revisited (video)

Oct 2011

  • Provenance in Stem Cell Research (pdf)

Aug 2011

  • Issues with Tissues (pdf)
  • Issues with Tissues (video)

Jul 2011

  • Events & Information that Require Prompt Reporting to the IRB (pdf)

May 2011

  • Unanticipated Problems (UPs) & Adverse Events (AEs) "more info" (pdf)

Apr 2011

  • Informed Consent Scenarios (Medical, pdf)
  • Informed Consent Scenarios (Non-Medical, pdf)

Mar 2011

  • Genetic Research: Basic Vocabulary and Terminology (pdf)

Feb 2011

  Data Safety Monitoring and the IRB (pdf)

Jan 2011

  Scientific and Scholarly Review (pdf)

Dec 2010

  • Criteria for IRB Approval of Research (pdf)

Nov 2010

  • Prisoner Research and the IRB (pdf)

Oct 2010

  • Vulnerable Populations and Human Subjects Review (pdf)

Sept 2010

  • Research Involving Children and Radiation Exposure (pdf)

Aug 2010

  • (A) Determination of Human Subject Research;
    (B) Exempt Categories (pdf)

  • [SCRO] Updates to Stem Cell Research Oversight (pdf)

Jul 2010

  • Certificates of Confidentiality (CoC) (pdf)

Jun 2010

  • IRB Quiz (pdf)

May 2010

  • Children in Research (Medical, pdf)
  • Children in Research (Non-Medical, pdf)

Apr 2010

  • Expedited Review (pdf)

Mar 2010

  • Guidance on Unanticipated Problems (UPs) and Adverse Events (AEs)
    (Medical, pdf)
  • Guidance on Unanticipated Problems (UPs) and Adverse Events (AEs)     
    (Non-Medical, pdf)

  • CIRM Disease Team MPP Grants (Presentation to IRB 3/SCRO, pdf)

Feb 2010

  • Ethnographical Research (Non-Medical, pdf)

Jan 2010

  • General Requirements for Informed Consent (Medical, pdf)
  • General Requirements for Informed Consent (Non-Medical, pdf)

  • SCRO Consent Requirements (pdf)

  • Stem Cell Terminology (pdf)

Dec 2009

  • Short Form Consent Process (pdf)

  • Sponsor-Investigator Research [SIR] and Investigational New Drugs [INDs] (pdf)

Nov 2009

  • Criteria for IRB Approval of Research (Medical, pdf)
  • Criteria for IRB Approval of Research (Non-Medical, pdf)

  • A Guide for the Combined IRB/SCRO (pdf)

Oct 2009

  • IRB Member Orientation (pdf)

  • Resources Supporting the HRPP (pdf)

Sept 2009

  • Funding Research (pdf)

Aug 2009

  • HIPAA (pdf)

July 2009

  • Understanding Waivers & Alterations of Consent (pdf)

Jun 2009

  • Laboratory Employees and Students as Research Subjects (pdf)

May 2009

  • Belmont Report - History, Principles and Application (pdf)

Apr 2009

  • IRB Determinations about Parental Permission (pdf)

Mar 2009

  • Additional Protections for Pregnant Women, Fetuses and Neonates (pdf)

  • Survey Research in Public Schools (PPRA Regulation, pdf)

Jan 2009

  • AAHRPP Site Visit - December 2008 (pdf)

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