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Presentations to the IRB

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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) ()

Oct 2012

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

Sept 2012

  • Recruitment ()

Aug 2012

  • Expedited Review Revisited ()

July 2012

  • Clinical Radiation Safety - Research with Children ()

May 2012

  • Human Subjects Protocols: Privacy Considerations ()

April 2012

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

March 2012

  • Expanded Access ()
  • Expanded Access ()

Feb 2012

  • Pregnant Women ()
  • Pregnant Women ()

Jan 2012

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

Dec 2011

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

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

Nov 2011

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

Oct 2011

  • Provenance in Stem Cell Research ()

Aug 2011

  • Issues with Tissues ()
  • Issues with Tissues ()

Jul 2011

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

May 2011

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

Apr 2011

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

Mar 2011

  • Genetic Research: Basic Vocabulary and Terminology ()

Feb 2011

  • Data Safety Monitoring and the IRB ()

Jan 2011

  • Scientific and Scholarly Review ()

Dec 2010

  • Criteria for IRB Approval of Research ()

Nov 2010

  • Prisoner Research and the IRB ()

Oct 2010

  • Vulnerable Populations and Human Subjects Review ()

Sept 2010

  • Research Involving Children and Radiation Exposure ()

Aug 2010

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

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

Jul 2010

  • Certificates of Confidentiality (CoC) ()

Jun 2010

  • IRB Quiz ()

May 2010

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

Apr 2010

  • Expedited Review ()

Mar 2010

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

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

Feb 2010

  • Ethnographical Research (Non-Medical, )

Jan 2010

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

  • SCRO Consent Requirements ()

  • Stem Cell Terminology ()

Dec 2009

  • Short Form Consent Process ()

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

Nov 2009

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

  • A Guide for the Combined IRB/SCRO ()

Oct 2009

  • IRB Member Orientation ()

  • Resources Supporting the HRPP ()

Sept 2009

  • Funding Research ()

Aug 2009

  • HIPAA ()

July 2009

  • Understanding Waivers & Alterations of Consent ()

Jun 2009

  • Laboratory Employees and Students as Research Subjects ()

May 2009

  • Belmont Report - History, Principles and Application ()

Apr 2009

  • IRB Determinations about Parental Permission ()

Mar 2009

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

  • Survey Research in Public Schools (PPRA Regulation, )

Jan 2009

  • AAHRPP Site Visit - December 2008 ()