|
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 ()
|
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