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) |