Archived 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 (pdf)
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 (pdf)
July 2012	• Clinical Radiation Safety - Research with Children
May 2012	• Human Subjects Protocols: Privacy Considerations (pdf)
April 2012	• Children's Findings – Assent and Permission (pdf) • Children's Findings – Assent and Permission
March 2012	• Expanded Access (pdf) • Expanded Access
Feb 2012	• Pregnant Women (pdf) • Pregnant Women
Jan 2012	• Phone Scripts, Questionnaires and Waivers of Documentation of Consent (pdf) • Phone Scripts, Questionnaires and Waivers of Documentation of Consent
Dec 2011	• Regulations for SCRO Clinical Trials and ClinicalTrials.gov (pdf) • Additional Element of Consent: ClinicalTrials.gov (pdf) • Additional Element of Consent: ClinicalTrials.gov
Nov 2011	• Informed Consent Requirements and Elements - Revisited (pdf) • Informed Consent Requirements and Elements - Revisited
Oct 2011	• Provenance in Stem Cell Research (pdf)
Aug 2011	• Issues with Tissues (pdf) • Issues with Tissues
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)

Archived Presentations to the IRB

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