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 A21 - IRB Review of Big Data Research
Talks & Presentations

A21 - IRB Review of Big Data Research

Date: November 6, 2017
Speakers: Jacob Metcalf, PhD; Laura Odwazny, JD, MA; Ivor A. Pritchard, PhD; Stephen J. Rosenfeld, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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SBER Network Resources

Final Rule Case Study – UNM IRB

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Case Studies and Snapshots

Research Ethics Snapshot: Decision-Making for Preexisting Studies

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Poster Abstracts

"A Real Super Ethical Super Moral Perspective": The Research Ethics of Research Participants

Category: 2015 AER Conference

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Workplace Tools

2017 IACUC Workload and Salary Survey

Date: June 30, 2017
Authors: PRIM&R
Description: One of PRIM&R's goals is to provide our members with tools that will help them become even more successful professionally. One such tool is our Workload and Salary Survey. PRIM&R’s Workload and Salary Surveys generates crucial data on workloads, salaries, and staffing patterns for resource management and professional advancement. The results of this 2017 survey, geared toward professionals who work primarily with institutional animal care and use committees, provide important insight into the trends and opportunities of this field.

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 Curriculum Sets

Genetics and Return of Results

Covering a wide range of topics in oversight of human subjects research and animal research, our Curriculum Sets assemble a variety of PRIM&R’s educational resources on a single topic, to facilitate comprehensive education in targeted subject areas.

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Talks & Presentations

Yourprof Lecture 1: Global Health Research Ethics

Speaker: Jim Lavery, MSc, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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 Curriculum Sets

Structuring Postapproval Monitoring Programs

Covering a wide range of topics in oversight of human subjects research and animal research, our Curriculum Sets assemble a variety of PRIM&R’s educational resources on a single topic, to facilitate comprehensive education in targeted subject areas.

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Workplace Tools

2017 IRB Workload and Salary Survey

Date: June 30, 2017
Authors: PRIM&R
Description: One of PRIM&R's goals is to provide our members with tools that will help them become even more successful professionally. One such tool is our Workload and Salary Survey. PRIM&R’s Workload and Salary Surveys generates crucial data on workloads, salaries, and staffing patterns for resource management and professional advancement. The results of this 2017 survey, geared toward professionals who work primarily with institutional review boards, provide important insight into the trends and opportunities of this field.

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Poster Abstracts

"Approval Parties!" Faculty Ad-Hoc Meetings for Exempt/Expedited Determinations

Category: 2015 AER Conference

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Case Studies and Snapshots

Research Ethics Snapshot: Development of a Broad Consent Document

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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SBER Network Resources

Things to Consider when Implementing the Final Rule

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 A4 - You'll Know It When You See It, or Will You?: Defining
Talks & Presentations

A4 - You'll Know It When You See It, or Will You?: Defining "Human Subjects Research" Under the Revised Common Rule

Date: November 6, 2017
Speakers: Warren Capell, MD; Dean R. Gallant, AB; Julia G. Gorey, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Talks & Presentations

Yourprof Lecture 2: Why is Global Health Science Complicated?

Speaker: Ross Upshur, MD, MSc

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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 A5 - Facilitating Informed Consent in Light of the Revised Common Rule
Talks & Presentations

A5 - Facilitating Informed Consent in Light of the Revised Common Rule

Date: November 6, 2017
Speakers: Susie R. Hoffman, RN, BSN, CIP; Angela Hvitved, PhD, MA; Jerry A. Menikoff, MD, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Case Studies and Snapshots

Research Ethics Snapshot: Reviewing Patient Records Without Consent

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Poster Abstracts

"But I WANT You to Review My Project!" An IRB’s Experience with Implementing Policy Change for Reviewing Undergraduate-Initiated Research Proposals

Category: 2015 AER Conference

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SBER Network Resources

Final Rule Topics

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 Curriculum Sets

The 3Rs and Alternatives

Covering a wide range of topics in oversight of human subjects research and animal research, our Curriculum Sets assemble a variety of PRIM&R’s educational resources on a single topic, to facilitate comprehensive education in targeted subject areas.

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Talks & Presentations

Yourprof Lecture 3: Health Research in Developing Countries

Speaker: Jerome Singh, LLB, LLM, PhD, MHSc

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Talks & Presentations

Yourprof Lecture 4: The Challenge of Seeking Consent

Speaker: Susan Bull, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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 A8 - The Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Talks & Presentations

A8 - The Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Date: November 6, 2017
Speakers: Owen Faris, PhD; Karen L. Ulisney, MS, CRNP;
Conference: 2017 AER Conference

Time: 1-2 Hours

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A Novel VBA-Based System Not Only Dramatically Facilitates IRB Protocol Pre-Review, but also Reveals
Poster Abstracts

A Novel VBA-Based System Not Only Dramatically Facilitates IRB Protocol Pre-Review, but also Reveals Previously Unrecognized Frequent Findings

Category: 2015 AER Conference

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SBER Network Resources

Minimal Risk Categories – University of New Mexico (UNM) IRB

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Case Studies and Snapshots

Research Ethics Snapshot: Benign Behavioral Interventions

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Case Studies and Snapshots

Research Ethics Snapshot: Broad Consent

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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SBER Network Resources

SBER Network Virtual Roundtable: Things to Consider when Implementing the Final Rule

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A Review of the New York State Psychiatric Institute’s IRB Serious Adverse Event Policy
Poster Abstracts

A Review of the New York State Psychiatric Institute’s IRB Serious Adverse Event Policy

Category: 2015 AER Conference

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 C15 - Final Rule for Clinicaltrials.gov: Requirements and Implementation
Talks & Presentations

C15 - Final Rule for Clinicaltrials.gov: Requirements and Implementation

Date: November 7, 2017
Speakers: Sherry Mills, MD, M.P.A.; Sarah A. White, MPH, CIP; Rebecca J. Williams, PharmD, MPH
Conference: 2017 AER Conference

Time: 1-2 Hours

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Talks & Presentations

Yourprof Lecture 5: Caring for Participants and Communities

Speaker: Alex John London, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Talks & Presentations

Yourprof Lecture 6: Why Communities Matter

Speaker: Fern Brunger, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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 C21 - The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Healt
Talks & Presentations

C21 - The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) Research

Date: November 7, 2017
Speakers: Jeremy N. Block, PhD, MPP; Brenda L. Curtis, PhD, MSPH;
Conference: 2017 AER Conference

Time: 1-2 Hours

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A Solution to Creating and Managing your Regulatory Binder Electronically
Poster Abstracts

A Solution to Creating and Managing your Regulatory Binder Electronically

Category: 2015 AER Conference

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Case Studies and Snapshots

Research Ethics Snapshot: Limited IRB Review

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Case Studies and Snapshots

Research Ethics Snapshot: Research Subject to Multiple Regulations

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Talks & Presentations

Yourprof Lecture 7: The Relevance of Culture

Speaker: Godfrey Tangwa, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Adherence to Integrity and Ethical Conduct in Publications by the Authors
Poster Abstracts

Adherence to Integrity and Ethical Conduct in Publications by the Authors

Category: 2015 AER Conference

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 Closing General Session Luncheon: The “Nuremberg Code” After 70 Years: Foundational or Forgotten?
Talks & Presentations

Closing General Session Luncheon: The “Nuremberg Code” After 70 Years: Foundational or Forgotten?

Date: November 8, 2017
Speakers: Alexander M. Capron, LLB; Tessa Chelouche, MD; Alex John London, PhD; Susan M. Miller, MD, MPH, FACP; Sheldon Rubenfeld, MD, FACP, FACE
Conference: 2017 AER Conference

Time: 1-2 Hours

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 D12 - Essential Documentation: IRB Membership, Record Keeping, Minutes, and More
Talks & Presentations

D12 - Essential Documentation: IRB Membership, Record Keeping, Minutes, and More

Date: November 7, 2017
Speakers: Janet C. Donnelly, RAC; Ada Sue Selwitz, MA; Irene E. Stith-Coleman, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Except
Poster Abstracts

An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Exceptions to Clinical Trials in the Committee on Human Research

Category: 2015 AER Conference

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Case Studies and Snapshots

Research Ethics Snapshot: Scholarly and Journalistic Activities

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Talks & Presentations

Yourprof Lecture 8: Guidelines Authority and Challenges

Speaker: Eric Meslin, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Talks & Presentations

Yourprof Lecture 9: The Expanding Role of the Private Sector

Speaker: Trudo Lemmens, LLM, DCL

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Analysis of the Barriers in the IRB Pre-Review Process
Poster Abstracts

Analysis of the Barriers in the IRB Pre-Review Process

Category: 2015 AER Conference

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 D16 - IRB Noncompliance and Liability in the Single IRB Era
Talks & Presentations

D16 - IRB Noncompliance and Liability in the Single IRB Era

Date: November 7, 2017
Speakers: Kate Gallin Heffernan, JD; Megan Kasimatis Singleton, JD, MBE, CIP
Conference: 2017 AER Conference

Time: 1-2 Hours

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 D25 - Understanding the Benign Behavioral Intervention Exemption
Talks & Presentations

D25 - Understanding the Benign Behavioral Intervention Exemption

Date: November 7, 2017
Speakers: Karen Christianson, RN, BSN; David H. Strauss, MD; Ivor A. Pritchard, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt
Poster Abstracts

Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt

Category: 2015 AER Conference

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Talks & Presentations

Yourprof Lecture 10: Priority Settings in Global Health Research

Speaker: Jim Lavery, MSc, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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 D4 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Talks & Presentations

D4 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule

Date: November 7, 2017
Speakers: Mark Barnes, JD, LLM; Julie Kaneshiro, MA; Susan Stayn, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Can Meaningful Use Improve Informed Consent Forms that Advance Health Literacy?
Poster Abstracts

Can Meaningful Use Improve Informed Consent Forms that Advance Health Literacy?

Category: 2015 AER Conference

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Centralizing IRB Review Functions for a Growing, Urban HealthCare System
Poster Abstracts

Centralizing IRB Review Functions for a Growing, Urban HealthCare System

Category: 2015 AER Conference

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 E24 - SBER in International Settings: Identifying Challenges and Finding Solutions Through Case Stu
Talks & Presentations

E24 - SBER in International Settings: Identifying Challenges and Finding Solutions Through Case Studies

Date: November 8, 2017
Speakers: Leslie D. Cannold, PhD; Kelly O'Keefe, MPH; Katie B. Speanburg, EdMA
Conference: 2017 AER Conference

Time: 1-2 Hours

 

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 Innovations A: Innovations in Emergency and Disaster Research Settings
Talks & Presentations

Innovations A: Innovations in Emergency and Disaster Research Settings

Date: November 7, 2017
Speakers: Emily E. Anderson, PhD, MPH; Michael Linke, PhD, CIP; Joan Patrice Packenham, PhD; Kristen Sullivan, PhD, MSW, MBA, MA
Conference: 2017 AER Conference

Time: 1-2 Hours

 

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Changing Culture: Introducing Post Approval Monitoring Through a ‘Soft-Rollout’
Poster Abstracts

Changing Culture: Introducing Post Approval Monitoring Through a ‘Soft-Rollout’

Category: 2015 AER Conference

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Collaboratively Delivering QA/QI Support, Tools, and Resources by Leveraging Internal and External E
Poster Abstracts

Collaboratively Delivering QA/QI Support, Tools, and Resources by Leveraging Internal and External Expertise: A Harvard Catalyst Model

Category: 2015 AER Conference

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 Keynote Address: Low Hanging Fruit in the Reproducibility and Translatability Crisis: How IRBs Can
Talks & Presentations

Keynote Address: Low Hanging Fruit in the Reproducibility and Translatability Crisis: How IRBs Can Critically Assess Animal Data Before Approving First-In-Human-Studies

Date: November 16, 2016
Speakers: Joseph Garner, DPhil
Conference: 2016 AER Conference

Time: 1-2 Hours

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 Keynote Address: The Continuum from Truth and Knowledge Generation to Opinion to False Information:
Talks & Presentations

Keynote Address: The Continuum from Truth and Knowledge Generation to Opinion to False Information: Do We Have the Right Balance?

Date: November 7, 2017
Speakers: Robert M. Califf, MD, MACC
Conference: 2017 AER Conference

Time: 1-2 Hours

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Conflict of Interest: A National Perspective
Poster Abstracts

Conflict of Interest: A National Perspective

Category: 2015 AER Conference

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Considerations for Informed Consent Process for a Rehabilitation Program for People Living with HIV/
Poster Abstracts

Considerations for Informed Consent Process for a Rehabilitation Program for People Living with HIV/AIDS in a Lower Middle Income Country

Category: 2015 AER Conference

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 Keynote Address: The Ethics Beat: Writing About Ethics for the Front Page and Beyond
Talks & Presentations

Keynote Address: The Ethics Beat: Writing About Ethics for the Front Page and Beyond

Date: November 6, 2017
Speakers: Amy Dockser Marcus, MBE
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Lifetime Achievement Award Plenary Address by Ruth Macklin, PhD: Dealing With Controversies in Rese
Talks & Presentations

Lifetime Achievement Award Plenary Address by Ruth Macklin, PhD: Dealing With Controversies in Research Ethics: Four Decades of Experience

Date: November 6, 2017
Speakers: Ruth Macklin, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Coordinating Multi-Site Input for Central IRBs
Poster Abstracts

Coordinating Multi-Site Input for Central IRBs

Category: 2015 AER Conference

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Creating a New Pathway to Differentiate QI and Human Subjects’ Research
Poster Abstracts

Creating a New Pathway to Differentiate QI and Human Subjects’ Research

Category: 2015 AER Conference

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 Panel I - New Frontiers: The Changing Landscape of Research Regulations
Talks & Presentations

Panel I - New Frontiers: The Changing Landscape of Research Regulations

Date: November 6, 2017
Speakers: Michele Russell-Einhorn, JD, Melissa E. Abraham, PhD, MS, John R. Baumann, PhD, Emily Chi Fogler, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Panel III - The Role of Research Ethics Consultation in IRB-Reviewed Research: Opportunities and Ch
Talks & Presentations

Panel III - The Role of Research Ethics Consultation in IRB-Reviewed Research: Opportunities and Challenges

Date: November 6, 2017
Speakers: Steven Joffe, MD, MPH; [Susan Z. Kornetsky, MPH; photo] Susan Z. Kornetsky, MPH; Holly A. Taylor, PhD, MPH; Benjamin S. Wilfond, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Decisions for Non-Significant Risk Device Studies: Laboratory-Developed Tests
Poster Abstracts

Decisions for Non-Significant Risk Device Studies: Laboratory-Developed Tests

Category: 2015 AER Conference

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Developing a Practice and Guidance Committee to Document IRB Standard Procedures and Pilot Projects
Poster Abstracts

Developing a Practice and Guidance Committee to Document IRB Standard Procedures and Pilot Projects

Category: 2015 AER Conference

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 Panel IV - What Is Comparative Effectiveness Research (CER) and Does it Raise Any Unique Ethical Is
Talks & Presentations

Panel IV - What Is Comparative Effectiveness Research (CER) and Does it Raise Any Unique Ethical Issues?

Date: November 7, 2017
Speakers: Ruth Macklin, PhD; Scott Y.H Kim, MD, PhD; John D. Lantos, MD; Jerry A. Menikoff, MD, JD; Charles Natanson, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Panel IX - Bioethics in the Biopharmaceutical Industry: A Glimpse of Bioethics in a Different Setti
Talks & Presentations

Panel IX - Bioethics in the Biopharmaceutical Industry: A Glimpse of Bioethics in a Different Setting

Date: November 8, 2017
Speakers: Barbara E. Bierer, MD; Karla Childers, MSJ; Tatjana Poplazarova, MSc, MA-Bioethics; Luann E. Van Campen, PhD, MA-Bioethics
Conference: 2017 AER Conference

Time: 1-2 Hours

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Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia
Poster Abstracts

Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia

Category: 2015 AER Conference

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Development of Automated Methods for Big Data to Achieve Compliance with IRB, Institutional, and Fed
Poster Abstracts

Development of Automated Methods for Big Data to Achieve Compliance with IRB, Institutional, and Federal Requirements

Category: 2015 AER Conference

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 Panel V - Social, Behavioral, and Biomedical Transgender Research: Needs and Challenges
Talks & Presentations

Panel V - Social, Behavioral, and Biomedical Transgender Research: Needs and Challenges

Date: November 7, 2017
Speakers: Jeremy Sugarman, MD, MPH, MA; Sean Cahill, PhD; Rimah Jaber
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Panel VIII - Making Consent Meaningful in the Context of the Revised Common Rule
Talks & Presentations

Panel VIII - Making Consent Meaningful in the Context of the Revised Common Rule

Date: November 8, 2017
Speakers: Neal W. Dickert, Jr., MD, PhD; Rebecca S. Dresser, JD; Jerry A. Menikoff, MD, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research from Foc
Poster Abstracts

Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research from Focus Group Discussions

Category: 2015 AER Conference

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Establishing a Cancer Research Ethics Committee in Resource Limited Setting
Poster Abstracts

Establishing a Cancer Research Ethics Committee in Resource Limited Setting

Category: 2015 AER Conference

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2015 IACUC Conference Town Hall Meeting
Talks & Presentations

2015 IACUC Conference Town Hall Meeting

Date: March 20, 2015
Speakers: F. Claire Hankenson, Christian Newcomer
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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A New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engi
Talks & Presentations

A New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine

Date: November 14, 2016
Speakers: Alexander M. Capron, Barbara E. Bierer, Steven Joffe, Heather H. Pierce
Conference: 2016 AER Conference

Time: 1-2 Hours

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Expanding a Post-Approval Monitoring Program: Building on Success
Poster Abstracts

Expanding a Post-Approval Monitoring Program: Building on Success

Category: 2015 AER Conference

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Facilitating the Ethical Conduct of Research
Poster Abstracts

Facilitating the Ethical Conduct of Research

Category: 2015 AER Conference

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A14 - Considerations When Transitioning to the Revised Common Rule
Talks & Presentations

A14 - Considerations When Transitioning to the Revised Common Rule

Date: November 6, 2017
Speakers: Lauren Hartsmith, JD; P. Pearl O'Rourke, MD; Heather H. Pierce, JD, MPH
Conference: 2017 AER Conference

Time: 1-2 Hours

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Talks & Presentations

Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient

Date: November 11, 2019

Authors: Gretchen L. J Anding, MA; Elizabeth A. Buchanan, PhD

Description: The criteria for IRB approval have always included a requirement that IRBs consider, when appropriate, that there are sufficient protections in place to maintain the confidentiality of data. The revised Common Rule, specifically the new requirements for limited IRB review, place emphasis on this review criterion. Minimal guidance exists to assist IRBs in determining whether proposed safeguards for research data are sufficient. This session will review the challenges IRBs face in reviewing protocols to determine if the plans for maintaining confidentiality are sufficient, and it will highlight solutions for how data management and security review may be incorporated into the IRB review process.

Time: 1.25 hours

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Genomic Advisory Panel: Human Subjects Protection in a Brave New World
Poster Abstracts

Genomic Advisory Panel: Human Subjects Protection in a Brave New World

Category: 2015 AER Conference

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How Instituting a Formalized Pre-IRB Review Process Improves IRB Review Outcomes
Poster Abstracts

How Instituting a Formalized Pre-IRB Review Process Improves IRB Review Outcomes

Category: 2015 AER Conference

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Talks & Presentations

Assessing Plans to Maintain Confidentiality: Q&A

Q&A: Is Your Data Security Plan Sufficient?
Date: May 12, 2020
Speakers: Gretchen L. J Anding, MA; Elizabeth A. Buchanan, PhD; Sharon C. Freitag

As part of 2020's Member Appreciation Month, PRIM&R released a recording of AER19 session D12: Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient and hosted a live Q&A with the session speakers and Membership Committee co-chair, Sharon Freitag exclusively for PRIM&R members.

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B12 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule, or Is it Exe
Talks & Presentations

B12 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule, or Is it Exempt?

Date: November 6, 2017
Speakers: Angela Hvitved, PhD, MA
Conference: 2017 AER Conference

Time: 1-2 Hours

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Implementation of an Educational Initiative for Addressing “Common Pitfalls” With IRB Submissions
Poster Abstracts

Implementation of an Educational Initiative for Addressing “Common Pitfalls” With IRB Submissions

Category: 2015 AER Conference

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Improved Data Security via Collaboration Between the Information Security Office and the IRB
Poster Abstracts

Improved Data Security via Collaboration Between the Information Security Office and the IRB

Category: 2015 AER Conference

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B14 - Tips and Tools for Implementing Single IRB Review
Talks & Presentations

B14 - Tips and Tools for Implementing Single IRB Review

Date: November 6, 2017
Speakers: Carol Pech, PhD; Kimberly K. Summers, PharmD
Conference: 2017 AER Conference

Time: 1-2 Hours

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B16 - Mastering Master Agreements: When Are Broad-Based Standardized Agreements Beneficial to Resear
Talks & Presentations

B16 - Mastering Master Agreements: When Are Broad-Based Standardized Agreements Beneficial to Research Collaborations?

Date: November 6, 2017
Speakers: Nichelle Cobb, PhD; Libby D. Salberg, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Improving the IRB Meeting Minutes Approval Process
Poster Abstracts

Improving the IRB Meeting Minutes Approval Process

Category: 2015 AER Conference

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Innovation in IRB Reliance: A New Model Advances Multi-Site Research
Poster Abstracts

Innovation in IRB Reliance: A New Model Advances Multi-Site Research

Category: 2015 AER Conference

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B18 -
Talks & Presentations

B18 - "Let it Go": What Should Be Exempt and How to Limit IRB Review of These Studies (Including Those With Sensitive Data)

Date: November 6, 2017
Speakers: Teresa Doksum, MPH, PhD; Lauren Hartsmith, JD; Daniel K. Nelson, MSc, CIP; Sean Owen, CISSP, CAP, CRISC; Katie B. Speanburg, EdM
Conference: 2017 AER Conference

Time: 1-2 Hours

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B24 - SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Change
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B24 - SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Changes

Date: November 6, 2017
Speakers: Yvonne Lau, MBBS, MBHL, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Innovative Tools and Approaches for Streamlining the Research Review Process for American Indian Tri
Poster Abstracts

Innovative Tools and Approaches for Streamlining the Research Review Process for American Indian Tribal IRBs

Category: 2015 AER Conference

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Internal QA/QI Process for an University IRB
Poster Abstracts

Internal QA/QI Process for an University IRB

Category: 2015 AER Conference

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Could this Happen to You? Lessons Learned from the University of Minnesota Reports
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Could this Happen to You? Lessons Learned from the University of Minnesota Reports

Date: November 13, 2015
Speakers: Elisa A. Hurley Brian Herman Steven Joffe Martha Jones
Conference: AER15 Conference

Time: 1-2 Hours

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Fallout from the Freedom of Information Act (FOIA)
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Fallout from the Freedom of Information Act (FOIA)

Date: March 20, 2015
Speakers: B. Taylor Bennett, Jori Leszczynski, David Lyons
Conference: 2015 IACUC Conference

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IRB and Patient Safety Office Collaboration to Improve Participant Safety in Clinical Research: A Sy
Poster Abstracts

IRB and Patient Safety Office Collaboration to Improve Participant Safety in Clinical Research: A Systems Approach eFeedback Model

Category: 2015 AER Conference

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IRB Grand Rounds: A Novel Educational Format for Human Subject Research Protection Programs
Poster Abstracts

IRB Grand Rounds: A Novel Educational Format for Human Subject Research Protection Programs

Category: 2015 AER Conference

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Field and Laboratory Animal Research in Emerging Zoonoses
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Field and Laboratory Animal Research in Emerging Zoonoses

Date: March 19, 2015
Speakers: Darin Carroll
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Henry Spira Memorial Lecture: Running Interference: What Don’t You Know?
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Henry Spira Memorial Lecture: Running Interference: What Don’t You Know?

Date: March 20, 2018
Speakers: Kathleen R. Pritchett-Corning, DVM, DACLAM
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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IRB Staff Meetings: Not Your Average Meeting
Poster Abstracts

IRB Staff Meetings: Not Your Average Meeting

Category: 2015 AER Conference

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Leave No Man Behind: A Novel Approach to Study Team Member Training
Poster Abstracts

Leave No Man Behind: A Novel Approach to Study Team Member Training

Category: 2015 AER Conference

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Henry Spira Memorial Lecture: The Increased Relevance of the 3Rs, the Evolving Role of the IACUC, an
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Henry Spira Memorial Lecture: The Increased Relevance of the 3Rs, the Evolving Role of the IACUC, and Opportunities to Manifest Change for the Betterment of Animal Welfare and Human Health

Date: April 1, 2016
Speakers: Joseph Garner, DPhil
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Managing Non-Compliance: Systematic Approach that Improves Human Subject Research Protections
Poster Abstracts

Managing Non-Compliance: Systematic Approach that Improves Human Subject Research Protections

Category: 2015 AER Conference

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Innovations in IRB Operations
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Innovations in IRB Operations

Date: November 13, 2015
Speakers: Elyse Summers, Charles Ryan, Rachael Sak, Jon Newlin
Conference: AER15 Conference

Time: 1-2 Hours

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Keynote Address: Beyond Pain: Alleviating Suffering in Laboratory Animals
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Keynote Address: Beyond Pain: Alleviating Suffering in Laboratory Animals

Date: April 1, 2016
Speakers: Bernard E. Rollin
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Multicenter Protocol Management at a Large Comprehensive Cancer Center
Poster Abstracts

Multicenter Protocol Management at a Large Comprehensive Cancer Center

Category: 2015 AER Conference

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On-Target With On-Site IRB Reviews and Approvals
Poster Abstracts

On-Target With On-Site IRB Reviews and Approvals

Category: 2015 AER Conference

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C12 - Let's Review a Protocol: Identifying and Applying Federal Regulations to the Review of Researc
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C12 - Let's Review a Protocol: Identifying and Applying Federal Regulations to the Review of Research That Requires Expedited or Full Board Review

Date: November 7, 2017
Speakers: Warren Capell, MD; Ada Sue Selwitz, MA; Amy C. Waltz, JD, CIP
Conference: 2017 AER Conference

Time: 1-2 Hours

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C19 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Socia
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C19 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior

Date: November 7, 2017
Speakers: Sean Cahill, PhD; John A. Guidry, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Optimizing Pathways to Reliance on Academic Health Center Central IRB Review for Private Practice Gr
Poster Abstracts

Optimizing Pathways to Reliance on Academic Health Center Central IRB Review for Private Practice Group Research Sites

Category: 2015 AER Conference

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Patient Lay Summaries: Meeting the Ethical Obligation to Share Trial Results With Study Volunteers
Poster Abstracts

Patient Lay Summaries: Meeting the Ethical Obligation to Share Trial Results With Study Volunteers

Category: 2015 AER Conference

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C5 - Building Bridges Through IRB Education Outreach
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C5 - Building Bridges Through IRB Education Outreach

Date: November 7, 2017
Speakers: Colleen P. Gilrane, PhD; Joy Jurnack, RN, CCRC, CIP;
Conference: 2017 AER Conference

Time: 1-2 Hours

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Closing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
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Closing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings

Date: November 16, 2016
Speakers: David H. Strauss, Karen Kaplan, Lisa M. Lee, Vinay K. Prasad, Gary Schwitzer
Conference: 2016 AER Conference

Time: 1-2 Hours

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Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a mhealth Study
Poster Abstracts

Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a mhealth Study of Polydrug Use

Category: 2015 AER Conference

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Protocol Information Management System Regulator Binder: Streamlining Regulatory Binder Documentatio
Poster Abstracts

Protocol Information Management System Regulator Binder: Streamlining Regulatory Binder Documentation Maintenance and Improving Compliance

Category: 2015 AER Conference

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D10 - NIH-FDA Clinical Trial Protocol Template: Making Protocol Writing Easier for the Investigator,
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D10 - NIH-FDA Clinical Trial Protocol Template: Making Protocol Writing Easier for the Investigator, While Enhancing Quality

Date: November 7, 2017
Speakers: Melissa W. Riddle, PhD; Carrie D. Wolinetz, PhD;
Conference: 2017 AER Conference

Time: 1-2 Hours

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E12 - Writing and Updating Standard Operating Procedures (SOPs) in Light of the Revised Common Rule
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E12 - Writing and Updating Standard Operating Procedures (SOPs) in Light of the Revised Common Rule

Date: November 8, 2017
Speakers: Jeffrey A. Cooper, MD, MMM; Karen N. Hale, RPh, MPH; Lauren Hartsmith, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Qualitative Review of Ethical Guidelines for Epidemiological Studies
Poster Abstracts

Qualitative Review of Ethical Guidelines for Epidemiological Studies

Category: 2015 AER Conference

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Raising the Bar: Improving Quality of Research Conduct Through a Study Initiation Program
Poster Abstracts

Raising the Bar: Improving Quality of Research Conduct Through a Study Initiation Program

Category: 2015 AER Conference

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E18 - Secondary Research in the New Age: Thinking Through Your Options
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E18 - Secondary Research in the New Age: Thinking Through Your Options

Date: November 8, 2017
Speakers: Karen Blackwell, MS, CIP; Kate Gallin Heffernan, JD; Julie Kaneshiro, MA
Conference: 2017 AER Conference

Time: 1-2 Hours

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E22 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
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E22 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections

Date: November 8, 2017
Speakers: Yvonne Lau, MBBS, MBHL, PhD; Kathy M. Partin, PhD; Lisa Rooney, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

 

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Reducing Unnecessary IRB Oversight
Poster Abstracts

Reducing Unnecessary IRB Oversight

Category: 2015 AER Conference

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Research Common Core: Revitalizing the Monthly Research Education Conference
Poster Abstracts

Research Common Core: Revitalizing the Monthly Research Education Conference

Category: 2015 AER Conference

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E5 - Improving Informed Consent Through Effective Communication Strategies and the Potential Use of
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E5 - Improving Informed Consent Through Effective Communication Strategies and the Potential Use of Decision Aids

Date: November 8, 2017
Speakers: George Gasparis, CIP; John A. Sauceda, PhD, MSc
Conference: 2017 AER Conference

Time: 1-2 Hours

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Henry Spira Memorial Lecture: Assumptions and Certainty
Talks & Presentations

Henry Spira Memorial Lecture: Assumptions and Certainty

Date: March 20, 2017
Speakers: William White, VMD, MS, DACLAM, Dip. ECLAM
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Shifting Perspectives: Changing the Way the IRB is Perceived Through Education and Superior Customer
Poster Abstracts

Shifting Perspectives: Changing the Way the IRB is Perceived Through Education and Superior Customer Service

Category: 2015 AER Conference

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Standardizing Implementation of the Good Participatory Practice Guidelines: A Distance Learning Appr
Poster Abstracts

Standardizing Implementation of the Good Participatory Practice Guidelines: A Distance Learning Approach

Category: 2015 AER Conference

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Keynote Address: Ethics in Animal Research: Why Investigators Must Lead the Way
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Keynote Address: Ethics in Animal Research: Why Investigators Must Lead the Way

Date: March 20, 2018
Speakers: Jerrold Tannenbaum, JD
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Keynote Address: Game Changer: A Boy, a Dog, and a Cure
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Keynote Address: Game Changer: A Boy, a Dog, and a Cure

Date: March 21, 2018
Speakers: Martin (Casey) K. Childers, DO, PhD, Alison Rockett Frase
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Teamwork Makes the Dream Work! The Implementation of an Immersion Based Group Training Program for N
Poster Abstracts

Teamwork Makes the Dream Work! The Implementation of an Immersion Based Group Training Program for New IRB Staff Members

Category: 2015 AER Conference

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The Impact of Student-Specific Workshops on IRB Applications
Poster Abstracts

The Impact of Student-Specific Workshops on IRB Applications

Category: 2015 AER Conference

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Keynote Address: Pain in Mice and Man: Ironic Adventures in Translation
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Keynote Address: Pain in Mice and Man: Ironic Adventures in Translation

Date: April 2, 2016
Speakers: Jeffrey S. Mogil, BSc, PhD
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Modeling the Origins and Mechanisms of Cystic Fibrosis
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Modeling the Origins and Mechanisms of Cystic Fibrosis

Date: March 19, 2015
Speakers: David Meyerholz
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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The Long and Winding Road: Development of a Central IRB Reliance Program at an Academic Medical Cent
Poster Abstracts

The Long and Winding Road: Development of a Central IRB Reliance Program at an Academic Medical Center

Category: 2015 AER Conference

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The Road to Success: Rolling Out Electronic Animal Study Protocol (ASP) Software
Poster Abstracts

The Road to Success: Rolling Out Electronic Animal Study Protocol (ASP) Software

Category: 2015 IACUC Conference

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Panel I: IACUC Oversight: Addressing the Challenges, Understanding the Consequences
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Panel I: IACUC Oversight: Addressing the Challenges, Understanding the Consequences

Date: April 1, 2016
Speakers: F. Claire Hankenson, JR Haywood, Cindy Pekow, Andrew Buermeyer
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Innovations A: Innovations in Public Perceptions of Research and Risks
Talks & Presentations

Innovations A: Innovations in Public Perceptions of Research and Risks

Date: November 15, 2016
Speakers: Warren Capell, Linda Petree, Jonathan Rabinowitz, Donald J. Willison
Conference: 2016 AER Conference

Time: 1-2 Hours

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Table Topics: A No-Cost IACUC Member Continuing Education Program
Poster Abstracts

Table Topics: A No-Cost IACUC Member Continuing Education Program

Category: 2015 IACUC Conference

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Innovations B: Innovations in IRB Function
Talks & Presentations

Innovations B: Innovations in IRB Function

Date: November 7, 2017
Speakers: Cheryl A. Savini, CIP; Serah W. Gitome, MB ChB, MPH, CIP; Melissa J. Ricker, MEd; Megan Williams, MPA
Conference: 2017 AER Conference

Time: 1-2 Hours

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Scripting the Way for Rodent Procedure Recordkeeping Compliance
Poster Abstracts

Scripting the Way for Rodent Procedure Recordkeeping Compliance

Category: 2015 IACUC Conference

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Postural Movements of Rabbits in Variable Height Caging
Poster Abstracts

Postural Movements of Rabbits in Variable Height Caging

Category: 2015 IACUC Conference

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Innovations B: Innovations in Respecting Persons
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Innovations B: Innovations in Respecting Persons

Date: November 15, 2016
Speakers: Emily E. Anderson, PhD, MPH, Michele Antisdel, MBA, CCRP, CIP, Susan J. Goo, MSN, RN, Jessica Macha, BA, CIP
Conference: 2016 AER Conference

Time: 1-2 Hours

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Innovations C: Innovations in Building Global Infrastructure for Ethical Research
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Innovations C: Innovations in Building Global Infrastructure for Ethical Research

Date: November 15, 2016
Speakers: Delia Y. Wolf, MD, JD, MSCI, Megan Kasimatis Singleton, JD, MBE, CIP, Marina Topuridze, MD, MS, Barthalomew Wilson
Conference: 2016 AER Conference

Time: 1-2 Hours

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Post-Approval Monitoring: Making it Stick
Poster Abstracts

Post-Approval Monitoring: Making it Stick

Category: 2015 IACUC Conference

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Innovations C: Innovations in Research With Overlooked Ethical Perspectives
Talks & Presentations

Innovations C: Innovations in Research With Overlooked Ethical Perspectives

Date: November 7, 2017
Speakers: Warren Capell, MD; Suzanne Carlberg-Racich, MSPH, PhD; Wendy A. Cook, PhD, MA, RN, CCNS; Carol Juliet Weil, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Implementing an Animal Welfare Quality Monitoring Program for Third Parties
Poster Abstracts

Implementing an Animal Welfare Quality Monitoring Program for Third Parties

Category: 2015 IACUC Conference

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From AAALAC Trends to a Complete Occupational Health and Safety (OH&S) Program
Poster Abstracts

From AAALAC Trends to a Complete Occupational Health and Safety (OH&S) Program

Category: 2015 IACUC Conference

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Keynote Address: “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials
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Keynote Address: “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials

Date: November 15, 2016
Speakers: Patricia Furlong
Conference: 2016 AER Conference

Time: 1-2 Hours

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Keynote Address: Gut Microbiota and Reproducibility of Rodent Models of Disease
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Keynote Address: Gut Microbiota and Reproducibility of Rodent Models of Disease

Date: March 20, 2017
Speakers: Craig Franklin, DVM, PhD, DACLAM
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Evaluation of Electronic Database Solutions for IACUC Operations
Poster Abstracts

Evaluation of Electronic Database Solutions for IACUC Operations

Category: 2015 IACUC Conference

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Establishing an Agricultural Animal Care and Use Committee: All Hands on Deck!
Poster Abstracts

Establishing an Agricultural Animal Care and Use Committee: All Hands on Deck!

Category: 2015 IACUC Conference

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Keynote Address: Integrating Systems Biology and Public Health to Implement
Poster Abstracts

Keynote Address: Integrating Systems Biology and Public Health to Implement

Date: March 21, 2017
Speakers: Elaine Faustman, PhD
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Keynote Address: The Challenges of Clinical Trials and Community Trust in the 21st Century
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Keynote Address: The Challenges of Clinical Trials and Community Trust in the 21st Century

Date: November 8, 2017
Speakers: Robert A. Winn, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Current and Prospective Status for Scientific Research on Fish Welfare in Egypt
Poster Abstracts

Current and Prospective Status for Scientific Research on Fish Welfare in Egypt

Category: 2015 IACUC Conference

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Continuing Education for IACUC Members
Poster Abstracts

Continuing Education for IACUC Members

Category: 2015 IACUC Conference

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Keynote Address: When Human Subjects, Science, and Consumer Rights Collide
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Keynote Address: When Human Subjects, Science, and Consumer Rights Collide

Date: November 14, 2016
Speakers: Mary L. Gray, PhD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Oversight of Protocols With Aquatics
Talks & Presentations

Oversight of Protocols With Aquatics

Date: April 2, 2016
Speakers: Robert S. Sikes, Terence Bradley, George Sanders, David Parichy
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Association of Primate Veterinarians (APV) Nonhuman Primate (NHP) Housing Survey
Poster Abstracts

Association of Primate Veterinarians (APV) Nonhuman Primate (NHP) Housing Survey

Category: 2015 IACUC Conference

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A Survey of Animal User Training Programs Across Academia, Industry, and Medical Centers
Poster Abstracts

A Survey of Animal User Training Programs Across Academia, Industry, and Medical Centers

Category: 2015 IACUC Conference

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Panel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
Talks & Presentations

Panel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?

Date: November 14, 2016
Speakers: Alexander M. Capron, Barbara E. Bierer, Susan E. Lederer, David H. Strauss
Conference: 2016 AER Conference

Time: 1-2 Hours

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Panel I: Virtual IACUC: This Meeting Is in Session!
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Panel I: Virtual IACUC: This Meeting Is in Session!

Date: March 20, 2018
Speakers: Janet D. Stemwedel, PhD, Valerie K. Bergdall, DVM, DACLAM, Gary L. Borkowski, DVM, MS, DACLAM, Patricia A. Brown, VMD, MS, DACLAM, Christopher Dillon, BA, LATG, CPIA, Robert M. Gibbens, DVM, Samuel K. Kulp, DVM, PhD, Sally E. Light, BA, CPIA, Drusilla D. Qualman, Robert A. Skipper, Jr., PhD
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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A Global Approach to Building a Positive Reinforcement Training (PRT) Program for Research Animals
Poster Abstracts

A Global Approach to Building a Positive Reinforcement Training (PRT) Program for Research Animals

Category: 2015 IACUC Conference

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A Collaborative Approach To The Development Of A Chinese Animal Ethics Committee
Poster Abstracts

A Collaborative Approach To The Development Of A Chinese Animal Ethics Committee

Category: 2015 IACUC Conference

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Panel I: Virtual IACUC: This Meeting Is in Session! (2017)
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Panel I: Virtual IACUC: This Meeting Is in Session! (2017)

Date: March 20, 2017
Speakers: Mindy Hollander, MS, CPIA. Robert Barbee, PhD, Joel Brown, PhD, Patricia Brown, VMD, MS, Larry Carbone, DVM, PhD, DACAW, DACLAM, Carol Clarke, DVM, DACLAM, Clarissa Dirks, PhD, Andrew Grady, DVM, MS, DACLAM, Jennifer Perkins, MA, CPIA, Janet Stemwedel, PhD
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Panel II - Sovereignty in Research
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Panel II - Sovereignty in Research

Date: November 6, 2017
Speakers: Sara Chandros Hull, PhD, Heather L. Larsen, MEd, Terry J. M Powell, Bobby R. Saunkeah, RN, MSHCE, CIP
Conference: 2017 AER Conference

Time: 1-2 Hours

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“Readiness Rounds”: Involving the Technical Staff in Post-Approval Monitoring (PAM)
Poster Abstracts

“Readiness Rounds”: Involving the Technical Staff in Post-Approval Monitoring (PAM)

Category: 2015 IACUC Conference

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Developing Elements of an Effective Safety Compliance Program by Collaboration of the IACUC and the
Poster Abstracts

Developing Elements of an Effective Safety Compliance Program by Collaboration of the IACUC and the Office for Research Safety

Category: 2018 IACUC Conference

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Panel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
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Panel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)

Date: November 14, 2016
Speakers: Jeremy Sugarman, MD, MPH, MA, Leonard Glantz, JD, Steven Joffe, MD, MPH, Kevin P. Weinfurt, PhD, Benjamin S. Wilfond, MD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Panel II: Options/Opportunities to Address Regulatory/Administrative Burden
Talks & Presentations

Panel II: Options/Opportunities to Address Regulatory/Administrative Burden

Date: March 21, 2018
Speakers: B. Taylor Bennett, DVM, PhD, DACLAM, DACAW, Patricia A. Brown, VMD, MS, DACLAM, Joseph R. Haywood, PhD, Sally Thompson-Iritani, DVM, PhD, CPIA
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Proactive Versus Reactive Post-Approval Monitoring: Effective Strategies Towards Fostering a Culture
Poster Abstracts

Proactive Versus Reactive Post-Approval Monitoring: Effective Strategies Towards Fostering a Culture of Compliance

Category: 2018 IACUC Conference

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Preparation of the Veterinary Clinical Trial IACUC Protocol
Poster Abstracts

Preparation of the Veterinary Clinical Trial IACUC Protocol

Category: 2018 IACUC Conference

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Panel II: Overcome the Fear: The Life Changing Magic of Tidying Up Your Animal Care and Use Program
Talks & Presentations

Panel II: Overcome the Fear: The Life Changing Magic of Tidying Up Your Animal Care and Use Program

Date: March 21, 2017
Speakers: Sally Thompson-Iritani, DVM, PhD, CPIA, Joel Brown, PhD, William Greer, BS, CPIA, LAT, Mindy Hollander, MS, CPIA
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Panel II: Oversight of Protocols With Aquatics
Talks & Presentations

Panel II: Oversight of Protocols With Aquatics

Date: April 2, 2016
Speakers: Robert S. Sikes, PhD, Terence Bradley, PhD, David M. Parichy, PhD, George E. Sanders, DVM, MS, Certified Fish Pathologist (AFS/FHS)
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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A Day at the PUB: The University of Washington’s Solution to IACUC Policy Bloat
Poster Abstracts

A Day at the PUB: The University of Washington’s Solution to IACUC Policy Bloat

Category: 2018 IACUC Conference

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Panel III: The Research Community’s Roles and Responsibilities in Outreach and Advocacy: How Can the
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Panel III: The Research Community’s Roles and Responsibilities in Outreach and Advocacy: How Can the IACUC Contribute to Public Understanding?

Date: March 21, 2018
Speakers: Jennifer A. Perkins, MA, CPIA, Matthew R. Bailey, Allyson J. Bennett, PhD, Ken Gordon
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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The Role of Bioethics in the Pharmaceutical Industry: Informal Review of Five-Year Trends and One Co
Poster Abstracts

The Role of Bioethics in the Pharmaceutical Industry: Informal Review of Five-Year Trends and One Company’s Systematic Approach

Category: 2015 AER Conference

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Throwing the Baby Out With the Bathwater and Other Changes Made to Improve Office Operations: Succes
Poster Abstracts

Throwing the Baby Out With the Bathwater and Other Changes Made to Improve Office Operations: Successes and Missteps

Category: 2015 AER Conference

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Panel III: The Three Rs: Putting the Principles Into Practice
Poster Abstracts

Panel III: The Three Rs: Putting the Principles Into Practice

Date: March 21, 2017
Speakers: B. Bennett, DVM, PhD, DACLAM, DACAW, Christopher Dillon, BA, LATG, CPIA, Jennie Lofgren, DVM, MS, DACLAM, Letty Medina, DVM, DACLAM
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Panel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
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Panel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?

Date: November 14, 2016
Speakers: Susan Z. Kornetsky, Janet L. Brody, Celia B. Fisher, Eric Kodish
Conference: 2016 AER Conference

Time: 1-2 Hours

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Transcending Turnover by Standardizing Staff Training
Poster Abstracts

Transcending Turnover by Standardizing Staff Training

Category: 2015 AER Conference

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Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience
Poster Abstracts

Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience

Category: 2015 AER Conference

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Panel III: Virtual IACUC: This Meeting Is in Session! (2016)
Talks & Presentations

Panel III: Virtual IACUC: This Meeting Is in Session! (2016)

Date: April 2, 2016
Speakers: Mary Jo Shepherd, DVM, CPIA, John F. Bradfield, PhD, DVM, DACLAM, Patricia A. Brown, VMD, MS, DACLAM, Andrew Burich, DVM, MS, DACLAM, CPIA, Carol Clarke, DVM, DACLAM, Alan B. Ekstrand, BS, CPIA, RLATG, Cynthia C. Goodwin, Norman J. Kleiman, PhD, Kari Lyn Koszdin, DVM, MS, Dipl. ACLAM, CPIA CPIA
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Panel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
Talks & Presentations

Panel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research

Date: November 15, 2016
Speakers: Owen Garrick, MD, MBA, Jonca C. Bull, MD, Coleman K. Obasaju, MD, PhD, Vickie M. Mays IV, PhD, MSPH
Conference: 2016 AER Conference

Time: 1-2 Hours

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Using In-Person Express Reviews to Accelerate Exempt Determinations and Foster Collaboration with Re
Poster Abstracts

Using In-Person Express Reviews to Accelerate Exempt Determinations and Foster Collaboration with Researchers

Category: 2015 AER Conference

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Violations Submissions via Protocol Information Management System-Phase II
Poster Abstracts

Violations Submissions via Protocol Information Management System-Phase II

Category: 2015 AER Conference

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Panel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Fund
Talks & Presentations

Panel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence

Date: November 16, 2016
Speakers: Melissa E. Abraham, PhD, MS, Elizabeth L. Hohmann, MD, Glenn O'Neill, Govind Persad, JD, PhD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Panel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
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Panel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?

Date: November 15, 2016
Speakers: P. Pearl O’Rourke, Ysabel Duron, Nancy E. Kass
Conference: 2016 AER Conference

Time: 1-2 Hours

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Welcome to the Electronic Age: Successes and Challenges of Implementing an eIACUC System
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Welcome to the Electronic Age: Successes and Challenges of Implementing an eIACUC System

Category: 2018 IACUC Conference

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Panel VI - When Citizens Do Science: The Democratization of Research
Talks & Presentations

Panel VI - When Citizens Do Science: The Democratization of Research

Date: November 7, 2017
Speakers: P. Pearl O'Rourke, MD; Jamie Holloway, PhD; Sally Okun, RN, BSN, MMHS; Alicia Zhou, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Independent Work and Critical Thinking: Effective Approaches of Training Husbandry Technicians for
Poster Abstracts

Independent Work and Critical Thinking: Effective Approaches of Training Husbandry Technicians for Proficiency and Consistency Screen reader support enabled.

Category: 2018 IACUC Conference

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Developing IACUC Expectations for the Evaluation of Challenging Experimental Housing Conditions Via
Poster Abstracts

Developing IACUC Expectations for the Evaluation of Challenging Experimental Housing Conditions Via a Working Group

Category: 2018 IACUC Conference

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Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent E
Talks & Presentations

Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist

Date: November 15, 2016
Speakers: Christine Grady, RN, PhD, Michelle H. Biros, MD, Neal Dickert Jr., MD, PhD, Robert Silbergleit, MD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Panel VII - Race Matters: Ethical Challenges for the Use of Racial Categories in Research
Talks & Presentations

Panel VII - Race Matters: Ethical Challenges for the Use of Racial Categories in Research

Date: November 8, 2017
Speakers: John J. Whyte, MD, MPH; Albert J. Allen, MD, PhD; Khiara M. Bridges, JD, PhD; Owen Garrick, MD, MBA
Conference: 2017 AER Conference

Time: 1-2 Hours

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New Design: Dr. Abdel-Baset Aref and Dr. Hoda Saady Research Center For Academic Biological Experime
Poster Abstracts

New Design: Dr. Abdel-Baset Aref and Dr. Hoda Saady Research Center For Academic Biological Experiments Achieves Three Rs: Reduction, Replacement, and Refinement of Experimental Animals

Category: 2017 IACUC Conference

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Panel VII: Amplifying the Challenges: Return of Results in Pediatric Research
Talks & Presentations

Panel VII: Amplifying the Challenges: Return of Results in Pediatric Research

Date: November 16, 2016
Speakers: Albert J. Allen, Celia B. Fisher, David G. Forster, Jill McNair
Conference: 2016 AER Conference

Time: 1-2 Hours

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Creation of a Risk Assessment and Operational Procedures Matrix for the Use of Hazardous Animal Prot
Poster Abstracts

Creation of a Risk Assessment and Operational Procedures Matrix for the Use of Hazardous Animal Protocol Related Chemicals in the Animal Facility

Category: 2017 IACUC Conference

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Panel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
Talks & Presentations

Panel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan

Date: November 16, 2016
Speakers: Laura Odwazny, JD, MA, Christine Grady, RN, PhD, Anne Drapkin Lyerly, MD, MA, Robert M. Nelson, MD, PhD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Optimization of the Animal Protocol Form: Utilizing Model Specific Questions
Poster Abstracts

Optimization of the Animal Protocol Form: Utilizing Model Specific Questions

Category: 2017 IACUC Conference

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Patients with Lethal Diseases: Experiments in Research Design
Talks & Presentations

Patients with Lethal Diseases: Experiments in Research Design

Date: November 12, 2015
Speakers: Alexander Capron, Jeffrey Clark, Richard Penson
Conference: AER15 Conference

Time: 1-2 Hours

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Streamlining the Amendment Review Process: Separate Forms for Administrative Amendments
Poster Abstracts

Streamlining the Amendment Review Process: Separate Forms for Administrative Amendments

Category: 2017 IACUC Conference

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Picked Out of a Crowd: Privacy and Re-Identification Research
Talks & Presentations

Picked Out of a Crowd: Privacy and Re-Identification Research

Date: November 13, 2015
Speakers: Laura Odwazny, Jim Adler, Madeleine Price Ball, Michelle Meyer
Conference: AER15 Conference

Time: 1-2 Hours

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Developing an Ergonomic Safety Risk Assessment and Identification Program for Workplace Injury in an
Poster Abstracts

Developing an Ergonomic Safety Risk Assessment and Identification Program for Workplace Injury in an Animal Care Organization

Category: 2017 IACUC Conference

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Developing and Retaining Professional IACUC Staff
Poster Abstracts

Developing and Retaining Professional IACUC Staff

Category: 2017 IACUC Conference

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Primate Social Intelligence
Talks & Presentations

Primate Social Intelligence

Date: March 20, 2015
Speakers: Frans de Waal
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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 A Survey of Institutional Post-Approval Monitoring Programs Screen reader support enabled.
Poster Abstracts

A Survey of Institutional Post-Approval Monitoring Programs Screen reader support enabled.

Category: 2017 IACUC Conference

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Structuring Your IACUC for Efficiency and to Facilitate Research
Talks & Presentations

Structuring Your IACUC for Efficiency and to Facilitate Research

Date: March 19, 2015
Speakers: Melinda Hollander, Valerie Bergdall, Sally Light, Leo Otterbein
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Studies of Animals When They Are the Targeted Beneficiaries
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Studies of Animals When They Are the Targeted Beneficiaries

Date: March 19, 2015
Speakers: Robert Sikes, Jeremy Coleman, David Skelly, Darin Carroll
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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All In: A Revolution From a Fully Paper-Based IACUC and Animal Care and Use Program to a 100% Electr
Poster Abstracts

All In: A Revolution From a Fully Paper-Based IACUC and Animal Care and Use Program to a 100% Electronic System: From Protocol Review to Animal Procurement, Census, and Billing

Category: 2017 IACUC Conference

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Libraries and the IACUC: Benefits and Characteristics of Successful Relationships
Poster Abstracts

Libraries and the IACUC: Benefits and Characteristics of Successful Relationships

Category: 2017 IACUC Conference

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The Challenges of Research on Campus Sexual Violence: Ethical, Scientific, and Political Dimensions
Talks & Presentations

The Challenges of Research on Campus Sexual Violence: Ethical, Scientific, and Political Dimensions

Date: November 12, 2015
Speakers: Claude Ann Mellins, Elizabeth Armstrong, Shamus Khan, Sharyn Potter
Conference: AER15 Conference

Time: 1-2 Hours

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Virtual IACUC: This Meeting Is in Session!
Talks & Presentations

Virtual IACUC: This Meeting Is in Session!

Date: April 2, 2016
Speakers: Mary Jo Shepherd, Carol Clarke, Patricia Brown, John Bradfield, Kari Koszdin, Andrew Burich, Norman Kleiman, Cindy Goodwin, Alan Ekstrand
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Reducing Regulatory Burden: Running Delegated Member Review
Poster Abstracts

Reducing Regulatory Burden: Running Delegated Member Review

Category: 2017 IACUC Conference

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Reducing Regulatory Burden: Protocol Form Focus on Deviations from Standards
Poster Abstracts

Reducing Regulatory Burden: Protocol Form Focus on Deviations from Standards

Category: 2017 IACUC Conference

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 Henry Spira Memorial Lecture: Improving the Treatment of Animals: A Practical Perspective
Talks & Presentations

Henry Spira Memorial Lecture: Improving the Treatment of Animals: A Practical Perspective

Date: March 30, 2009
Speakers: Temple Grandin
Conference: 2009 IACUC Conference

Time: 1-2 Hours

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Virtual IACUC: This Meeting Is in Session! (2015)
Talks & Presentations

Virtual IACUC: This Meeting Is in Session! (2015)

Date: March 20, 2015
Speakers: Mary Jo Shepherd, Patricia Brown, Carol Clarke, Michael Huerkamp, Natalie Mays, Tammy Dellovade, Leo Otterbein, Janet Stemwedel, John Bradfield
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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The Launch: Getting
Poster Abstracts

The Launch: Getting "Lean" to Streamline Animal Use Protocol Review

Category: 2017 IACUC Conference

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When the Lines are Blurred Between SBER and Biomedical Research: Challenges for SBER IRBs
Talks & Presentations

When the Lines are Blurred Between SBER and Biomedical Research: Challenges for SBER IRBs

Date: November 13, 2015
Speakers: Celia Fisher, Melissa Abraham, Michele Kuchera, Elena Leonidovna Grigorenko
Conference: AER15 Conference

Time: 1-2 Hours

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Novel Strategies to Manage Departures from the Guide
Poster Abstracts

Novel Strategies to Manage Departures from the Guide

Category: 2017 IACUC Conference

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Mechanism for Reporting Adverse Events and Serious Adverse Events
Poster Abstracts

Mechanism for Reporting Adverse Events and Serious Adverse Events

Category: 2017 IACUC Conference

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Founding the Future
Poster Abstracts

Founding the Future

Category: 2017 IACUC Conference

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Characterization of a Behavioral Assay to Assess the Affective State of Mice
Poster Abstracts

Characterization of a Behavioral Assay to Assess the Affective State of Mice

Category: 2017 IACUC Conference

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Evaluation of Rat Well-Being During Euthanasia
Poster Abstracts

Evaluation of Rat Well-Being During Euthanasia

Category: 2017 IACUC Conference

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Post-Approval Monitoring: The Binding Material for the Three Legged Stool of Animal Welfare, and the
Poster Abstracts

Post-Approval Monitoring: The Binding Material for the Three Legged Stool of Animal Welfare, and the Vehicle for Exchanging Knowledge Between Researchers

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Evaluation of Essential Personnel on Their Knowledge and Awareness of the IACUC Emergency Disaster P
Poster Abstracts

Evaluation of Essential Personnel on Their Knowledge and Awareness of the IACUC Emergency Disaster Plan

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Establishing an IACUC Grant-Protocol Congruency Review Team
Poster Abstracts

Establishing an IACUC Grant-Protocol Congruency Review Team

Category: 2017 IACUC Conference

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Start-up Meetings Improve Safety and Fulfill Training Expectations
Poster Abstracts

Start-up Meetings Improve Safety and Fulfill Training Expectations

Category: 2017 IACUC Conference

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Development and Implementation of an Overcrowding Policy for Rodents
Poster Abstracts

Development and Implementation of an Overcrowding Policy for Rodents

Category: 2017 IACUC Conference

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Promotion of Alternatives and the Three Rs: An Animal Health Industry Perspective
Poster Abstracts

Promotion of Alternatives and the Three Rs: An Animal Health Industry Perspective

Category: 2017 IACUC Conference

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IACUC Site Visit 101: An Institution's Inside Journey to Create Tools and Training for Better IACUC
Poster Abstracts

IACUC Site Visit 101: An Institution's Inside Journey to Create Tools and Training for Better IACUC Semi-Annual Facility Inspections

Category: 2017 IACUC Conference

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Cultivating a Successful Partnership Between Institutions and Central IRBs
Poster Abstracts

Cultivating a Successful Partnership Between Institutions and Central IRBs

Category: 2017 AER Conference

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Animal Research Coordinator Certification: How Disseminating Knowledge Increases Compliance and Effi
Poster Abstracts

Animal Research Coordinator Certification: How Disseminating Knowledge Increases Compliance and Efficiency in an Animal Welfare Program

Category: 2017 IACUC Conference

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Progress Under the Animal Welfare Act in Humane Animal Care from 1966 to the Present
Poster Abstracts

Progress Under the Animal Welfare Act in Humane Animal Care from 1966 to the Present

Category: 2017 IACUC Conference

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Design and Development of an IACUC
Poster Abstracts

Design and Development of an IACUC

Category: 2017 IACUC Conference

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Inconsistencies Among IRBs’/Ethics Committees’ Approvals When Determining the Risk-Benefit Category
Poster Abstracts

Inconsistencies Among IRBs’/Ethics Committees’ Approvals When Determining the Risk-Benefit Category for Research with Children

Category: 2017 AER Conference

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Insider Experiences: United States Military Service Members as Participants in Health Research
Poster Abstracts

Insider Experiences: United States Military Service Members as Participants in Health Research

Category: 2017 AER Conference

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The Consent Paradox: the 2018 Common Rule Revisions Leave HIPAA-Covered Researchers in the Dark
Poster Abstracts

The Consent Paradox: the 2018 Common Rule Revisions Leave HIPAA-Covered Researchers in the Dark

Category: 2017 AER Conference

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Electronic Consent: Pros, Cons and Cautions
Poster Abstracts

Electronic Consent: Pros, Cons and Cautions

Category: 2017 AER Conference

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Risk-Benefit Analysis Under the 2016 Council for International Organizations of Medical Sciences (CI
Poster Abstracts

Risk-Benefit Analysis Under the 2016 Council for International Organizations of Medical Sciences (CIOMS) Guidelines

Category: 2017 AER Conference

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Using Systems Integration and a Central Approach to Achieve Compliance with ClinicalTrials.gov
Poster Abstracts

Using Systems Integration and a Central Approach to Achieve Compliance with ClinicalTrials.gov

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Conducting Science in Disasters: Recommendations from the NIH/National Institute of Environmental He
Poster Abstracts

Conducting Science in Disasters: Recommendations from the NIH/National Institute of Environmental Health Sciences Working Group for Special IRB Considerations in the Review of Disaster Related Researc

Category: 2017 AER Conference

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IRB Restructuring and Researcher Satisfaction
Poster Abstracts

IRB Restructuring and Researcher Satisfaction

Category: 2017 AER Conference

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Utilizing Peer Review for Quality Improvement and Training in Research
Poster Abstracts

Utilizing Peer Review for Quality Improvement and Training in Research

Category: 2017 AER Conference

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IRB Assessment of Internal Auditing Reports
Poster Abstracts

IRB Assessment of Internal Auditing Reports

Category: 2017 AER Conference

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Creating a Post-approval Monitoring (PAM) Checklist for Social-behavioral Researchers
Poster Abstracts

Creating a Post-approval Monitoring (PAM) Checklist for Social-behavioral Researchers

Category: 2017 AER Conference

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Decreasing Participating Site Time-to-Activation on Investigator-Initiated Multicenter Studies
Poster Abstracts

Decreasing Participating Site Time-to-Activation on Investigator-Initiated Multicenter Studies

Category: 2017 AER Conference

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Understanding How to “Walk the Line”: A Novel Survey of Institutional Human Subject Compliance Progr
Poster Abstracts

Understanding How to “Walk the Line”: A Novel Survey of Institutional Human Subject Compliance Programs (CPs) and Determinations of Serious and Continuing Noncompliance

Category: 2017 AER Conference

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Transitioning to In-House Reviewers for Expedited IRB Submissions
Poster Abstracts

Transitioning to In-House Reviewers for Expedited IRB Submissions

Category: 2017 AER Conference

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Analysis of the Present Recognition Toward Central IRB System in Japanese Medical Schools
Poster Abstracts

Analysis of the Present Recognition Toward Central IRB System in Japanese Medical Schools

Category: 2017 AER Conference

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Innovations to Promote Longevity and Ongoing Development of IRB Staff
Poster Abstracts

Innovations to Promote Longevity and Ongoing Development of IRB Staff

Category: 2017 AER Conference

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UP AND RUNNING: IRB Submission Assistance Program – Centralized Application Support for Investigator
Poster Abstracts

UP AND RUNNING: IRB Submission Assistance Program – Centralized Application Support for Investigators in Need

Category: 2017 AER Conference

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The Collaborative Academic IRB
Poster Abstracts

The Collaborative Academic IRB

Category: 2017 AER Conference

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Characterization of Biomedical IRB Effort for Reportable New Information within a Large Academic Med
Poster Abstracts

Characterization of Biomedical IRB Effort for Reportable New Information within a Large Academic Medical Center

Category: 2017 AER Conference

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Clinical Coordination Center and Academic Central IRB: The Central IRB Liaison Team -- The Tie That
Poster Abstracts

Clinical Coordination Center and Academic Central IRB: The Central IRB Liaison Team -- The Tie That Binds Them

Category: 2017 AER Conference

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Standardizing the Meeting Minutes Developing and Review Process
Poster Abstracts

Standardizing the Meeting Minutes Developing and Review Process

Category: 2017 AER Conference

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User Attitudes Towards Implementation of a Commercial Electronic Review System at a Naval Medical Ce
Poster Abstracts

User Attitudes Towards Implementation of a Commercial Electronic Review System at a Naval Medical Center

Category: 2017 AER Conference

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Negotiating Change: A Qualitative Analysis of Meeting Discussions during the Implementation of an El
Poster Abstracts

Negotiating Change: A Qualitative Analysis of Meeting Discussions during the Implementation of an Electronic IRB Work Management System

Category: 2017 AER Conference

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Using Lean Methodology to Improve the Implementation of a Web-Based IRB Submission System
Poster Abstracts

Using Lean Methodology to Improve the Implementation of a Web-Based IRB Submission System

Category: 2017 AER Conference

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Using Reliable Methods and Simple Rules to Encourage Consistency in IRB Review
Poster Abstracts

Using Reliable Methods and Simple Rules to Encourage Consistency in IRB Review

Category: 2017 AER Conference

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Using Advanced Statistics to More Accurately Predict IRB Outcomes
Poster Abstracts

Using Advanced Statistics to More Accurately Predict IRB Outcomes

Category: 2017 AER Conference

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The Heat of Summer: Managing Visiting Summer Student Researchers
Poster Abstracts

The Heat of Summer: Managing Visiting Summer Student Researchers

Category: 2017 AER Conference

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From Zero to Phase I – Blast Off!
Poster Abstracts

From Zero to Phase I – Blast Off!

Category: 2017 AER Conference

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Use of Statistical Reviewers on an IRB
Poster Abstracts

Use of Statistical Reviewers on an IRB

Category: 2017 AER Conference

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Integration of Department of Veterans Affairs (VA) Medical Facilities into the Stroke Trial Network
Poster Abstracts

Integration of Department of Veterans Affairs (VA) Medical Facilities into the Stroke Trial Network (NIH StrokeNet)

Category: 2017 AER Conference

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Building an Effective, Collaborative, and Accountable Human Research Protection Program
Poster Abstracts

Building an Effective, Collaborative, and Accountable Human Research Protection Program

Category: 2017 AER Conference

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The Professionalization of IRB Staff Members
Poster Abstracts

The Professionalization of IRB Staff Members

Category: 2017 AER Conference

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Joint Ethics Review of a Clinical Trial in Sudan: Experiences and a Way Forward
Poster Abstracts

Joint Ethics Review of a Clinical Trial in Sudan: Experiences and a Way Forward

Category: 2017 AER Conference

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Smart Checklists in the Boston Medical Center and Boston University Medical Campus Electronic System
Poster Abstracts

Smart Checklists in the Boston Medical Center and Boston University Medical Campus Electronic System

Category: 2017 AER Conference

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Establishing a Single IRB Team
Poster Abstracts

Establishing a Single IRB Team

Category: 2017 AER Conference

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Building Capacity by Engaging Chief Residents and Fellows as Committee Members
Poster Abstracts

Building Capacity by Engaging Chief Residents and Fellows as Committee Members

Category: 2017 AER Conference

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Implementing a Central IRB at an Academic Medical Center: Lessons Learned
Poster Abstracts

Implementing a Central IRB at an Academic Medical Center: Lessons Learned

Category: 2017 AER Conference

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Ch...Ch...Changes and Their Management: Creating a Process to Improve Outcomes
Poster Abstracts

Ch...Ch...Changes and Their Management: Creating a Process to Improve Outcomes

Category: 2017 AER Conference

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A Conscientious Consenting Process for Research in Drug-Using Populations
Poster Abstracts

A Conscientious Consenting Process for Research in Drug-Using Populations

Category: 2017 AER Conference

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FDA and IRB Approval of a Novel Prehospital Consent Process for Emergency Research
Poster Abstracts

FDA and IRB Approval of a Novel Prehospital Consent Process for Emergency Research

Category: 2017 AER Conference

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Understandable to the Subject' -- Plain Language IRB Informed Consents for Research
Poster Abstracts

Understandable to the Subject' -- Plain Language IRB Informed Consents for Research

Category: 2017 AER Conference

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Informed Consent Process when Conducting Genomic Research in Populations Characterized to Have Low L
Poster Abstracts

Informed Consent Process when Conducting Genomic Research in Populations Characterized to Have Low Literacy Levels

Category: 2017 AER Conference

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Creation of Transnational Collaboration to Strengthen Ethics Review of Human Subject Research
Poster Abstracts

Creation of Transnational Collaboration to Strengthen Ethics Review of Human Subject Research

Category: 2017 AER Conference

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Pregnant Women & the Zika Virus Vaccine Research Agenda: Recommendations for Ethical Priorities and
Poster Abstracts

Pregnant Women & the Zika Virus Vaccine Research Agenda: Recommendations for Ethical Priorities and Pathways

Category: 2017 AER Conference

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Risk and Surrogate Benefit for Pediatric Phase 1 Trials in Oncology: A Systematic Review with Meta-A
Poster Abstracts

Risk and Surrogate Benefit for Pediatric Phase 1 Trials in Oncology: A Systematic Review with Meta-Analysis

Category: 2017 AER Conference

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Scientific Misconduct as Injury: Employing Public Health Tools
Poster Abstracts

Scientific Misconduct as Injury: Employing Public Health Tools

Category: 2017 AER Conference

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 Women’s Views about Rules Governing Reproductive Issues in the Context of Biomedical Clinical Trial
Poster Abstracts

Women’s Views about Rules Governing Reproductive Issues in the Context of Biomedical Clinical Trials

Category: 2017 AER Conference

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Redefining Minimal Risk Standards
Poster Abstracts

Redefining Minimal Risk Standards

Category: 2017 AER Conference

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From Belmont (1979) to Helsinki (2013). A New Perspective on Vulnerability in Council for Internatio
Poster Abstracts

From Belmont (1979) to Helsinki (2013). A New Perspective on Vulnerability in Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Re

Category: 2017 AER Conference

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Controlling Privacy Risk in Database Studies for Human Subject Protection (HSP) via a Privacy Budget
Poster Abstracts

Controlling Privacy Risk in Database Studies for Human Subject Protection (HSP) via a Privacy Budgeting System

Category: 2017 AER Conference

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Understanding the Full Continuum of Identifiable to De-identifiable Data in the World of Big Data to
Poster Abstracts

Understanding the Full Continuum of Identifiable to De-identifiable Data in the World of Big Data to Minimize Privacy Risk in Database Studies

Category: 2017 AER Conference

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Recognizing Dignity Harms as Legitimate Risks Warranting Integration Into Research Practice
Poster Abstracts

Recognizing Dignity Harms as Legitimate Risks Warranting Integration Into Research Practice

Category: 2017 AER Conference

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Agency in Photovoice Research: Exploring the Lived Experience of Persons who Inject Drugs (PWIDs)
Poster Abstracts

Agency in Photovoice Research: Exploring the Lived Experience of Persons who Inject Drugs (PWIDs)

Category: 2017 AER Conference

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Pregnancy Prevention in Clinical Trials (Steps Toward Increasing Adherence to Birth Control Requirem
Poster Abstracts

Pregnancy Prevention in Clinical Trials (Steps Toward Increasing Adherence to Birth Control Requirements in Study Enrollees)

Category: 2017 AER Conference

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 New IRB Member Training and On-boarding Program
Poster Abstracts

New IRB Member Training and On-boarding Program

Category: 2017 AER Conference

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Improving IRB Application Success through a Learning Management System
Poster Abstracts

Improving IRB Application Success through a Learning Management System

Category: 2017 AER Conference

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Dedicated IRB Educator Impact on Researcher Satisfaction
Poster Abstracts

Dedicated IRB Educator Impact on Researcher Satisfaction

Category: 2017 AER Conference

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Training Needs Assessment of Research Ethics Committees in a Low-income Country
Poster Abstracts

Training Needs Assessment of Research Ethics Committees in a Low-income Country

Category: 2017 AER Conference

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Quality Assurance without Carrots or Sticks: Using Feedback Loops for Good Clinical Practice Audits
Poster Abstracts

Quality Assurance without Carrots or Sticks: Using Feedback Loops for Good Clinical Practice Audits

Category: 2017 AER Conference

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Face-to-Face Education is Coming: The Downfall of a Web-Based Training Program
Poster Abstracts

Face-to-Face Education is Coming: The Downfall of a Web-Based Training Program

Category: 2017 AER Conference

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Improving Quality through Comprehensive IRB Staff Training for Taking IRB Meeting Minutes
Poster Abstracts

Improving Quality through Comprehensive IRB Staff Training for Taking IRB Meeting Minutes

Category: 2017 AER Conference

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Improving HRPP Assessment of Community Outreach Activities
Poster Abstracts

Improving HRPP Assessment of Community Outreach Activities

Category: 2017 AER Conference

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Knowledge is Power: Developing a Suite of Educational Materials for Research Participants
Poster Abstracts

Knowledge is Power: Developing a Suite of Educational Materials for Research Participants

Category: 2017 AER Conference

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Re-Engaging Ethics: Development of Stakeholder-Driven Recommendations for the Ethical Review and Con
Talks & Presentations

Re-Engaging Ethics: Development of Stakeholder-Driven Recommendations for the Ethical Review and Conduct of Engaged Scholarship

Category: 2017 AER Conference

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Multi-Site Survey of Cancer Patients Who Donated Excess Surgical Tissue for Broad Future Research Us
Poster Abstracts

Multi-Site Survey of Cancer Patients Who Donated Excess Surgical Tissue for Broad Future Research Uses

Category: 2017 AER Conference

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The Million Veteran Program: Enhancing and Expanding Recruitment for a Representative Cohort
Poster Abstracts

The Million Veteran Program: Enhancing and Expanding Recruitment for a Representative Cohort

Category: 2017 AER Conference

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Before the Subjects Arrive: Advanced Planning of Critical Human Subjects Protections with Researcher
Poster Abstracts

Before the Subjects Arrive: Advanced Planning of Critical Human Subjects Protections with Researchers

Authors: Katherine W. Todman, LCSW-C; Carol J. Squires, LCSW; Mary Ellen Cadman, RN, MSN, LCSW-C; Julie Brintnall-Karabelas, LCSW-C; and Maryland Pao, MD
National Institute of Mental Health
Programmatic Submission
Category: 2016 AER Conference

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Development of Vulnerable Population Checklist as an Alarm System in Changhua Christian Hospital, Ta
Poster Abstracts

Development of Vulnerable Population Checklist as an Alarm System in Changhua Christian Hospital, Taiwan

Authors: Shu-Yu Chen; Ying-Ming Chiu; Sock-Ping Ng; Chin-San Liu; and Shou-Jen Kuo
Changhua Christian Hospital, Taiwan
Programmatic Submission
Category: 2016 AER Conference

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Parental Opinion About Pediatric Biospecimen Permission
Poster Abstracts

Parental Opinion About Pediatric Biospecimen Permission

Authors: Francis J. DiMario, Jr., MA, MD, CIP, University of Connecticut School of Medicine, Connecticut Children's Medical Center; Julia M. Vresilovic, BS, Trinity College
Scientific Submission
Category: 2016 AER Conference

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United States Military Service Members' Reasons for Deciding to Participate in Health Research
Poster Abstracts

United States Military Service Members' Reasons for Deciding to Participate in Health Research

Authors: Wendy A. Cook, PhD, MA, RN, CCNS, Naval Medical Center San Diego, University of Washington; Kristal C. Melvin, PhD, NP-C, Brooke Army Medical Center; Ardith Z. Doorenbos, PhD, RN, FAAN, University of Washington
Scientific Submission
Category: 2016 AER Conference

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Approaches and Challenges of Research Ethics Policy Development in the Country of Georgia
Poster Abstracts

Approaches and Challenges of Research Ethics Policy Development in the Country of Georgia

Authors: Marina Topuridze, MD, MS Epidemiology, National Center for Disease Control and Public Health, Georgia; Ketevan Shermadini, MD, Infectious Diseases, AIDS, and Clinical Immunology Research Center, Georgia; Givi Javashvili, MD, PhD, The National Council on Bioethics of Georgia; Andrei Fomenco, MD, Legal Medicine State Service of the Republic of Belarus; Sean Philpott-Jones, PhD, MSB, Clarkson University
Programmatic Submission
Category: 2016 AER Conference

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Challenges and Barriers in the Research Ethics Committee System and Regulations in the Country of Ge
Poster Abstracts

Challenges and Barriers in the Research Ethics Committee System and Regulations in the Country of Georgia

Authors: Ketevan Shermadini, MD, Infectious Diseases, AIDS, and Clinical Immunology Research Center, Georgia; Marina Topuridze, MD, MS Epidemiology, National Center for Disease Control and Public Health, Georgia; Givi Javashvili, MD, PhD, The National Council on Bioethics of Georgia; Andrei Famenka, MD, MS, Legal Medicine State Service of the Republic of Belarus; Martin A. Strosberg, MA, MPH, PhD, Union College; Sean Philpott-Jones, PhD, MSB, Clarkson University
Scientific Submission
Category: 2016 AER Conference

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Mobilizing the Troops: A Model for Preparing Investigators and the IRB for Research Supported by the
Poster Abstracts

Mobilizing the Troops: A Model for Preparing Investigators and the IRB for Research Supported by the DOD

Authors: Elizabeth Jach, MA; Therese Barenz, CCRC, CIP; Patricia Katopol, PhD; Michele Countryman, CIP; and Laura Dallas, CIP
University of Iowa
Programmatic Submission
Category: 2016 AER Conference

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Breaking it Off: Ending IRB Oversight When Applications and Proposals Lack Definite Plans for Involv
Poster Abstracts

Breaking it Off: Ending IRB Oversight When Applications and Proposals Lack Definite Plans for Involvement of Human Subjects

Authors: Allison Blodgett, PhD, CIP, University of Massachusetts Medical School; Michael Centola, MHS, CIP, New England Independent Review Board; Sharon Wang, CIP, CIM, University of Massachusetts Medical School
Programmatic Submission
Category: 2016 AER Conference

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Content Analysis of Free Newspaper Clinical Trial Advertisements
Poster Abstracts

Content Analysis of Free Newspaper Clinical Trial Advertisements

Authors: Cristóbal S. Berry-Cabán, PhD and Cheri L. Portee, BSN, Womack Army Medical Center; Sara Boltinhouse, BSCR; Devan Conley, BSCR; and Kaylyn Thompson, BSCR, Campbell University College of Pharmacy and Health Sciences
Scientific Submission
Category: 2016 AER Conference

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An Example of Interinstitutional Cooperation Through the Network of Research Ethics Committees in Ca
Poster Abstracts

An Example of Interinstitutional Cooperation Through the Network of Research Ethics Committees in Cali, Colombia

Authors: Paula Albarello, BS, MBA, Centro Médico Imbanaco de Cali South America; Jackeline Bravo Chamorro, RN, Centro Internacional de Entrenamiento e Investigaciones Médicas
Programmatic Submission
Category: 2016 AER Conference

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Understanding Ethical Oversight Perceptions of a Predominately Undergraduate University Research Com
Poster Abstracts

Understanding Ethical Oversight Perceptions of a Predominately Undergraduate University Research Community

Authors: James K. Vance; and Elizabeth A. Buchanan, PhD
University of Wisconsin-Stout
Programmatic Submission
Category: 2016 AER Conference

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Human Subject Research Regulatory Compliance Programs: Structures, Responsibilities, Processes, and
Poster Abstracts

Human Subject Research Regulatory Compliance Programs: Structures, Responsibilities, Processes, and Determinations of Serious/Continuing Noncompliance

Authors: Madelon Baranoski, PhD; Jessica Randall, MA, CIP; and Jeri Barney, JD, MS, CIP
Yale University
Scientific Submission
Category: 2016 AER Conference

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Clinical Trials Integrity from the Research Directorate Perspective
Poster Abstracts

Clinical Trials Integrity from the Research Directorate Perspective

Author: Tam Nguyen, PhD, MBA
St. Vincent's Hospital Melbourne, Australia
Programmatic Submission
Category: 2016 AER Conference

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Conducting a QA/QI Program Risk Assessment
Poster Abstracts

Conducting a QA/QI Program Risk Assessment

Authors: Julie Moore, JD, MS, PA; and Wendy Duncan, RN, BS
University of South Florida
Programmatic Submission
Category: 2016 AER Conference

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Aligning Processes and Procedures: Lessons Learned from the Implementation of a QA/QI Database
Poster Abstracts

Aligning Processes and Procedures: Lessons Learned from the Implementation of a QA/QI Database

Authors: Michele Gomez, BA, CIP and Sarah A. White, MPH, CIP, Partners Healthcare System, Inc.; Sana Khoury-Shakour, PhD, CCRP and Terry M. VandenBosch, PhD, RN, CIP, CCRP, University of Michigan; Avery Avrakotos, MPH Candidate, University of Michigan School of Public Health
Programmatic Submission
Category: 2016 AER Conference

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Using Metrics to Perform Risk-Based Assessments of HRPPs
Poster Abstracts

Using Metrics to Perform Risk-Based Assessments of HRPPs

Authors: Monique Hawkins, BA, CIP, Office of Naval Research; COL Molly Klote, MD, Army Human Research Protections Office
Programmatic Submission
Category: 2016 AER Conference

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IRB QI Initiative: Creating a Self-Certification Tool for QI and Program Evaluation Activities
Poster Abstracts

IRB QI Initiative: Creating a Self-Certification Tool for QI and Program Evaluation Activities

Authors: Gretchen Anding, MA and Nichelle Cobb, PhD, University of Wisconsin-Madison; D. Paul Moberg, PhD, University of Wisconsin-Madison
Programmatic Submission
Category: 2016 AER Conference

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Use of Lean Methodologies to Streamline the Continuing Review Process at a Large Academic Medical Ce
Poster Abstracts

Use of Lean Methodologies to Streamline the Continuing Review Process at a Large Academic Medical Center

Authors: Liz Tioupine, CIP; and Christopher M. Ryan, PhD
University of California, San Francisco
Programmatic Submission
Category: 2016 AER Conference

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Development of a Specialized IRB for Genetics and Genomics Research
Poster Abstracts

Development of a Specialized IRB for Genetics and Genomics Research

Authors: Brenda Ruotolo; Alan Teller; Deirdre Lombardi; and Michael Rossano
Columbia University
Programmatic Submission
Category: 2016 AER Conference

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Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium
Poster Abstracts

Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium

Author: Brandy Stoffel, JD, LLM, CIP
University of Wisconsin-Madison
Programmatic Submission
Category: 2016 AER Conference

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Use of IRB Reliance in Multi-Site Studies: An Evaluation of Contributing Factors
Poster Abstracts

Use of IRB Reliance in Multi-Site Studies: An Evaluation of Contributing Factors

Authors: Todd Rice; Emily Sheffer; Jull Pulley; Terri Edwards; Julie Ozier, MHL, CIP; and Gordon Bernard Vanderbilt University Medical Center
Scientific Submission
Category: 2016 AER Conference

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Limiting Pre-Meeting Stipulations Improves Overall Time to Approval
Poster Abstracts

Limiting Pre-Meeting Stipulations Improves Overall Time to Approval

Author: Kate Nolan, MPH, CIP; Ann Lazar, PhD, MS; and Christopher M. Ryan, PhD
University of California, San Francisco
Programmatic Submission
Category: 2016 AER Conference

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Implementation of Internal Audit to Monitor the Quality of Review in Changhua Christian Hospital, Ta
Poster Abstracts

Implementation of Internal Audit to Monitor the Quality of Review in Changhua Christian Hospital, Taiwan

Authors: Sock-Ping Ng; Kun-Tu Yeh; Chin-San Liu; and Shou-Jen Kuo
Changhua Christian Hospital, Taiwan
Programmatic Submission
Category: 2016 AER Conference

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Risk-Based Review of Ethics Applications: A Service Framework to Meet Increasing Demand
Poster Abstracts

Risk-Based Review of Ethics Applications: A Service Framework to Meet Increasing Demand

Authors: Kim Madison, BA (Psych Hons), DipEd, MAppSocRes, Assoc MAPS; and Rick Williams, B.Comm, M.TechMgt
Griffith University, Australia
Programmatic Submission
Category: 2016 AER Conference

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When Does QI Need IRB Review and Approval?
Poster Abstracts

When Does QI Need IRB Review and Approval?

Category: 2015 AER Conference

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Working Meetings with IRB Chairs: An Opportunity Not to Be Missed
Poster Abstracts

Working Meetings with IRB Chairs: An Opportunity Not to Be Missed

Authors: Judith Birk, JD; and Claudia Krcmarik, BS
University of Michigan Medical School
Programmatic Submission
Category: 2016 AER Conference

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Breaking Apart Institutional Review and IRB Review
Poster Abstracts

Breaking Apart Institutional Review and IRB Review

Authors: Hallie Kassan; Cerdi Beltre; and Cynthia Hahn
Northwell Health
Programmatic Submission
Category: 2016 AER Conference

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Integration of an Electronic External Interest Review Process into the HRPP Review Process
Poster Abstracts

Integration of an Electronic External Interest Review Process into the HRPP Review Process

Authors: Hallie Kassan; Emmelyn Kim; Scott Beardsley; and Gerry Kassoff
Northwell Health
Programmatic Submission
Category: 2016 AER Conference

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Implementing Flexibility and Being Flexible
Poster Abstracts

Implementing Flexibility and Being Flexible

Authors: Alexis Clasca, CIP; and Carmen Lam, CIP
University of California, Berkeley
Programmatic Submission
Category: 2016 AER Conference

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Improving IRB Efficiency Using Logic Models for Non-Traditional IRB Determinations
Poster Abstracts

Improving IRB Efficiency Using Logic Models for Non-Traditional IRB Determinations

Author: Adriana Brigatti, JD, MPH, LLM, CIP
Children's National Medical Center
Programmatic Submission
Category: 2016 AER Conference

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The National Approach: A Model of Single Ethical Review in the Australian Public Health System
Poster Abstracts

The National Approach: A Model of Single Ethical Review in the Australian Public Health System

Authors: Pamela Blaikie, PhD, St. Vincent's Hospital Sydney, Australia; Tam Nguyen, PhD, MBA, St. Vincent's Hospital Melbourne, Australia
Programmatic Submission
Category: 2016 AER Conference

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Establishing a Central IRB for a Large, Multi-Site Network
Poster Abstracts

Establishing a Central IRB for a Large, Multi-Site Network

Author: Kathleen A. Seabolt, CIM, CIC
Phoenix Children's Hospital
Scientific Submission
Category: 2016 AER Conference

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Restructure of Regulatory Analyst Roles to Promote Professional Development and Advancement
Poster Abstracts

Restructure of Regulatory Analyst Roles to Promote Professional Development and Advancement

Authors: Judith Birk, JD; Diana Miller, MS; and S. Joseph Austin, JD, LLM
University of Michigan Medical School
Programmatic Submission
Category: 2016 AER Conference

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Assent: How Young is Too Young? A Physician's Perspective
Poster Abstracts

Assent: How Young is Too Young? A Physician's Perspective

Authors: Rebecca Abel, MA, CIP and Julie Ozier, MHL, CIP, Vanderbilt University Medical Center; Cathryn Oldmixon, RN; and Nancy Ringwood, RN, CCRA, Massachusetts General Hospital
Programmatic Submission
Category: 2016 AER Conference

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Broad Consent Template for Prospective Permission from Vulnerable Populations for the Storage and Us
Poster Abstracts

Broad Consent Template for Prospective Permission from Vulnerable Populations for the Storage and Usage of Samples in Future Unspecified Research

Authors: Alberto (Betto) A. Ortiz-Osorno, MS, PMP, CIPM; and Linda A. Ehler, RN, MN
Protection of Participants, Evaluation, and Policy Branch, Division of AIDS, NIH, HHS
Programmatic Submission
Category: 2016 AER Conference

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Consent Consultation
Poster Abstracts

Consent Consultation

Authors: Monika Lau, MEd, CIP; Michele Antisdel, MBA, CIP; Jennifer Reese, MS, CIP; and Cathleen Montano, JD, CIP
Yale University
Programmatic Submission
Category: 2016 AER Conference

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An Indian Perspective Regarding Research Participants' Perceptions of Informed Consent
Poster Abstracts

An Indian Perspective Regarding Research Participants' Perceptions of Informed Consent

Author: Shubhan Alva, BDS
A.J. Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Conducting Research in an International Setting: Resources and Guidelines
Poster Abstracts

Conducting Research in an International Setting: Resources and Guidelines

Authors: Adrienne Tanner, CIP; and Colleen Kohashi, MA, CIP
University of California, Berkeley
Programmatic Submission
Category: 2016 AER Conference

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Building Global Ethics Review Capacity: An Innovative Model for IRB Administrator Training
Poster Abstracts

Building Global Ethics Review Capacity: An Innovative Model for IRB Administrator Training

Authors: Megan Kasimatis Singleton, JD, MBE, CIP, University of Pennsylvania; Ana Sofia Fabian Ortiz, BA, University of Pennsylvania, Universidad de Francisco Marroquin; Candida Franco Lemus, DDS, MBE and Luis Manuel López Dávila, MSocSc, MA, MD, Dr.PH, Universidad de San Carlos de Guatemala; Francis Barchi, PhD, MBE, Rutgers, The State University of New Jersey; Erwin Calgua Guerra, MD, Universidad de San Carlos de Guatemala; Sergio Martinez-Siekavizza, MD, Universidad de Francisco Marroquin; Jon F. Merz, MBA, JD, PhD, University of Pennsylvania
Programmatic Submission
Category: 2016 AER Conference

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Adapting Standard Clinical Trial Monitoring for Implementation Science in a Global HIV Context
Poster Abstracts

Adapting Standard Clinical Trial Monitoring for Implementation Science in a Global HIV Context

Authors: Tanya Jennings LMSW; Dhelia Williamson PhD; Carin Molchan, MS; and Katina Pappas-DeLuca, PhD
Centers for Disease Control and Prevention
Programmatic Submission
Category: 2016 AER Conference

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State-of-the-Art Adverse Event Monitoring for Behavioral Health Clinical Trials
Poster Abstracts

State-of-the-Art Adverse Event Monitoring for Behavioral Health Clinical Trials

Authors: Stacey Young-McCaughan, RN, PhD; Allison Hancock, PhD; John Roache, PhD; Jeslina Raj, PsyD; Tabatha Blount, PhD; Antionette Brundige, MS; and Alan Peterson, PhD, ABPP
University of Texas Health Science Center, San Antonio
Programmatic Submission
Category: 2016 AER Conference

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Awareness of Scientific Misconduct Among Tertiary Hospital Healthcare Professionals
Poster Abstracts

Awareness of Scientific Misconduct Among Tertiary Hospital Healthcare Professionals

Authors: Pooja Shetty, MDS, Postgraduate Diploma in Bioethics and Medical Ethics
A.J. Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Setting Maximal Risk Threshold
Poster Abstracts

Setting Maximal Risk Threshold

Authors: Joanna K. Rozynska, PhD
University of Warsaw
Scientific Submission (ethical analysis)
Category: 2016 AER Conference

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Health Literacy Challenges of Returning Neuroimaging Incidental Finding Radiology Reports in Researc
Poster Abstracts

Health Literacy Challenges of Returning Neuroimaging Incidental Finding Radiology Reports in Research

Authors: Jody Shoemaker, MS, CCRP, CIP and Caitlin Rancher, BA, Mind Research Network; Linda Petree, BA, CIP, The University of New Mexico; Mark Holdsworth, PharmD; John Phillips, MD; and Deborah Helitzer, ScD, University of New Mexico Health Sciences Center
Scientific Submission
Category: 2016 AER Conference

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Simultaneous and Sequential Study Enrollment Among 34,237 Clinical Trial Patients and Patients' Moti
Poster Abstracts

Simultaneous and Sequential Study Enrollment Among 34,237 Clinical Trial Patients and Patients' Motivation for Duplicate Enrollment

Authors: Jonathan Rabinowitz, PhD, Bar Ilan University; Nomi Werbeloff, PhD, University College London; Francine Mandel, PhD, Pfizer; Shitij Kapur, MBBS, PhD, FMedSci, King's College London
Scientific Submission
Category: 2016 AER Conference

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Attitudes and Perceptions in an Authorized Deception Placebo Analgesia Research Study
Poster Abstracts

Attitudes and Perceptions in an Authorized Deception Placebo Analgesia Research Study

Authors: Susan J. Goo, MSN, RN, Clinical Center Nursing Department, NIH; Emily A Richards, BA, National Center for Complementary and Integrative Health, NIH; Lucy Justement, BSN, MA, RN; and Patrick Korb, BSN, RN, Clinical Center, NIH; Brian Walitt, MD, MPH, National Institute of Nursing Research, NIH; M. Catherine Bushnell, PhD, National Center for Complementary and Integrative Health, NIH
Scientific Submission
Category: 2016 AER Conference

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 Ethical Perspectives in the Use of Personal Data from Medical Records for Health Research
Poster Abstracts

Ethical Perspectives in the Use of Personal Data from Medical Records for Health Research

Authors: Vijaya Hegde, MDS, Postgraduate Diploma in Bioethics and Medical Ethics
A.J. Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Applications for Research Concerning Fetal or Placental Tissue and Expected IRB Responses
Poster Abstracts

Applications for Research Concerning Fetal or Placental Tissue and Expected IRB Responses

Authors: Lynn Borgatta, MD, MPH, Quorum Review, Inc.; David Babaian, JD, LLM, Kinetiq, Inc.; Judith P. Kelly, BSN, MS, Boston University School of Public Health; Mary Banks, BS, BSN, Boston University School of Medicine; David Kaufman, ScD, Boston University School of Public Health
Scientific Submission
Category: 2016 AER Conference

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Increasing Attendance at IRB Education and Training
Poster Abstracts

Increasing Attendance at IRB Education and Training

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Guiding Researchers Through the IRB Submission Process by Diversifying IRB Educational Resources and
Poster Abstracts

Guiding Researchers Through the IRB Submission Process by Diversifying IRB Educational Resources and Training

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Using Lean Management Principles to Decrease IACUC Protocol Review Time
Poster Abstracts

Using Lean Management Principles to Decrease IACUC Protocol Review Time

Authors: Lindsay Pascal, Katie Pasichnyk
Category: 2016 IACUC Conference

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The Incorporation of a Research Study Plan to Enhance Support of Research Oversight Activities
Poster Abstracts

The Incorporation of a Research Study Plan to Enhance Support of Research Oversight Activities

Authors: K. A. Overhulse, C. Cheevers, E. Nelson, P. Trennery
Category: 2016 IACUC Conference

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Tackling the Challenge of Tracking and Training Students Involved in Animal Activities
Poster Abstracts

Tackling the Challenge of Tracking and Training Students Involved in Animal Activities

Authors: Astrid Haakonstad
Category: 2016 IACUC Conference

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Successfully Implementing Protocol Software: Creating Efficiencies & Avoiding Disruptions
Poster Abstracts

Successfully Implementing Protocol Software: Creating Efficiencies & Avoiding Disruptions

Authors: Patti Shanders
Category: 2016 IACUC Conference

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Stepping into the Future: The Blueprint to Creating a Fully Electronic IACUC Office
Poster Abstracts

Stepping into the Future: The Blueprint to Creating a Fully Electronic IACUC Office

Authors: Mandy Kozlowski, Paul Mireles, Russuell Greene, Angela Brinkley
Category: 2016 IACUC Conference

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Reducing Semiannual Review Burden Using the One Page Project Management Tool
Poster Abstracts

Reducing Semiannual Review Burden Using the One Page Project Management Tool

Authors: Lindsay Pascal, Katie Pasichnyk
Category: 2016 IACUC Conference

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Performance Evaluation of Institutional Animal Care and Use Committees in Egypt
Poster Abstracts

Performance Evaluation of Institutional Animal Care and Use Committees in Egypt

Authors: Abeer Badr; Sohair Fahmy; Kareem Morsy; Amel Soliman; Ibrahim Abdel Kader; Kohar Varjabedian; Ahmed Afifi; Ayman Saber; Atef Abdel Monem; Khadiga Gaafar Faculty of Science, Cairo University Elham Hassan; Fathy Zaki Faculty of Veterinary Medicine, Cairo University Azza Azzelarab Faculty of Oral and Dental Medicine, Cairo University Azza Hassan; Gamalat Othman; Saber Sakr Faculty of Science, Menoufia University Khaled Sharafeldin Faculty of Science, Benha University Maram Zaghloul Children Cancer Hospital Egypt 53753 Maiada Moustafa Faculty of Science, Helwan University
Category: 2016 IACUC Conference

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Managing Expired Protocols: A Process Improvement Initiative
Poster Abstracts

Managing Expired Protocols: A Process Improvement Initiative

Authors: Anne Clancy, Donna Matthews Jarrell, Jane Branca, Gerard M. Cronin, Mark Depathy, Nicole Freeman, Jason Fuller, Diane McCabe, Robin Minkel
Category: 2016 IACUC Conference

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Incorporation of the OLAW Guidance on Significant Changes to Animal Activities
Poster Abstracts

Incorporation of the OLAW Guidance on Significant Changes to Animal Activities

Authors: V. Cuevas, K. Blanchette
Category: 2016 IACUC Conference

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Environmental Monitoring to Support Extended Cage Change Frequency in Mouse Individually Ventilated
Poster Abstracts

Environmental Monitoring to Support Extended Cage Change Frequency in Mouse Individually Ventilated Cages (IVCs)

Authors: Andrea Swanson, Jeffrey W. Grimm
Category: 2016 IACUC Conference

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Collaborative Approach to Enhance IACUC Member Training through an Annual Educational Retreat
Poster Abstracts

Collaborative Approach to Enhance IACUC Member Training through an Annual Educational Retreat

Authors: Farah I. Moulvi, Paul A. Mackley, Archie O. Ellwood
Category: 2016 IACUC Conference

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Addressing the 3Rs: Process to Request an Animal Care and Use Protocol Literature Search
Poster Abstracts

Addressing the 3Rs: Process to Request an Animal Care and Use Protocol Literature Search

Authors: Toni O'Connell, Kevin Ogborne, Donna Zyry
Category: 2016 IACUC Conference

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IRB Member Comprehensive Handbook Resource
Poster Abstracts

IRB Member Comprehensive Handbook Resource

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Increasing Accuracy and Efficiency by Refreshing IRB Member Training
Poster Abstracts

Increasing Accuracy and Efficiency by Refreshing IRB Member Training

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Perception of Donation of Teeth to Science Among Dentists and Patients at a Tertiary Care Hospital i
Poster Abstracts

Perception of Donation of Teeth to Science Among Dentists and Patients at a Tertiary Care Hospital in India

Authors: Bhakti Sadhu, MDS, Postgraduate Diploma in Bioethics and Medical Ethics
Coorg Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Implementation of Post IRB Approval Education Targeting Novice Investigators
Poster Abstracts

Implementation of Post IRB Approval Education Targeting Novice Investigators

Authors: Judith A. Pride, RN, MSHS, CCRC, CCRP, CIP; Susan M. Garrow-Sloan, RN, BSN, CCRP; and Jennifer L. Pacheco, MPH, CIM, CIP
Baystate Health System
Category: 2016 AER Conference

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Developing a New IRB Administrator
Poster Abstracts

Developing a New IRB Administrator

Authors: Mary Prather, RN, MPH, CIP; Thomasena Williams, MPH; Helen Collins, RN, MN, LPC; and Shelli Golson-Mickens, MPH
Palmetto Health
Programmatic Submission
Category: 2016 AER Conference

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Knowledge and Practice of Research Ethics Among Biomedical Researchers in Southern Nigerian Tertiary
Poster Abstracts

Knowledge and Practice of Research Ethics Among Biomedical Researchers in Southern Nigerian Tertiary Institutions

Authors: Florence Ogunrin, PhD, University of Benin Nigeria; Olubunmi Ogunrin, MD, FWACP, FRCP, University of Liverpool, University of Benin; Bobbie Murray MS, I-O (Psych) HPA, US Army Command and General Staff College
Scientific Submission
Category: 2016 AER Conference

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Houston We Have a Problem: What Happened When We Added a Hospital to Our System
Poster Abstracts

Houston We Have a Problem: What Happened When We Added a Hospital to Our System

Authors: Tara Moore; and Elayne Grim
WellSpan Health
Programmatic Submission
Category: 2016 AER Conference

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The Network of Human Research Ethics Committees in Cali, Colombia: Institutional Expertise
Poster Abstracts

The Network of Human Research Ethics Committees in Cali, Colombia: Institutional Expertise

Authors: Arturo Herreño Marin, San Buenaventura University; Gloria I. Palma, Universidad del Valle; Jackeline Bravo Chamorro, RN, Centro Internacional de Entrenamiento e Investigaciones Médicas
Programmatic Submission
Category: 2016 AER Conference

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The Clinical Research Training and Mentoring Program, University of Maryland Baltimore, 2012-2016
Poster Abstracts

The Clinical Research Training and Mentoring Program, University of Maryland Baltimore, 2012-2016

Authors: Robert Edelman, MD; James D. Campbell, MD, MS; Anthony Sadzewicz, MS; and Julie Doherty, MSN, RN, CIP
University of Maryland, Baltimore
Programmatic Submission
Category: 2016 AER Conference

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Creating a Culture of Compliance With Integrity: It Takes More Than Solid Policies and a Snazzy Subm
Poster Abstracts

Creating a Culture of Compliance With Integrity: It Takes More Than Solid Policies and a Snazzy Submission System

Authors: Hila F. Berger, MPH, CIP; Amy Krenzer, CIP; Mylka Biascochea, CIM; and Susan Pereny
Montclair State University
Programmatic Submission
Category: 2016 AER Conference

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Social Mobilization and Communication: An Essential Component of Success of the Partnership for Rese
Poster Abstracts

Social Mobilization and Communication: An Essential Component of Success of the Partnership for Research on Ebola Virus in Liberia (PREVAIL) I Ebola Vaccine Study Conducted During the Ebola Outbreak

Authors: Barthalomew Wilson; Joseph Boye Cooper; and Julia Lysander, PREVAIL, US Joint Clinical Research Partnership; Khalipha Bility, Leidos Biomedical Research, Inc.; Jestina Doe Anderson, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.; Hassan Kiawu, PREVAIL; Laurie Doepel and Elizabeth Higgs, National Institute of Allergy and Infectious Diseases, NIH; Juli Endee, Liberia Crusaders for Peace
Programmatic Submission
Category: 2016 AER Conference

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Public Perspectives on Use of De-Identified Health Information for Private Sector or Commercial Uses
Poster Abstracts

Public Perspectives on Use of De-Identified Health Information for Private Sector or Commercial Uses

Authors: Donald J. Willison, ScD, University of Toronto; Kieran O'Doherty, PhD. University of Guelph; Ana Komparic, BSc, University of Toronto
Scientific Submission
Category: 2016 AER Conference

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What Children and Adolescents Value in Research and the Assent Process: A Pediatric Hospital's Exper
Poster Abstracts

What Children and Adolescents Value in Research and the Assent Process: A Pediatric Hospital's Experience

Authors: Rose Singh, MPH; Jessica Macha, BA, CIP; Eriika Etshokin, MA; and Susanna McColley, MD
Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago
Programmatic Submission
Category: 2016 AER Conference

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