Programmatic Abstracts

Abstracts from the Ninth Annual Poster Session - Programmatic
presented at the 2009 Advancing Ethical Research Conference.

*Poster selected for presentation at a moderated abstract discussion.
**Poster selected for presentation at a plenary session.

Ethics and Risk Assessment

1. *360 Degrees of Human Subjects Protections in Community Engaged Research: A Proposed Taxonomy of Risks and Their Management
2. Navigating the NIH Roadmap: Review of a Clinical Data Repository for Translational Research
3. *Incomplete Disclosure: A Partial Truth
4. Development and Implementation of an Evidence-Based, Institution-Wide Clinical Research Risk Management Program
5. Assessing the Efficacy of Your After Hours Research Answering Service
6. Experience with IRB Review in Data Sharing for Genome Wide Association Studies: From the eMERGE (electronic medical records and genomics) Network
7. Challenges of Securing Privacy and Confidentiality in Behavioral Research in Post-Confict Liberia
8. Cost Benefits of an Institutionally-Based Subject Injury Compensation Program
9. Beyond Subject Injury: Development and Implementation of a Comprehensive Clinical Research Risk Program
10. Data Sharing & Security Framework: An Ethical, Regulatory & Proprietary Analytical Tool

Informed Consent

1. *Empowering Populations to Understand Clinical Trials
2. *That's a Wrap: Using Film to Educate About the Practical Aspects of the Informed Consent Process
3. **Informed Consent: Hollywood Style
4. Informed Consent – One Size Does Not Fit All
5. Elements of a Successful Consent
6. A Web-Based Community Consultation Data Management System for Large Multi-Center EFIC Trials
7. To intervene or not? Ethical Issues in Observational Research on the Informed Consent Process
8. Impact of Cultural & Educational Differences On Informed Consent Process In Liberia
9. Student IRB Service Learning: Measurable Impact on Consent Form Readability

International

1. Building Bridges Between Community Advisory Boards and Ethics Committees
2. Random Musings on “Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols” - The Nigerian Scenario
3. Evaluating International Collaborators’ Training Needs for Capacity Building in Research Ethics and Responsible Conduct of Research (RCR)
4. Innovation For Research-Oriented Educational Program About Research Ethics of Tokyo Medical and Dental University in Japan
5. The Contribution of the Kintampo Health Research Centre-Institutional Ethics Committee in Promoting Human Research Ethics Among Its Research Professionals
6. Situational Analysis of Botswana National Health Research Ethics Committee: A Strategy to Strengthen Capacity

IRB Operations

1. Biobanking Considerations & The C-PROBE Paradigm
2. *Implementation of the University of California System's IRB Memorandum of Understanding
3. *Improving Turn-Around Time for Initial IRB Review of Minimal Risk Studies
4. **From Shut Down to AAHRPP Full Accrediation in 10 short Years: A Case Study of the Operational & Organizational Changes at the DUHS IRB
5. Creation of a Comprehensive Research Patient Data Warehouse at Washington University
6. The VA Central IRB - Development Through the First Year of Operation
7. Tracking Database Views to Minimize Errors and Expedite Study Submission Processing Time
8. Streamlining the Administrative Review Process
9. Development of an Efficient and Effective System for IRB review of Non-Exempt Quality Improvement Projects
10. Protocol And Consent Form Amendments : A Look At The Submission And Review Process
11. Reduction of Rework for IRB Submissions – a DMAIC Project
12. Exception From Informed Consent Projects Conducted for Emergency Settings (EFIC)—The University Of Michigan Experience
13. Constructing an Automated Online IRB Application: A Collaborative Process
14. Improved Protocol Analyst Processing through the use of an Activity Guidebook
15. Assessment of “Speak to A Regulatory Analyst” (STARS) Program at the University of Michigan Medical School IRBs (IRBMED)
16. Tip of the Week
17. Department Focused IRB Model
18. An Innovative Approach to Streamlining Research Review: The Joint IRB/CTRC Review Committee
19. Streamlining the IRB Review Process: Accountability, Consistency and Simplicity
20. Saving the IRB Coordinator’s Time by Activity-Based Cost Accounting
21. A Model for Human Subjects Protections and Research Compliance
22. Blogging at the IRB
23. Pregnancy Testing Policy
24. Challenges of a Faith Based IRB
25. The Great American Cookie Experiment Research Program: A Strategy to Support Novice Nurse Researchers to Navigate the IRB Process
26. Expanding IRB Member Education: Incorporating IRB Staff Training Into IRB Member Educational Initiatives
27. Columbia University IRB’s Education and Training Initiatives: Bridging The Road to Success
28. Developing an IRB Educational Curriculum
29. Rapid Cycle Improvement of Expedited Review at the IRB
30. An Ounce of Prevention: Undergraduate Workshops
31. PTMS: A Custom, Electronic Platform for Improving IRB Processes
32. The Challenges of Instituting a National Ehics Committee and an Institutional Review Board in Human Research Ethics in Developing Countries
33. Research Based Radiation Procedures: A Comprehensive, Parallel Review Process
34. "Response To IRB Conditions" - A New Way To Accelerate The Process Following A Full Board Meeting
35. Enabling Excellence in Human Subject Protection Across the U.S. Department of Energy

Post Approval Monitoring

1. Nurturing the IRB-Investigator Relationship
2. A Brief Description of the Current Status, Structure and Function of 15 Research Ethics Committees Which Are Members of the Peruvian Network of Research Ethics Committees
3. Research On IRB Processes: A Methodological Study Describing The Evaluation of Two Central IRBs
4. Getting the Message Out: Innovative Training Methods for IRB Members
5. Crucial Choices: A Pilot Study of Interactive Research Ethics Education Methods for IRB Members at the University of Pennsylvania’s Office of Regulatory Affairs
6. Lessons Learned From Community-Wide IRB Authorization Agreements
7. Ensuring Quality Assurance: Educating, Not Policing
8. From the Crow’s Nest: Oversight and Monitoring in the Department of the Navy Human Research Protection Program
9. Post Approval Monitoring of the Informed Consent: 45CFR46.116(a)(7)
10. System For The Registration and Monitoring of Clinical Trials in Peru

QA/QI

1. IRB Pilot Evaluating an IRB Screening Tool to Differentiate Quality Improvement and Research
2. Promoting Quality Improvement Activities in the Research Community
3. Decentralized Exemption Determination Process
4. Critical Strategies in Research Compliance: Managing the Research Complaint
5. Tools, Templates, and Training for GCP Compliant Protocol Development
6. Enhancing Audit Effectiveness: Development and Implementation of a Web-based Human Research Compliance Database
7. Audit Program Extends to the IRB's electronic Research Compliance Solution
8. The Broad and Blurred Boundary Between Quality Improvement (QI) and Human Subjects Research
9. Enhancing Efficiency in a Compliance Oversight Program
10. An Essential Regulatory Compliance Tool for the Development of an Administrative Monitoring Plan
11. A Systematic Approach to Tracking Regulatory Data
12. Using Current Technology and Interactive Dialogue with IRB Documents Committee to Create Simplified Forms
13. Assuring Regulatory Compliance for Research Tissue Collection in the Operating Room (OR)
14. Development of an Electronic Data Collection Tool to Improve Internal IRB Quality Assurance

Regulations and Guidelines

1. Streamlining of Regulatory Processes at M.D. Anderson Cancer Center Orlando
2. Institutional Compliance with 45 CFR 46.103(b)(2): Are We Doing Enough?
3. Revitalizing the Human Subjects Protection Program at a Small Independent Specialized Health Care Education Institution
4. Promoting Communication Within a Centralized Office of Research Administration
5. Clinical Trials Network Cooperative Approach to Implementing Exception From Informed Consent (EFIC) for Emergency Research

Special Populations

1. *Implementation and Outcomes of a Research Ethics Education Program for Cardiovascular Investigators
2. *Protecting Human Subjects Participating in Mental Health Research Via Ongoing Consent Monitoring
3. Additional Protections for Subject with Impaired Decision-Making Abilities—The University of Michigan Program
4. A Model of Collaboration for the Education & Continued Informed Consent for Participants in Schizophrenia Research
5. The Ethical Implications of Engaging in Decolonizing Methodologies in a Canadian Aboriginal Reserve