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Full Schedule
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7:30 AM - 5:30 PMRegistration Opens
8:30 AM - 5:00 PMBiobanking in an Era of Research Towards Precision Medicine: Approaches to the Ethical, Regulatory, and Practical Challenges
- 8:30 AM - 4:30 PM2016 AER Conference: Pre-Conference Programs
8:30 AM - 4:30 PMCritical Topics in SBER
8:30 AM - 4:30 PMEthical and Practical Issues in Global Human Research
8:30 AM - 12:00 PMIntegrity in Research: Responsible Conduct in Research Concepts and Cases (half day)
8:30 AM - 4:30 PMIRB 101sm
8:30 AM - 4:30 PMIRB 201: An In-Depth Analysis of the Criteria for Review
8:30 AM - 4:30 PMIRB Chairs Boot Camp: Tools for Successful IRB Leadership
8:30 AM - 4:30 PMSingle IRBs Are Here: Are You Ready?
1:00 PM - 4:30 PMA Systematic Exploration of IRB Review and Oversight of Research On, About, and Including Vulnerable Populations (half day)
4:30 PM - 6:00 PMPre-Conference Programs Networking Reception
7:00 AM - 5:30 PMRegistration Opens
7:00 AM - 8:00 AMContinental Breakfast to Welcome First-Time Attendees – SOLD OUT!
7:00 AM - 8:00 AMPeer-to-Peer Networking Continental Breakfast – SOLD OUT!
8:00 AM - 8:20 AMWelcome from the Conference Co-Chairs
8:20 AM - 8:35 AMWelcome from PRIM&R’s Executive Director
8:35 AM - 8:50 AMPresentation of the Research on Medical Practice Study Results
8:55 AM - 9:40 AMKeynote Address: When Human Subjects, Science, and Consumer Rights Collide
9:45 AM - 11:00 AMA New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine
11:00 AM - 11:30 AMBeverage Break
- 11:30 AM - 1:00 PMConcurrent Plenary Sessions
11:30 AM - 12:45 PMPanel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
11:30 AM - 1:00 PMPanel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
11:30 AM - 12:45 PMPanel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
12:45 PM - 2:00 PMNetworking Lunch
12:45 PM - 2:00 PMResearch Ethics Book Group Lunch and Book Signing: A Life Everlasting, The Extraordinary Story of One Boy’s Gift to Medical Science
1:30 PM - 1:50 PMDemonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC)
1:45 PM - 2:15 PMFDA Office Hours
1:45 PM - 2:15 PMMeet the AER16 Supporters and Exhibitors
1:45 PM - 2:15 PMOHRP Office Hours
1:55 PM - 2:15 PMOverview of PRIM&R’s Member Benefits
- 2:30 PM - 3:45 PMDidactic Sessions and Workshops Series A
2:30 PM - 3:45 PMA1 – A Dialogue with the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission)
2:30 PM - 3:45 PMA2 – A Dialogue with the Secretary's Advisory Committee on Human Research Protections (SACHRP)
2:30 PM - 3:45 PMA3 – Tips on Involvement of US Army Personnel as Human Subjects
2:30 PM - 3:45 PMA4 – You'll Know it When You See it: Defining "Human Subjects Research" Under the DHHS Regulations
2:30 PM - 3:45 PMA5 – Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff
2:30 PM - 3:45 PMA6 – Examining Participant Perspectives on Social and Structural Constraints on Research Involving Vulnerable Populations
2:30 PM - 3:45 PMA7 – Introduction to Ethical Principles for Research Involving Human Participants as Study Subjects
2:30 PM - 3:45 PMA8 – A Primer in Determining When an Investigational New Drug (IND) Application Is Needed for Studies Involving Drugs or Biologics
2:30 PM - 3:45 PMA9 – Different Models of Review: A Global Comparison
2:30 PM - 3:45 PMA10 – Updated International Guidelines for Stem Cell Research: Implications for IRBs, Stem Cell Research Oversight Committees (SCROs), and Institutions
2:30 PM - 3:45 PMA11 – Implementing NIH Single IRB Policy Using the National Center for Advancing Translational Sciences (NCATS) SMART IRB Reliance Platform in the Clinical and Translational Science Award (CTSA) Program
2:30 PM - 3:45 PMA12 – How Do We Assess the Quality of an HRPP?
2:30 PM - 3:45 PMA13 – Pre-IRB Review: IRB Ready or Not?
2:30 PM - 3:45 PMA14 – IRB Chairs and Members: Recruiting, Developing, Training, and Managing
2:30 PM - 3:45 PMA15 – Re-Evaluating Risk Tolerance: Are You Overdoing It?
2:30 PM - 3:45 PMA16 – Designing and Implementing Expanded Access Programs
2:30 PM - 3:45 PMA17 – Reserved for Late-Breaking Session
2:30 PM - 3:45 PMA18 – The Inside Scoop: What Every Non-Scientist IRB Member Should Know
2:30 PM - 3:45 PMA19 – The ABCs of Genetics, DNA, and Related Research Issues
2:30 PM - 3:45 PMA20 – Defining Vulnerability: Regulations and Beyond
2:30 PM - 3:45 PMA21 – Nuts and Bolts of Investigator Site Audits
2:30 PM - 3:45 PMA22 – IRB Review of Big Data Research
2:30 PM - 3:45 PMA23 – Does Anyone Here Get What I Do? Educating Your Institution on What the HRPP Is All About
2:30 PM - 3:45 PMA24 – Best Practices for Assessing Risks and Benefits in SBER
2:30 PM - 3:45 PMA25 – Mandatory Reporting
3:45 PM - 4:00 PMBeverage Break
- 4:00 PM - 5:15 PMDidactic Sessions and Workshops Series B
4:00 PM - 5:15 PMB1 – A Dialogue With the Office for Human Research Protections (OHRP)
4:00 PM - 5:15 PMB2 – A Dialogue With the Department of Energy (DOE)
4:00 PM - 5:15 PMB3 – Things that Keep an Institutional Official (IO) Up at Night
4:00 PM - 5:15 PMB4 – Opposing Forces: How to Align Flexibility and Consistency in Reliance Agreements
4:00 PM - 5:15 PMB5 – Training for Success: Tools and Educational Methods for IRB Staff
4:00 PM - 5:15 PMB6 – Panel Follow-Up: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
4:00 PM - 5:15 PMB7 – Ethical Issues in Community-Based Participatory Research (CBPR)
4:00 PM - 5:15 PMB8 – FDA Oversight and IRB Review of Investigational In Vitro Diagnostics (IVDs)
4:00 PM - 5:15 PMB9 – Ensuring Research Compliance of Multicenter and International Research
4:00 PM - 5:15 PMB10 – Competence Standardization, Development as a Means to Improving Patient Safety and Clinical Trial Operations
4:00 PM - 5:15 PMB11 – Reserved for Late-Breaking Session
4:00 PM - 5:15 PMB12 – The Characteristics of "High Performance" HRPPs
4:00 PM - 5:15 PMB13 – Essential Documentation: IRB Membership, Record Keeping, Minutes, and More
4:00 PM - 5:15 PMB14 – Evaluating Members, Chairs, and Staff: What Works and What Doesn’t?
4:00 PM - 5:15 PMB15 – Case Studies in IRB Quality Improvement Initiatives
4:00 PM - 5:15 PMB16 – Considerations for Effective IRB Review and Management of Protocol Deviations and Violations
4:00 PM - 5:15 PMB17 – Certificates of Confidentiality (CoCs): When, Why, and So What?
4:00 PM - 5:15 PMB18 – Keys to the Magic Kingdom: Defining Roles, Expectations, and Challenges for the Non-Scientist IRB Member
4:00 PM - 5:15 PMB19 – Consenting Subjects for Bio/Data Repositories: Evaluating Approaches and Their Implications for Future Solutions
4:00 PM - 5:15 PMB20 – Research With Children: Regulations and Beyond
4:00 PM - 5:15 PMB21 – Nuts and Bolts of Assessing IRB Compliance
4:00 PM - 5:15 PMB22 – Clinical Research in the Age of Digital Health: Best Practices for IRBs
4:00 PM - 5:15 PMB23 – Building and Maintaining an HRPP Within a Primarily SBER Institution with a Small Research Portfolio
4:00 PM - 5:15 PMB24 – Scientific Merit, Generalizability, and Risks in Qualitative Research: A Case Study Approach
4:00 PM - 5:15 PMB25 – Understanding Qualitative Research and Associated Ethical Issues to Protect Research Participants from Harm
5:15 PM - 6:30 PMAER16 Welcome Reception Supported by Schulman IRB
5:15 PM - 5:35 PMDemonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC)
5:15 PM - 6:30 PMRoundtable Discussions
5:40 PM - 6:00 PMDemonstration of PRIM&R’s Knowledge Center
7:00 PM - 9:00 PMYoung Professionals Networking Reception
7:00 AMRegistration Opens
7:00 AM - 8:00 AMCertified IRB Professional (CIP®) Continental Breakfast – SOLD OUT!
8:00 AM - 8:15 AMWelcome from the Conference Co-Chairs
8:15 AM - 8:25 AMPresentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Patricia A. MacCubbin, MS, President and CEO, Research Ethics Group
8:30 AM - 9:15 AMKeynote Address: “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials
9:15 AM - 9:45 AMBeverage Break
- 9:45 AM - 11:00 AMInnovations in… Series
11:00 AM - 11:15 AMBreak
- 11:15 AM - 1:45 PMDidactic Sessions and Workshops Series C
11:15 AM - 12:30 PMC1 – A Dialogue With the Food and Drug Administration (FDA)
11:15 AM - 12:30 PMC2 – A Dialogue With the Office for Research Integrity (ORI)
11:15 AM - 1:45 PMC3 – Risky Business: Exposing Children to Potential Harm Without Compensating Clinical Benefit
11:15 AM - 12:30 PMC4 – Crossing the Line: When Does Innovative Care Become Research?
11:15 AM - 12:30 PMC5 – Recruiting, Educating, and Retaining Non-Scientist/Community IRB Members
11:15 AM - 12:30 PMC6 – Preventive Misconception in HIV Prevention: What it Is and How to (Try to) Measure it
11:15 AM - 1:45 PMC7 – Ethical and Regulatory Review of Research: Case Studies
11:15 AM - 12:30 PMC8 – What Are Dietary Supplements and How Are They Regulated by the FDA?
11:15 AM - 12:30 PMC9 – Determining Vulnerable Populations and Associated Risks in Developing Country Settings: Additional Ethical Considerations
11:15 AM - 12:30 PMC10 – The Certified IRB Professional (CIP®) Credential: What Is it About?
11:15 AM - 12:30 PMC11 – Reserved for Late-Breaking Session
11:15 AM - 1:45 PMC12 – Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should Consider
11:15 AM - 1:45 PMC13 – Let's Review a Protocol: Regulatory Considerations in the IRB Review Process
11:15 AM - 1:45 PMC14 – IRB Chairs Forum: A Structured Discussion for IRB Chairs
11:15 AM - 1:45 PMC15 – Operationalizing Collaborative IRB Review
11:15 AM - 12:30 PMC16 – Patient-Centric Trial Design and Conduct
11:15 AM - 1:45 PMC17 – When it Happens to You: Preparing for Phase II Health Insurance Portability and Accountability Act (HIPAA) Audits and Identifying and Managing Privacy Breaches in Research
11:15 AM - 1:45 PMC18 – Statistics Without Tears
11:15 AM - 1:45 PMC19 – Return of Individual Research Results - Complex Considerations for a Not So Simple Request: Perspectives from Scientists, Subjects, and Regulators
11:15 AM - 12:30 PMC20 – Populations on the Edge: The Homeless, Substance Abusers, the Lesbian, Gay, Bisexual, and Transgender (LGBT) Community, and More
11:15 AM - 1:45 PMC21 – Novel Methods, Approaches, and Tools for QA/QI, Including Electronic Systems and Technology
11:15 AM - 1:45 PMC22 – The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) Research
11:15 AM - 1:45 PMC23 – Flying Solo: A Moderated Discussion on Challenges Encountered by Single Staff IRB Offices
11:15 AM - 1:45 PMC24 – College Students and Research: Challenges and Issues for IRBs
11:15 AM - 12:30 PMC25 – FDA Oversight, SBER, and the IRB
12:45 PM - 1:45 PMNetworking Lunch
- 2:00 PM - 3:15 PMConcurrent Plenary Sessions
2:00 PM - 3:15 PMPanel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
2:00 PM - 3:15 PMPanel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
2:00 PM - 3:15 PMPanel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist
3:15 PM - 3:30 PMBeverage Break
- 3:30 PM - 4:45 PMDidactic Sessions and Workshops Series D
3:30 PM - 4:45 PMD1 – A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
3:30 PM - 4:45 PMD2 – Exploring and Enhancing Diversity Within Our Compliance Committees
3:30 PM - 4:45 PMD3 – Moving From Fossils to Young Blood for the HRPP/IRB Engine
3:30 PM - 4:45 PMD4 – The Seven Habits of Highly Effective and Flexible IRBs
3:30 PM - 4:45 PMD5 – Recruitment Strategies: Sharing Our Secrets for Success
3:30 PM - 4:45 PMD6 – Strategies for Incorporating Empirical Research into IRB Member Education
3:30 PM - 4:45 PMD7 – The International Conference for Harmonization (ICH) E6 Integrated Addendum: What Do the Proposed Changes to the Good Clinical Practice (GCP) Guidelines Mean for the Clinical Research Community?
3:30 PM - 4:45 PMD8 – Expanded Access and Off-Label Use of Medical Devices
3:30 PM - 4:45 PMD9 – Cutting-Edge Challenges in HIV Research Ethics in the Resource Limited Settings: Lessons from the Ethics Working Group (EWG) of the HIV Prevention Trial Network (HPTN)
3:30 PM - 4:45 PMD10 – IRB Considerations When Conducting Research During Public Health Emergencies: Ebola, Influenza, Zika and Whatever Is Next...
3:30 PM - 4:45 PMD11 – Building a Better Clinical Trial: Enhancing Stewardship at NIH
3:30 PM - 4:45 PMD12 – Potential Litigation and Enforcement Actions: Past, Present, and Future, Under the NIH Single IRB Review Policy and Highly Anticipated Revised Common Rule
3:30 PM - 4:45 PMD13 – The ABCs of Writing Standard Operating Procedures (SOPs)
3:30 PM - 4:45 PMD14 – Meeting Management for IRB Chairs
3:30 PM - 4:45 PMD15 – True Stories from the IRB and their Impact on IRB Operations
3:30 PM - 4:45 PMD16 – Making Risk-Based Quality “Fit for Purpose” for Your Organization
3:30 PM - 4:45 PMD17 – You’ve Heard the Noise, Now What Are the Facts? The Legal Underpinnings of Fetal Tissue Research
3:30 PM - 4:45 PMD18 – It Takes a Village: Community Members as Research Partners in Community-Based Participatory Research (CBPR)
3:30 PM - 4:45 PMD19 – In the ERA of Big Data: Data Sharing
3:30 PM - 4:45 PMD20 – Meeting of the Minds: Research and Consent with Subjects with Impaired Decisional Capacity
3:30 PM - 4:45 PMD21 – Beyond Auditing and Monitoring and Towards Quality Improvement
3:30 PM - 4:45 PMD22 – Ethical Issues in Patient-Led and Crowdsourced Clinical Research
3:30 PM - 4:45 PMD23 – All By Myself: Where Can You Go for Mentorship When You Are the Only Person in the IRB Office?
3:30 PM - 4:45 PMD24 – School Rules! Conducting Research in Elementary and Secondary Public Schools
3:30 PM - 4:45 PMD25 – Yours, Mine, and Ours: IRB Arrangements for Multiple Institutions Involving Research With Vulnerable Populations and Sensitive Topics
4:45 PM - 5:05 PMDemonstration of PRIM&R’s Ethical Research Oversight Course (E-ROC)
4:45 PM - 6:00 PMFDA Office Hours
4:45 PM - 6:00 PMMeet the AER16 Poster Authors
4:45 PM - 6:00 PMNetworking Reception with the Supporters and Exhibitors
4:45 PM - 6:00 PMOHRP Office Hours
4:45 PM - 6:00 PMVA Office Hours
5:35 PM - 5:55 PMOverview of PRIM&R’s Member Benefits
7:00 AMRegistration Opens
8:00 AM - 8:15 AMWelcome from the Conference Co-Chairs
8:15 AM - 8:25 AMPRIM&R Membership Update
8:30 AM - 9:15 AMKeynote Address: Low Hanging Fruit in the Reproducibility and Translatability Crisis: How IRBs Can Critically Assess Animal Data Before Approving First-In-Human-Studies
9:15 AM - 9:45 AMBeverage Break
9:35 AM - 9:40 AMTreasure Hunt Prize Drawing
- 9:45 AM - 11:00 AMConcurrent Plenary Sessions
9:45 AM - 11:00 AMPanel VII: Amplifying the Challenges: Return of Results in Pediatric Research
9:45 AM - 11:00 AMPanel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
9:45 AM - 11:00 AMPanel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence
11:00 AM - 11:15 AMBreak
- 11:15 AM - 12:30 PMDidactic Sessions and Workshops Series E
11:15 AM - 12:30 PME1 – A Dialogue With the National Institutes of Health (NIH)
11:15 AM - 12:30 PME2 – A Dialogue With the Association for the Accreditation of Human Research Protection Programs (AAHRPP, Inc.)
11:15 AM - 12:30 PME3 – When Exception Does Not Apply: Practical Strategies for Ethical Enrollment of Situationally Impaired Subjects in Clinical Trials in the Emergency Setting
11:15 AM - 12:30 PME4 – IRB Oversight and the Boundaries Between Evidence-Based Practice (EBP), Performance Improvement, and Research
11:15 AM - 12:30 PME5 – Exploring Strategies on How to Effectively Provide Education on Human Research Protections to Investigators
11:15 AM - 12:30 PME6 – Ethical Risks and Remedies for Recruiting and Obtaining Consent in Adolescent Risk Research Involving Sexual and Gender Minority Youth (SGMY)
11:15 AM - 12:30 PME7 – Research Ethics Through the Eyes of a Subject
11:15 AM - 12:30 PME8 – An Overview of FDA’s Program Alignment and What it Means for Your Next Inspection
11:15 AM - 12:30 PME9 – Data Access Versus Patient Privacy in the European Union (EU): Ethical Mandates in the Crucible of Public Debate
11:15 AM - 12:30 PME10 – Study Review Using Single IRBs (sIRBs)
11:15 AM - 12:30 PME11 – Reserved for Late-Breaking Session
11:15 AM - 12:30 PME12 – Top Considerations for Leadership When Accepting Department of Defense (DOD)-Supported Research
11:15 AM - 12:30 PME13 – Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs
11:15 AM - 12:30 PME14 – IRB Chair Responsibilities and Roles: Beyond the IRB Meeting
11:15 AM - 12:30 PME15 – Enhancing Effective Communications Between IRBs and Investigators
11:15 AM - 12:30 PME16 – New Frontiers in Collaboration: Emerging Models of Collaboration Between Industry and Academic Organizations
11:15 AM - 12:30 PME17 – O…R...I Have No Idea What You’re Talking About!
11:15 AM - 12:30 PME18 – Scientific Aspects of Study Design: A Primer for Non-Scientist IRB Members
11:15 AM - 12:30 PME19 – Beyond Basic Biobanking: Issues Related to the Collection, Storage, and Future Research Uses of Pediatric Biospecimens, Newborn Blood Spots, and Fetal Tissue
11:15 AM - 12:30 PME20 – Representing Prisoners: Insights from an IRB Member Who Has Been Incarcerated
11:15 AM - 12:30 PME21 – Development of an Effective QA/QI Program at Your Institution
11:15 AM - 12:30 PME22 – Crawling in the Dark: The Ethics of Research Use of Data from the Dark Web
11:15 AM - 12:30 PME23 – Building and Maintaining HRPP in a Large Health System With a Small Research Portfolio
11:15 AM - 12:30 PME24 – Social Media and Participant Recruitment in SBER
11:15 AM - 12:30 PME25 – You Want to Do What? Developing Best Practices for IRB Review of Research Investigating Illegal/Illicit Behaviors
12:45 PM - 1:45 PMNetworking Lunch
- 2:00 PM - 3:15 PMClosing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
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