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Affinity Groups

To help those attending the 2013 AER Conference connect with colleagues who have similar job responsibilities and interests, PRIM&R is pleased once again to host Affinity Groups (AGs) at this year’s meeting.  

What are PRIM&R’s AGs?
AGs are small groups of people who share areas of specialized professional interest and are designed to foster networking and community building before, during, and after the conference.  PRIM&R will host the following groups:

  • Educators/Trainers
  • Diversity
  • Global Research
  • Institutional Officials (IOs)
  • IRB Chairs
  • Quality Assurance/Quality Improvement (QA/QI)
  • Small Research Programs
  • Social, Behavioral, and Educational Research (SBER)
  • Human Specimen/Tissue Banking
  • Unaffiliated/Community Members  

How will being part of an AG enhance your conference experience?
In addition to networking with other attendees during the conference sessions, meals, and receptions, the following opportunities to meet others with similar job responsibilities and interests will be available to those who sign up for an AG: 

  • LinkedIn Group for connecting with members and co-facilitators before and after the conference
  • Color-coded networking ribbons to help AG members identify one another
  • Dedicated message board in the Registration Area
  • AG lounge (location TBA) for office hours meetings with group facilitators, informal discussion with peers, or just to relax
  • Office hours with AG facilitators on November 7 and 8 (sign-up at the AG Booth in the Registration Area)
  • AG Networking Continental Breakfast on Thursday, November 7, from 7:00 to 8:00 AM
  • Designated section at the welcome reception on Thursday, November 7, from 5:15 to 7:00 PM
  • Informal dinners with other AG members on Thursday, November 7 at 7:00 PM (sign-up at the AG message board in the Registration Area)
  • AG Networking Lunch on Friday, November 8, from 12:45 to 1:45 PM
  • Grand Finale AG wrap-up session on Saturday, November 9, from 3:30 to 4:45 PM, which will address how the group will stay connected after the conference, as well as address any remaining questions or concerns that came up at the conference

How do I sign up for an affinity group?
If you are interested in enhancing your onsite experience by participating in an AG, please select your preference during the online registration process.  If you have already registered, but still want to sign up for an AG, please email us or visit the AG booth located at conference registration onsite and a staff member will happily help you. 

Affinity Groups

Educators/Trainers (blue)
This AG is intended for those responsible for educating/training their IRB chairs, members, administrators, other compliance personnel, researchers, research staff, research nurses, or CRO employees, on human subjects protections, the federal regulations, ethical issues of importance, and best practices.

Co-facilitators

Mina Busch, MS, CCRP, CIP
ORCRA Education Consultant
Cincinnati Children's Hospital
Medical Center
Charlotte Coley, MACT, CIP
Director, IRB Educational Programs
Duke University Health System

Learn more about this year’s Education/Trainers AG co-facilitators

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

  • Educating Research Teams Track
  • A13: Practical Tools for Dealing with Conflict: Helping IRB Staff Communicate More Effectively with Investigators (IRB Operations and Toolkit Track)
  • B3: Improving Relationships between Researchers and the IRB  (Accreditation of HRPPs Track) 
  • B19: Making your QA/QI Program Work for You (QA/QI and Post-approval Monitoring Track)  
  • D13: Evaluating Member Performance (IRB Operations and Toolkit Track)
  • E24: Comparing the Contract with the Protocol and Consent Forms When You Have Limited Access to a Contract Officer and/or a General Counsel Office (Small Research Programs Track)
  • GF2: Affinity Groups: Wrap-Up Meetings

Diversity (orange)
This AG is for individuals who are responsible for addressing the issue of diversity at their institution and in the research being conducted at that institution, who are interested in addressing the lack of diversity in the human research protections professions, and/or who want to engage around the question of why diversity is not directly addressed in the federal regulations governing human subjects research.

Co-facilitators

Melissa Epstein, PhD, CIP
IRB Administrator
Albert Einstein College of Medicine of Yeshiva University
Dorotha Love Hall, PhD, CIP
Public Health Administration
Centers for Disease Control and Prevention (CDC)

Learn more about this year’s Diversity AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions:

  • A9: It Takes a Village: Models for Community Consultation in International Research (Global Research Track)
  • A23: Aligning IRB Review with Community Cultural Ethics and Standards (SBER II – Advanced Track)
  • A24: Developing an HRPP at an Institution with a Small Social and Behavioral Research Portfolio
  • A25: The Roles and Responsibilities of the Unaffiliated and Non-Scientist Member of the IRB (Unaffiliated and Non-Scientist IRB Members Track)
  • B6: The Making of a Successful Research Team: Essential Components of an Educational Program (Educating Research Teams Track)
  • B9: New Policies for Clinical Trials in India: Promises and Pitfalls (Global Research Track)
  • B18: New Tactics in Recruiting and Retaining Unaffiliated or Non-Scientist IRB Members (Potpourri Track)
  • C6: The Certified IRB Professional (CIP®) Credential: What’s it About? (Educating Research Teams Track) 
  • C7: Looking Beyond Responsible Conduct of Research: Ethical Research From Design to Data Collection to Dissemination of Results (Ethical Issues Track)
  • C17: Research Involving Native American Populations (Populations Requiring Additional Protections Track) 
  • D3: Succeeding at Community Engagement (Accreditation of HRPPs Track)
  • D12: The Ins and Outs of IRB Offices (IRB Bootcamp Track)
  • D13: Evaluating Member Performance (IRB Operations and Toolkit Track)
  • E17: Community-Based Participatory Research (CBPR) as a Corrective Lens for Research: Case Studies in Psychiatric Research (Populations Requiring Additional Protections Track)
  • Innovations C: Innovations in Influences on Research Participation
  • Innovations D: Innovations in Communication with Research Subjects
  • GF4: The Uncomfortable Conversation: Talking about Diversity

Global Research (gold)
This AG is for non-U.S.-based research professionals and U.S.-based professionals working outside North America who are interested in the conduct of ethical research across geographic and cultural borders.

Co-facilitators

Karen Hansen
Director, Institutional Review Office
Fred Hutchinson Cancer Research Center
Rosemary Musesengwa, MPH, CRA
National Coordinator
Medical Research Council of Zimbabwe

Learn more about this year’s Global AG co-facilitators

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

  • Pre-conference program on November 6: Ethical Issues in Global Research
  • Global Research Track
  • A14: Emerging Issues for Pharmaceutical/Biotechnology Companies and Contract Research Organizations in Research Conducted Abroad (Issues for Pharma/Biotech Track)
  • A23: Aligning IRB Review with Community Cultural Ethics and Standards (SBER II – Advanced Track)
  • Panel IV: Applying the Belmont Principles Across Borders and Cultures
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

Institutional Officials (IOs) (black)
This AG is for IOs (and others with oversight responsibilities) interested in discussing shared concerns, problems, strategies, best practices, and other useful innovations.

Co-facilitators

Jeffrey P. Braff, DrPH, CIP
Director, Human Research Protections
Kaiser Foundation Research Institute
Kaiser Permanente Oakland
Celia Molvin, MSW, CIP
Senior HRPP Lead
Research Compliance Office
Stanford University

Learn more about this year’s IOs AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions:

  • Pre-conference program on November 6: Hot Topics for Institutional Officials
  • Institutional Officials Track
  • Accreditation of HRPPs Track
  • Legal Track
  • Small Research Programs Track
  • A18: Streamlining IRB Review for Multi-Site Research: Results of a Randomized, Controlled Trial of Central Versus Local IRB Review ( Potpourri Track)
  • A21: Research Data Security: Protecting Human Subjects’ Identifiable Data in the University Setting (Research Involving the Internet & Social Networking Track)
  • C5: Future Trends in the Relationship between Central/Independent IRBs and Research Institutions: Risk/Benefit Ratio (Advanced Forum for IRB Professionals Track)
  • D18: Alleged Misconduct in Clinical Research: Challenges for IRBs and Research Integrity Officers (RIOs) (Potpourri Track)
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

IRB Chairs (teal)
This AG is for IRB chairs interested in engaging with each other about “hot button” issues and everyday aspects of their jobs.

Co-facilitators

Kari Babski Reeves, PhD, CPE
Associate Professor
Mississippi State University
Bruce Gordon, MD
Executive Chairman, IRB;
Professor, Pediatrics
University of Nebraska Medical Center

Learn more about this year’s IRB Chairs AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

  • Pre-conference program on November 6: Advanced Research Ethics
  • Pre-conference program on November 6: IRB 201: An In-Depth Analysis of the Criteria for Review
  • Pre-conference program on November 6: IRB 202: Review and Application of the Regulatory Criteria for Approval
  • Pre-conference program on November 6: Ethical Issues in Global Research
  • Pre-conference program on November 6: Regulatory, Ethical, and Technical Challenges in Internet Research
  • Accreditation of HRPPs Track
  • Advanced Forum for IRB Professionals Track
  • Ethical Issues Track
  • IRB Operations and Toolkit Track
  • Out of Body Experiences: Research Involving Tissue and Data Track
  • Populations Requiring Additional Protections Track
  • Regulatory Balance Track
  • Research Involving the Internet & Social Networking Track
  • Small Research Programs Track
  • A18: Streamlining IRB Review for Multi-site Research: Results of a Randomized, Controlled Trial of Central Versus Local IRB Review ( Potpourri Track)
  • B18: New Tactics in Recruiting and Retaining Unaffiliated or Non-Scientist IRB Members (Potpourri Track)
  • C14: Flexible Adaptive Clinical Trial Designs: Understanding Such Designs, and Implications for Informed Consent and IRB Review (Issues for Pharma/Biotech Track)
  • C18: Forming Medical and Non-Medical Data Repositories: Review and Oversight Responsibilities for the IRB (Potpourri Track)
  • D14: Unanticipated Problems and Adverse Events:  A Practical Approach for IRBs (Issues for Pharma/Biotech Track)
  • D15: When Noncompliance Processes Collide: How To Manage Multiple Different Internal Investigations of an Event (Legal Track)
  • D18: Alleged Misconduct in Clinical Research: Challenges for IRBs and Research Integrity Officers (RIOs) (Potpourri Track)
  • E15: The Rules of Engagement: Analyzing Challenging Scenarios Under the Existing OHRP Engagement Framework (Legal Track)
  • E18: Empirical Research on Research Ethics: How Can Data Inform IRB Deliberations?  (Potpourri Track)
  • Panel I: When Research Offends: Ethics, IRB Review, and the Risk of Stigma
  • Panel III: The Increasingly Blurry Distinction Between Medical Research and Practice:  Implications for Ethical Oversight
  • Panel V: A Moderated Debate: Doctor Knows Best? Risk and Consent when Research Involves “Standard of Care” Interventions
  • Panel VIII: Taking Control: Ethical Challenges for Participant-Centered and Participant-Led Research
  • Panel XII: Is Meaningful Regulatory Change Possible?
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

Quality Assurance/Quality Improvement (QA/QI) (navy)
This AG is for those working in or with QA/QI programs, post-IRB approval monitoring programs, or other institutional entities charged with activities such as not-for-cause study reviews, follow-up after monitoring, review visits, reports, corrective action plans, and education.

Co-facilitators

Jessica Randall-Aprea, MA, CIP
Manager, Compliance Oversight Team Institutional Review Board
Columbia University Medical Center
Sarah White, MPH, CIP
Director, Human Research Quality Improvement Program
Partners HealthCare System

Learn more about this year’s QA/QI AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

  • QA/QI and Post-approval Monitoring Track
  • C4: QA/QI/Program Evaluation: Is it or is it Not “Research”? (Activities Along the Boundaries Between Research and Practice Track)
  • C24: Managing the HRPP in an Institution with a Small Research Portfolio (Small Research Programs Track)
  • D23: Identifying, Assessing, and Resolving Issues in Greater than Minimal Risk SBER (SBER II – Advanced Track)
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

Small Research Programs (neon green)
This AG facilitates networking among those in small research programs, recognizing that “small” is typically a self-imposed designation, and may be indicative of protocol workload, number of FTE IRB staff, research budget, number of IRB members, and/or the character of the institution/researcher community.  As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.

Co-facilitators

Greg E. Manship, MDiv, MT(ASCP), CIP
IRB Coordinator and Human
Protections Administrator
University of Indianapolis
Erica Tauriello, CIP
Manager, Human Research Program
Wentworth Douglass Hospital

Learn more about this year’s Small Research Programs AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions:

  • Any of the pre-conference programs being offered on November 6.
  • A Dialogue with the Feds I and II Tracks
  • Accreditation of HRPPs Track
  • IRB Operations and Toolkit Track
  • Legal Track
  • Potpourri Track
  • Regulatory Balance Track
  • Small Research Programs Track
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

Social, Behavioral, and Educational Research (SBER) (violet)
This AG is for those involved and/or interested in the conduct and review of SBER.

Co-facilitators

Emily E. Anderson, PhD, MPH
Assistant Professor of Bioethics
Loyola University Chicago
Marguarette M. Bolton-Blatt, BA, CIP
IRB Administrator
New York University

Learn more about this year’s SBER AG co-facilitators

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

  • Pre-conference program on November 6: IRB 101sm
  • Pre-conference program on November 6: IRB 201: An In-Depth Analysis of the Criteria for Review
  • Pre-conference program on November 6: IRB 202: Review and Application of the Regulatory Criteria for Approval
  • Pre-conference program on November 6: Regulatory, Ethical, and Technical Challenges in Internet Research
  • SBER I – Basic Track
  • SBER II – Advanced Track
  • A21: Research Data Security: Protecting Human Subjects’ Identifiable Data in the University Setting (Research Involving the Internet & Social Networking Track)
  • A24: Developing an HRPP at an Institution with a Small Social and Behavioral Research Portfolio (Small Research Programs Track)
  • Panel I: When Research Offends: Ethics, IRB Review, and the Risk of Stigma
  • Panel II: Internet Research: Is it Different? Is it “Special”? Points to Ponder for Social and Behavioral Investigators, IRBs, and Subjects
  • Panel IX: Nearly Unavoidable: Cluster Randomized Trials in Social and Behavioral Research
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

Human Specimen/Tissue Banking (neon pink)
This AG is for those working with the complex evolving ethical and regulatory issues for the collection and banking of biological specimens for both clinical and genetic research.

Co-facilitators

Marianna J. Bledsoe, MA
Independent Consultant
Nicole Sieffert
Program Director
Biorepository Regulatory Support
M. D. Anderson Cancer Center

Learn more about this year’s Human Specimen/Tissue Banking AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

  • Pre-conference program on November 6: Contemporary Issues in Biobanking: Engagement, Governance, and Trust
  • Out of Body Experiences: Research Involving Tissue and Data Track
  • D9: Private Sector Concerns Regarding Biorepositories and Tissue Banking (Global Research Track)
  • Innovations B: Innovations in Genomics and Biobanking
  • GF2: Affinity Groups (AG) Wrap-Up Meetings

Unaffiliated/Community Members (peach)
This AG is for unaffiliated/community IRB members interested in discussing our roles and responsibilities as members of an IRB, how we relate to the scientific members of our IRB, what we can accomplish as members of our IRB, strategies for successful and meaningful participation on an IRB, and other aspects of our unique position, as well as connecting with others in the same role.

Co-facilitators

Dahron Johnson, BA
Chaplain and IRB Community Member
Tennessee Valley Healthcare System
Kenneth A. von Kluck, JD
Attorney
Howard & Howard PLLC

Learn more about this year’s Unaffiliated/Community Members AG co-facilitators!

Those interested in attending this AG might consider attending one or more of the following sessions, and checking out the suggested session tracks:

For the most up-to-date information about AG activities, including facilitator office hours and chances to meet up with your group at particular conference sessions, keep your eye on the AG message board, the Daily Schedules (available each day in the Registration area), and the looping slides that play each morning before each keynote and plenary session.

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Questions?
Please contact us via email or telephone at 617.423.4112, ext. 0. Thank you!