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Educational Conference Call Series on Institutional Review Boards (IRBs) and Ethical Issues in Research

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This call series was jointly sponsored by CCPH and the Tuskegee University National Center for Bioethics in Research and Health Care (the Bioethics Center) during January-June 2007. The call series sought to increase understanding of the role of IRBs and other mechanisms for assuring that human subjects research is ethical and appropriate - both at individual and community levels. The aim of the series was to provide a comprehensive understanding of the options and tools necessary for communities to determine the approach that is best for them. The series sought to also inform the development of future initiatives undertaken by CCPH and the Bioethics Center on IRBs and ethical issues in community-campus partnerships.

Click on the title of the call in the series below for more information, including corresponding audiofile, speaker biographies, slide presentations, and handouts.

Call #1 "What is an Institutional Review Board (IRB) and What Purpose Does it Serve?"
Call #2 "Highlighting the Importance of the Non-Affiliated (Community) IRB Member"
Call #3 "Community-Based Participatory Research (CBPR) Proposals and the Human Subjects Review Process: Methods for Working with University IRBs"
Call #4 "Beyond the University IRB: Understanding Alternative Models for Human Protection, Part I: Supplementing the IRB for Community Protection with a Community Advisory Board"
Call #5 "Beyond the University IRB: Understanding Alternative Models for Human Protections, Part II: Creating an Independent Community IRB - When is it Right for You?"
Call #6 "IRB Reform: Changing Policy and Practice to Protect Communities"

Evaluation Results

A total of 467 participants in the conference call series were emailed a short survey to help determine next steps and get feedback from participants on how to improve future call series. The evaluation results are available here.

Proceedings

Published in 2008, Ensuring Community-Level Research Protections is the proceedings from the call series. The report is intended as a resource and discussion piece for a wide variety of groups interested in learning about community-level research protections from unique perspectives. The report provides guidance for what you can do as a community member, research ethics committee member or researcher to ensure that communities involved in research maximize their benefits and minimize their risks. Community-based organizations involved in research, community-institutional research partnerships, IRBs, research ethics boards and community advisory boards will be especially interested in this report. An extensive list of resources, including publications, organizations and websites, is provided.


Call #1 "What is an Institutional Review Board (IRB) and What Purpose does it Serve?"

This first call in the series covered these topics:

  • The Belmont Principles, Nuremberg Code, and protection of human rights
  • How and why IRBs were established
  • How IRBs function today, including how many “community” members are required to serve and what roles they play
  • The pros and cons of the IRB process, but why it is ultimately important

Speakers:

  • Shirley Hicks, Director, Division of Education and Development, Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services (DHHS), Rockville, Maryland
  • Bill Freeman, Director of Tribal Community Health Programs & Human Protections Administrator, Northwest Indian College, Bellingham, Washington

During this call, Shirley Hicks discussed some of the unethical research projects that strongly influenced the subsequent development of HHS regulations to protect the rights and welfare of human research subjects. She also provided a brief review of how OHRP continues to strengthen HHS-supported human subject research and share resources available. Bill Freeman presented federal regulations and their applicability by using a case example of diabetes screening within a community setting.

Please click here to listen to a digital audio recording of the conference call. The transcript is available here.

Please click on the title below to open the corresponding PowerPoint presentations and handouts:

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Call #2 "Highlighting the Importance of the Non-Affiliated (Community) IRB Member"

This second call in the series covered these topics:

  • The role of community members on IRBs
  • How community member roles can go beyond reviewing consent forms—the importance of the perspective and expertise they bring to IRBs
  • How to improve communication between IRBs and communities

Speakers:

  • Elda Railey, Co-Founder, Research Advocacy Network, Arlington Heights, Illinois
  • Mary Lou Smith, Co-Founder, Research Advocacy Network, Arlington Heights, Illinois
  • Lucille Webb, Director, Strengthening the Black Family, Raleigh, North Carolina and North Carolina State Department of Public Health IRB Non-Affiliated (Community) Member
  • Gigi McMillan, Director, We Can Pediatric Brain Tumor Network, Los Angeles, California and University of California – Los Angeles IRB Non-Affiliated (Community) Member

Please click here to listen to a digital audio recording of the conference call. The transcript is available here.

Please click on the title below to open the corresponding PowerPoint presentations and handouts:

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Call #3 "Community-Based Participatory Research Proposals and the Human Subjects Review Process: Methods for Working with University IRBs"

This third call in the series covered these topics:

  • Promising practices and helpful tips for getting IRB approval for CBPR projects
  • Methods for developing an understanding of CBPR among IRBs
  • Models for moving CBPR through the University IRB process, including CBPR projects conducted by students
  • How to improve communication between IRBs and CBPR practitioners

Speakers:

  • Sherril Gelmon, Professor of Public Health, Mark O. Hatfield School of Government, Portland State University, Portland, Oregon
  • Ruth Malone, Professor, School of Nursing, University of California – San Francisco, San Francisco, California
  • Elleen Yancey, Director, Morehouse University School of Medicine Prevention Research Center, Atlanta, Georgia

Please click here to listen to a digital audio recording of the conference call. The transcript is available here.

Please click on the title below to open the corresponding PowerPoint presentations and handouts:

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Call #4 "Beyond the University IRB: Understanding Alternative Models for Human Protection, Part I: Supplementing the IRB for Community Protection with a Community Advisory Board"

This fourth call in the series covered these topics:

  • Introduction to the wide range of human protections options developed by community-based organizations and CBPR partnerships, from Community Advisory Boards that supplement University IRBs to independent Community Review Boards
  • Examples of Community Advisory Boards that have been created for additional protections for the community, but work collaboratively with University IRBs
  • Why and how these entities were created
  • How these entities function and what purposes they serve
  • How and when to develop a Community Advisory Board

Speakers:

  • Otsehtokon Alex M. McComber (Mohawk), Former Training Coordinator, Kahnawake Schools Diabetes Prevention Project, Kahnawake Mohawk Territory, Quebec, Canada
  • Stephen B. Thomas, Professor of Community Health and Social Justice, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA
  • Vickie Ybarra, Director of Outreach and Services, Yakima Valley Farmworkers Clinic, Toppenish, WA

Please click here to listen to a digital audio recording of the conference call. The transcript is available here.

Please click on the title below to open the corresponding PowerPoint presentations and handouts:

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Call #5 "Beyond the University IRB: Understanding Alternative Models for Human Protections, Part II: Creating an Independent Community IRB - When is it Right for You?"

This fifth call in the series will cover these topics:

  • Review of the wide range of human protections options developed by community-based organizations and CBPR partnerships, from Community Advisory Boards that supplement University IRBs to independent Community Review Boards
  • Examples of independent Community IRBs that have been created to serve the needs of their communities
  • Why and how these entities were created
  • How these entities function and what purposes they serve
    How and when to develop an independent Community Review Board
  • Community ownership of data and benefits from research - how does this differ between Community IRBs and University IRBs?

Speakers:

  • Sheila Beckham, Preventive Health Services Director, Waianae Coast Comprehensive Health Center, Waianae, Hawaii
  • Bill Freeman, Director of Tribal Community Health Programs & Human Protections Administrator, Northwest Indian College, Bellingham, Washington
  • Jacqueline Tran, Program Manager, Orange County Asian and Pacific Islander Community Alliance, Garden Grove, California
  • Eric Wat, Data Manager, Special Services for Groups, Los Angeles, California

Please click here to listen to a digital audio recording of the conference call. The transcript is available here.

Please click on the title below to open the corresponding PowerPoint presentations and handouts:

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Call #6 "IRB Reform: Changing Policy and Practice to Protect Communities"

The sixth call in the series covered these topics:

  • Findings from recent studies of IRBs and CBPR
  • Do IRB policies and practices adequately protect communities? How should they be changed?
  • Ideas and recommendations for how IRBs could better protect
    communities

Speakers:

  • Syed Ahmed, Director of the Center for Healthy Communities (CHC) & Professor of Family and Community Medicine, Medical College of Wisconsin, Milwaukee, WI
  • Sarah Beversdorf, Rural Health Liaison for the Healthier Wisconsin Partnership Program, Medical College of Wisconsin, Milwaukee, Wisconsin
  • Sarah Flicker, Assistant Professor, York University, Toronto, Ontario, Canada
  • Robb Travers, Scientist and Director of Community-Based Research, Ontario HIV Treatment Network, Toronto, Ontario, Canada
  • Nancy Shore, Assistant Professor at the University of New England School of Social Work, Portland, Maine

Please click here to listen to a digital audio recording of the conference call. The transcript is available here.

Please click on the title below to open the corresponding PowerPoint presentations and handouts:

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