News. The Community IRB Member: Neighbor & Partner

April 2007 News

The latest issue of the U.S. Department of Energy, office of Biiological and Environmental Research quarterly newsletter on Protecting Human Subjects is now available.

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Community-Campus Partnerships for Health is looking for examples of structures or mechanisms that communities and community-academic partnerships in the U.S.
and Canada have developed to assess research proposals (i.e., to make decisions about whether to approve a study as ethical, to make decisions about whether to engage as a partner in the research, etc). These structures or mechanisms might include, for example, community advisory boards established by a community-academic partnership, a research committee established by a community-based organization, or a community-based Institutional Review Board/Ethics Review Board (IRB/ERB) established by a community.

If you have one or more examples to share, please respond to ccphirb@u.washington.edu with the following information by May 4:

*Name of the community, community organization or community-academic partnership that developed the mechanism or structure *Brief description of the mechanism or structure *Any relevant websites or attachments that may help explain the mechanism or structure in more detail *Name, phone and email for a contact person we may follow up with for more information

We are also interested in identifying "promising practices" in the following
areas:

-Meaningfully involving community-based individuals as IRB/ERB members -Improving the process of IRB/ERB review of community-based participatory research proposals

We may follow up with you for more information. A summary of responses will be shared back on the listserv.

Please note that there is an Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research underway, cosponsored by CCPH and the Tuskegee University National Center for Bioethics in Research and Health Care. The next two calls in the series will provide several examples of such community-based structures and mechanisms and what has been learned from them. Details are at http://depts.washington.edu/ccph/irbcalls.html

If you have any questions, please contact ccphirb@u.washington.edu

March 2007 News

Community-Campus Partnerships for Health (CCPH) and the Tuskegee University National Center for Bioethics in Research and Health Care (the Bioethics
Center) invite you to participate in their jointly sponsored Educational Conference Call Series on Institutional Review Boards (IRBs) and Ethical Issues in Research.

The series is intended 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 is to provide a comprehensive understanding of the options and tools necessary for communities to determine the approach that is best for them. The series will also inform the development of future initiatives undertaken by CCPH and the Bioethics Center on IRBs and ethical issues in community-campus partnerships.

Online registration is now open for Call #2 and Call #3 in the series. Please see details below. The calls are free, but the number of incoming lines is limited. To maximize participation, we encourage gathering colleagues to dial-in together using one phone line with speaker phone capabilities. Those completing the online form will be notified as to whether their registration is confirmed, and sent instructions for dialing into the call. Handouts and digital audiofiles will be posted on the CCPH website at www.ccph.info shortly after each call takes place. To learn more about the series, visit http://depts.washington.edu/ccph/PM_012607.htm#MessagefromourED

If you have comments and suggestions on the call series, including ideas for additional call topics, please contact the call series organizers CCPH Program Director Kristine Wong (Kristine@u.washington.edu) or CCPH Graduate Research Assistant Jessica Grignon (jgrignon@u.washington.edu).

Call #1 entitled "What is an Institutional Review Board (IRB) and What Purpose does it Serve?" took place on February 14, 2007. An audiofile of the call and other resources are available at:
http://depts.washington.edu/ccph/pastpresentations.html

Call #2 - March 14, 2007, 12:00 to 1:30 p.m. Pacific Standard Time Highlighting the Importance of the Non-Affiliated (Community) IRB Member

Moderator:
*Vanessa Northington Gamble, Director of the Bioethics Center

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

Elda Railey and Mary Lou Smith of Research Advocacy Network will discuss the history and role of community (non-affiliated and non-scientific) members on IRBs. They will provide the results of focus groups of IRB administors and community members that demonstrate the value of having community members on IRBs and the challenges they face in representing the community. Lucille Webb will demonstrate the benefits of the lay perspective through discussion of her experience as an IRB community member with North Carolina State Department of Public Health. Gigi McMillan will also discuss her role as a community IRB member at University of California, Los Angeles, and she will highlight her efforts to create support systems and ongoing training opportunities that strengthen the role of the community member.

To register for this call, complete the online registration form at
https://catalysttools.washington.edu/survey/kristine/31948

Call #3 - Wednesday, April 18, 2007, 12:00 - 1:30 p.m. Pacific Standard Time Community-Based Participatory Research (CBPR) Proposals and the Human Subjects Review Process: Methods for Working with University IRBs

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

This call will cover:
*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 *How to improve communication between IRBs and CBPR practitioners

To register for this call, complete the online registration form at
https://catalysttools.washington.edu/survey/ccphuw/33262

August 2006 News

Human Subjects Protection Resource Book

The Human Subjects Protection Resource Book is an attempt to synthesize the information currently available on the protection of human subjects in research, the continuing application of such information to new areas of endeavor, and the ever-changing rules, regulations, and guidance involved in the hope that it might provide useful information for investigators, Institutional Review Boards (IRBs), research organizations, research subjects, and others. The book contains chapters that provide background information on the history and development of the federal regulations, chapters that discuss procedural and substantive issues regarding the review and conduct of human subjects research, and chapters that are specific to one type of research (e.g., genetics, biological samples) or research in specific populations (e.g., international settings, children, and workers).

The resource book was a joint project of several agencies: DOE, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. However, this manual does not represent the official views or policies of any of these or any other agencies.

July 2006 News

Call for Abstracts - PRIM&R/ARENA is pleased to announce the Call for Abstracts for the 2006 Annual HRPP Conference to be held November 15-18, 2006 in Washington, DC. There will be two categories for abstract submissions: Programmatic and Scientific.

The Programmatic Abstracts have been an important part of the Conference for the last five years. These abstracts describe novel or innovative approaches to the management, functions, and operations of Institutional Review Boards.

New this year is the solicitation specifically of Scientific Abstracts, i.e., empirical research on research ethics. Presenting this research at the 2006 Annual HRPP Conference, which describe important scientific work.

Guidelines for Submission:

Programmatic Abstract: Please prepare an abstract of no more than one, single-spaced page. At a minimum, the abstract should include:

TITLE of the project
AUTHOR(s)
INSTITUTIONAL AFFILIATION(s)
FUNDING SOURCE/SPONSOR
OVERVIEW OF THE PROJECT - Include a statement of the problem or issue the program is intended to address including a definition of the intended outcome, a thorough description of the program, how the program was evaluated, and suggestions for the future or for implementation at other sites.

Scientific Abstract: Please prepare an abstract of no more than one, single-spaced page. At a minimum, the abstract should include:

STUDY TITLE
AUTHOR(s)
INSTITUTIONAL AFFILIATION(s)
FUNDING SOURCE/SPONSOR
CITATION (If the research has been previously published or presented)
RESEARCH
- Background
- Research Question or Hypothesis
- Methods, including sample size justification and analytic methods
- Results
- Conclusions
- Limitations
- Next steps

*In addition to the above information, each author must certify that the research has received IRB approval to the extent required by regulations and your institution's requirements.

Submission: Submit your abstract electronically using either the Scientific Abstract Template or the Programmatic Abstract Template, as appropriate, to PRIM&R/ARENA.

Deadline: Abstracts should be submitted by August 15, 2006. You will be notified by September 15, 2006 of acceptance of your abstract for poster and/or presentation.

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June 7, 2006 -- OHRP Guidance on the Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e)

The Office for Human Research Protections (OHRP) has issued guidance on how to determine whether the HHS regulations at 45 CFR part 46 are applicable to the activities covered by the Food and Drug Administration's interim final rule, "Medical Devices; Exception From General Requirements for Informed Consent" (21 CFR 50.23(e)). Specifically, the document provides guidance on the following: (1) The determination of when institutions conducting activities covered by 21 CFR 50.23(e) would be engaged in non-exempt human subjects research; and (2) The requirements for obtaining or waiving informed consent under 45 CFR 46.116.

This guidance can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.html (HTML format) and http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.pdf (PDF format). OHRP welcomes comments on this guidance document. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with "OHRP guidance on 21 CFR 50.23(e)" in the subject line.

May 2006 News

Spring 2006 Issue of Protecting Human Subjects Newsletter

The U.S. Department of Energy, Officie of Biological and Environmental Research's quarterly newsletter, Protecting Human Subjects, is available at: http://www.science.doe.gov/ober/humsubj/spring06.pdf

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World Health Organization Announces New Standards for Registration of All Human Medical Research

The World Health Organization (WHO) is urging research institutions and companies to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers.

http://www.who.int/mediacentre/news/releases/2006/pr25/en/index.html

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Community Outreach Speakers Bureau

This is a non-commercial public service message.

Every year, it gets harder to recruit subjects for clinical research studies. One reason is that the public only hears alarmist, one-sided stories in the media.

Please join the First Clinical Research Speakers Bureau. It's free. Our speakers are available to visit schools, churchs and other community groups to explain clinical research in an objective manner, without taking sides. The Speakers Bureau provides slides and handouts for your use.

We need your participation for broad geographical coverage.

More information is at http://www.firstclinical.com/resources/bureau/bureau.html