WINTER 2011WINTER 2011

Advance Newsletter Transitions Online

THE FINAL PRINT EDITION

WINTER 2011

The Association for the Accredita-tion of Human Research Protec-tion Programs (AAHRPP) newsletter, Advance, is now available in elec-tronic form at the AAHRPP site (www.aahrpp.org). Marking the transition, this winter edition will be Advance’s final print issue.

When AAHRPP published the first Advance newsletter, in the fall of 2004, the goal was to bring awareness to the research commu-nity about human research pro-tection programs (HRPPs) and the need for and benefits of accredita-tion of those programs. Over the past 26 issues in print, Advance has highlighted innovative practices to protect research participants, de-scribed trends in human research protection, and provided clarity on challenging issues such as fi-nancial conflict’s of interest. In a large and diverse research enter-prise, Advance has brought together the different components, reveal-ing their commonalities and facili-

tating collaborative relationships.In recent years, more and more

organizations located outside the United States have sought accredi-tation. AAHRPP is pleased to make Advance available to all clients and to invite everyone to join the active and lively dialogue about human research protection programs.

By simply transitioning to an online platform Advance will become a tool for readers to use to share their knowledge and expertise. Without the limitations of print media, Advance will reach a broader and more diverse international readership in real time. AAHRPP will be able to release articles as in-formation becomes available, when readers want it most. Moreover, everyone will be able to comment directly on articles encouraging readers to inform AAHRPP of their ideas, opinions, suggestions, and in-the-field experiences. This feedback is central to supporting AAHRPP’s goal of improving the systems

that protect the rights and welfare of individuals who participate in research.

To receive the latest Advance articles, sign up online at www.aahrpp.org.

Read the new Advance at

www.aahrpp.org.

V O L U M E 8 • N U M B E R 1

2Delivering a Better Product to Improve Protections

3 AAHRPP 2011 Conference

4 Webinars Address Challenging Issues

2 A A H R P P A D V A N C E

Delivering a Better Product to Improve Protections for Research ParticipantsHelping organizations provide pro-tections for research participants through accreditation is AAHRPP’s main goal. As we enter into our tenth year of accreditation, we are taking steps that directly support this goal. We are making the Advance accessible to all online (See Page 1). This transition will leverage the Advance’s ability to provide reliable and relevant infor-mation to a much larger commu-nity of those involved in protecting research participants and promoting ethically sound research. We hope that by closing the print editions we will open an avenue to listening, where we will be able to turn your feedback into actionable change that matters most to research par-ticipants and organizations.

In addition to changes with the Advance, we have released an updated Evaluation Instrument for Accreditation. While the Accred-itation Standards and Elements remain unchanged, the require-ments to meet certain Elements have been updated, primarily in response to changes in guidance from federal agencies. Most notably, the stipulations in VHA Handbook 1200.05, “Requirements for the Protection of Human Subjects in Research,” released on May 21, 2010, from the Department of Veterans Affairs, have been added.

These VHA Handbook re-quirements must be imple-mented by March 31, 2011.

Other updates to the Evalu-ation Instrument were minor, reflecting the addition and removal of guidance docu-ments issued by the Office for Human Research Protections.

The AAHRPP Accreditation Pro-cedures were updated on December 14, 2010, with two changes. First, when organizations submit a Step 1 application, they will have one year to respond to the review provided

by AAHRPP staff and move to the next step – submission of the Step 2 application. While most organiza-tions have responded quickly, some have not. The one-year period is intended to motivate organizations to respond promptly and keep the goal of achieving accreditation as a top priority of the organization.

Second, when organizations earn reaccreditation, the five-year period will be set to the expiration date of the last accreditation. This means that organizations placed in Reac-creditation-Pending will earn ac-creditation for five years minus the time they were in the pending category. Accreditation assures the public that organizations are achieving high standards for pro-tecting research participants only

if organizations put into place and maintain policies, procedures, and practices that meet the accredita-tion standards. Sometimes, cir-cumstances such as loss of staff or funds will have negative conse-quences on a human research pro-tection program. Nonetheless, it is important for organizations to maintain the quality of their pro-tection programs, especially as the public is beginning to rely more and more on the AAHRPP accredi-tation seal as a sign of excellence.

The Evaluation Instrument for Accreditation and AAHRPP Ac-creditation Procedures are avail-able at www.aahrpp.org.

-Marjorie A. Speers, Ph.D.

AAHRPP has accredited 223 programsWASHINGTON, D.C., December 16, 2010—The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is pleased to announce that it has accredited the human research protection programs (HRPPs) at three additional organizations, including a private research organization, a prominent children’s hospital, and a renowned university.

Miami Research Associates (MRA) contin-ues the trend of accreditation by leading industry private research sites. Established in 1996, Miami Research Associates is the largest physician-owned multi-specialty clinical research center in the United States. MRA has successfully conducted over 1,000 clinical trials in Phase’s I through IV. The staff consists of over 35 board-certified physician investigators and more than 38 Association of Clinical Research Professionals—certi-fied clinical research coordinators.

These diverse organizations bring the total number of accredited HRPPs to 223, representing nearly 1,100 entities. Following is a list of the newly accredited organizations:

■ Miami Research Associates, Miami, FL ■ The Children’s Hospital of Philadelphia, Philadelphia, PA ■ Yale University, New Haven, CT

“This addition to the increasing group of accredited research organiza-tions is evidence of the growing public perception that earning AAHRPP’s gold seal is the right and smart thing to do for government, nonprofit, and for-profit organizations,” said Marjorie A. Speers, Ph.D., President and CEO of AAHRPP. “It also increases the number of accredited options for industry sponsors, researchers, and participants.”

2 A A H R P P A D V A N C E

A A H R P P A D V A N C E 3

A A H R P P A D V A N C E 7

breakingbarriers

AAHRPP’s 2011 Conference in Washington, D.C. / April 6-8

And get ready to start

Engage with experts who have overcome these challenges, including AAHRPP accreditation directors, executive leadership, government officials, and your peers, on such topics as:

n Choosing risk tolerance over risk aversion in research.

n Unifying divergent institutional committees in the HRPP.

n Achieving global standards of protection for participants.

n Expanding the meaning of collaboration in multiinstitutional human research.

n Infusing quality systems into every aspect of the human research process.

n Building successful university-hospital research partnerships.

n Partnering with the public for better research.

n Collaborating with other IRBs.

n That keep IRBs, administrative officials, and researchers and staff from supporting one another.

n That keep hospitals, academic institutions, independent IRBs, sponsors, CROs, and private research sites from collaborating with one another.

n That keep research participants around the world from being protected by a single, global set of standards.

Mark your calendars for

Contact AAHRPP at (202) 783-1112 or accredit@aahrpp.org, or visit www.aahrpp.org for additional information.

that keep hospitals, academic institutions, independent IRBs, sponsors, CROs, and private research sites from collaborating with the community for better research.

A A H R P P A D V A N C E 7

breakingbarriers

AAHRPP’s 2011 Conference in Washington, D.C. / April 6-8

And get ready to start

Engage with experts who have overcome these challenges, including AAHRPP accreditation directors, executive leadership, government officials, and your peers, on such topics as:

n Choosing risk tolerance over risk aversion in research.

n Unifying divergent institutional committees in the HRPP.

n Achieving global standards of protection for participants.

n Expanding the meaning of collaboration in multiinstitutional human research.

n Infusing quality systems into every aspect of the human research process.

n Building successful university-hospital research partnerships.

n Partnering with the public for better research.

n Collaborating with other IRBs.

n That keep IRBs, administrative officials, and researchers and staff from supporting one another.

n That keep hospitals, academic institutions, independent IRBs, sponsors, CROs, and private research sites from collaborating with one another.

n That keep research participants around the world from being protected by a single, global set of standards.

Mark your calendars for

Contact AAHRPP at (202) 783-1112 or accredit@aahrpp.org, or visit www.aahrpp.org for additional information.To find more sessions on collaborating with the community, visit www.aahrpp.org.

Future of Research – Why Collaborations Are Es-sentialJerry Menikoff, M.D., Office for Human Research Protections

Taking It to the Community: Increasing Knowl-edge About Human Research Protections and the IRB Among Community Partners Kathleen Uscinski, M.B.A., C.I.P., Yale University

Remote/Virtual Audits of IRBs: A Sponsor and IRB Collaboration—Doing More, NOT Spending MoreJeffrey Wendel, Chesapeake IRBKerrick Wilson, GlaxoSmithKline

Community Advisory Boards: When Do They Reach the Level of Community Engagement?Steve Wakefield, Fred Hutchinson Cancer Center

Building International Research Collaboration Networks – Experiences from Yale University and University Hospitals Case Medical CenterSandra Alfano, M.D., Yale UniversityJoe Gibbons, M.D., University Hospitals Case Medical Center

A A H R P P A D V A N C E 3

Begin Your Self-assessment with AAHRPP’sGetting Started WebinarMost accredited organizations agree that the work you do on your self-assessment drives both the effi-ciency and the effectiveness of the application process. Learn how to do it well by scheduling a webinar tailored to your organization, con-ducted by Peter Vasilenko, Ph.D., Vice President of Accreditation at AAHRPP. If you need assistance ini-tiating the accreditation process at your organization, this webinar explains the value and the process of accreditation, including how to lead your self-assessment, how to use the Evaluation Instrument for Accreditation effectively, and how to respond to accreditation stan-dards organizations sometimes find difficult. Schedule your two-hour

Getting Started webinar by contact-ing us at accredit@aahrpp.org.

Webinars Address Challenging IssuesThis spring, AAHRPP will conduct the first in a series of educational webinars that will discuss some of the more complex issues facing HRPPs.

Peter Vasilenko, Ph.D., AAHRPP’s Vice President of Accredita-tion, will host the first webinar.

IRB Consideration of Data and Safety Monitoring Plans (Element II.3.B.)April 26 and April 28

Collecting and Using Metrics as Part of Your Quality Improvement Plan (Elements I.5.A. and I.5.B.)July 26 and July 28

Protecting Vulnerable Populations in Research (Elements II.4.A. and II.4.B.)October 25 and October 27

Fill out the registration form at www.aahrpp.org and send one copy back for each computer you want to connect to the webinar. As many colleagues as you want may participate through that connec-tion. If you would like to propose topics for discussion in subsequent webinars, you may send your sug-gestions to accredit@aahrpp.org.

Published quarterly by the Associationfor the Accreditation of Human ResearchProtection Programs, Inc.

PRESIDENT & CEO: Marjorie A. Speers, Ph.D.

EDITOR: Kirsten E. Blanton, M.S.

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second DOe Lab Accredited AlongWith Five Other OrganizationsWASHINGTON, D.C., September 23, 2010—The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is pleased to announce that it has accredited the human research protec-tion programs (HRPPs) at another six organizations, including a second National Laboratory from the U.S. Department of Energy (DOE).

Brookhaven National Laboratory joins the Pacific Northwest National Laboratory in earning the AAHRPP seal. HRPPs accredited at the September meeting of the Council on Accreditation represent a diverse group of government, for-profit, and academic organizations and bring the total number of accredited HRPPs to 220, representing nearly 1,100 entities.

Following is a list of the newly accredited organizations:

n Brookhaven National Laboratory, Upton, NYn Compass IRB, LLC, Mesa, AZn Mid*Lands IRB, LLC, Overland Park, KSn State University of New York at Stony Brook, NYn The University of Central Florida, Orlando, FLn Tulane University, New Orleans, LA

“These additions to the increasing group of accredited organizations demonstrate that earning AAHRPP’s gold seal is the right and smart thing to assure the protection of research participants,” said Marjorie A. Speers, Ph.D., President and CEO of AAHRPP. “It also increases the number of accredited options for industry sponsors and researchers.”

AAHRPP promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs).

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april 6-8, 2011foR tHRee DAys of

breaking

barriers at the AAHRPP

Annual ConferenceWashington, D.C.

see Page 7 inside, for details Engage with Your HRPP CommunitySign Up for Online PublicationAs this is the final print edition of the Advance, to receive the latest Advance articles, please sign up online at www.aahrpp.org. We thank all our loyal readers for their part in making the Advance what it is today, and we look forward to hearing from you online!