WINTER 2011 WINTER 2011
THE FINAL PRINT EDITION
Advance Newsletter Transitions Online The Association for the Accreditation of Human Research Protection Programs (AAHRPP) newsletter, Advance, is now available in electronic 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 community about human research protection programs (HRPPs) and the need for and benefits of accreditation of those programs. Over the past 26 issues in print, Advance has highlighted innovative practices to protect research participants, described trends in human research protection, and provided clarity on challenging issues such as financial conflict’s of interest. In a large and diverse research enterprise, Advance has brought together the different components, revealing their commonalities and facili-
tating collaborative relationships. In recent years, more and more organizations located outside the United States have sought accreditation. 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 information 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 inthe-field experiences. This feedback is central to supporting AAHRPP’s goal of improving the systems
Read the new Advance at
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.
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Delivering a Better Product to Improve Protections AAHRPP 2011 Conference Webinars Address Challenging Issues
Delivering a Better Product to Improve Protections for Research Participants Helping organizations provide protections 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 information to a much larger community 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 participants and organizations. In addition to changes with the Advance, we have released an updated Evaluation Instrument for Accreditation. While the Accreditation Standards and Elements remain unchanged, the requirements 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 requirements must be implemented by March 31, 2011. Other updates to the Evaluation Instrument were minor, reflecting the addition and removal of guidance documents issued by the Office for Human Research Protections. The AAHRPP Accreditation Procedures 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 2
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by AAHRPP staff and move to the next step – submission of the Step 2 application. While most organizations 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 Reaccreditation-Pending will earn accreditation for five years minus the time they were in the pending category. Accreditation assures the public that organizations are achieving high standards for protecting research participants only
if organizations put into place and maintain policies, procedures, and practices that meet the accreditation standards. Sometimes, circumstances such as loss of staff or funds will have negative consequences on a human research protection program. Nonetheless, it is important for organizations to maintain the quality of their protection programs, especially as the public is beginning to rely more and more on the AAHRPP accreditation seal as a sign of excellence. The Evaluation Instrument for Accreditation and AAHRPP Accreditation Procedures are available at www.aahrpp.org. -Marjorie A. Speers, Ph.D.
AAHRPP has accredited 223 programs WASHINGTON, 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) continues the trend of accreditation by leading industry private research sites. Established in 1996, Miami Research Associates is the largest physicianowned 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—certified 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 organizations 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.”
Mark your calendars for AAHRPP’s 2011 Conference in Washington, Mark your calendarsD.C. for/ April 6-8 AAHRPP’s 2011 Conference in Washington, D.C. / April 6-8
And get ready to start
breaking breaking barriers barriers And get ready to start
that keep n That keephospitals, IRBs, administrative officials, and researchers and staff academic institutions, from supporting onesponsors, another. independent IRBs, CROs, and private research n That keep IRBs, administrative hospitals, academic sites from collaborating officials, andindependent researchers and institutions, IRBs,staff with the community for from supporting one another. sponsors, CROs, and private better research. research sites from collaborating n n
That keep hospitals, academic with one another. institutions, independent IRBs, sponsors, CROs, and private That keep research participants research sites fromfrom collaborating around the world being with one another. protected by a single, global set of standards. That keep research participants around the world from being protected by a single, global set of standards.
Engage with who have overcome these Future of experts Research – Why Collaborations Are Eschallenges, including AAHRPP accreditation directors, sential
executive leadership, officials, and your Jerry Menikoff, M.D., government Office for Human Research Protections peers, on such topics as: Taking It experts to thewho Community: KnowlEngage with have overcomeIncreasing these challenges, including AAHRPP accreditation directors, edge About Research Protections n Choosing riskHuman tolerance over risk aversion in research. and the executive leadership, government officials, and your IRB Among Community Partners n Unifying divergent institutional committees in the peers, on such topics as: Kathleen Uscinski, M.B.A., C.I.P., Yale University HRPP. n Achieving global standards protection for Remote/Virtual Audits of IRBs: A n Choosing risk tolerance overofrisk aversion inSponsor research. and participants. IRB Collaboration—Doing More, NOT Spending n Unifying divergent institutional committees in the n Expanding the meaning of collaboration in More HRPP.
Jeffrey Wendel, Chesapeake multiinstitutional humanIRB research. n Achieving global standards of protection for Kerrick Wilson, GlaxoSmithKline n Infusing quality systems into every aspect of the participants. human research process. Boards: When Do They Community n Expanding theAdvisory meaning of collaboration in n Building successful university-hospital research Reach the Levelhuman of Community Engagement? multiinstitutional research. partnerships. Steve Wakefield, Fred Hutchinson Cancer Center n Infusing quality systems into every aspect of the n Partnering with the public for better research. human research process. Building International Research Collaboration n Collaborating with other IRBs. Networks – Experiences from Yale University and n Building successful university-hospital research partnerships.Hospitals Case Medical Center University
Sandra Alfano, M.D., University n Partnering with theYale public for better research. Contact AAHRPP at University (202) 783-1112 or Case firstname.lastname@example.org, Joe Gibbons, M.D., Hospitals Medical Center n Collaborating with other IRBs.
or visit www.aahrpp.org for additional information.
Contact at (202) on 783-1112 or email@example.com, To findAAHRPP more sessions collaborating with or visit www.aahrpp.org for additional information. the community, visit www.aahrpp.org. A A H R P P A D VA N C E
AR HPRPP PA D AD A AA H VV AANNCCE E
2301 M Street, N.W., Suite 500 Published quarterly by the Association Washington, DC 20037
for the Accreditation of Human Research
Protection Programs, Inc. Office: (202) 783-1112 fax: (202) 783-1113 PRESIDENT & CEO:
Non-Profit Org. U.S. Postage PAiD Washington, DC Permit No. 96
Marjorie A. Speers, Ph.D.
firstname.lastname@example.org www.aahrpp.org EDITOR: Kirsten E. Blanton, M.S.
Todd Allan Printing Co., Inc., Beltsville, MD 2301 M Street, N.W., Suite 500 Washington, D.C. 20037 Office: (202) 783-1112 Fax: (202) 783-1113 email@example.com www.aahrpp.org
save april 6-8, 2011 foR tHRee DAys of
Begin Your Self-assessment with AAHRPP’s Getting Started Webinar
Most accredited organizations agree AAHRPP that the work you at do the on your selfassessment drives both the effiAnnual Conference ciency and the effectiveness of the Washington, D.C. application process. Learn how to do it well by scheduling a webinar Page 7 inside, for details tailored tosee your organization, conducted by Peter Vasilenko, Ph.D., Vice President of Accreditation at AAHRPP. If you need assistance initiating 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 standards organizations sometimes find difficult. Schedule your two-hour
second DOe Lab Accredited Along With Five Other Organizations WASHINGTON, 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 protection programs (HRPPs) at another six organizations, including a second Protectingof Vulnerable National Laboratory from the U.S. Department Energy (DOE). Populations in Research Brookhaven National Laboratory joins the Pacific Northwest National (Elements II.4.A. and II.4.B.) October 25 accredited and October 27 Laboratory in earning the AAHRPP seal. HRPPs at the September meeting of the Council onFill Accreditation represent a diverse out the registration form at group of government, for-profit, andwww.aahrpp.org academic organizations and and send one Getting Started webinar by contactback for each computer you total number of accredited copy HRPPs to 220, representing ing bring us at the firstname.lastname@example.org. want to connect to the webinar. As nearly 1,100 entities. many colleagues as you want may Webinars Address Following is a list of the newly accredited organizations: participate through that connecChallenging Issues tion. If you would like to propose n Brookhaven National Laboratory, Upton, NY topics for discussion in subsequent This spring, AAHRPP will n Compass LLC, Mesa, AZ webinars, you may send your sugconduct the first IRB, in a series n Mid*Lands IRB, LLC, Park, KS to email@example.com. of educational webinars that Overland gestions willndiscuss of the more Statesome University of New York at Stony Brook, NY Engage with complex issues facing HRPPs. n The University of Central Florida, Orlando, FL Your Peter Vasilenko, Ph.D., AAHRPP’s HRPP Community n Tulane University, New Orleans, LA Vice President of AccreditaSign Up for Online tion, will host the first “These additions to webinar. the increasing group of accredited organizations Publication that AAHRPP’s gold seal is the right and smart IRB demonstrate Consideration of earning Data and As this is the final print edition of thing to assure the protection of research participants,” said Marjorie Safety Monitoring Plans the Advance, to receive the latest (Element II.3.B.) A. Speers, Ph.D., President and CEO ofAdvance AAHRPP. “It alsoplease increases articles, signthe up April 26 andofApril 28 number accredited options for industry sponsors and researchers.” online at www.aahrpp.org. We thank all our loyal readers for Collecting and Using Metrics as Part AAHRPP promotes high-quality research through an accreditation their part in making the of Your Quality Improvement Plan processI.5.A. that helps organizations worldwide strengthen human Advance what it istheir today, (Elements and I.5.B.) research protection programs (HRPPs). and we look forward to July 26 and July 28 hearing from you online!