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AAHRPP Brochure 2011
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AccreditAtion for
HumAn reseArcH Protection ProgrAms
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one set of stAndArds,WorldWide
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The Association for the Accreditation of Human Research Protection Programs
(AAHRPP) promotes high-quality research through an accreditation process that
helps organizations worldwide strengthen their Human Research Protection
Programs (HRPPs).
As an independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-
driven, educational model to ensure that HRPPs meet rigorous standards for quality
and protection.
To earn accreditation, organizations provide tangible evidence—through policies,
procedures, and practices—of their commitment to scientifically and ethically
sound research, and to continuous improvement.
As the ”gold seal” for research practice, AAHRPP accreditation offers assurances—
to research participants, researchers, sponsors, government regulators, and the
general public—that an HRPP focuses first and foremost on excellence.
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The accreditation process requires your organization to take a comprehensive look
at your HRPP—in order to identify and address any weaknesses and to build upon
your strengths.
When your organization joins the ranks of the accredited, you:
Meet HigH StandardS.AAHRPP’s ethical and professional standards provide the most comprehensive
protections for research participants. These standards exceed the requirements set
by the United States and other countries for safeguarding participants, and they
extend to every study overseen by your HRPP.
ConduCt HigH-Quality reSearCH.Accreditation is a signal of the quality of a research program. The AAHRPP seal
indicates that your data are credible and reliable. Data quality and protections go
hand in hand.
iMprove effiCienCy and effeCtiveneSS.AAHRPP requires organizations to conduct an unprecedented, consistent, in-depth
analysis of their research protection programs—to make sure that policies and
procedures are not only in place but also documented and actually practiced.
Such analysis helps shape more efficient and effective policies and procedures and
demands superior record keeping. As a result, government regulators find fewer
problems in accredited organizations than in non -accredited ones.
Hold a CoMpetitive edge.Industry sponsors, government agencies, and other funders recognize that
accredited organizations have more efficient operations, produce high-quality
data, provide more comprehen sive protections, and strengthen public confidence
in their organizations. It’s no accident that pharmaceutical companies increasingly
expect research organizations and independent IRBs to be accredited.
StrengtHen publiC truSt.Prospective participants, and the public in general, are looking to the research
enterprise to take respon sibility for ensuring that research is conducted safely
and ethically. Because accreditation is a voluntary, objective measure of quality,
participants are more likely to choose organizations that have earned the AAHRPP
seal.
Why Pursue Accreditation?
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Recognized by sponsors as the industry gold standard, AAHRPP accreditation
already extends protections to research participants around the world—by
setting uniform, high-quality standards across the research enterprise in industry,
government, and the non-profit sector.
In place of a patchwork of regulations from one country to another, AAHRPP
provides a single, comprehensive set of accreditation standards that include—and
usually exceed—specific country regulations.
To achieve accreditation, you must demonstrate that your HRPP meets the AAHRPP
standards in the following areas:
doMain iOrganization
doMain iiInstitutional Review Board or Ethics Committee
doMain iiiResearch and Research Staff
One Set of Standards, Worldwide
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Experience and Flexibility
While AAHRPP accreditation is awarded to the entire organization, AAHRPP accredits
only an organization’s HRPP. AAHRPP designs the accreditation standards with the
flexibility to apply to a variety of HRPP models in a broad range of organizations.
AAHRPP has experience accrediting all types and sizes of organizations and applies
flexibility in the Standards based on the type of the organization.
aCadeMiC inStitutionS
AAHRPP has accredited numerous universities, including single-campus and
multi-campus organizations, those with medical schools that conduct biomedical
research, and those that conduct primarily behavioral and social science research.
For behavioral and social science research AAHRPP promotes the use of the
flexibility built into the regulations (Department of Health and Human Services)
and the development of equivalent standards when the regulations do not
apply. In addition, AAHRPP accredits to the unique additional regulations from
the Department of Defense, the Department of Education, the Department of
Energy, the Department of Justice, the Department of Veterans Affairs, and the
Environmental Protection Agency, and the Food and Drug Administration.
ContraCt reSearCH organizationS
Aware of the distinctive role of contract research organizations, AAHRPP applies
its standards, as well as regulations and laws, according to where research is
conducted. AAHRPP stresses communication and sharing of responsibilities
among CROs, IRBs, sponsors, and local research sites.
governMent agenCieS and laboratorieS
AAHRPP has experience working with government agencies and national
laboratories and assists the organizations to comply with the standards while
operating within federal guidelines.
HoSpital and MediCal CenterS
Accredited hospitals range from small community hospitals to large hospital
networks and medical centers, including specialty hospitals such as psychiatric
hospitals and children’s hospitals. AAHRPP accredits to the Food and Drug
Administration (FDA) regulations as well as the Department of Health and Human
Services (DHHS) regulations and the International Conference on Harmonization –
Good Clinical Practice (E6), when applicable.
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independent irbS
Small and large independent IRBs are among AAHRPP-accredited organizations.
Several new independent IRBs have developed their business and standard
operating procedures around the AAHRPP Standards. AAHRPP is experienced with
the unique structures and operations of independent IRBs and applies its standards
appropriately.
international organizationS AAHRPP accredits organizations worldwide. For each country, AAHRPP accredits
its standards as well as any country-specific laws or regulations that apply. For
each country AAHRPP develops an Addendum to its Evaluation Instrument for
Accreditation that lists country-specific requirements that are beyond those in the
AAHRPP standards, and makes the Addendum available to the international client
as well as site visitors.
private reSearCH SiteS
Private research sites have HRPPs even though they do not have their own IRBs.
AAHRPP accredits these sites according to the standards in Domain I, Organization,
and Domain III, Researchers and Research Staff, and expects sites to use accredited
IRBs. AAHRPP does not enforce standards that are not applicable. For example,
emergency use of test articles may not be conducted at some sites.
SponSorS
Sponsors that conduct human participant research within their organizations are
also eligible to become accredited. Sponsors have recognized that protecting
human participants in research is a shared responsibility and that accreditation is a
benchmark of the high standards of conducting research.
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Defining Your HRPP
Model 1Organizations use varying combinations
of HRPPs and IRBs to protect research
participants. In some organizations, all
HRPP functions are performed internally. In
others, outside organizations handle certain
functions, such as IRB review. For example,
some hospitals, independent IRBs, and,
especially, large universities have a single,
central HRPP with any number of internal
IRBs working with the HRPP.
HRPP
IRB
Model 2Smaller hospitals and universities, research
sites, and clinical research organizations
often use one or more external IRBs, which
either are accredited themselves or must
meet accreditation standards for the research
organization to be accredited.
HRPP
IRB
IRB
IRBIRB
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A Joint Effort
Accreditation is a joint effort—between applicants and AAHRPP—to improve the
quality and efficiency of research and to strengthen research protections.
Applicants and AAHRPP staff work together to build understanding of the
accreditation standards and their role in ensuring trust in the ethics and excellence
of human research.
The Accreditation Process
before you apply
Step 1
Step 2
aCCreditation deterMination
Obtain Organizational Commitment
PerformSelf-Assessment
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Submit Step 2 Application
Site Visit
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Draft Site Visit Report &
Response
Application Determination
& Final Site Visit Report
Submit Step 1 Application
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Application Review & Response
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5 7
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Before You Apply
obtain organizational CoMMitMent The accreditation process emphasizes accountability at every level of your HRPP.
Before you start the process, make certain that accreditation is, indeed, a strategic
goal of your organization and that the highest echelons of administration and
management are committed to achieving the excellence it demands.
Once those officials are invested in pursuing accreditation, look at the structure
of your organization and determine which entity or entities require accreditation.
Make one person in your office responsible for overseeing your accreditation
effort. Be sure to devote sufficient staff, resources, and time to review, document,
and prepare your program for accreditation.
To familiarize yourself with the accreditation process, take advantage of the
resources at aahrpp.org, including workshops on getting started and the AAHRPP
Annual Conference. If you have any questions, please confer with colleagues in
other accredited organizations, and feel free to call AAHRPP to discuss accreditation
with our staff.
perforM Self-aSSeSSMent Conducting an in-depth assessment of your current protection program is the
most important part of the accreditation process. The self-assessment serves as
the baseline from which you develop your accreditation applica tion. Many of the
improvements you make in your program will start from what you discover as a
result of this intensive self-examination.
Before you begin the self-assessment, review “How to Conduct a Self-Assessment,”
as well as the “Evaluation Instrument for Accreditation,” which are both available
at aahrpp.org. The Evaluation Instrument will guide you through an element-by-
element examination of your protection program.
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2
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SubMit Step 1 appliCation Using the results of your self-evaluation, complete the Step 1 application form and
your program overview, and then submit them to AAHRPP, along with copies of
your policies and procedures, and an index for those documents.
appliCation review & reSponSe
AAHRPP will then review your application materials and, typically within 60 days,
request any necessary revisions or additional documentation.
Step 1
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SubMit Step 2 appliCation Your Step 2 application includes all of the information submitted in Step 1, plus
each of the policies and procedures that have been revised in order to meet
the accreditation standards. The application also has a list of IRB minutes and
correspondence and active protocols. Once you have submitted the application,
AAHRPP staff will begin working with you to set up your site visit.
Site viSit During the visit, the site visitors will evaluate how well your actual practices meet
each element of the accreditation standards. Your site visit team will include
from two to four of your professional peers, chosen specifically for their expertise
and experience with your research setting. A member of AAHRPP’s Council on
Accreditation or a senior site visitor will lead the team.
Once you know the date of your site visit, begin reviewing the Web page “Preparing
for Your Site Visit” at aahrpp.org. The sub-menu for that page links to another
resource titled “Who’s Interviewed.”
During the two to four days of the site visit, the AAHRPP team will interview your
key organizational officials; IRB members, chairs, and staff; researchers and research
staff; as well as others involved with your HRPP.
draft Site viSit report & reSponSe AAHRPP will give you a Draft Site Visit Report within 30 days of the last day of
the site visit. Once you receive the Draft Site Visit Report, study the site visitors’
observations and feel free to contact AAHRPP with any questions or clarifications.
Tips on developing your response to the report are also available on the “Preparing
for Your Site Visit” Web page. Your response will be carefully evaluated as an
integral part of your application. Be sure that you have staff available to prepare
your response. Please note that the due date for your response is strictly observed.
Step 2
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5
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appliCation deterMination & final Site viSit report AAHRPP’s Council on Accreditation will discuss your organization at its next
quarterly meeting following your site visit. In that meeting, the Council will
evaluate your Step 2 application, your Draft Site Visit Report, and your response
to the report and decide whether your HRPP meets the accreditation standards.
The Council will then issue a Final Site Visit Report, including its determination of
your accreditation status.
The Council meets four times a year. You will be notified of the Council decision
shortly after the meeting. Because the accreditation process is confidential, AAHRPP
publishes only the names of those organizations that achieve Full or Qualified
Accreditation. AAHRPP will not make public any information about organizations
that have applied for accreditation or are in the accreditation process.
Council on Accreditation
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As part of our educational approach, AAHRPP offers a wealth of resources that
support your organization’s efforts to learn how to understand and apply the
standards you must meet in order to earn accreditation. Just as important in
any learning process, AAHRPP also creates oppor tunities for you to connect and
collaborate with colleagues at other accredited organizations, and thus benefit
from one another’s experience and insight.
web reSourCeS
You can access what you need to learn about accreditation, including the resources
below, at our Web site: aahrpp.org.
doCuMent library
All the documents you need in order to apply for and maintain accreditation
appear in the Document Library.
tip SHeetS
Tip Sheets to help organizations write HRPP policies, procedures, and other
supporting documents they need to meet the accreditation standards.
evaluation inStruMent for aCCreditation
Perhaps the most valuable aid in conducting your self-assessment and completing
your Step 1 application, the Evaluation Instrument covers what is necessary to
meet the AAHRPP standards.
MetriCS on Hrpp perforManCe
Objective data show how accredited HRPPs perform. The figures and tables provide
sponsors, researchers, and IRBs with objective data to answer such questions
as how long it takes the average accredited institutional review board or ethics
committee to move a protocol from submission to approval. In fact, because
so many groups have asked about the research enterprise—without uncovering
many evidenced-based answers—AAHRPP updates these charts regularly and adds
new data annually.
working witH an aCCreditation direCtor When you become a client of AAHRPP, by pre-paying your application fee, our
accreditation directors will work with you as you conduct your self-assessment.
They will answer questions about the accreditation standards and help you develop
an approach to conduct the self-assessment.
Educational Resources
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networking witH aCCredited organizationS
Learn from your colleagues at organizations that have earned accreditation when
you reach them through aahrpp.org. Many are earnestly interested in sharing their
experience and insights with you and in learning from your organization, as well.
web-baSed SeMinarS
getting Started webinarS/getting on board webinarS (non-ClientS)These webinars help those who are responsible for leading your team, and
especially those conducting your self-assessment, to initiate the accreditation
process. They cover the accreditation process, leading the self-assessment, effective
use of the Evaluation Instrument for Accreditation, and ways to demonstrate how
organizations can satisfy accreditation standards that they commonly find difficult
to meet.
eduCational webinarS
These sessions offer the in-depth give-and-take of a seminar led by an expert on
human research protection. They help you think through hot topics, government
regulations and guidance that are puzzling to interpret, and challenging policies
that are challenging to put into practice.
aaHrpp’S annual ConferenCe
This meeting is the ideal opportunity to learn more about accreditation, to
advance ethical research practices, and to network with colleagues who share your
concerns about human research protections.
The conference has sessions designed specifically for those who are new to
accreditation or working their way through the accreditation process.
aaHrpp advanCe newSletter
This online newsletter has practical, topical information on accreditation and
accredited organizations. You can subscribe, read the latest articles, or browse
through any past issue at advance.aahrpp.org.
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our mission AAHRPP accredits high-quality human research protection
programs in order to promote excellent, ethically
sound research. Through partnerships with research
organizations, researchers, sponsors, and the public,
AAHRPP encourages effective, efficient, and innovative
systems of protection for human research participants.
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For more information, contact:
Association for the Accreditation of Human Research Protection Programs, Inc.2301 M Street, N.W., Suite 500Washington, DC 20037
(202) 783-1112 phone(202) 783-1113 faxwww.aahrpp.org
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