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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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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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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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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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