In the four years since the founding of the Association for the Accreditationof Human Research ProtectionPrograms (AAHRPP), the move towardaccreditation has surpassed expecta-tions. Sponsors, federal regulatingbodies and other government agen-cies, and voluntary health agenciesnow acknowledge that accreditationholds research organizations to ahigher standard — offering the bestprotection for research participantsand promoting quality research. As a result, organizations in all sectors of the research enterprise, bothnationally and internationally, are seeking accreditation.

Already, 28 organizations repre-senting 88 entities nationwide haveearned accreditation, demonstratingtheir commitment and adherence to a“gold standard” for research. Amongthem are community hospitals, teaching hospitals, and cancer centers;independent IRBs; research institutes;and universities. Another 210 organi-zations are working toward accredita-tion, and, over the next four years, all of the nation’s major researchorganizations will have completed the accreditation process.

These statistics provide compellingproof that accreditation is fast becom-ing the standard of practice. At thesame time, they underscore AAHRPP’scritical role in ensuring accountabilityamong research programs, safe-guarding research participants, and promoting quality research.

Indicators of success

AAHRPP’s progress is evident in theresponse across the research enterpriseand from those it represents.

Candidates for accreditation■ Nearly 80% of academic medical

centers either have already earnedaccreditation or have begun theaccreditation process. These leadersin research are raising the bar forethical standards and creating pressure for others to follow suit.

■ Other universities whose researchportfolios are primarily behavioraland social science also are seekingaccreditation, as are teaching hos-pitals, community hospitals, inde-pendent IRBs, government agen-cies, research sites, and clinicalresearch organizations.

Stakeholders ■ Leaders in the research community

have joined AAHRPP as SupportingMembers (see AAHRPP WelcomesFirst Supporting Members, Page 8)and are urging organizationsengaged in research to pursueaccreditation as an assurance of quality.

■ Some of the strongest support is evident in the government’s ownactions. The Department of Energy,the Department of Health andHuman Services, and the Depart-ment of Defense are seeking accreditation for their intramuralresearch programs.

■ The Office for Human ResearchProtections (OHRP) and the Foodand Drug Administration plan toinquire about accreditation statusin their proposed IRB registrationsystem. OHRP already takes accred-itation status into account in prioritizing its not-for-cause compliance visits.

■ Sponsors and other funding agencies recognize that accreditedorganizations have more efficientoperations, provide better and more comprehensive protections ofresearch participants, and producehigh-quality data. Accredited

AAHRPP Accreditation: Gold Standard and Standard Practice

V O L U M E 2 • N U M B E R 4

4 HRPP Innovations

5 Insights into IRBs

7 AAHRPP AccreditationConference

CONTINUED ON PAGE 3

WINTER 2005

The market has spoken.

Loudly and clearly it has opted not just for accreditation but foraccreditation by AAHRPP.

As of November 15, 2005, thePartnership for Human ResearchProtection (PHRP) ceased operations,leaving AAHRPP as the sole nationaland international accrediting body for research organizations. Some havemistakenly interpreted PHRP’s dissolu-tion as a sign that accreditation hasnot taken hold in the field of humanresearch. In fact, as the article on Page 1 indicates, the reverse is true.Accreditation not only is alive andwell but is fast becoming standardpractice — with AAHRPP serving asthe standard-bearer.

Our success is no accident. It is rooted in the philosophy andapproach of AAHRPP, undertakensince our founding members joinedforces in 2001 to create an accredita-tion program. From the start, theseseven organizations — Association of American Medical Colleges,Association of American Universities,Consortium of Social ScienceAssociations, Federation of AmericanSocieties for Experimental Biology,National Association of StateUniversities and Land-Grant Colleges,National Health Council, and PublicResponsibility in Medicine and Health— were clear about their intentions forAAHRPP. Above all, AAHRPP wouldsafeguard research participants bypromoting sound, ethical research. It would raise the bar in humanresearch protection. And it wouldestablish itself as the program ofchoice through an accreditationprocess based on self-assessment, peer review, and education.

The market recognizes the addedvalue that this model and AAHRPPbring to the accreditation process and the research enterprise. As evi-dence, we need only look to the ever-increasing list of accredited organiza-tions and the recent decision of sevenorganizations to join AAHRPP asSupporting Members. (See story, Page 8.)

An enduring commitment

Organizations that attain AAHRPPaccreditation do so, in part, because of their commitment to continuedimprovement. AAHRPP supports thiscommitment through ongoing educa-tion. A prime example is our annualconference, which is highlighted onPage 7. The conference, “Quality

Human Research ProtectionPrograms,” is geared toward accredit-ed and non-accredited organizationsand stakeholders and provides awealth of information about accredi-tation and about practices thatimprove protections for research participants. This year we are offeringfour special tracks for those who preferto focus on a specific area of interest.

We know, from those who attendedlast year’s conference, how much youwelcome the opportunity to collabo-rate and benefit from one another’sexperiences. That’s why our 2006

conference includes networking sessions and roundtable discussions.It’s also why, in each issue of AAHRPPAdvance, we invite individuals andorganizations to highlight effectivepractices and share their perspectives.This issue showcases innovations fromCedars-Sinai Medical Center in Los

Angeles and the University of SouthDakota (Page 4). It also features Dr. Michael Oakes’ Insights on IRBs(Page 5). On behalf of AAHRPP, I’dlike to thank them for agreeing to bepart of this issue.

I’d also like to express my apprecia-tion to all of you who have attainedor are pursuing accreditation. In theprocess, you have joined the marketforces in selecting AAHRPP. Even moreimportant, however, you have demon-strated your dedication to the higheststandards in protecting research participants.

2 AAHRPP ADVANCE

A Model for Success

M A R J O R I E A . S P E E R S , Ph.D.

“Our success is no accident. It is rooted in the philosophy and approach of AAHRPP, undertakensince our founding members joined forces in 2001 to create an accreditation program.”

“Clarifications” on Web Site

A new “Clarifications” section on theAAHRPP Web site provides Council onAccreditation explanations of its inter-pretation of accreditation standards.Clarifications will be updated eachquarter, after the Council onAccreditation meeting.

Now in Publication

Two members of the Council onAccreditation and one member of theBoard of Directors have authoredbooks on ethics in research.

■ Is There an Ethicist in the House?On the Cutting Edge of Bioethics

Jonathan D. Moreno, Ph.D.(Council on Accreditation Member)Indiana University Press

Dr. Moreno tackles some of today’smost important clinical ethics ques-tions, addressing them with a clarityand insight that will be welcomedboth by medical professionals and bylay readers seeking to understand thephilosophical foundation of contem-porary medical issues. He draws on hisown experience as a hospital ethicist

and discusses his understanding ofbioethics, in theory and in practice.

■ The Ethics and Regulation ofResearch with Human Subjects

Carl H. Coleman, Jerry A. Menikoff,Jesse A. Goldner (Council onAccreditation Member), and Nancy N. Dubler (AAHRPP Boardof Directors Member)LexisNexis Publishing

This book offers a comprehensiveoverview of the ethical and regulatorystructure governing research withhuman subjects in the United States,as well as an in-depth exploration ofa broad range of ethical and policyquestions. It includes numerousexcerpts from articles by leadingscholars, advisory commissions, andothers. It also features more than 700notes and questions that guide thereader in developing an understand-ing of the subject matter. A referencework, the book can also be used as acourse text with an accompanyingteacher’s manual.

AAHRPP ADVANCE 3

Welcome New AAHRPPBoard Members:

Nancy Neveloff Dubler, L.L.B.Montefiore Medical Center

Sandra Harris-Hooker, Ph.D.The Morehouse School ofMedicine

organizations report that pharma-ceutical companies have pre-approved them for clinical trialsand waived inspections because oftheir accreditation status. Some vol-untary health agencies that awardgrants now inquire about accredita-tion as part of the grant-makingprocess. As accreditation becomesthe standard, stakeholder organiza-tions are expected to begin exertingpressure, requiring accreditation asa condition of research support.

Behind the growth

The push for accreditation reflects a heightened awareness of the bene-fits to the research enterprise as awhole. As the gold standard, AAHRPP

accreditation serves as proof that anorganization adheres to the highestethical practices in protecting researchparticipants. It helps build public trustand can lead to increased enrollmentin research — and additional sponsorsupport.

The accreditation process itself also offers advantages and has beeninstrumental in securing AAHRPP’splace as the accrediting body of choicefor those engaged in human research.The self-assessment that AAHRPPrequires can lead to more effective utilization of staff and resources and can prevent costly shutdowns,problematic inspections, and misinterpretation of regulations.

Because AAHRPP standards exceedU.S. and international requirementsfor safeguarding research participants,accredited organizations must contin-ually assess their research programs

with an eye toward improvement. By seeking accreditation, they signaltheir willingness to raise and main-tain the quality of their humanresearch protection programs — and their long-term commitment to sound, ethical research.

AAHRPP AccreditationCONTINUED FROM PAGE 1

The Research Compliance Office ofthe University of South Dakota (USD)— fully accredited by AAHRPP as ofSeptember 16, 2005 — has developedstandard operating policies and pro-cedures (SOPs) that stand out for theirclarity and ease of application. As aresult, they not only facilitate compli-ance with government regulationsand USD requirements but also serveas a training tool for researchers whoare new to the university.

According to Lisa Korcuska,Associate Director, ResearchCompliance at USD, the policies arethe product of a more-than-two-yeareffort, including a review of best prac-tices of other AAHRPP-accreditedinstitutions. The SOPs also reflect Ms.Korcuska’s experience as a clinical

trial coordinator and her desire thatUSD policies be “specific, yet easy tofollow. What we want,” she says, “isto foster compliance.”

Ms. Korcuska offers the followingtips to those who are drafting orupdating SOPs:

1. Learn from others’ experiences. In addition to reviewing policies of other accredited organizations,USD purchased templates, com-plete with citations of applicableregulations, to use as the founda-tion for its own SOPs.

2. Keep language clear and concise.Ms. Korcuska enlisted non-researchers and non-IRB staff toread drafts of USD policies to makesure they were easy to understand.

3. Take a step back. After drafting a policy, let it sit for a few days.Return to it with a critical eye, andask yourself if it does, indeed, saywhat you intended.

4. Routinely distribute policies andupdates. USD researchers receive abinder with a complete set of SOPs.If a policy is updated, the ResearchCompliance Office announces theupdate via e-mail and attaches acopy of the revised SOP. Recipientscan then print the revised policyand update their binders.

Information: Lisa Korcuska, lkorcusk@usd.edu, (605) 677-6067.

Volunteers for psychiatric research atCedars-Sinai Medical Center (CSMC)— fully accredited by AAHRPP sinceApril 20, 2004 — now benefit from animproved screening protocol thathelps match participants with currentclinical studies, identify and referthose in need of treatment, and builda registry of individuals who might beeligible and interested in participatingin future studies.

The new, consolidated screeningprotocol replaces the telephone screen-ings that previously were conductedfor each clinical study. It relies on 13diagnostic tools to provide a moredetailed assessment of prospectiveresearch participants.

By capturing significantly more

information than can be obtained viaphone, the consolidated screening canbetter identify individuals with theappropriate inclusion criteria forspecific research studies. With volun-teers’ consent, diagnostic and demo-graphic information is maintained ina research database, making it easierto identify eligible individuals forfuture studies.

“In the past, we would performpieces of this screening for everystudy,” explains Russell E. Poland,Ph.D., Director of Psychiatry Researchat CSMC. “Now, we perform a com-prehensive assessment that providesuseful screening information for allexisting studies and a much clearerdiagnosis. We’re investing a lot more

time in assessing subjects, but theadditional information will help us in the long run.”

The information also is beneficialto participants, who receive a detailedreport on their assessment, as well asreferrals for CSMC or community-based services, when needed.

“The assessment is above andbeyond what’s done by most practi-tioners, and it is provided free ofcharge, regardless of whether theyqualify for a study,” Dr. Poland says.“In that regard, it’s a valuable community service.”

Information: Russell E. Poland,Ph.D., Russell.Poland@cshs.org, (310) 423-3533.

University of South Dakota: Policies that Promote Compliance

New CSMC Protocol Benefits Volunteers, Research Program

Ideas for ”Innovations”AAHRPP Advance welcomes theopportunity to showcase innovativeprograms and practices developedby our accredited organizations. Tosuggest an innovation, send an e-mail to accredit@aahrpp.org. Please include a brief descriptionand contact information.

4 AAHRPP ADVANCE

Q&AQ. How do most investigators or

IRB professionals define anIRB?

A. In my experience, research investi-gators and IRB professionals typicallyhave different, often opposing, viewsof IRBs. I find many investigators, particularly those in the social sci-ences, believe they should have freerein to conduct research without beingsubject to review. To them, the IRB is a bureaucratic hurdle to overcome. Incontrast, most IRB professionals viewthe IRB as absolutely essential toensure fairness for research partici-pants and protection against potentialself-interests. Not only is there tensionbetween the two views, but this ten-sion is increasing.

Q. How do IRBs function associal institutions?

A. Social institutions solve collectiveproblems to provide “public goods.” In the case of IRBs, the public good istrust — for research subjects and forinvestigators. Each IRB review hasimplications beyond the specific proto-col under consideration. Each review

represents a collective obligationbecause it affects the trust required byall research participants, current andfuture. In much the same way, eachreview has the potential to influenceinvestigators regarding a particularstudy, and studies nationwide, by pro-viding assurances that all investiga-tors are held to the same standardand that none can gain a competitiveadvantage by cutting ethical corners.

Q. What are the obligations ofIRBs as social institutions?

A. There’s no question that the firstresponsibility of IRBs is to protectresearch participants — to revieweach research protocol and make surethere’s no coercion and no undue risk.But from the framework of social insti-tutions, IRBs must also take steps tomaintain the confidence of everyoneinvolved: future researchers, futureparticipants, and future funding agen-cies. The way to accomplish this isthrough consistency. AAHRPP playsan important role here because itensures that IRBs from accreditedorganizations are following the samestandards.

Q. What makes an IRB legitimate?

A. The short answer is fairness,accomplished through transparencyand peer review. The latter is criticalbecause it can address the tensioncited earlier between the IRB andinvestigators. As the IRB professionincreases in prestige, there appears tobe a growing sense on the part ofsome investigators that their peers areno longer reviewing their research.That is not the case. Peer review onIRBs is done by other scientists andcommunity members who fully com-prehend the research. This peer reviewis an important part of the scientificprocess. It is as valuable and legiti-mate as the peer review required tosubmit an article for publication in ascientific journal or to apply for a fed-eral grant. From a social institutionperspective, one might predict tensionbetween IRBs and researchers to abateif/when serving on the IRB is consid-ered to be as prestigious as serving onan NIH grant review panel.

Insights into IRBsFederal regulations define an Institutional Review Board (IRB) as a committee of “at least five members, with varying backgrounds to promote complete and ade-quate review of research activities commonly conducted by the institution.” The reg-ulations require that an IRB “be sufficiently qualified through the experience andexpertise of its members and the diversity of their backgrounds … to promoterespect for its advice and counsel in safeguarding the rights and welfare of humansubjects … and to ascertain the acceptability of proposed research in terms of insti-tutional commitment and regulations, applicable law, and standards of profession-al conduct and practice.”

Despite the federal requirement for IRB oversight, tension sometimes existsbetween IRB professionals and investigators — and their different views on the roleof IRBs in the research enterprise. In the Questions and Answers below, J. MichaelOakes, Ph.D., Assistant Professor of Epidemiology at the University of Minnesota,shares his perspective on IRBs as social institutions based on his research on IRBs.Dr. Oakes also is Chairperson of one of the university’s IRBs and is an activeresearcher subject to IRB review.

AAHRPP ADVANCE 5

J . M I C H A E L O A K E S , Ph.D.

2006 Fee ScheduleAAHRPP has simplified its fee schedule for 2006. Both application and annual fees are now based only on thenumber of active protocols. A new category, “Level 0,” addresses the needs of organizations that rely solely onexternal IRBs for review, and contract for that review via AAHRPP-accredited organizations.

2006 APPLICATION FEE

Program Size Application Fee(based on number of active protocols*) (U.S. dollars)

Level 0 ** $5,500

Level 1 (1 – 100 protocols) $9,000

Level 2 (101 – 500 protocols) $13,000

Level 3 (501 – 1,000 protocols) $16,500

Level 4 (1,001 – 1,500 protocols) $20,500

Level 5 (1,501 – 2,000 protocols) $24,500

Level 6 (2,001 – 2,500 protocols) $28,500

Level 7 (2,501 – 3,000 protocols) $32,500

Level 8 (3,001 – 3,500 protocols) $36,500

Level 9 (3,501 – 4,000 protocols) $40,500

Level 10 (4,001 – 4,500 protocols) $44,500

Level 11 (4,501 – 5,000 protocols) $48,500

Level 12 (5,001 – 5,500 protocols) $52,500

Level 13 (5,501 – 6,000 protocols) $56,500

Level 14 (6,001 – 6,500 protocols) $60,500

Level 15 (6,501 – 7,000 protocols) $64,500

Level 16 (7,001 or more protocols) $68,500

2006 ANNUAL FEE

Program Size Annual Fee(based on number of active protocols*) (U.S. dollars)

Level 0 ** $2,475

Level 1 (1 – 100 protocols) $4,050

Level 2 (101 – 500 protocols) $5,850

Level 3 (501 – 1,000 protocols) $7,425

Level 4 (1,001 – 1,500 protocols) $8,610

Level 5 (1,501 – 2,000 protocols) $9,800

Level 6 (2,001 – 2,500 protocols) $11,400

Level 7 (2,501 – 3,000 protocols) $11,700

Level 8 (3,001 – 3,500 protocols) $12,045

Level 9 (3,501 – 4,000 protocols) $13,365

Level 10 (4,001 – 4,500 protocols) $14,685

Level 11 (4,501 – 5,000 protocols) $16,005

Level 12 (5,001 – 5,500 protocols) $17,325

Level 13 (5,501 – 6,000 protocols) $18,645

Level 14 (6,001 – 6,500 protocols) $19,965

Level 15 (6,501 – 7,000 protocols) $21,285

Level 16 (7,001 or more protocols) $22,605

Newly Accredited Organizations Announced

6 AAHRPP ADVANCE

*The total number of active protocols is the sum of the number of protocols reviewed by the full IRB, the number reviewed by the expeditedprocedure, and the number of protocols granted exemption in the previous 12 months.

**Level 0: This fee category applies to organizations that rely entirely on the services of one or more external IRBs that are accredited by AAHRPP as part of another organization’s human research protection program.

■ University of Pittsburgh, Pittsburgh, Pennsylvania — Full AAHRPP Accreditation

■ The University of South Dakota, Vermillion, South Dakota — Full AAHRPP Accreditation

■ University of California, Irvine, Irvine, California — Qualified AAHRPP Accreditation

The organizations listed here were awarded accreditation at the September 16 meeting of the AAHRPP Council on Accreditation.

The Council on Accreditation will meetagain on December 16, 2005. A complete list of accredited organizations is available at www.aahrpp.org.

Conference attendees will:

1. Learn to identify the key aspects of theaccreditation process and acquire the skillsto complete each phase.

2. Learn to identify the common problemsorganizations are experiencing in meetingthe accreditation standards and ways toaddress them.

3. Become familiar with innovative practicesto improve protections for research partici-pants.

4. Interact with individuals from accreditedorganizations.

The conference dates are February 27 – 28.Pre-conference workshops will take place onFebruary 26.

Main Conference:Plenary Session Topics

■ The Need for Partnerships in the GlobalResearch Enterprise

■ Legislative Initiatives Affecting HumanResearch Protection

■ Ask Legal Counsel

■ The Role of Voluntary Health Agencies inProtecting Participants

■ Regulation and Guidance: Is There aDifference?

Breakout SessionsSeveral special tracks are being offered duringthe breakout sessions for those who wish toconcentrate on a particular topic:

Track #1 General accreditation procedures.This is a six-session series over the course of

the two days focusing on how to conduct a self-assessment and review of the fivedomains of the accreditation standards.

Track #2 Accreditation procedures forbehavioral and social science research pro-grams. This is a six-session series over thecourse of the two days focusing on how toconduct a self-assessment with review ofeach of the five domains of the accreditationstandards. This track will concentrate onissues specific to non-biomedical researchprograms.

Track #3 Industry-sponsored research. These six sessions will address:

■ Industry audits and accreditation

■ Clinical trials agreements

■ Academic/industry partnerships

■ International collaborative research

■ ICH-GCPs, FDA, and DHHS regulations

■ Safety monitoring

Track #4 This track is designed especially forinstitutional officials, and institutional officialswill present the sessions.

■ What is a human research protection program, and what organizational components are involved?

■ What is the process of accreditation and to what am I signing on?

■ What happens after the site visit?

■ What will accreditation mean for the institution?

■ Managing conflict of interest

■ Reporting to regulatory authorities

In addition to these four tracks, there will be sessions on:■ Continuing review■ Non-compliance■ Unanticipated problems ■ Suspensions/terminations■ Emergency research■ Streamlining the IRB process■ Research involving children■ Research involving cognitively

impaired individuals■ Computer systems for IRBs■ Putting together the accreditation

application■ Consent waivers and HIPAA■ Scientific review

Attendees may attend any of the breakoutsessions. All breakout sessions are open toeveryone.

Pre-conference workshops:

#1 Introduction to the FDA regulations— intended for those individuals who gener-ally work with federally funded research

#2 Federal regulations and guidance —intended for those individuals who want tounderstand the federal regulations and guidance as they relate to accreditation

#3 Education programs for investiga-tors, IRBs, and institutional officials —intended for those individuals who are interested in developing or enhancing educational programs

#4 Defining human subjects researchunder the federal regulations — intended for those individuals who wish to understand the DHHS and FDA regulatorydefinitions of research and human subjects,particularly as they relate to data collectionactivities on the boundary between researchand non-research

This year, lunch will be provided. During thelunches, we will offer a networking sessionwith accredited organizations on February 27and topical roundtables on February 28.

Don’t miss the second annual accreditation conference in Phoenix, Arizona,February 26 – 28, geared to individuals from both accredited and non-accredited organizations, including those working on accreditation or thosewho are new to the accreditation process. The conference is also targeted to stakeholders — government, industry, voluntary health agencies, and community groups — that are concerned with promoting human researchprotection and quality research. Institutional officials, IRB professionals andchairs, compliance professionals, researchers, sponsors, and patient groupleaders should attend.

2006 AAHRPP Conference:Quality Human Research Protection Programs

Information/Registration: www.aahrpp.org

AAHRPP ADVANCE 7

AAHRPP ADVANCEis published quartely by the Associationfor the Accreditation of Human ResearchProtection Programs, Inc.

Executive Director:Marjorie A. Speers, Ph.D.

Editor:Elisa GallaroClifton Park, NY

Design: Levine & Associates, Inc.Washington, DC

Printing: Federation of American Societiesfor Experimental Biology (FASEB)

Non-Profit Org.U.S. Postage

P A I DWashington, DCPermit No. 96

Seven leading organizations in theresearch community have joinedAAHRPP as its first SupportingMembers, lending their voices to those encouraging research organ-izations to seek accreditation.

As Supporting Members, theseorganizations will help AAHRPP fur-ther its mission to raise both the levelof protection for research participantsand the quality of research programs.They also send a powerful message to research organizations and the general public that accreditation is the right and smart thing to do.

The Supporting Members representmajor voluntary health agencies andprofessional and educational associa-tions. They include:

■ AAALAC International

■ Alliance of Independent AcademicMedical Centers

■ Alpha-1 Foundation

■ American Lung Association

■ American Society for InvestigativePathology

■ Leukemia & Lymphoma Society

■ National Alopecia AreataFoundation

Their status as Supporting Membersgives these organizations the opportu-nity to have input into AAHRPP’saccreditation program, such as nomi-nation of site visitors and early inputinto accreditation standards. Equallyimportant, their partnership withAAHRPP signals their unwaveringsupport for sound, ethical researchand their willingness to take a standon behalf of human participants.

“Our supporting membership is atangible indicator of our commitmentto research, AAHRPP, and accredita-

tion,” says Kimberly Pierce-Boggs,Executive Director of the Alliance ofIndependent Academic MedicalCenters. “We have a fundamentalbelief not just in the importance ofresearch but also in ensuring that it isconducted properly.”

For the Leukemia & LymphomaSociety, becoming a SupportingMember is a natural extension of theorganization’s efforts on behalf ofpatients and their families.

“Our mission is to improve thequality of life for those with bloodcancer and, ultimately, to find a cure,”explains Louis J. DeGennaro, Ph.D.,Senior Vice President, Research. “Oursupport for AAHRPP and accreditationlets researchers know that we holdthem to the higher standards set byAAHRPP. It also assures patients thattheir safety comes first.”

AAHRPP Welcomes First Supporting MembersLeaders in research community promote accreditation