The Association for the Accreditationof Human Research ProtectionPrograms (AAHRPP) has accredited itsfirst international human researchprotection program — SamsungMedical Center (SMC) in Seoul,Republic of Korea.

The accreditation underscoresSMC’s commitment to humanresearch protections. It also signals thebeginning of international acceptanceof accreditation as the means to provide better protections for researchparticipants — and of AAHRPP asaccreditation’s standard-bearer.

As the only non-U.S. accreditedorganization, SMC gains significantadvantages in the global marketplace.Its accreditation status offers assur-ances — to research participants, investigators, and sponsors — thatresearch conducted at SMC adheres to AAHRPP’s exacting standards forclinical research. Accreditation alsomarks another in a series of “firsts” for an institution that is building areputation as Korea’s leader in clinical care and research. (See SMC at a Glance, left.)

“It is a great honor to be accredited,for our hospital, our IRB, our ClinicalTrials Center, and for fellow membersof the Korean Association of IRBs,”says Hojoong Kim, M.D., ViceChairperson of SMC’s Clinical TrialsCenter and of IRB Panel C. “We areproud to be first, but it is even moreimportant to us that we meet theworld’s most rigorous requirements forprotecting participants in research.”

The decision to seek AAHRPPaccreditation was the natural nextstep for SMC, which has dedicateditself to becoming a global medicalcenter. In keeping with that objective,SMC established its Clinical Trials

Center in 1999 and, two years later, registered with the U.S. Office forHuman Research Protections andadopted the U.S. Food and DrugAdministration regulations for clinicalresearch.

In 2005, SMC made the decision to seek accreditation and, in prepara-tion, attended the annual AAHRPPConference: Quality Human ResearchProtection Programs. “The conferenceprovided helpful illustrations of howAAHRPP evaluates human researchprotection programs,” Dr. Kim says.“We strongly recommend it.”

He describes the accreditationprocess as “rigorous and educational

AAHRPP Accredits First International Center

CONTINUED ON PAGE 3

FALL 2006

SMC at a Glance■ Established November 9,

1994.

■ A 25-story, 2.1 million-square-foot facility with 1,278 bedsand 4,000 employees, includ-ing 900 doctors and 1,100nurses.

■ Participates in approximately30 multi-center clinical trialseach year.

■ Partner in research withKorea Advanced Institute ofScience and Technology.

■ Teaching affiliate,SungKyunKwan UniversitySchool of Medicine.

V O L U M E 3 • N U M B E R 3

3 The Global ResearchEnterprise

4 Insights into IRBs

6HRPP Innovations

Each AAHRPP accreditation representsanother milestone for human researchprotections. Some accreditations, how-ever, have more far-reaching implica-tions than others. A prime example is that of Samsung Medical Center(SMC) in Seoul, Republic of Korea (seepage 1), the first international organi-zation to demonstrate compliancewith AAHRPP’s rigorous standards.

This particular accreditation hassignificance for SMC, for AAHRPP, and for research in general. It marksthe first time that non-U.S. researchparticipants are assured of the samesafeguards as their U.S. counterparts,demonstrating that it is, indeed, possi-ble to embrace common, stringentstandards for research ethics and practices — worldwide. At the sametime, it underscores that AAHRPP isthe organization of choice to set thosestandards, not just in the United Statesbut around the globe.

SMC’s accreditation also delivers acritical message to research sponsors:that they can tap the potential ofinternational markets without com-promising the quality and safety oftheir research. In partners like SMC,sponsors have access to state-of-the-artfacilities and highly trained investiga-tors who share a fundamental com-mitment to human research protec-tions. Given today’s research trends —increased globalization and growingconcerns with protecting human participants — we have every reasonto believe that other internationalorganizations will follow SMC’s lead.That, in turn, will give sponsorsgreater opportunities to choose accredited international partners andto provide research participants withthe assurances they deserve. As moreand more sponsors indicate a prefer-

ence for accredited partners, we willsee a dramatic shift in the globalresearch enterprise, and accreditationultimately will become the norm.

Among the advantages of accredi-tation is the opportunity to learn fromone another’s best practices. In fact,for those of us involved in the accredi-tation process, one of the most inter-esting aspects is to see, firsthand, theinnovative approaches that organiza-tions develop to ensure the utmostprotection for their research partici-pants. Our 2007 conference is theideal venue to showcase some of theseinnovations, so on page 8, we issue a Call for Abstracts From AccreditedOrganizations.

We also continue our practice ofreporting on two innovations in eachissue of AAHRPP Advance. On page 6, we highlight the University ofConnecticut Health Center’s processfor identifying all new hires involvedin human research to ensure that theyreceive the required HRPP training as

soon as possible. We also featureHunter Holmes McGuire VeteransAffairs Medical Center and its“Research Day,” an annual event thatshines the spotlight precisely where itbelongs: on research participants. Onpages 4 and 5, our Insights into IRBsfocuses on Baylor Research Institute’ssuccessful efforts to build a culture of

compliance among its 13 accreditedentities.

It’s not too soon to make yourplans for the coming year — and tomake sure they include the 2007AAHRPP Conference. As you can seefrom the conference description onpage 7, we will offer a combination ofpre-conference workshops, introducto-ry seminars, and breakout sessions ontopics of interest to stakeholders andaccredited and non-accredited organi-zations. If you’ve attended one of ourconferences in the past, you know that

they offer invaluable opportunities to learn more about accreditation,promote ethical research practices,and network with others who shareyour concern about human researchprotections. If you haven’t attended,2007 is the ideal year to start. We look forward to seeing you there.

2 AAHRPP ADVANCE

Setting the Standards, at Home and Abroad

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

“…we will see a dramatic shift in the global research

enterprise, and accreditation ultimately will become

the norm.”

AAHRPP ADVANCE 3

Recent years have brought significantgrowth in international research, especially clinical trials, and with itincreased concern about safeguardingresearch participants, particularly in developing countries. Although estimates vary on the scope of globalresearch, there is agreement that thenumber of international protocols hasincreased dramatically — and thatthis trend will continue.

Federal agencies appreciate thevalue of international research as asource of data in assessing the safetyand efficacy of new drugs and treat-ments. However, these same agenciesacknowledge the difficulties in moni-toring foreign protocols and ensuringadequate protections for research par-ticipants.

According to The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects, a reportissued in 2001 by the Department ofHealth and Human Services (DHHS)Office of Inspector General, the Foodand Drug Administration (FDA) nowoversees significantly more foreignresearch than in the past. In fact,between 1990 and 1999, the numberof foreign clinical investigators who submitted Investigational New DrugApplications to the FDA increasedmore than 16-fold, from 271 in 1990to 4,458 by the end of the decade.During the same period, the numberof countries engaged in researchtracked by the FDA increased from 28 to 79. Many, including those experiencing the greatest growth, arerelatively unfamiliar with clinical trials and human research protections.

The DHHS report cites several reasons for the increase in interna-tional research involving human participants:

■ Easy access to large numbers ofprospective participants and theability to obtain data on differentracial or ethnic groups.

■ The opportunity to develop potentially lucrative markets for thestudy drugs, should they receiveFDA approval.

■ Efforts by the InternationalConference on Harmonization tostandardize procedures for trialdesign, ethics review, and researchconduct, resulting in greater FDAwillingness to accept data from foreign research sites.

The report also acknowledges thatthe FDA cannot ensure that researchparticipants in foreign trials receivethe same protections as their U.S.counterparts, and points to concerns— by the pharmaceutical industry,national regulatory agencies, theNational Bioethics AdvisoryCommission, and the World HealthOrganization — about the lack ofexperience and inadequate monitor-ing practices of some international

ethics committees (term used mostoften for IRBs outside the UnitedStates).

Finally, it recommends an increasein human subject protection effortsand cites accreditation as one meansof achieving this objective. In thewords of the report, “Encouraging participation of institutional reviewboards in a voluntary accreditationsystem is one way to improve thecapacity to conduct appropriatereviews of human subject protectionsin proposed research.”

AAHRPP was among the first to recognize the role accreditation canplay in ensuring comprehensive pro-tections for research participants. Inthe years since the DHHS report wasissued, AAHRPP has established itselfas an international accrediting body.To date, 39 organizations with 106entities have attained accreditation,including Samsung Medical Center inSeoul, Republic of Korea (see page 1).Another 380 organizations are in theaccreditation process.

Each accreditation affirms that theorganization involved places the safe-ty of research participants above allelse. Equally important, each accredi-tation raises the global benchmark forhuman research protection in science.

The Global Research EnterpriseA growing market brings growing concerns

for all of us. It taught us about theimportance of taking a multifacetedapproach to human research. In thepast, we focused our efforts in onedirection, primarily on the IRB. Theaccreditation process showed us theadvantages of welcoming feedbackand discussion among the IRB,research participants, and otherorganizations.”

Dr. Kim credits AAHRPP withprompting SMC to develop a moreconcrete, systematic human researchprotection program and with layingthe foundation for the continuousimprovement that is expected of

organizations that earn and maintainaccreditation.

Among the most difficult tasks forSMC was translating information onresearch protocols into English for theAAHRPP team of site visitors. Even so,SMC encourages other Korean entitiesto tackle the challenge.

“We are trying to spread the wordabout the importance of accredita-tion,” Dr. Kim says. “We would like tosee others in the Korean Associationfor IRBs apply to AAHRRP and, per-haps, become the second and thirdinternational organizations to beaccredited.”

Samsung Medical Center CONTINUED FROM PAGE 1

4 AAHRPP ADVANCE

LAWRENCE R. SCHILLER, M.D.

Q. What, exactly, do we meanby a culture of compliance?

A. Over the last 30 years, a series ofrules, regulations, and practices hasdeveloped in the research communityin an attempt to assure that researchinvolving human beings is conductedwith the highest ethical standards.Rules don’t mean much unless theyare followed, so a variety of methodsto assure compliance with the rules isin place. Written protocols to describeexplicitly what will be done, clearinformed consent documents to educate prospective volunteers aboutresearch, and thoughtful review byboth scientists and lay people aresome of those methods. Periodicreviews of the progress of experimen-tal studies also serve to check on compliance with the rules.

These methods can only be effectiveto a point; violations of the rulesmight occur and only be found in retrospect. Such violations couldendanger research subjects until such time as they were discovered and corrected. A much better way ofsafeguarding participants in research

studies is to have everyone in theresearch community understand thegoals of subject protection and policethemselves to assure compliance withthe rules. When investigators, coordi-nators, and research staff all recognizethe importance of compliance withresearch rules and regulations andwork toward that end, a “culture ofcompliance” can be said to be present.

For those of us involved withhuman subject protection, developinga culture of compliance is the bestway to be sure that investigators arecarrying out their responsibilities. To accomplish these goals, membersof the research community must beeducated about their rights asresearch subjects, the methods used toassure compliance, and their responsi-bilities to the process. Compliancewith the rules and regulations must bemonitored, and positive guidance andcorrective actions need to be utilizedwhen the rules are not followed. Byapplying this approach consistently,the research community will incorpo-rate human research protection intoevery aspect of investigation.

Q. What is the IRB’s role indeveloping and sustaining such a culture?

A. IRBs have been positioned as keyentities for assuring compliance withhuman research regulations. The original concept of peer review hasbeen expanded in every way since thedevelopment of IRBs in the 1970s, buta continuing element of the functionof IRBs is interaction with investiga-tors. This extends not only to review of proposed and ongoing protocolsbut also to educating investigatorsand their staffs about participants’rights, investigator responsibilities,and local policies. Everyone involvedwith human research must under-stand what is expected in order toassure that research is conducted inan ethical fashion.

By having clear rules and regula-tions and transparent methods forreviewing and approving protocols,IRBs also teach their research commu-nities how to conduct research studiesso that participant protection has ahigh priority. Monitoring ongoingresearch also is an important tool for

Insights into IRBsHuman research protections are most effective when they become ingrainedin an organization as part of a “culture of compliance.” Such a culture isbuilt over time, through an ongoing emphasis on human research protections,not just as a requirement but as the right thing to do — and as the responsi-bility of everyone engaged in research, no matter how peripherally.

In the Questions-and-Answers session below, Lawrence R. Schiller, M.D., discusses the successful efforts to instill a culture of compliance at BaylorResearch Institute in Dallas, Texas. The Chairperson of both IRBs at Baylor,Dr. Schiller also is a member of the medical staff at Baylor University MedicalCenter and has been an investigator for numerous research protocols.

AAHRPP ADVANCE 5

discovering problems with the processand correcting them.

Through these efforts, the IRBs canhold investigators to high standardsand help them internalize humansubject protection into their approachto research. When investigatorsunderstand the “why” and “how” ofthe protection requirements, they aremuch less likely to grouse about themand much more likely to follow them.

Q. Who else at the institutionmust play a pivotal role?

A. In short, everyone! The clinicalcare staff must be aware that researchactivities are going on and must havesome knowledge that special rulesapply to research participants. For example, if a research participantis admitted to a hospital ward (evenfor a non-research problem), the nurs-ing staff needs to know to call theinvestigator and be briefed on theresearch and how it might affect theircare of the subject/patient. Likewise,the staff in the operating room needsto recognize when investigationaldevices are being installed and toknow that the surgeon has beenauthorized to install that device.

Administrative support for researchis key as well. Research costs money,and mechanisms should be in placeto ensure that funds are distributedonly for approved research byapproved investigators. In addition,administrative support for education-al efforts, for enforcement of policies,and for IRB activities in general isessential.

Q. Have you undertaken anyspecific efforts/initiatives to foster such a culture atBaylor Research Institute?

A. We are very proud of our educa-tional efforts. We conduct quarterlyeducational conferences for ourresearch community on the nuts and

bolts of conducting ethical research.Special meetings are held for new IRBmembers, investigators, and coordina-tors to teach them the rationale andspecific policies of our IRBs.

In addition, everyone involved inhuman research activities — IRBmembers, investigators, coordinators,and staff members — must take andpass an online examination that cov-ers the history of regulations govern-ing human research, requirements forsubject protection, and local policiesbefore undertaking any research project.

All protocols undergo careful IRBstaff review before being presented to IRB members for review to ensurethat all needed forms are completedcorrectly and that documentationmeets minimal standards for form,content, and language. Problems canbe worked out at this stage, and thestudy staff receives practical educationabout requirements for submission.(This also reduces the number of protocols sent back to the investigatorfor extensive revision.)

All meetings of the IRBs are opento research staff, and we encourageinvestigators to be present when theirprotocols are presented. (They areexcused from the meetings whenvotes are taken on their protocols.)This transparency permits the investi-gators and their research staffs to see

the importance that the committeeplaces on participant protection andto learn the best practices of otherresearch teams.

We also have enhanced our assess-ment of compliance by having a staffmember assigned to monitor the con-duct of studies by reviewing primarydocumentation at the study sites.These surveys are done randomly or“for cause” if unexpected events ordeviations are discovered. Compliancewith the protocol and institutionalpolicies is assessed directly, anddetailed feedback is given to the investigator and staff. These surveystypically result in upgrading investi-gator policies and procedures andenhanced subject protection.

Q. Have you seen a difference,as a result, in the way inves-tigators approach theirresearch protocols?

A. Yes! Investigators and their staffshave discovered that the IRB is a part-ner — not an antagonist — for theirresearch efforts. The investigatorshave learned that by following IRBrules and policies their research cango forward ethically, efficiently, andpromptly. We have far fewer com-plaints about “needless paperwork”and “barriers” and more acceptanceof IRB efforts to ensure human subjectprotection.

Newly Accredited Organizations The following organizations were awarded accreditation at the June 16, 2006, meeting of the AAHRPP Council on Accreditation.

Full Accreditation■ Quorum Review Inc., Seattle, WA

Qualified Accreditation■ Samsung Medical Center, Seoul, Republic of Korea

■ The University of Nevada, Reno, Reno, NV

■ University of Connecticut Health Center, Farmington, CT

6 AAHRPP ADVANCE

The Human Subjects Protection Office(HSPO) and the Human Resources(HR) Department at the University of Connecticut Health Center inFarmington, Connecticut (UCHC) —awarded qualified AAHRPP accredita-tion on June 16, 2006 — have joinedforces to identify all new hiresinvolved in human subjects researchand make sure they receive therequired training in human researchprotections.

Together, the HSPO and HR havedeveloped a simple, yet effectiveprocess that addresses the need forhuman research protection trainingas soon as an individual joins UCHC.The process begins with a questionincluded in the search paperwork filedwith HR for every position: Does thejob involve the administration or con-duct of human subject research? If thebox next to the question is checked,the new hire is “flagged,” and his orher name, department, and mail codeare included in a report that is for-warded to the HSPO every pay cycle.The HSPO then sends an e-mail tothose listed in the report, introducingthem to UCHC’s IRB and its policiesand procedures; informing them ofthe required human research protec-tion training; and inviting them tovoluntary education sessions.

“We’ve been doing this for about a year and a half as a proactive wayto reach out to investigators — and it’s working,” explains Deborah Gibb,HSPO Deputy Director. “What we’refinding is that we’re casting the netbroader and reaching more people,sooner.”

The process has proved beneficial

to both the IRB and investigators.With routine, early identification,training is typically completed soonafter an individual is hired. Thatmeans IRB staff members spend lesstime seeking out those engaged inresearch, and protocols are less likelyto be delayed because of failures to

fulfill the training requirement.Early communication with new

hires also has enhanced the relation-ship between the IRB and investiga-tors. “More people are attending thevoluntary education sessions and, asa result, are more familiar with ourdepartment and more comfortableasking questions,” Ms. Gibb explains.“That, in turn, leads to greater under-standing of the IRB and our standardsfor human research protection.”

Information: Deborah Gibb,gibb@uchc.edu, 860-679-3054.

UCHC: Reaching Out With Training

For the past 10 years, Hunter HolmesMcGuire Veterans Affairs MedicalCenter in Richmond, Virginia(McGuire VAMC) — awarded fullAAHRPP accreditation on August 13,2003 — has hosted a “Research Day”to recognize research participants,update them on the results of clinicaltrials, and provide investigators with a compelling reminder of why humanresearch protections are so important.

The event is held each spring anddraws more than 400 research partici-pants and spouses, plus 40 to 50investigators. When it was introducedin 1996, Research Day’s primary purpose was to thank veterans whoparticipate in research and let themknow how their participation has contributed to medical knowledge and treatments. More recently, however, McGuire VAMC added abrief discussion on the importance of understanding the risks of researchand the need for informed consent.

“There’s no question that this eventmakes our research participants feelappreciated,” explains Franklin J.Zieve, M.D., Ph.D., Associate Chief ofStaff for Research at McGuire VAMC.“But it also addresses a key element ofhuman subject protection. There’s an

enormous difference between thinkingof human subject protection in theabstract and sitting down with aresearch participant, looking him inthe eye, and asking yourself, ‘Am Iputting this person who trusts me at risk?’

“This is a very important reminderto every investigator and coordina-tor,” he adds, “because it puts ahuman face on research protections.”

The annual event also is one waythat McGuire VAMC addressesAAHRPP’s fifth domain: ParticipantOutreach. Along with their invitation,participants receive a brief surveyabout their research experience.Questions focus on topics such as theconsent process, respect for privacy,and other protection issues.

With an annual budget of about$17,000, Research Day represents afairly significant investment of fundsand resources for McGuire VAMC. But, as Dr. Zieve says, “whenever weare asked, ‘Can you afford to keepdoing this?’ we reply, ‘Can we affordnot to?’ ”

Information: Franklin J. Zieve, M.D., Ph.D., frank@vadiabetes.org, 804-675-5151.

McGuire VAMC: Putting a Face on Research

Conference attendees will:1. Learn to identify the key aspects of the

accreditation process and acquire the skills to complete each phase.

2. Learn to identify the common problemsthat organizations are experiencing inmeeting the accreditation standards andways to address them.

3. Learn what others are doing to improveprotections for research participants.

4. Learn about current challenges facingaccredited organizations and strategies to address them.

Main Conference:This year we are offering a wide variety ofsessions to address both topics of interestand knowledge level of accreditation. For those who are new to accreditation,three different seminars will address theaccreditation process in detail.

Introductory seminars:

■ General accreditation — Addresses the five domains of accreditation

■ Behavioral and social science —Addresses the five domains of accreditationas they relate to behavioral and social science

■ Hospitals — Addresses the five domainsof accreditation as they relate to HRPPs inhospitals

Breakout Sessions:Specialized breakout sessions cover topicsdesigned for all interest groups. Examplesinclude:

For institutional officials■ Models of HRPPs■ Financial costs of accreditation■ Metrics for accreditation■ What happens after the site visit

For those who are already accredited■ Re-accreditation procedures■ Regulatory misfits with research: options

for addressing them■ AAHRPP Annual Reports and reporting

requirements

For those new to the accreditation process■ Conducting a self-assessment ■ Writing a good preliminary application

For behavioral and social scienceresearch programs■ Unique features of an HRPP for behavioral

and social science■ Forms and checklists that drive your

HRPP/behavioral and social science

For hospitals■ Defining research in a hospital setting:

When is an activity research or qualityimprovement?

■ Creating a “circle of support” for accreditation within your organization

Other breakout sessions of interest■ Conducting an effective continuing review■ Managing non-compliance■ Identifying, managing, and reporting

unanticipated problems■ Systems of oversight for protocols

reviewed by external IRBs■ ICH guidelines ■ Managing staff changes■ Medical device research

All breakout sessions are open to all attendees.

Pre-conference workshops (February 25):Workshop I: Federal regulations and guidance — for those who want tounderstand federal regulations and guidanceas they relate to accreditation

Workshop II: Effective IRB and legal counsel collaborations — for those who work with legal counsel withintheir organization

Workshop III: Writing policies and procedures — for those who aredeveloping or revising policies and procedures

Workshop IV: Increasing and main-taining compliance in the workforce —for those who wish to learn about ways toidentify and manage investigators who donot follow institutional policies and proce-dures

Don’t miss the third annual accreditation conference, which will be held in

Baltimore, Maryland, February 25 – 27, 2007. The conference is geared to

individuals from accredited and non-accredited organizations, as well as stake-

holders — government, industry, voluntary health agencies, and community

groups — that are concerned with promoting human research protection and

quality research. Institutional officials, IRB professionals and chairs, compliance

professionals, researchers, sponsors, and patient group leaders should attend.

Conference dates: February 26– 27. Pre-conference workshops: February 25.

2007 AAHRPP Conference:Quality Human Research Protection Programs

Information/Registration: www.aahrpp.org

AAHRPP ADVANCE 7

The 2007 conference will be our first to include abstracts from AAHRPP-accredited organizations. We invite youto submit abstracts on the followingtopics to share innovative practicesand strategies for increasing protec-tions for research participants:

■ Quality improvement activities for HRPPs

■ Participant outreach activities

■ Educational programs for investigators

■ Management of investigator conflict of interest — case studies

■ Effective policies and procedures

■ Protecting adults who have a decision-making impairment

Please contact AAHRPP for submissionguidelines. The submission deadline isSeptember 30, 2006.

Redesigned Web Site

We have redesigned our Website,www.aahrpp.org, to make it more user-friendly. The new site includes asecure section for AAHRPP clients thatare accredited, where you’ll find infor-mation on promoting accreditationwithin your organization, tips for issuing news releases, and the AAHRPPseals for accreditation. We also offer a section for research participants,complete with a discussion of researchand accreditation and links to otherresources.

AAHRPP ADVANCEis published quarterly 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

Important Dates:

Accreditation Workshops■ September 22, 2006■ November 10, 2006

Workshops are conducted from9 a.m. to 4 p.m. at AAHRPP;lunch is provided.

Third Annual AAHRPP Conference■ February 25–27, 2007

Baltimore, MD

New for 2007 Conference: Call for Abstracts From Accredited Organizations