8
As the research enterprise has changed, so has the role of the organi- zational official. As a result, few are as influential — or as accountable — as those charged with integrating and overseeing their organization’s human research protection program (HRPP). Today’s organizational official has more responsibilities than in the past, takes those responsibilities more seriously, and maintains a delicate balance among often competing objec- tives. In essence, the organizational official is advocate and enforcer, nego- tiator and educator, all rolled into one. When the job is performed well, the benefits are enormous and obvious. Strong, effective leadership by an organizational official trans- lates into a sound, quality-driven HRPP. That, in turn, furthers research and the advances it makes possible. According to Richard W. Bianco, Associate Vice President for Regulatory Affairs at the University of Minnesota, the most successful organizational officials are those who take the broad- est possible view of compliance and protection efforts. “It is no longer enough to focus just on the activities of the institutional review board (IRB),” Mr. Bianco says. “The IRB is essential, but it is also just one piece of what should be a com- prehensive, centralized research protection program.” In fact, today’s HRPPs must inte- grate all components of research compliance — including such areas as conflict of interest, research integrity, and environmental safety — with pro- tections for participants. This is possi- ble only if the organizational official is equipped with all of the following: Broad authority over the organiza- tion’s research and compliance activities. Extensive experience in research, regulations, and compliance oversight. Sufficient resources, including facilities, staffing, and systems and financial support. Buy-in, starting with the chief executive officer of the organization and extending through the ranks of everyone involved in research. An understanding of the organiza- tional culture and the ability to effect change within that culture. A commitment to ongoing commu- nication and education with and among investigators, IRB members, and others engaged in research — including research participants. A fundamental appreciation of the importance of compliance, both to safeguard participants and to promote research. Effective organizational officials also view compliance efforts as facili- tative, not punitive, and welcome accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) as a means of bolstering their efforts to build awareness and support for a culture of compliance. “Through accreditation, we have a constructive way to get people’s atten- tion and involve them in improving and advancing research,” Mr. Bianco says. “AAHRPP’s application process is a form of self-inspection and intro- spection. At the University of Minnesota, that process gave us an appreciation of the scope of our pro- gram and how the pieces fit together to ensure quality research.” The Role of the Organizational Official Unparalleled influence and responsibility VOLUME 4 NUMBER 3 3 2008 Conference 7 HRPP Innovations 8 Newly Accredited Organizations FALL 2007 Officials point to benefits of accreditation PAGE 4

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Officials point to benefits of accreditation PAGE 4 FALL 2007 Organizations VOLUME 4 • NUMBER 3 Revised Publication Schedule: Deadline for submission: November 1 Submission guidelines are available at www.aahrpp.org. Send abstracts to [email protected] November 1. 2 AAHRPP ADVANCE

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Page 1: V4.3 - Advance - Fall 2007

As the research enterprise haschanged, so has the role of the organi-zational official. As a result, few are asinfluential — or as accountable — asthose charged with integrating andoverseeing their organization’s humanresearch protection program (HRPP).

Today’s organizational official hasmore responsibilities than in the past,takes those responsibilities more seriously, and maintains a delicate balance among often competing objec-tives. In essence, the organizationalofficial is advocate and enforcer, nego-tiator and educator, all rolled into one.

When the job is performed well, the benefits are enormous and obvious. Strong, effective leadership by an organizational official trans-lates into a sound, quality-drivenHRPP. That, in turn, furthers researchand the advances it makes possible.

According to Richard W. Bianco,Associate Vice President for RegulatoryAffairs at the University of Minnesota,the most successful organizationalofficials are those who take the broad-est possible view of compliance andprotection efforts.

“It is no longer enough to focus juston the activities of the institutionalreview board (IRB),” Mr. Bianco says.“The IRB is essential, but it is also justone piece of what should be a com-prehensive, centralized research protection program.”

In fact, today’s HRPPs must inte-grate all components of research

compliance — including such areas asconflict of interest, research integrity,and environmental safety — with pro-tections for participants. This is possi-ble only if the organizational officialis equipped with all of the following:

■ Broad authority over the organiza-tion’s research and complianceactivities.

■ Extensive experience in research,regulations, and compliance oversight.

■ Sufficient resources, including facilities, staffing, and systems and financial support.

■ Buy-in, starting with the chief executive officer of the organizationand extending through the ranks of everyone involved in research.

■ An understanding of the organiza-tional culture and the ability toeffect change within that culture.

■ A commitment to ongoing commu-nication and education with andamong investigators, IRB members,and others engaged in research —including research participants.

■ A fundamental appreciation of the importance of compliance, bothto safeguard participants and topromote research.

Effective organizational officialsalso view compliance efforts as facili-tative, not punitive, and welcomeaccreditation by the Association forthe Accreditation of Human ResearchProtection Programs (AAHRPP) as a

means of bolstering their efforts tobuild awareness and support for a culture of compliance.

“Through accreditation, we have aconstructive way to get people’s atten-tion and involve them in improvingand advancing research,” Mr. Biancosays. “AAHRPP’s application process is a form of self-inspection and intro-spection. At the University ofMinnesota, that process gave us anappreciation of the scope of our pro-gram and how the pieces fit togetherto ensure quality research.”

The Role of the Organizational OfficialUnparalleled influence and responsibility

V O L U M E 4 • N U M B E R 3

3 2008 Conference

7 HRPP Innovations

8 Newly AccreditedOrganizations

FALL 2007

Officials point to benefits of accreditation PAGE 4

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To date, we have accredited 81 organi-zations. Without exception, thoseorganizations that succeed — both inattaining accreditation and maintain-ing high-quality research programs — can trace their success to strongleadership from their organizationalofficials.

As we point out in The Role of theOrganizational Official on Page 1, theseindividuals bear the ultimate responsi-bility for their organizations’ humanresearch protection programs (HRPPs).But their influence extends wellbeyond their own HRPPs. They areamong the research enterprise’s mosteffective advocates — for complianceand protection and for the improvedhealth and quality of life that societyenjoys as a result of research.

Organizational officials fulfill their responsibilities in many ways:building the infrastructure forresearch, protections, and compliance;encouraging innovation; supportingresearchers and helping them navi-gate today’s increasingly difficultresearch environment; and recogniz-ing that accreditation helps furtherresearch.

Starting on Page 4, we introduceyou to 12 organizational officials who discuss some of the benefits theirorganizations have realized as a resultof accreditation. These individuals represent organizations large andsmall, from major teaching hospitalsand research universities to communi-ty hospitals, independent reviewboards, and contract research organi-zations. (Additional testimonials willbe posted on our Web site in the weeksto come.) We share these with youbecause we believe they provide valuable insights about accreditedHRPPs, their organizational officials,

and the positive effects of accreditation.Since registration is underway for

our 2008 AAHRPP Conference, onPage 3 we present conference high-lights. As in the past, we will be offer-ing a combination of fascinating andthought-provoking plenary andbreakout sessions. Also included inthis issue is a Call for Abstracts fromindividuals at accredited organiza-tions.

Those of you who have attendedour conferences in the past know thatthey afford a wonderful opportunity to learn more about accreditation,research trends, and challenges and tonetwork with your peers. I look for-ward to seeing you in Minneapolis,February 24 – 26.

— Marjorie A. Speers, Ph.D.

2 AAHRPP ADVANCE

Call for Abstracts for 2008 Conference

Deadline for submission: November 1

AAHRPP invites accredited organizations to participate in its conferencebreakout sessions by sharing innovative practices and strategies forincreasing research protections. We welcome abstracts on the following:

■ Education Programs

■ Outreach Programs for Research Participants

■ Reaccreditation

■ Orienting the IRB Toward Customer Service

■ A Cohesive HRPP — The Organizational Official, IRB, and Researchers Working Together

■ Consent Processes

■ Institutional Conflict of Interest

■ General Issues Related to HRPPs

Submission guidelines are available at www.aahrpp.org.Send abstracts to [email protected] by November 1.

Partners in Furthering ResearchRevised PublicationSchedule:Starting with this issue ofAAHRPP Advance, we are adjust-ing our publication schedule tomore closely coincide with ourCouncil on Accreditation meet-ings. The schedule change willallow us to provide more timelyrecognition of organizationsthat are awarded accreditationby the Council. We will contin-ue to publish quarterly, but inJanuary, April, July, andOctober — in each case,approximately one month afterthe Council on Accreditationannounces its decisions.

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Conference attendees will:1. Learn the key aspects of the accreditation

process and acquire the skills necessary tocomplete each phase.

2. Identify common problems that organiza-tions experience in meeting the accredita-tion standards and ways to address them.

3.Become familiar with what others aredoing to improve protections for researchparticipants.

4.Learn about current challenges facingaccredited organizations and strategies toaddress them.

MAIN CONFERENCE:

Plenary Sessions

■ Common Accreditation Findings andDistinctions

■ Taming the Taboos: “_ism” and “_ability”Research — Have IRBs Gone Too Far?

■ Incidental Findings in Research — What Are the Ethical Obligations?

■ Current Issues Facing Federal Agencies

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

For organizational officials■ Addressing Tensions between IRBs and

Researchers■ Developing a Cohesive and Effective

Relationship between the OrganizationalOfficial and the IRB

■ Managing the Full Array of HumanResearch Responsibilities

■ Overseeing Biomedical Research Overseas— A Case Study in Mali

■ The Common Rule — Is It BecomingUncommon?

■ Pursuing Accreditation When There Are No Dedicated Resources

■ International Research Ethics — Issues inPrevention Trials

■ Leveraging Accreditation within YourOrganization

■ The HRPP As Part of the Organization’sIntegrated Compliance Program

For those new to the accreditationprocess■ Conducting a Self-Assessment■ Getting the Go Ahead to Seek

Accreditation from Senior Officials■ Writing a Response to an AAHRPP Report■ Negotiating Contracts with Sponsors■ Application Forms■ Reviewer Checklists■ Consent Templates■ Putting Together the Application

for Accreditation

For behavioral and social scienceresearch programs■ Challenges in Conducting and Overseeing

Education Research■ Practical Solutions to Ethical Issues Involved

in Conducting Research over the Internet■ Meeting the Ethical Challenges in

International Research■ Creating a Whole HRPP — Issues to

Consider When Relying on an External IRB■ Following DoD Regulations ■ Overseeing Research That Puts the

Researcher at Risk: Whose Responsibility Is It?

For VA facilities■ Identifying and Managing Institutional

Conflict of Interest■ Responsibilities of the Research and

Development Committee and the IRB■ Closing the Gap When Using an

External IRB■ What Activities Constitute Research,

Research Involving Human Subjects, and Exempt Research Involving HumanSubjects?

Other breakout sessions of interest■ ICH/GCP — Should Our Organization

Commit to Following the Guidelines?■ How Is Your IRB Doing? Metrics for IRBs■ HIPAA and Research■ Reaccreditation■ Ethical Issues to Consider in Using Tissue

Repositories■ Orienting the IRB toward Customer Service■ A Cohesive HRPP — The Organizational

Official, IRB, and Researchers WorkingTogether

■ Scientific Review — What Is It and When Is It Present?

■ Strategies to Enhance Communicationamong Committees That Contribute toHuman Research Protection Programs —IRB, COI, Radiation Safety, and More

■ Community Hospitals■ Writing a Policy on Unanticipated

Problems Involving Risks to Participants or Others in the Context of the RecentOHRP and FDA Guidelines

All breakout sessions are open to all attendees.

Pre-conference workshops (February 24):■ Workshop I: AAHRPP: Getting Started■ Workshop II: Current Challenges for

Social/Behavioral Research HRPPs■ Workshop III: Reaching Your Goal of

Accreditation — Case Studies of SmallHRPPs

■ Workshop IV: Managing an EffectiveHuman Research Protection Office

Don’t miss the fourth annual accreditation conference, which will be held in Minneapolis, Minnesota, February 24 – 26. The conference is geared to individuals from accredited and non-accredited organizations, as well as stake-holders — government, industry, voluntary health agencies, and communitygroups — that are concerned with promoting human research protection andquality research. Institutional officials, IRB professionals and chairs, complianceprofessionals, researchers, sponsors, and patient group leaders should attend.

Conference dates: February 25 – 26. Pre-conference workshops: February 24.

2008 AAHRPP Conference:Quality Human Research Protection Programs

Information/Registration: www.aahrpp.org

AAHRPP ADVANCE 3

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4 AAHRPP ADVANCE

Meeting FDA RequirementsSandra J. Degen, Ph.D.Vice President for ResearchUniversity of Cincinnati

“We’ve only beenaccredited a shorttime, so most ofthe benefits we’veseen are theresult not ofaccreditationitself but of theself-assessment

process. Even so, the benefits havebeen significant. For example, to meetthe accreditation standards, we imple-mented a formal auditing and moni-toring system — something that hadnot existed before. Subsequently, wewere audited by the FDA, which foundthat the necessary safeguards were inplace. I can honestly say that’sbecause of AAHRPP. We did whatAAHRPP required, and that made thedifference when the FDA came in.

“We also believe that our accredita-tion status — and that of CincinnatiDepartment of Veterans AffairsMedical Center and CincinnatiChildren’s Hospital Medical Center —will give a boost to our joint applica-tion for an NIH Clinical and

Translational Science Award (CTSA)grant. All three of us have received theAAHRPP stamp of approval, indicat-ing that we’ve harmonized ourhuman research protection programsand that we’re communicating with one another and working well together.”

The ‘Magnet’ EquivalentBen H. Brouhard, M.D.Executive Vice President for MedicalAffairs & Chief Medical OfficerThe MetroHealth System

“For hospitalsand health caresystems, AAHRPPaccreditation isthe official desig-nation of excel-lence — theHRPP equivalentof Magnet status.

Like Magnet, accreditation requires along-term commitment and is some-thing that all organizations should bestriving to achieve.

“Many of the advantages of accred-itation are actually realized during theself-assessment process because of theincreased focus on policies and proce-dures. At MetroHealth, we’ve seen aheightened awareness and under-

standing of what our policies and procedures require and what consti-tutes a deviation. That, in turn, results in improved compliance.”

A Centralized, IntegratedProgramRichard W. BiancoAssociate Vice President forRegulatory AffairsUniversity of Minnesota

“What AAHRPPdoes particularlywell is assess theentire researchprotection pro-gram, not justthe role of theIRB or the activi-ties of the investi-

gators. Accreditation encouragesorganizations to develop a centralized,integrated program and to supportthat program with a culture of respectfor compliance, from the president on down.

“We have hundreds and hundredsof organizations in the United Statesthat conduct research and, until now,there’s been no consistency. AAHRPPis changing that by requiring allaccredited research programs toadhere to the same high standards.”

Organizations are seeking accreditation because itoffers significant benefits both to research participantsand to research protection programs. All accreditedorganizations benefit from higher standards; compre-hensive systems, policies, and procedures; and theresulting improved compliance.

As you can see from the comments below, organiza-tional officials point to these and other — sometimesunexpected — advantages, ranging from additionalopportunities for partnerships and collaboration togrowing respect, within and beyond their organizations.

AAHRPP Accreditation Results in Tangible Advantages for OrganizationsOfficials cite improved protections, compliance, respect, and other benefits

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Competitive AdvantagesThrough PartnershipsFelix A. Khin-Maung-Gyi,Pharm.D., M.B.A., C.I.P., R.A.C.Founder / CEOChesapeake Research Review, Inc.

“We are startingto see some ofthe longer-termbenefits ofaccreditation,such as theopportunity topartner with ethica Clinical

Research, another accredited organi-zation, for mutually beneficial out-comes. We believe that accreditationand this partnership make us morecompetitive because we can demon-strate — to our institutional andindustry colleagues — that we’vemade a concerted commitment toexcellence.

“Everyone in our organization has embraced accreditation and itsstandards. Whenever we consider achange, we evaluate it with respect to accreditation standards. We areconstantly cognizant of where the barought to be because accreditation hasgiven us a visible, tangible target.”

On Par with Major Teaching HospitalsLeslie G. Selbovitz, M.D.Chief Medical Officer and SeniorVice President for Medical AffairsNewton-Wellesley Hospital

“As a communi-ty teaching hos-pital, Newton-Wellesley consid-ers research to be a key compo-nent of physi-cian trainingand patient care.

Our accreditation demonstrates thatcommunity hospitals can adhere tothe same high standards — and con-duct research of the same caliber — as the major medical centers. We canbring the advantages of research andthe highest principles of protectiondirectly to our community.

“We recognized early on that every-one involved, from investigators topatients, would benefit if our HRPPwere accredited. We decided to beamong the first to seek accreditation,and we made that decision at a timewhen our program was expanding.We knew AAHRPP’s requirementswould force us to develop and main-tain the necessary protections.”

Aligning Sister InstitutionsLaurence J. Meyer, Ph.D., M.D.Associate Chief of Staff for Researchand DevelopmentDepartment of Veterans Affairs SaltLake City Health Care System

“The accredita-tion processrequired us towork closelywith our sisterinstitution.We’ve alwaysbeen fortunateto have a very

cooperative, robust human researchprogram with our academic affiliate,the University of Utah, but now ourprograms are better and are moreclosely aligned than before. The self-assessment made us aware of areasthat needed improvement, and weimproved them. It made us considerscenarios that we hadn’t experiencedand required us to develop proceduresto cover those scenarios.

“Within our community ofresearchers, accreditation is highlyrespected. When they see the AAHRPPseal on our applications and our pro-

gram description, it’s evidence that wehave a good program — and thatwe’ve documented it.”

Respect and CollaborationLaura J. Jenski, Ph.D.Vice President for ResearchThe University of South Dakota

“A major benefitof accreditationis the respectthat our pro-gram has gainedfrom faculty.They appreciatethe effort andinput that went

into attaining accreditation, and theyrealize its significance to our programand to the university. As a result, theyhave a better understanding of whatwe require of them, and why.

“Accreditation also has providedvaluable opportunities for us to net-work with other accredited organiza-tions — to exchange information andcollaborate with institutions that havesimilar experiences and face the samecomplex issues.”

Providing an AccreditedChoiceSharon Hill Price, B.S.N., M.S.Founder and CEO Copernicus Group IRB

“We soughtaccreditationbecause we rec-ognized itspotential toassure the bestpossible protec-tions for researchsubjects. Once

we attained accreditation, we felt anobligation not just to continue toimprove our own processes but also to

AAHRPP ADVANCE 5

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6 AAHRPP ADVANCE

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educate the public — to let themknow that, increasingly, they willhave a choice between accreditedand non-accredited organizations.

“Over the past three years, we’veseen a growing awareness ofAAHRPP and the value of accredita-tion. In fact, when people approachus about providing IRB services, oneof the top five questions they ask is‘Are you accredited?’”

Building Integrity,ConfidenceChee Yam Cheng, M.B.B.S.,F.A.M.S., F.R.C.P. (London),F.R.A.C.P.Assistant CEO (Clinical)National Healthcare Group,Singapore

“The rigorousaccreditationprocess resultedin system wideimprovementsthat providegreater protec-tion for researchparticipants and

ensure the integrity of the researchconducted in our institutions.Because AAHRPP accreditation setsthe highest standards for clinicalstudies, the pharmaceutical industry,academic drug developers, and regu-latory bodies can have confidence inthe quality of data they receive fromstudies conducted here.

“With accreditation has comeincreased awareness of the impor-tance of a robust HRPP. Consequently,we are allocating more resources toeducate investigators and coordina-tors and to engage patients on theirrights and safety. We are also build-ing a pool of talented clinician scientists to support the growth ofSingapore’s biomedical industry.”

Continuous ImprovementLynn A. Meyer, C.I.P., C.I.M.PresidentIntegReview Ethical Review Board

“AAHRPP’semphasis oncontinuousprocessimprovement is a significantbenefit for ourclients and for us.

Accreditation provides an assuranceof an ongoing commitment to ethics,standards, and quality. It requires usto stay on top of changes and addi-tions to guidelines and regulations,and to incorporate them effectivelyinto our policies and practices.

“Already we’re seeing the impactof having the AAHRRP seal of excel-lence on our Web site and printedmaterials. We are being contacted bynew clients who are interested in usbecause they know we’re accredited.”

Increased Awareness,InvestmentJuan M. Sanchez, Ph.D.Vice President for ResearchUniversity of Texas at Austin

“In my view, theaccreditationprocess was thebest thing thatcould have hap-pened to ourprogram. Theprocess hasraised the level

of awareness of administrators, facul-ty, and students. It also has driven asignificant increase in our investmentin compliance. We now have anOffice of Research Support andCompliance that coordinates humansubjects research, animal care and

use, and biosafety. We have fourcoordinators for human subjectsresearch, all of whom have a Ph.D.or medical degree.

“The quality of our program hasalways been good, but now we putan even greater emphasis on trainingfor everyone involved. One result isthat our graduate students are moreaware of research protections andbetter prepared as they move on to develop their own research programs.”

International AssurancesJanice E. Parente, Ph.D.Presidentethica Clinical Research, Inc.

“Our joint ven-ture with MatrixGroup in Indiawould not havebeen possible ifwe weren’taccredited. BothMatrix Groupand the Indian

government wanted a partner theycould count on to hold itself to highstandards and minimize the risks toresearch volunteers. As the only con-tract research organization (CRO) inthe world to have earned AAHRPPaccreditation to date, ethica was in aunique position to provide whatMatrix Group and the Indian govern-ment were seeking.

“Having that seal of excellencefrom AAHRPP served almost as ourletter of recommendation. It offeredassurances that no other CRO couldprovide.”

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For the University of SouthernCalifornia (USC), AAHRPP accredita-tion represents an important step inan ongoing effort to remain amongthe nation’s leading human researchprotection programs (HRPPs).

Even before the university was noti-fied that it had been awarded fullaccreditation, Susan L. Rose, Ph.D.,Executive Director of USC’s Office forthe Protection of Research Subjects(OPRS), had developed an ambitiousagenda for the 2007–2008 academicyear, building upon the lessonslearned during the accreditationprocess. At the heart of that agenda isa continued emphasis on innovation,collaboration, education, qualityimprovement, and communication.

OPRS presented its plans to theUSC community in the July issue ofthe OPRS newsletter, detailing a com-prehensive, coordinated plan to

ensure continued adherence to theexpectations set and promises madeduring the accreditation process. The newsletter is available atwww.usc.edu/admin/provost/oprs/news/archives/index.html. Click on Volume 3, Issue 4.

“Accreditation is the gold standard,but that doesn’t mean we stop oncewe attain it,” Dr. Rose explains.“Instead, we view accreditation as avalidation of our program and anincentive to push forward.”

In the 2007– 2008 academic year,OPRS will collaborate with researchprofessionals from the university’sHealth Research Association, HealthSciences Campus, School ofPharmacy, and General ClinicalResearch Center to implement a con-tinuous quality improvement pro-gram that will involve regulatory science students in designing and

conducting audits. In October, USCand the University of California, LosAngeles will host an IRB retreat fea-turing guest speakers and topics thatgo well beyond regulatory issues.

As part of its education efforts,OPRS will continue to conduct month-ly education sessions during the aca-demic year and offer individual, class-room, faculty, and group sessionsupon request. OPRS is also developinga first-of-its kind education guide forcommunity members who serve onIRBs. Like all OPRS publications, theguide will be available for usersnationwide. It is the next in a series ofpublications that target specific audi-ences, including students, investiga-tors, and research participants.

All OPRS efforts are designed toexceed the requirements and fulfillthe intent of accreditation. “AAHRPPaccreditation isn’t just about followingregulations,” Dr. Rose says. “It’s aboutdoing everything we can — often asinnovatively as possible — to protectparticipants.”

Information: Susan L. Rose, Ph.D.,[email protected], www.usc.edu/admin/provost/oprs/, (213) 821-1154.

AAHRPP ADVANCE 7

The University of Kentucky’s (UK)Office of Research Integrity maintainsa list of international and culturalconsultants to streamline the protocol review process, ensure thatInstitutional Review Board (IRB) decisions reflect cultural sensitivities,and provide maximum protection for research participants.

Before it is submitted to the IRB,each research protocol is screened todetermine whether an internationalor cultural consultant will be required.Consultants are selected, based ontheir expertise, from a list that is

continually updated to make sure itremains current and comprehensive.

“The consultants qualify on thebasis of their cultural or linguisticknowledge or training,” explains JohnV. Ryan, J.D., Professional Associate in UK’s Office of Research Integrity.“And, of course, there can be no conflict of interest or even appearanceof impropriety.”

UK developed the list and screeningprocess, in part, in response to anincrease in the number of researchprotocols, especially those involvinginternational participants and indi-

viduals from geographic regions notrepresented on the IRB.

“Identifying consultants is a chal-lenge for IRBs everywhere,” says AdaSue Selwitz, Director of UK’s Office ofResearch Integrity. “Our university’sOffice of International Affairs is avaluable resource in identifying con-sultants. Others are recruited at therecommendations of investigators andIRB members. Once an individual isrecruited, we ask permission to addthem to our list for future reviews.”

Information: John V. Ryan, J.D.,[email protected], (859) 257-2978.

UK: Tapping International Consultants

USC: Moving Forward with a Fully Accredited HRPP

Page 8: V4.3 - Advance - Fall 2007

AAHRPP ADVANCEis published quarterly by the Association for 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: Todd Allen Printing Co., Inc.

Association for the Accreditation of Human Research Protection Programs, Inc.®

(AAHRPP®)915 15th Street, NW, Suite 400Washington, DC 20005Phone: (202) 783-1112Fax: (202) [email protected] www.aahrpp.org

Non-Profit Org.U.S. Postage

P A I DWashington, DCPermit No. 96

AWARDED SEPTEMBER 2007

Full Accreditation■ Department of Veterans Affairs Huntington

VA Medical Center, Huntington, WV■ Edith Nourse Rogers Memorial Veterans

Hospital, Bedford, MA ■ Edward Hines Jr. VA Hospital and North

Chicago, VA Medical Center, Hines, IL■ Harvard University Faculty of Medicine,

Boston, MA■ Manchester Veterans Affairs Medical Center,

Manchester, NH■ Marshall University, Huntington, WV■ The Board of Regents of the University of

Oklahoma, Oklahoma City, OK■ The Department of Veterans Affairs New York

Harbor Healthcare System, Brooklyn, NY■ The Memphis Veterans Affairs Medical Center,

Memphis, TN■ University of Kansas Medical Center,

Kansas City, KS■ VA Sierra Nevada Health Care System,

Reno, NV■ Veterans Affairs Caribbean Healthcare System,

San Juan, PR■ Veterans Affairs Medical Center, Oklahoma City,

OK

AWARDED JUNE 2007

Full Accreditation■ Cincinnati Children’s Hospital Medical Center,

Cincinnati, OH■ Cincinnati Department of Veterans Affairs

Medical Center, Cincinnati, OH■ Department of Veterans Affairs (VA) Salt Lake

City Health Care System, Salt Lake City, UT■ IntegReview Ethical Review Board, Austin, TX■ The MetroHealth System, Cleveland, OH■ The University of Utah, Salt Lake City, UT■ The Veterans Affairs Pacific Islands Health Care

System, Honolulu, HI■ University of Cincinnati, Cincinnati, OH■ University Hospitals Case Medical Center,

Cleveland, OH■ University of Kentucky, Lexington, KY■ University of Rochester, Rochester, NY■ University of Southern California, Los Angeles, CA■ VA Palo Alto Health Care System, Palo Alto, CA■ Veterans Affairs Healthcare Network Upstate

New York at Albany, Albany, NY■ Virginia Commonwealth University,

Richmond, VA

Qualified Accreditation■ Lexington VA Medical Center, Lexington, KY

Newly Accredited Organizations