The Association for the Accreditationof Human Research ProtectionPrograms (AAHRPP) has won a $4.9 million contract from the U.S.Department of Veterans Affairs (VA) to provide accreditation services to VA facilities nationwide.

The five-year contract took effectDecember 1, 2005. It calls for AAHRPPto administer its accreditation pro-gram to all VA facilities that engagein human research. To attain accredi-tation, facilities must adhere to thehighest research ethics and practices,and must demonstrate that extensivesafeguards are built into every level of their research operation.

“The VA fully intends to be a leader in research and the way it’sconducted — with a heavy emphasison the ethics of human research andprotection of participants’ rights andwelfare,” explains K. Lynn Cates,M.D., VA Assistant Chief Research & Development Officer.

“We are serious about doing thisright,” she adds. “While we certainlywant all of our facilities to be in com-pliance with all regulations, we alsointend to go beyond that. We wanteach program looked at very carefullyto make sure it is of the highest quali-ty possible. Our contract with AAHRPPwill help us accomplish this goal.”

AAHRPP is the nation’s onlyaccrediting body for human researchprotection programs. To date, it hasaccredited 33 organizations represent-ing 97 entities across the country, several of which are academic affiliates of VA facilities.

Contracting with AAHRPP is inkeeping with the VA’s 60-year historyof fostering relationships with its affiliates. It also demonstrates the VA’s commitment to meet the samerigorous standards as other AAHRPP-accredited institutions, including academic medical centers.

AAHRPP Awarded $4.9 Million Contract to Accredit VA Facilities

V O L U M E 2 • N U M B E R 5

4 Community HospitalAccreditation

5 Insights into IRBs

7 HRPP Innovations

CONTINUED ON PAGE 3

SPRING 2006

From coast to coast — in institutionslarge and small, public and private —AAHRPP is strengthening the researchenterprise and safeguarding partici-pants.

Perhaps the most obvious inroadsare in the government sector, wherethe Department of Veterans Affairs(VA) has contracted with AAHRPP for accreditation services (see page 1).As a result, by year-end 2007, all 119VA facilities that conduct research willhave undergone the accreditationprocess.

We can point to similar progresswith academic research institutions.Over the next three or four years, allof the nation’s major research organi-zations also will have completed theaccreditation process.

The goal, of course, is for as manyas possible to join the 33 organiza-tions encompassing 97 entities thathave attained AAHRPP accreditationby demonstrating their adherence tothe highest ethical standards andhuman research protections. But thiswill not be easy. AAHRPP accredita-tion is meaningful — to sponsors,investigators and most important ofall, to research participants — precise-ly because it is difficult to obtain.Organizations must earn the right todisplay the AAHRPP seal by provingnot only that they have systems inplace to protect participants but alsothat those systems are continuallyreviewed with an eye toward improvement.

In truth, some research programshave not yet reached this higher bar. But even they can benefit byundertaking the self-assessment that represents the first step of the accreditation process — and of the

critical task of identifying areas inneed of strengthening.

A supportive relationship

AAHRPP standards meet or exceedfederal regulatory requirements forprotection and are reasonable, attain-able, and representative of currentbest practices. What’s more, througheducation and peer review, AAHRPPhelps research organizations meet thestandards. After all, that is the pur-pose of accreditation: to recognizethose programs whose policies andpractices reflect an unwavering com-mitment to the protection of researchparticipants and to encourage otherprograms to follow suit.

As you will read in Accreditation an Asset to Community Hospitals onpage 4, AAHRPP serves as a resourcethroughout the accreditation process.Our workshops, online tools, andother materials spell out the standardsand take you, element by element,through a comprehensive self-evalua-tion. We also are available for pre-accreditation consultation. A key message of that article — and a pointthat also is driven home in Insightsinto IRBs on pages 5 and 6 is thataccreditation can bring substantialbenefits to smaller research programs.

In keeping with our educational

approach, and because we recognizethat accredited organizations can beof help to one another, each issue ofAdvance showcases HRPP Innovations.On page 7, we feature the Universityof Maryland, Baltimore’s policy

requiring data and safety monitoringplans. We also highlight the successfulcooperative relationship between EastTennessee State University and theJames H. Quillen Veterans AffairsMedical Center, which share an IRB.

Finally, in News & Notes on page 8,we publish the dates of our upcomingworkshops and our third annualaccreditation conference. We encour-age you to take advantage of asmany of these educational opportuni-ties as possible so you can see, first-hand, that accreditation is achievableand of value to everyone in theresearch enterprise.

2 AAHRPP ADVANCE

Reshaping the Research Enterprise

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

“AAHRPP accreditation is meaningful — to sponsors,

investigators, and, most important of all, to research

participants — precisely because it is difficult to obtain.”

AAHRPP ADVANCE 3

Accreditation increasingly is gain-ing recognition as the best indicationof a research program’s quality. Infact, in an address to VA IRB chair-persons in Washington, D.C., in April2004, Bernard A. Schwetz, D.V.M.,Ph.D., Director of the Office for HumanResearch Protections, challenged the VA research community tobecome the model for human subjectprotection and cited accreditation as a critical step toward achieving thisobjective.

A proud tradition ofresearch

The VA research program wasdeveloped as part of post-World War II efforts to advance health care forveterans and the nation. Today, VA

research focuses on the followingareas: aging and age-related changes;acute and traumatic injury; military,occupational, and environmentalexposures; chronic diseases; sensorydisorders and loss; mental illness; substance abuse; special (underserved,high-risk) populations; and healthservices and systems.

Over the years, VA researchers haverevolutionized medicine by developingtreatments ranging from medicationto transplants to technology. (See VAResearch Milestones, below.) Three VAresearchers have been awarded theNobel Prize for Medicine for their discoveries.

Equally important, the VA is in a unique position to ensure thatpatients benefit from advances inresearch. More than 70 percent of VA investigators also serve as clinicians. This dual role allows therapid application of research results to patient care.

In much the same way as it hasbeen in the forefront of research, theVA intends to play a leading role inhuman research protection.

“Our contract with AAHRPPdemonstrates our determination to set the standard for safety and ethics,” Dr. Cates says.

AAHRPP AccreditationCONTINUED FROM PAGE 1 VA at a Glance

■ $1.5 billion in research in2005.

■ 3,000 researchers nationwide.

■ 119 VA facilities engaged inhuman research.

■ By year-end 2007, all VA facilities that conduct humanresearch will have undergonethe accreditation process.

VA Research MilestonesVA researchers have invented or helped pioneer the following:

■ Therapies for tuberculosis

■ Cardiac pacemakers

■ Computerized axial tomography

(CAT scan)

■ First liver transplant

■ Nicotine patch

■ Functional electrical stimulation (FES)

systems to allow patients to move

paralyzed limbs

■ Kidney dialysis and home dialysis

techniques

■ Hepatitis vaccine

■ Treatments for schizophrenia, diabetes,

depression, heart disease, and stroke

■ Identification of genes associated with risks for the

following: dementia, schizophrenia, and Werner’s

syndrome, a disease marked by premature aging

■ Improved wheelchair designs

■ Therapies for liver disease and viral hepatitis

■ Guidelines for cholesterol screening

■ Better-fitting, lighter artificial limbs

■ Preventive use of aspirin for cardiovascular health and

for those at high risk for certain cancers

Some community hospitals have been hesitant to seek AAHRPP accreditation, in part over concernsthat the costs may outweigh the benefits to smaller research programs.Those that have attained accredita-tion, however, say the effort is wellworth it. In fact, in their experience,AAHRPP accreditation has resulted ina stronger human research protectionprogram and increased confidence on the part of investigators, sponsors,and research participants.

“If you’re a smaller institution andyou want to engage in research, youneed to be accredited to promote public trust,” says Donna Bennett,B.S.N., M.S., J.D., AdministrativeDirector, Research Services, at CatholicMedical Center (CMC) in Manchester, New Hampshire. CMC received fullAAHRPP accreditation on December

30, 2003, making it the first commu-nity hospital in the nation to achievethis designation.

Since then, “we’ve seen an increasein sponsor requests and received posi-tive comments from surveyors repre-senting other accrediting bodies,” Ms. Bennett says. “We’ve also seenincreased satisfaction from our IRBmembers and among our researchstaff.”

Hope Violette, R.Ph., Manager,Office of Research at Newton-Wellesley Hospital in Newton,Massachusetts, reports similar advantages. The community teaching hospital received fullAAHRPP accreditation on July 30,2004.

“One reason we sought accredita-tion was to help us promote thegrowth of our research program —

and it did that,” Ms. Violette says.“But, even more important, accredita-tion helped us manage our growth.

“The accreditation process forced usto look at things more systematically— to include checklists, policies, andprocedures that take us through ourprocesses in a consistent, organizedway,” she adds. “As a result, everyoneinvolved in our research program isconfident that our systems assurecompliance.”

Both Ms. Violette and Ms. Bennettacknowledge that, at first, the accredi-tation process can seem daunting tocommunity hospitals, which tend tohave fewer resources than larger institutions. But both encouragesmaller facilities to pursue accredita-tion and offer the following strategiesfor success:

■ Seek champions among hospital leadership. Make surethe leadership team is aware of the benefits of accreditation, andencourage team members to con-vey those benefits to other key constituents, including physicians,IRB members, and investigators. At CMC, Ms. Bennett and otherproponents spent about a year edu-cating individuals throughout theinstitution on the importance ofaccreditation, how it complementsCMC’s mission, and its positive influence on the hospital’scredibility, reputation, and competitive position.

■ Tap internal support. Theaccreditation process is a detailedone, and few community hospitalscan add staff or dedicate employeesto the effort full time. Instead, usecommittees or task forces alreadyin place in your institution, andspread the work among as manyindividuals as possible.

Accreditation an Asset to Community Hospitals

4 AAHRPP ADVANCE

Newton-Wellesley Hospital / Newton, Massachusetts

■ 236-bed community teaching hospital

■ Full AAHRPP accreditation July 30, 2004

■ 35 new protocols each year

■ Member, Partners HealthCare

AAHRPP ADVANCE 5

■ Take advantage of externalresources. AAHRPP provides avariety of tools to assist organiza-tions throughout the accreditationprocess. Marketing materials,designed specifically for communityhospitals, can help communicatethe advantages of accreditationboth within and outside the hospi-tal. AAHRPP also offers workshops,tip sheets, an evaluation instru-ment, and other resources, and will visit applying hospitals to helpprepare for accreditation.

Organizations that have alreadyachieved accreditation are anexcellent source of information andassistance. “Never be afraid to askfor guidance,” Ms. Violette says.“The AAHRPP staff is incrediblyhelpful, and most accredited organ-izations are more than willing toshare their policies, forms, and procedures. Many even allow youto freely access that informationonline.”

■ Allow sufficient time. Expect the process to take about 18months. That will give youenough time to conduct the self-assessment, review your policiesand procedures in light of theaccreditation standards, and pre-pare for the on-site evaluation —without placing undue burden onstaff.

AAHRPP recognizes that some community hospitals have humanresearch programs but not their ownIRBs. Since the IRB is only one com-ponent of a quality protection pro-gram, these hospitals are still eligibleto apply for accreditation. The focusis on demonstrating a commitmentto accountability and public safetythrough all the other measures inplace to protect research participants.AAHRPP charges a reduced accredita-tion fee and offers a truncated self-assessment process in these cases.

According to Ms. Violette, accredita-tion may be just as important — if notmore so — for hospitals without theirown IRB. Newton-Wellesley is in theunusual position of having its ownIRB and using an external IRB, thePartners HealthCare IRB, for collabo-rative research within the PartnersHealthCare System. The hospitalchose to seek accreditation on its ownto demonstrate its commitment toprotecting the rights and safety ofhuman subjects enrolled in studies.Newton-Wellesley Hospital was thefirst member of Partners HealthCareto receive accreditation.

“At the time, we had to addresseach AAHRPP standard twice — oncefor protocols reviewed by our internalIRB and once for those reviewed bythe external IRB,” Ms. Violetteexplains. “Whether we use an inter-nal or external IRB, the research is still being conducted in our facility,using our resources and our staff.

We are completely responsible forensuring compliance, and we takethat responsibility seriously.”

Insights into IRBsFederal agencies require institutionalreview board (IRB) oversight forresearch involving human partici-pants but offer some latitude in howthat oversight is provided. Institutionschoose, for example, whether toestablish their own IRB or to contractfor services from an external IRB.They also determine the size andcomposition of their IRB, provided itmeets federal requirements for atleast five members with the varyingbackgrounds necessary to ensurecomplete, adequate review ofresearch and protection of partici-pants. Perhaps most important, theinstitution decides how best to ensurethe integrity of the IRB and facilitatecommunication and respect between

the IRB and institutional leadership.In the Questions and Answers

below, Eleanor Wm. Dahar, Esq., IRB Chairperson and member of theBoard of Trustees at Catholic MedicalCenter, New Hampshire, discusseshow that hospital chose to structureits IRB and the relationship betweenthe IRB and CMC leadership.

CONTINUED ON PAGE 6

Catholic Medical CenterManchester, New Hampshire

■ 330-bed community hospital

■ Full AAHRPP accreditationDecember 30, 2003

■ 18 active protocols, with an average of five new protocolseach year

■ Home to New England Heart Institute

Q. How is the Catholic MedicalCenter (CMC) IRB structured?

A. The IRB is a committee of the hospital’s Board of Trustees and ischaired by a trustee. It has eight voting members, all of whom areappointed by the Board of Trustees.Along with myself, current membersinclude two physician scientists whoalso are on the medical staff of CMC;

6 AAHRPP ADVANCE

two community members not affiliated with CMC, one of whom is a scientist; the CMC vice president ofemergency services; a CMC pharma-cist; and a CMC trustee who also serveson the Board’s Finance Committee.In addition, CMC’s IRB administratorserves as a non-voting member.

Terms are for three years, and IRBmembers may be reappointed twice,serving a maximum of three, three-year terms — or nine years. Terms arestaggered, with roughly one-third ofmembers up for reappointment eachyear. This ensures that the IRB isalways staffed with a majority ofmembers who are experienced in the workings and responsibilities of the IRB.

Q. Why did CMC choose thisparticular structure?

A. It’s in compliance with federal regulations for IRBs, so in that sensewhat we’ve done is not unique. Byrequiring, in our bylaws, that thechairperson be a member of the Boardof Trustees, we’ve ensured direct accessto CMC leadership — to the CEO andthe Board. We’ve also demonstratedthat our commitment to safe, ethicalresearch starts at the top and extendsthroughout the organization.

Q. Why did you agree to serve as chairperson?

A. The IRB is known as one of themore labor-intensive committees, butit truly is a labor of love. I’ve been thechairperson for four years now andhave never seen a more committedgroup. We receive a huge volume of

materials each month, and, withoutexception, everyone does their home-work and is an active participant inthe discussions.

We’re definitely making a differ-ence and helping to improve patients’lives. Many of the studies that wereview are for devices or medicationsthat are on the cutting edge. It’s agreat opportunity to help make medical advances possible in a waythat protects research participants.

Q. What is the relationshipamong the IRB, the institutional official, theinvestigators, and the CEO?

A. We view all of these relationshipsas partnerships. At CMC, the institu-tional official is the IRB administrator.She reviews the protocols before we do to make sure they satisfy federalregulations and the hospital’s ownguidelines. Have they, for instance,addressed the issues relating toinformed consent? Is the description of the protocol in the consent docu-ment worded clearly and simply, soresearch participants genuinely under-stand? Have there been adverse effectsduring similar studies? What is therelationship, if any, among the protocol’s sponsors, investigators, and participants?

The IRB administrator also providestraining for the investigators so theyknow what the IRB expects. Thereview by the IRB is very rigorous, andit’s not uncommon for us to ask theinvestigator to return at our nextmonthly meeting with more informa-tion. Sometimes, that can be a sourceof frustration, primarily because the

investigator would like patients toreap any benefit of the study as soonas possible. Most of the time, though,the investigators understand the needfor more information and are excitedat the prospect of eventually beingable to offer the study to our patients.

Because the IRB is a committee ofthe Board of Trustees, we report to theBoard and to the CEO. They takegreat interest in the research protocolsthat we approve, and they hold usaccountable — as they should.

Q. What influence has AAHRPPaccreditation had on CMCand the IRB?

A. For CMC and the IRB, accredita-tion was a monumental achievement.We were the first community hospitalto be recognized by a nationallyrespected accrediting body, and thathas given our research program a lotof credibility — with patients and ourcommunity, sponsors, and investiga-tors. It also has given those of us onthe IRB a profound sense of the valueof our efforts. What we’re doing to further research and safeguard participants not only is correct but is recognized on a national scale.

Insights into IRBsCONTINUED FROM PAGE 5

ELEANOR WM. DAHAR, ESQ.

The University of Maryland, Baltimore(UMB) — awarded qualified AAHRPPaccreditation on December 16, 2005— provides an added level of protec-tion via an IRB policy that requiresresearch applications to include plans for data and safety monitoring,regardless of the level of risk involvedin the research.

According to Robert Edelman, M.D.,UMB IRB Chairman and AssociateDirector for Clinical Research, Centerfor Vaccine Development, UMB addedthe data and safety monitoring require-ment several years ago “to set the barhigher by sealing any potential holesthat could affect the integrity of dataand the safety of our volunteers.”

The UMB policy is modeled afterthe National Institute of Allergy andInfectious Diseases Policy for Data andSafety Monitoring, which requiresmonitoring commensurate with risksfor all clinical trials. At UMB, at mini-mum, data and safety monitoringplans must detail the following:

■ How risks are minimized and whythey are reasonable in relation topotential benefits.

■ Who is responsible for data andsafety monitoring: a protocol safetymonitor, independent safety moni-tor, independent safety committee,or data safety monitoring board,the selection of which depends onthe level of study risk. A study’s risklevel is judged to be minimum, low,moderate, or high, based on prede-fined criteria.

■ A general data and safety monitoring plan.

■ Plans to monitor progress and safety.

■ Plans to report adverse events orunanticipated problems involvingrisks to participants or others.

■ Plans to report suspensions of funded trials to the grants programdirector.

■ Plans to assure data accuracy andprotocol compliance.

“We realize that minimum risk protocols require a different level ofmonitoring than higher-risk, multi-site studies,” Dr. Edelman says. “At thesame time, we believe it’s important— regardless of the study — for inves-tigators to think through their proce-dures and determine, ahead of time,how they will safeguard participantsand ensure accurate results.”

Information: Dr. Robert Edelman,redelman@medicine.umaryland.edu,(410) 706-8443.

UMB: Raising the Bar for Data and Safety Management

For the past two decades, medicalresearch at East Tennessee StateUniversity (ETSU) — awarded fullAAHRPP accreditation on December16, 2005 — and the James H. QuillenVeterans Affairs Medical Center(VAMC) has been overseen by theshared ETSU/VA IRB. The arrange-ment is a success not only because theIRB truly is a joint venture but alsobecause both institutions have madecommunication a priority.

“Effective communication canmake all the difference in a relation-ship,” explains Janine Richardson,B.S.N., C.C.R.C., Director, ETSU Officefor the Protection of Human ResearchSubjects (OPHRS). “If they have aquestion, I try to get the answerimmediately, and they extend thesame courtesy to me.”

The IRB is structured to promoteinteraction and cooperation betweenETSU and VAMC. It includes represen-tatives of both institutions, all ofwhom are approved by the Presidentof ETSU and the Director of VAMC.Ex-officio members include theDirector of the ETSU OPHRS, theAdministrative Officer andChairperson of VAMC Research andDevelopment (VA R&D), and a VAMC

research pharmacist. In addition, theETSU OPHRS Director and theETSU/VA IRB Chair serve as ex-officiomembers of the VA R&D Committee.

These memberships are “not just aformality,” Ms. Richardson says. Ex-officio members take their roles seri-ously, attending meetings regularly toensure a good flow of informationand minimize the potential for mis-understanding.

In addition, whenever possibleETSU and VAMC have simplified com-pliance by standardizing policies andprocedures. For example, investigatorsat both institutions complete theCollaborative IRB Training Initiative.Informed consent templates for ETSUand VAMC are similar, except thatVAMC includes additional VA-man-dated disclosures.

“We’ve incorporated what the VArequires into ETSU policies and viceversa, and we’ve included the VArequirements in our IRB and investi-gator handbooks,” Ms. Richardsonsays. “At both institutions, if one of us gets a phone call, we know it’simportant — and we treat it as such.”

Information: Janine Richardson,richardf@mail.etsu.edu, (423)-439-6054.

ETSU/VA IRB Emphasizes Ongoing Communication

AAHRPP ADVANCE 7

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

■ March 24, 2006■ May 12, 2006■ July 14, 2006■ September 22, 2006■ November 10, 2006

Workshops are conducted from 9 a.m. to 4 p.m. at AAHRPP; lunch is provided.

Third Annual AAHRPP Conference■ February 25 - 27, 2007

Baltimore, Maryland

Newly Accredited Organizations The following organizations were awarded accreditation at the December 16, 2005 meeting of the AAHRPP Council on Accreditation.

Full Accreditation■ Baylor College of Medicine

Houston, Texas■ East Tennessee State University

Johnson City, Tennessee■ The University of Arizona, Tucson, Arizona■ University of California, San Francisco

San Francisco, California

Qualified Accreditation■ Michigan State University

East Lansing, Michigan■ University of Maryland, Baltimore

Baltimore, Maryland

A total of 33 organizations representing 97 entitieshave now attained accreditation. The complete list is available at www.aahrpp.org.

New Supporting Member:

The American Heart Association has joined AAHRPP as its eighth supporting member. A select group of professional, educational, or health-based organizations and businesses,supporting members are committed

to the highest ethical principles andstandards in protecting research participants and the advancement of research. They promote accredita-tion of human research protectionprograms and encourage thoseengaged in human research to seek accreditation.