The Association for the Accreditationof Human Research ProtectionPrograms (AAHRPP) has simplified theaccreditation process to meet theneeds of the research community —without changing the standards thathave been in place since AAHRPP wasfounded more than five years ago.

The revisions reflect input thatAAHRPP has received from accreditedorganizations and prospective appli-cants, as well as the understandingthat AAHRPP has gained throughsite visits and other interaction withresearch organizations.

The goals are to clarify guidance,streamline the evaluation instrument,and create a more efficient, transpar-ent process that strikes a balancebetween written materials andperformance.

“The emphasis on performance isone of the big improvements. Whiledocumentation certainly is important,it’s not always the best measurement.We want to make it clear that we’reevaluating whether the organizationis performing, not just whether it’sdeveloping written materials.” saysDavid I. Wynes, Ph.D., Chair ofAAHRPP’s Council on Accreditationand Vice President for ResearchAdministration at Emory University.Before joining Emory earlier this year,Dr. Wynes was Senior Associate VicePresident for Research at the

University of Iowa, one of the firstorganizations to attain AAHRPPaccreditation.

The first revisions to the accredita-tion process, the changes are the natu-ral next step for AAHRPP as a matur-ing institution. “We now have a trackrecord, and our experience shows usthat there are some elements thatinstitutions consistently miss,” Dr.Wynes explains. “The question weasked ourselves was, ‘How can we pro-vide better guidance so organizationsunderstand what we’re looking for?’ ”

He underscores that the purpose ofaccreditation is to raise the bar forhuman research protections — andencourage as many organizations aspossible to clear that bar.

“Our goal is to define the criteria sothat organizations know exactly howthey will be evaluated,” Dr. Wynessays. “We measure our success notby how many organizations fail toachieve accreditation, but by howmany join us in demonstrating aproven commitment to safe, ethicalresearch.”

To date, 52 organizations repre-senting a total of 171 entities haveattained AAHRPP accreditation. Anadditional 400 organizations are inthe accreditation process.

The most significant changes tothe accreditation process involve theAAHRPP Evaluation Instrument for

Site Visitors, which has been renamedthe Evaluation Instrument forAccreditation. (See page 8.) The instru-ment continues to serve as the roadmap for the accreditation process.Available since June 1, 2007, therevised instrument can be found atwww.aahrpp.org under “Standards.”

Organizations that are working ontheir self-assessments will find it easierto use the new evaluation instrument.The same holds true for those prepar-ing for reaccreditation.

Improving the Accreditation ProcessStreamlined approach maintains standards

VOLUME 4 • NUMBER 2

3 ReaccreditationStarts Now

4 A Guide to theSelf-Assessment

6 Preparing for YourSite Visit

SUMMER 2007

Setting high standards is not enough.That’s why we emphasize continuousimprovement for human research pro-tection programs (HRPPs) — and forAAHRPP. We view each accreditationnot just as evidence that anotherorganization has attained our stan-dards but also as an opportunity toidentify innovative practices and sharethem throughout the research enter-prise.

In addition, each accreditationprovides an opportunity for AAHRPPto assess its own practices. Since webegan accrediting HRPPs, we havesolicited input from applicants on howAAHRPP can improve the accredita-tion process. We have also gained abetter understanding, from one-on-one interaction with many of you andfrom our site visits, of how we can bet-ter communicate both the standardsthemselves and the way we evaluatewhether they are met.

That input and understandingare reflected in this special edition ofAAHRPP Advance, which introducesour streamlined EvaluationInstrument for Accreditation (page 8).This issue also features information onapplying for reaccreditation (page 3),conducting your self-assessment(pages 4 and 5), and preparing foryour site visit (pages 6 and 7). Weencourage you to keep this issue forfuture reference; it also is available onour Web site at www.aahrpp.org under“Education.”

Four years after awarding our firstaccreditations, we are more convincedthan ever that accreditation benefitsresearch participants, research organi-zations, and the research enterprise asa whole. We know, from reports fromaccredited organizations, that HRPPsare strengthened by their self-assess-

ment, site visit, and commitment tocontinuous improvement. We alsoknow that stronger HRPPs can lead tomore effective safeguards for researchparticipants. That, in turn, builds trustand encourages participation inresearch.

We applaud the 52 organizationsrepresenting a total of 171 entities thathave already attained accreditation.We also offer our support and encour-agement to the 400 organizations thathave initiated the accreditationprocess. If you’re among them andhave not completed your self-assess-ment, begin using the revisedEvaluation Instrument forAccreditation. You’ll find it much easier.

Like our accredited organizations,we remain committed to continuousimprovement, so we welcome youropinion on the revised evaluationinstrument and the tips we’ve provid-ed to guide you through the accredita-

tion process. We thank those of youwho shared the benefit of your experi-ence (see With Appreciation, below)to assist your peers. Finally, we urgethose of you who are still consideringaccreditation to take advantage of theinformation in this newsletter and onour Web site, and to begin the accredi-tation process. Although the process isrigorous, we’re confident that you canachieve accreditation — and that it isthe right thing to do.

2 AAHRPP ADVANCE

Benefiting from Continuous Improvement

MAR JOR I E A . S P E ER S , Ph.D.

With Appreciation

AAHRPP would like to thank the following individuals and organiza-tions for their input on how we could improve the accreditation process,and their willingness to share their tips at our annual conference and inthis special accreditation edition of AAHRPP Advance:

Mickey Clarke, Washington University in St. Louis

Karen Hansen, Fred Hutchinson Cancer Research Center

Martha Jones, The University of Iowa

Moira Keane, University of Minnesota

Lisa Korcuska, The University of South Dakota

Susan Rose, University of Southern California

Mare Ryan, Liberty IRB

Lysa Triantafillou, Copernicus Group IRB

Linda Triemer, Michigan State University

Hope Violette, Newton-Wellesley Hospital

AAHRPP ADVANCE 3

� Keep your application current.Your organization earned accredita-tion, in part, because of its commit-ment to continuous improvement.It’s only natural, then, that some ofyour practices, policies, and proce-dures will change in the three yearsafter you submit your originalaccreditation application. Each timea change is approved, update theapplication immediately. Treat it asa “live document” and you willalways have an accurate record ofyour organization’s efforts to safe-guard research participants. Youalso will spare yourself the time andfrustration of researching threeyears’ worth of changes just beforethe application is due to AAHRPP.Check the AAHRPP Web site period-ically, attend conferences, andnetwork with other accreditedorganizations to stay abreast ofaccreditation updates and innova-tive practices. After June 1, 2007,organizations seeking reaccredita-tion should use the revisedEvaluation Instrument forAccreditation(page 8), which is available atwww.aahrpp.org under “Standards.”

The streamlined evaluation instru-ment is easier to follow and cleareron what is expected for meetingeach standard and element.

� Have a backup. This applies topeople as well as to paperwork. Staffchanges and unforeseen events canderail reaccreditation efforts.If possible, have one or two staffmembers who are familiar with theapplication, are comfortable main-taining it, and know exactly whereyou stand in the reaccreditationprocess. As always, back up theelectronic version of the document,and have a current hard copy onfile.

� Start your reassessment inplenty of time to meet thedeadline for renewal. Yourreaccreditation application is duenine months before the regularlyscheduled Council on Accreditationmeeting. Use this meeting date toestablish the time frame for yourself-evaluation, which is an integralcomponent of reaccreditation. Threeto six months before your applica-tion submission deadline, start the

same detailed self-assessment thatyou conducted for your originalaccreditation. Typically, this shouldoccur at approximately the sametime that you are preparing yoursecond annual report. The self-assessment will help you evaluateyour human research protectionprogram and ensure that you’re upto date on AAHRPP’s interpretationof the accreditation standards.Helpful hint: If your organization isplanning a major change, if possi-ble, delay it until after reaccredita-tion, so you can give accreditation— and the organizational change— the attention that each deserves.

� Communicate constantly andeffectively.Maintain the relation-ships that you built during theoriginal accreditation process.Involve others, and ask for help.Continue to emphasize the valueof accreditation, and keep institu-tional officials and co-workersinformed of your progress. Makesure that procedural and policychanges are communicated andadopted throughout the organiza-tion. Remember: Documentationalone is not enough; policies andprocedures must be put intopractice.

� Save time for formatting.The application for reaccreditationis submitted as a PDF, with links tosupporting documents. Allow oneto two weeks to convert your appli-cation from word-processing formatto PDF.

� Prepare for your site visit.Reaccreditation involves the samecomprehensive, on-site evaluationthat’s required for accreditation.See page 6 for more information.

Reaccreditation Starts NowAccredited organizations renew every three years by perform-ing the same self-assessment and gap analysis required forthe initial accreditation application. To renew your accredita-tion, you do not need to pay an application fee; annual feescover the costs of reaccreditation.

This time around should be easier. You know the AAHRPPdomains, standards, and elements — and the standardshave NOT changed. Depending on your organization’sapproach to accreditation, though, you could already befalling behind in the reaccreditation process. The followingtips can help you put together your renewal application.

4 AAHRPP ADVANCE

In general

� Read, read, and read somemore. Start with the AAHRPP Website, www.aahrpp.org, and newslet-ter. Read institutional review board(IRB) journals, and check the Websites of other accredited organiza-tions and relevant federal agenciesor offices, such as the Food andDrug Administration and the Officefor Human Research Protections.On the AAHRPP Web site under“Apply,” pay particular attentionto the sections on “How to apply”and “How to conduct a self-assess-ment .” Information on theAAHRPP Web site is available to allat no charge. Work at your ownpace. You can start the self-assess-ment whenever you’re ready andwork on it as long as necessary.

� Get commitment from thehighest level. Accreditation isattainable only if your entireorganization fosters a culture ofaccountability and makes humanresearch protection a priority. Whenyou begin the process, obtain insti-tutional commitment, backed bybudgetary support.

� Establish an accreditationteam. Identify key individuals whocan help with accreditation, andinvite them to join the team. Beclear about the responsibilities ofeach teammember, and set realisticdeadlines for meeting those respon-sibilities. To oversee the accredita-tion process, choose a team leaderwho is organized and has an orga-nizational perspective with anunderstanding of how all the com-ponents of your HRPP fit together.

� Strive for protection, not per-fection. The goal is to have aneffective HRPP, whose activitiesachieve the desired outcome: toprotect research participants. Ifpractices and policies meet theAAHRPP element and standard,don’t spend time revising them fur-ther. Instead, focus your energy onidentifying and correcting gaps.

� Check for inconsistencies. Doyour procedures match your formsand checklists? Are your proceduresan accurate reflection of how yourorganization oversees its researchactivities and protects researchparticipants?

� Create and maintain anaccreditation intranet site. If

you have the resources, this is aconvenient way to keep everyone inyour organization up to date onissues, news, schedules, and otheraccreditation-related information.

Getting ready

� Download the EvaluationInstrument for Accreditation,available at www.aahrpp.orgunder “Standards.” Read throughthe entire document before tacklingany of the steps in earnest.Familiarize yourself with thestandards and elements.

� Gather all written policies andprocedures, and organize themby topic. Remember to think interms of the entire HRPP, and, ifapplicable, include policies andprocedures for areas such ashuman resources, budgeting, coun-seling services, pharmacy, studentorientation, corporate ethics, andcorporate compliance. In mostcases, your HRPP will have a policy,procedure, or practice to demon-strate that you meet the elementand the standard.

� Share the load. As you read overthe self-assessment, identify expertsfor each domain and even for eachstandard within a domain. Then,enlist their help.

� Use the AAHRPP Tip Sheets.These are available atwww.aahrpp.org under“Education.” They also are refer-enced in the updated EvaluationInstrument for Accreditation(page 8).

Specific tips

� Save the first element, I.1.A,for last. This element is global innature and cannot adequately beaddressed until you’ve completedthe entire self-assessment.

A Guide to the Self-AssessmentAt the heart of the accreditation process is a comprehensive self-assess-ment during which an organization reviews its human research protectionprogram (HRPP) and evaluates its compliance with 20 AAHRPP standardsand 77 elements. Given the scope of these standards and elements, it’s notsurprising that one of the most frequent questions that AAHRPP receives is“Where do we begin?”

Following are some tips designed to answer that question and help youachieve the goal — accreditation. As you move forward with accreditation,keep in mind that the process is meant to be rigorous, not overwhelming.Even more important, the effort is worth it — for your organization, forresearch participants, and for the future of research.

� Start with Domain II:Research Review Unit, includ-ing the IRB. This domain will bemost familiar to you and, therefore,easiest to complete.

� Tackle the evaluation instru-ment element by element. Foreach element, identify the policiesand procedures that spell out howyour HRPP meets the element. Ifsomeone in your organization is anexpert in the requirements coveredby a particular element, assign theelement to that expert. If an ele-ment does not apply to your organ-ization, just indicate that it’s notapplicable.

� Don’t write. Instead, list.Most elements can be addressedby your existing documents.Examples include policy state-ments, procedures, checklists,guidelines, educational materials,job descriptions, bylaws, memoran-da, forms, templates, strategicplans, slide presentations, Websites, charters, and mission state-ments. Find the appropriatedocument, and cite the nameand relevant section.

� If you must write, do it foryour organization — not forAAHRPP. If you find yourselfwriting a detailed explanation inresponse to an element, chancesare you need to create a documentfor your own organization. Onceyou’ve done that, reference the doc-ument for the applicable element.

� Some elements don’t requiredocumentation. They are evalu-ated during the site visit, throughinterviews with members of yourorganization. For these elements,provide a brief description of yourpractice.

� Identify and fill in the gaps.Most self-assessments identify anumber of gaps between the

AAHRPP standards and your orga-nization’s human research protec-tion practices. When you find agap, design a policy, procedure, orpractice that makes sense for yourHRPP and then use the AAHRPPstandards to refine what you’vedeveloped. Communicate the newpolicy, procedure, or practicethroughout your HRPP.

� Construct an element-by-ele-ment index of your supportingdocuments. For each element, listthe supporting document, assign ita number, and provide a very briefexplanation. Use page numbers,paragraph numbers, item num-bers, titles, and headings to pin-point the information. (This indexbecomes Section C of your accredi-tation application.)

� Copy your documents. Provideone copy of each document cited inyour element-by-element index.Do not include non-organizationaldocuments. Cross-reference and citeeach document as many times asnecessary, but include only onecopy. (These copies becomeSection D of your accreditationapplication.)

� Don’t be afraid to ask. AAHRPPis available as a resource through-out the accreditation process. If youhave questions or need help, justask.

Once you start the self-assessment,you will be surprised at how quicklyeverything falls into place — and howvaluable the self-assessment proves instrengthening your HRPP.

Go to the SourceNo one knows more about accreditation than AAHRPP, so if you havequestions or need help, there’s no better place to turn. In fact, AAHRPPoffers a number of resources for organizations that are interested inaccreditation or have begun the accreditation process:

� One-day workshops, held in our Washington, D.C., office, provideinvaluable assistance in navigating the accreditation process. Spendan entire day with Jeffrey Cooper, M.D., M.M.M., Deputy Director,AAHRPP, to go over the self-assessment process and accreditationstandards. For information on cost and dates, or to register, go towww.aahrpp.org, and, under “Education,” click on the link for“Workshops.”

� The annual AAHRPP conference includes sessions designed specificallyfor those who are working on accreditation or are new to the accredita-tion process. The 2008 conference will be held February 24-26 inMinneapolis.

� Tip Sheets, FAQs, and back issues of the AAHRPP Advance newsletterare available online at www.aahrpp.org.

� Organizations can get together and invite an AAHRPP official to con-duct a local session on accreditation. These sessions offer an opportuni-ty to learn more about the accreditation process and to build under-standing and support among your organization’s leadership.

� If you have specific questions about accreditation, feel free to e-mailAAHRPP at accredit@aahrpp.org.

AAHRPP ADVANCE 5

Before the visit

Four to eight weeks before

AAHRPP will send an initial e-mailwith a draft agenda for the site visitand other information to help you getready. This initial e-mail helps estab-lish contact between the organizationand the accreditation director andother AAHRPP staff who will worktogether to answer your questionsrelating to accreditation and the sitevisit. This e-mail includes:

� A list of members of your organiza-tion who will be interviewed, alongwith a proposed schedule of inter-view times. Helpful hint: Review theagenda, and make sure it includesthe appropriate people. Then, beginpreparing them for the site visit. Youcan make changes to the agenda,but let AAHRPP know as soon asyou can. AAHRPP will accommo-date your requests for changeswhen possible. If necessary, conductmock interviews so that staff will bebetter prepared to address the ques-tions asked during the meeting withthe AAHRPP team.

� An explanation of the types ofmeetings that will occur during thesite review: the introduction, pro-gram overview, interviews, recordreview and executive session, dailycloseout, AAHRPP staff session, leadcontact review, and final closeout.

� A list of the individuals who will bemembers of your site visit team.If you have questions about themembers of your site visit team,ask AAHRPP.

� A request for logistical and travelinformation, such as the location ofthe nearest airport and recommen-dations for lodging and meals.

� A request that you set aside a cer-tain number of rooms that can beused exclusively by the team duringthe site visit.

� A request for any additional infor-mation about your organizationthat’s not included in the applica-tion but could influence the sitevisit. For example, if you use anelectronic system that requires spe-cial permission for the site visitteam to access it, let AAHRPP knowearly on.

Five business days before

AAHRPP will send a second e-mail fivebusiness days prior to the start of thesite visit. This e-mail includes a finalagenda, other logistical details, and alist of the records and documents youmust have ready for the site visitors onthe first day of the site visit.

The list of documents is mostlyprotocol files. The number of request-ed documents ranges from 10 to 100,depending on the size of your organi-zation. Most organizations are askedto pull 50 protocol files.

During the visit

Following are brief descriptions ofsome key meetings that will occurduring the site visit:

� Introduction session. This typicallyincludes the site visit team, the leadcontact from your organization, theorganizational official, and otherstaff members that you’d like toinvite. Teammembers will describethe accreditation process. This isalso an ideal time for representa-tives of your organization to askquestions.

� Program overview. The programoverview is an opportunity for thesite visitors to ask questions aboutyour organizational structure andhow your Human ResearchProtection Program (HRPP) func-tions within your organization.Invite the people who are mostinvolved with the overall operationof the HRPP. Include the lead con-tact and key managers of the insti-tutional review board, HRPP, andcompliance oversight. Attendeesshould be able to answer questionsand present overviews on howvarious components of yourorganization interact.

6 AAHRPP ADVANCE

Preparing for Your Site VisitAfter you submit your application, AAHRPP staff will contact

you to schedule a site visit. This visit typically occurs within

three months after your application is received. Don’t make

the mistake of viewing the site visit as a formality. It is a com-

prehensive peer-review evaluation. Depending on the size

and scope of your organization, the site visit will last from two

to four days and involve from two to six visitors.

AAHRPP ADVANCE 7

� Interviews. These are confidentialand are limited to the individualslisted on the agenda, unless otherarrangements have been made inadvance.

� Lead contact review. Site visitors willgive specific observations abouteach standard and will mention thetypes of issues that will be noted inthe draft site visit report. Site visitorsmay provide suggestions, but thesewill not be included in the report.Therefore, it’s a good idea to invite asmall group of people who are inti-mately involved in the operations ofyour HRPP and to have them takenotes.

� Closeout session. Designed for thesenior leadership of your organiza-tion, this session will provide ahigh-level overview, including yourHRPP’s major strengths andweaknesses for each domain.

After the visit

� AAHRPP will provide a draft reportto you within 30 days of the last dayof the site visit. While waiting forthe report, debrief everyone whowas interviewed during the site visit.This can help you anticipate someof the comments you might see inthe draft site visit report. Take abreather, but remain focused onaccreditation. Review the notes youtook during the site visit, and beginworking on improvements that willaddress the observations that thesite visitors reported.

� Once you receive the report, studythe observations and ask AAHRPPfor clarifications. Your response isdue to AAHRPP within 30 days.Helpful hint: Pay attention to thedue date in the letter you receive

along with the draft site visit report.This deadline is strictly observed.

� Respond to any errors of fact. Ifyou’ve made any changes to yourHRPP since the site visit, make sureto note those changes in yourresponse.

� For some organizations, theresponse and resulting correctionsinvolve more work than expected.Helpful hint: If the report includes

a lot of observations, pick a few andrespond well.

� If you plan to send a response toAAHRPP, have staff available toassist you. Although a significantamount of the work in achievingaccreditation is finished by the endof the site visit, your response to thedraft site visit report is an integralpart of your application. The appli-cation process does not end untilyou’ve submitted your response.

Newly Accredited Organizations

(Awarded March 2007)

Full Accreditation� Cleveland Clinic Foundation,

Cleveland, Ohio

� Fargo Veterans AdministrationMedical Center,Fargo, North Dakota

� W.G. (Bill) Hefner Department ofVeteran Affairs Medical Center,Salisbury, North Carolina

� National Healthcare Group, Singapore

� Southern Arizona VA Health Care System,Tucson, Arizona

� Veteran Affairs Medical Center Northport,Northport, New York

Qualified Accreditation� University of Pennsylvania,

Philadelphia, Pennsylvania

As of June 1, 2007, organizations thatapply for accreditation or reaccredita-tion benefit from a revised evaluationinstrument that is much shorter, is eas-ier to understand, and provides tipsand examples of how to demonstratethat an organization meets theAAHRPP standards and elements.The standards themselves haveNOT changed.

The updated instrument is nowknown as the Evaluation Instrumentfor Accreditation to encourage appli-cantsto use it to conduct their organization’sself-assessment. The instrumentremains the primary evaluationtool for AAHRPP site visitors.

Following are some highlights ofwhat to expect in the revised instrument.

� The explanation of each elementincludes:

� A brief Commentary that providesan overview of what the element isdesigned to evaluate.

� A list ofRegulatory andGuidance References.

� A discussion ofRequiredWrittenMaterials to meet each element.

� A new section that gives examplesof Common Types of MaterialsThat May Be Used to Meet theElement.

� RevisedOutcomes descriptions thatfocus on performance.

� If Tip Sheets are available for anelement, they are cited in the sectiondevoted to that element.

� The evaluation instrument has beenredesigned to increase readability.The type size is larger, there is morewhite space, and sections are clearlydelineated.

The Evaluation Instrument forAccreditation is available atwww.aahrpp.org under “Standards.”As in the past, it can be downloadedfree of charge. Separate versions, forCanadian and other internationalapplicants, are also available.Department of Veterans Affairs (VA)facilities have their own version ofthe Evaluation Instrument forAccreditation, at www.aahrpp.orgunder “Apply,” “For VA facilities andtheir academic affiliates.” Additionalinformation can be found on the VAWeb site, www.research.va.gov/pro-grams/pride/aahrpp/default.cfm.

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. PostageP A I D

Washington, DCPermit No. 96

The Revised Evaluation InstrumentSimpler, clearer, more user-friendly