SPRING 2008

Quality improvement activities inmedicine are widely regarded as crucial to efforts to reduce health careerrors and improve patient outcomes.In some cases, however, such activitiesare research and involve human participants and, therefore, are subjectto federal regulations regardinghuman research protections.

The dilemma—for researchers,health care practitioners, andInstitutional Review Boards (IRBs)—is to distinguish between the two, evermindful of the potential unintendedconsequences: that patients will bedeprived of the benefits of additionalsafety measures or that research participants will not receive the protections they deserve.

The Association for theAccreditation of Human ResearchProtection Programs (AAHRPP)addresses this dilemma in ElementI.3.C. of its accreditation standards:The Organization has and follows writtenpolicies and procedures for determiningwhen studies meet the regulatory definitions of human research.

What AAHRPP looks for, then, is for organizations to consider eachquality improvement activity on itsown, in light of the federal regulatorydefinition of research as “a systematic investigation … designed to developor contribute to generalizable knowledge.”

“Many would like to be able todraw a bright line, to label all qualityimprovement activities as eitherresearch or non-research,” explainsDavid L. Wynes, Ph.D., Chair ofAAHRPP’s Council on Accreditation.“Our position is that some qualityimprovement activities meet the defi-nition of research under the federalregulations and some do not, andmost can be easily categorized asresearch or non-research.

“For those in the gray area,” he adds, “it is in the best interest ofpatients and research participants to have the organization and the IRB carefully evaluate each one individually.”

This issue came under scrutinyrecently when the Office for HumanResearch Protections (OHRP) investi-gated a quality improvement projecton reducing catheter-related infec-tions. Ultimately, OHRP concludedthat because its goal was to producegeneralizable knowledge, the projectwas research and not exempt fromreview. OHRP also determined that

the research study posed no morethan minimal risk and, as a result,qualified for review using the expedit-ed procedure.

Quality Improvement: Research or Non-Research?AAHRPP’s Perspective

V O L U M E 5 • N U M B E R 2

CONTINUED ON PAGE 2

3 Over 100 OrganizationsAccredited

4 Addressing Tensions

5 Enhancing Competitiveness

7 Expanding the IRB Discussion

“For those in the gray area, it is in the best interest ofpatients and research participants to have the organizationand the IRB carefully evaluate each one individually.”

—DAVID L . WYNES , Ph .D .CHAIR OF AAHRPP ’S COUNCIL ON ACCREDITAT ION

The need and obligation to protectresearch participants are indisputable.But that’s where the certainty ends.Across the research enterprise, we find differences of opinion—on whatconstitutes research, on what the regulations require, and on how toensure that research participantsreceive protections without impedingresearch.

AAHRPP could easily sit back andlet others take on these issues. But thatwould not be beneficial to the researchenterprise.

Six years ago, we staked out ourposition: We would urge the researchcommunity to join us in setting andembracing high standards for researchprotections. In the process, we wouldfurther high-quality research.

With that position comes a responsibility beyond assessing andimproving human research protectionprograms. AAHRPP must also informpublic debate on research issues andencourage the research enterprise toexplore new territory. Even on contro-versial concerns, we must provide aforum for discussion and for dissent.

That’s why, on page 1 of this issue,we share AAHRPP’s perspective onQuality Improvement: Research or Non-Research? and why our 2008 AAHRPPConference included such topics asAddressing Tensions Between IRBs andResearchers (page 4) and FindingFlexibility in the Regulations—It’s There if You Look (page 5). On page 7, EatonLattman, Ph.D., of Johns HopkinsUniversity, offers his views onExpanding the Discussion on IRBs and the Humanities and Social andBehavioral Sciences in response to an article published in the Winter2008 issue of AAHRPP Advance.

AAHRPP also has some consider-able accomplishments to report. Wenow have more than 100 accreditedorganizations (page 3), including ourfirst Department of Energy researchlaboratory and our first state depart-ment of public health. Our 2008Conference, held in February inMinneapolis, was our most successfulyet, drawing participants from coastto coast and from around the world.

We highlight three conference presen-tations (pages 4-6) to give you a flavorof the breadth of topics covered and toentice you to attend next year’s event,which is scheduled for February 22-24in Los Angeles.

Please mark your calendar andplan on joining us—at the conferenceand in our mission to promote excel-lent, ethically sound research.

—Marjorie A. Speers, Ph.D.

2 AAHRPP ADVANCE

Taking the Lead on Issues of Research, Protection

AAHRPP could easily sit back and let others take on

these issues. But that would not be beneficial to the

research enterprise.

AAHRPP maintains that it is theIRB’s responsibility to familiarize itself with the federal regulations andexercise its judgment to determinewhether a study is exempt from IRBreview, whether the study qualifiesfor review under the expedited procedure, and whether the consentprocess can be waived.

“Even when quality improvementactivities do advance generalizableknowledge, there is some latitude inapplying the federal regulations,” Dr.Wynes says. (See Finding Flexibility inthe Regulations—It’s There if You Look,page 5.) “But IRBs can only take

advantage of that latitude if boththey and the investigators involvedhave the knowledge and expertise toensure adequate protections forresearch participants.”

AAHRPP is quick to point out thatIRBs cannot and should not regulateall data collection activities. Thattype of approach would hamperquality improvement efforts. It alsowould tax the resources of IRBs anddivert attention from studies thatwarrant closer scrutiny because they pose more than minimal riskto participants.

Quality Improvement CONTINUED FROM PAGE 1

With its most recent round of accredi-tations, AAHRPP has surpassed the100 mark and added its first statehealth department and first U.S.Department of Energy (DOE) researchlaboratory to the ranks of accreditedorganizations.

Fifteen organizations (see box, thispage) were awarded accreditation during AAHRPP’s quarterly Councilon Accreditation meeting in March. A total of 107 organizations represent-ing 445 entities are now accredited,including organizations in 35 states,Puerto Rico, Canada, Korea, andSingapore.

Among the newly accredited organizations are the FloridaDepartment of Health (DOH) and the Pacific Northwest NationalLaboratory (PNNL) in Washington.

Florida DOH

The Florida DOH accreditationextends to the Institutional ReviewBoard (IRB) and all members of theFlorida DOH research community,including 67 county health depart-ments. In announcing the accredita-tion, State Surgeon General Ana M.Viamonte Ros, M.D., M.P.H., called on“all research institutions in Florida tojoin the department by pursuing bestpractices, ensuring ethical conduct ofresearch, and protecting participantsin research.”

She cited a number of benefits ofaccreditation, including a competitiveedge when seeking agency fundingand an improved infrastructure for research. In preparation for accreditation, Florida introduced anelectronic system to manage researchapplications, implemented new train-ing requirements for researchers andstudy personnel at DOH and partner

organizations, revised policies andprocedures, and mandated ethicstraining for all DOH epidemiologists.

Pacific Northwest National Laboratory

For PNNL, accreditation is “a visibleway of demonstrating that we valueresearch protections for human sub-jects and that we are worthy of ourclients’ confidence and collaborationin research,” says Sherry Davis,Manager of PNNL’s Human ResearchProtection Program and IRB. “It wasimportant to our laboratory to takeour place among institutions that

have earned this prestigious distinction.”

The decision to seek accreditationcame at the urging of DOE and thePNNL laboratory director and wassupported at all levels, by manage-ment, researchers, IRB members, and support staff.

“We are very serious about promoting quality improvement forall activities conducted at our labora-tory,” Ms. Davis says. “While we recognize that our human researchprotection program will always be awork in progress, accreditation is a significant milestone and an affirma-tion of our efforts.”

More Than 100 Organizations Now AccreditedLatest additions include first state health department and first DOE research lab

Newly Accredited Organizations Awarded March 2008

Full Accreditation■ Florida Department of Health, Tallahassee, FL

■ Fred Hutchinson Cancer Research Center, Seattle, WA

■ Harry S. Truman Memorial Veterans’ Hospital, Columbia, MO

■ James J. Peters Veteran Affairs Medical Center, Bronx, NY

■ New Mexico VA Health Care System, Albuquerque, NM

■ New York University School of Medicine, New York, NY

■ Pacific Northwest National Laboratory, Richland, WA

■ Tuscaloosa VA Medical Center, Tuscaloosa, AL

■ University of Michigan, Ann Arbor, MI

■ VA Illiana Health Care System, Danville, IL

■ VA Nebraska-Western Iowa Health Care System, Omaha, NE

■ Veterans Affairs San Diego Healthcare System, San Diego, CA

Qualified Accreditation■ Louis Stokes Cleveland Department of

Veterans Affairs Medical Center, Cleveland, OH

■ Syracuse University, Syracuse, NY

■ University of Missouri-Columbia, Columbia, MO

AAHRPP ADVANCE 3

4 AAHRPP ADVANCE

Back in the summer of 2006, the relationship between social andbehavioral researchers and theInstitutional Review Board (IRB) atOhio State University was so strainedthat some 160 faculty memberssigned a petition detailing their con-cerns. Today, the relationship ismarked by increased understanding,the result of nearly a year of dialogueand collaboration to balance the concerns of researchers with theresponsibilities of the IRB.

In response to faculty concerns,both the Behavioral and SocialSciences IRB and Ohio State’s Office ofResponsible Research Practices (ORRP)are making adjustments to facilitateoff-site research, streamline review ofresearch that presents only minimalrisk, develop research-specific formsand guidance, and increase educationand outreach.

Faculty members, in turn, are gaining a new awareness of the roleof the IRB and its obligation to review

research involving human partici-pants, including social science, behavioral, educational, and humanities studies.

“We are very encouraged with theprogress we’re making,” says KarenHale, R.Ph., M.P.H., C.I.P., AssociateDirector, ORRP, The Ohio StateUniversity. “We know this is not theend of the story, but we’ve laid thefoundation to keep moving forward in a positive way.”

An AAHRPP site visitor and member of AAHRPP’s Council onAccreditation, Ms. Hale shared OhioState’s experience and its solutionsduring her conference presentation,“Addressing Tensions Between IRBsand Researchers.” The session drew anaudience of more than 100, an indica-tion that such tensions are commonon university campuses.

Resolving the issues

The tensions at Ohio State revolvedprimarily around concerns that IRB

requirements were curtailing behav-ioral and social sciences research andresearch in education and thehumanities. Faculty questioned theneed for IRB oversight of such studiesand expressed dissatisfaction with the review and noncomplianceprocesses. Faculty also were critical ofthe timelines set by the IRB, the varia-tions they perceived in IRB reviewsand interpretations, and the modifica-tions that were often required as acondition of IRB approval.

Faculty expressed these concerns inthe petition, which was sent to OhioState’s vice president for research. Hisresponse was to establish a facultywork group charged with defining spe-cific concerns, evaluating IRB practicesat Ohio State, assessing best practicesat other organizations, facilitatingcommunication between faculty andthe IRB, and recommending solutions.

The work group met monthly fornearly a year. “It was the best thingthat could have happened,” Ms. Hale

Addressing Tensions Between IRBs and Researchers

More than 400 participants—from 43 states, 5 countries, and 58 accredited organizations—attended the 2008 AAHRPP Conference: Quality

Human Research Protection Programs, which tackled someof the most pressing challenges facing the research enterprise.

The conference was held February 24-26, 2008, inMinneapolis. Next year’s event is scheduled for February22-24, 2009, in Los Angeles. Registration opens October 1,2008.

The 2008 Conference featured more than 45 presenta-tions. Some focused on the nuts and bolts of accreditation;others covered topics of interest to specific audiences. Stillother sessions presented potential solutions to issues thatconfront and, in some instances, divide the research community.

Summaries of three such presentations are provided onthese pages. The first, Addressing Tensions Between IRBs andResearchers, was presented by Karen Hale, R.Ph., M.P.H.,

C.I.P., Associate Director of the Office for ResponsibleResearch Practices at The Ohio State University. Her presen-tation discusses Ohio State’s progress in accommodatingthe different perspectives of faculty members and theInstitutional Review Board.

The second, Enhancing Competitiveness: BuildingCollaborative Networks and Harmonizing Practices, takes onthe cutting-edge topic of transforming rivals into collabora-tors. It was presented by Anne N. Hirshfield, Ph.D.,Associate Vice President for Health Research at GeorgeWashington University, a member of the WashingtonRegional Institute for Clinical and Translational Scienceconsortium.

The third, Finding Flexibility in the Regulations—It’s There ifYou Look, offers guidance on how to streamline the reviewprocess for certain protocols without sacrificing researchprotections. The presenter was AAHRPP President and CEOMarjorie A. Speers, Ph.D.

Conference Showcases Challenges, Solutions

CONTINUED ON PAGE 6

AAHRPP ADVANCE 5

In today’s research environment,organizations that traditionally haveapplied and competed individually forgovernment funding are being told tocollaborate instead. But, as sevenWashington, D.C., organizations havediscovered, the challenges of buildingtrust and consensus among once-rivalinstitutions can be considerable.

“We found that the complexities were enormous and that we needed a road map that would help usapproach the process in an organizedfashion,” says Anne N. Hirshfield,Ph.D., Associate Vice President for Health Research at GeorgeWashington University, one of sevenorganizations that joined forces toestablish the Washington RegionalInstitute for Clinical and TranslationalScience (WRICTS) consortium. “Wealso needed guidance from an objec-

tive, external source for those situa-tions where we may disagree on howsomething should be done or whatstandards to use.”

WRICTS members—Children’sNational Medical Center, GeorgetownUniversity, George WashingtonUniversity, Howard University,MedStar Research Institute, Universityof Maryland College Park, andWashington, D.C., VA Medical Center—found that objective source in AAHRPP.

Dr. Hirshfield detailed WRICTS’approach during her 2008 AAHRPP Conference presentation,“Enhancing Competitiveness: Building Collaborative Networks andHarmonizing Practices.” The sessionhighlighted WRICTS’ progress in tran-sitioning from rivals to co-applicantsfor a grant under the National

Institutes of Health (NIH) Clinical andTranslational Science Award (CTSA)program. Such partnerships areexpected to become increasingly common as competition intensifies for government funding for researchand as private sponsors seek more efficient ways to enroll research participants. For industry sponsors,working with a consortium of institutions in a geographic area is preferable to approaching eachinstitution separately.

Eliminating barriers

WRICTS is rooted in the CTSA philosophy that interdisciplinary part-nerships can help transform clinicaland translational research and spurscientific advances. Through shared

Enhancing Competitiveness:Building Collaborative Networks and Harmonizing Practices

Institutional Review Boards (IRBs) canstreamline the research review processby knowing when and how to takeadvantage of the flexibility that’sinherent in the federal regulations.

That was the message delivered byMarjorie A. Speers, Ph.D., AAHRPPPresident and CEO, during her 2008Conference presentation, “FindingFlexibility in the Regulations—It’sThere if You Look.”

Dr. Speers used the presentation tohighlight opportunities to exemptresearch from review or to reviewresearch using the expedited proce-dure. She also addressed common misconceptions, including the beliefthat flexibility translates into lesserprotections.

“Being flexible doesn't mean lower-ing standards,” Dr. Speers says. “Onecan be flexible and, at the same time,apply equivalent protections.”

In some instances, decisions thatseem overly rigid may actually reflectthe perspective of the organization andthe IRB, not the federal regulations.For example, the regulations includeexemptions for some research. Theyalso permit review using the expeditedprocedure or waiver of informed con-sent in certain types of research.

“Some institutions make a con-scious decision not to exempt researchor not to use the expedited review pro-cedure,” Dr. Speers says. “This is notwhat the regulations require, and itdoesn’t necessarily result in strongerprotections.”

She also highlighted opportunitiesfor flexibility in research that’s notfunded nor supported by the federalgovernment. In such cases, the organi-zation can decide not to follow theDepartment of Health and HumanServices regulations—but to provide

comparable protections instead.For this approach to be effective,

researchers and IRB professionals musthave an in-depth understanding of theintent of the regulations.

“The decision to opt out of the regu-lations for non-federally fundedresearch can place a greater burden onthe researchers and IRB professionals,”Dr. Speers explains. “They must under-stand the regulations well enough tochoose alternate means of protectionthat genuinely meet the standard setby the regulations.”

For more specifics, view Dr. Speers’ presentation, which is available in itsentirety on the AAHRPP Web site. Go to www.aahrpp.org, and, under“Education,” click on “Education,Resources, Regulations, and Guidance.”

Finding Flexibility in the Regulations—It’s There if You Look

CONTINUED ON PAGE 6

6 AAHRPP ADVANCE

governance and a collaborative struc-ture, the consortium seeks to capitalizeon the strengths and resources ofWRICTS members. The goal is todevelop and deliver new treatmentsand cures more quickly and efficiently.

First, however, the consortium hadto address barriers to collaboration,including differences in institutionalstandards and practices. Membersbegan by establishing a CTSA planning committee and choosingindividuals to take responsibility forspecific components of the CTSA grant application. Dr. Hirshfield ledthose assigned to address research compliance and support.

Her team quickly realized that harmonizing human research protec-tions would be among their most critical and, perhaps, most difficulttasks. Members were accustomed toworking with their own InstitutionalReview Boards and, without commonstandards, were uncomfortable delegating the responsibility for

human research protections to another institution in the consortium.

Members were particularly concerned about how to resolve differences of opinion. Dr. Hirshfieldsuggested they look to AAHRPP.

“As an AAHRPP site visitor, I knewthat AAHRPP has done a great deal to clarify and set standards,” she says.“I also knew that AAHRPP has an outstanding instrument for self-assessment, which we could use across the consortium so each institution could apply the same standards to its own activities.”

In essence, each member wouldconduct the self-assessment that’srequired as part of the AAHRPPaccreditation process. The AAHRPPstandards and self-assessment wouldserve as the mechanism to:

■ Build trust across the consortium.

■ Establish consistency among institutions.

■ Create a track record of cooperation.

■ Demonstrate measurable improve-ments in effectiveness and efficiencies.

■ Establish multi-institutional teams.

■ Increase communication.

■ Share resources and expertise.

■ Demonstrate commitment toadopting and implementingnational standards.

“This is one of the best ways we can demonstrate to NIH that we canand will work together,” Dr. Hirshfieldsays, “that the consortium is trulyfunctional and the whole is greaterthan the sum of the parts.”

She cites “tremendous benefits” to WRICTS and the community thatconsortium members serve. “We willhelp each other achieve a higher levelof research compliance, will share best practices, and will build relation-ships with peers who we can call upon for advice and assistance,” Dr. Hirshfield says.

says. “Before the group started meet-ing, people assumed, incorrectly, thatthey appreciated where other mem-bers of the group were coming from.We were surprised at the misconcep-tions on both sides, and we have wel-comed the opportunity to correctthem.”

The work group was so effectivethat establishing a similar forum topsthe following list of suggestions thatMs. Hale proposes for organizationsexperiencing tension between IRBsand researchers:

■ Create a forum for meaningful dialogue between the IRB, IRBchair, IRB staff, investigators, and institutional officials.

■ “Uncheck the box” on the Federal-wide Assurance of Compliance.Consider alternative ways to provideequivalent protections for researchthat is not federally funded.

■ Facilitate off-site research and consultant review.

■ Fully utilize exempt categories.Reconsider organizational “exceptions,” if any.

■ Use the expedited procedure forreview and approval of minorchanges. Simplify the submissionprocess, and increase the number of reviewers who can perform the expedited review.

■ Develop research-specific guidanceand consent templates for differenttypes of research.

■ Offer to help researchers completeIRB forms. Provide sample submis-sions that can serve as examples.

■ Emphasize education. Provide Weband staff resources, and involverespected institutional “agents” andrecognized experts. Schedule officehours in satellite locations that areconvenient for researchers.

Many of these recommendationsfocus on practical steps that IRBs cantake to make the review process lessburdensome. Others underscore thatORRP and IRB staff are readily avail-able to answer questions and offerassistance. All are designed tostrengthen the relationship and com-munication lines among researchers,ORRP, and the IRB—and to clear theway for future issues to be addressedopenly, expeditiously, and jointly.

Enhancing Competitiveness CONTINUED FROM PAGE 5

Addressing Tensions CONTINUED FROM PAGE 4

Scholars in the humanities and socialand behavioral sciences have continu-ing concerns about the role of theInstitutional Review Board (IRB) inapproving and monitoring theirresearch. Within this realm, there areimportant distinctions between the“harder” and “softer” sides of thesedisciplines and among the modelsthat each side uses when carrying outresearch. Yet discussion often focuseson the harder side and its therapeuticor hypothesis-driven models, exclud-ing a significant research community—those engaged in research thattends to be exploratory or descriptivein nature.

The excluded areas are discussed,for example, in a Chronicle of HigherEducation (53(48), B16, 2007) columnby Adil Shamoo, who suggests thatIRBs, in dealing with such areas asoral history, cultural anthropology,and journalism, have extended theirreach too far. He argues that, in some cases, IRBs violate the FirstAmendment by imposing priorrestraint on faculty members’ speech. This discussion gives rise to five questions:

1. What are the boundaries betweenjournalism and interview-basedresearch?

2. Can we help scholars identify proj-

ects that do not meet the Office forHuman Research Protections(OHRP) definition of research and,therefore, need not come before anIRB? Could a simple checklist do?

3. What human subjects researchtraining is available for scholarspursuing interview-based projects?

4. What training is available to helpIRBs deal with interview-based proj-ects and allow them to interpret theregulations in the lightest possibleway?

5. Is there any case law—either in fed-eral courts or from administrativehearings—that bears on the issuesdiscussed here?

Questions 1 and 2 merit further comment.

Shamoo describes many projectsthat fit poorly into the regulatorymodel under which IRBs operate. The nature of these projects makes it impossible to provide a list of questions in advance or to describe a protocol. Take, for example, a question such as, “What is the under-ground economy in country X reallylike?” and the difficulties of interview-ing individuals on this topic. In atotalitarian country, the individualconducting such interviews is likely to be breaking the law.

One could argue that many suchprojects are in fact not research asdefined by OHRP and need nevercome before an IRB. Some projects are not research because they are not“systematic.” There is no protocol, no fixed body of questions, and nopredetermined way of combininginformation derived from variousindividuals. Other projects involveinterviews with individuals who speakin their public and professional capac-ity—as economists, members of thinktanks, or talking heads of any kind.

These interviews do not involve pri-vate information as defined by OHRP,and there is no expectation of privacy.They are not research involvinghuman subjects.

Other cases are not as clear. TheWorld Is Flat, by New York Timesreporter Tom Friedman, is full of inter-views with identified individuals. Itmakes conclusions that Mr. Friedmanbelieves are generalizable. It could becalled research—or not. Yet Mr.Friedman certainly did not seekapproval for his book from an IRB.Indeed, one could argue, as above,that mandatory IRB approval wouldconstitute prior restraint.

On the other extreme are environments where talking with anAmerican puts individuals in jeop-ardy. Journalists still do this freely,feeling that dissidents, unlike patients,understand the risks involved andneed not provide informed consent.But the argument for universitiesallowing similar practices is much less compelling.

Despite their differences, IRBs andscholars in the humanities andbehavioral and social sciences have a common goal: to advance ethicalresearch and the knowledge thatresults. Therefore, it’s in their bestinterest—and that of society as awhole—to address the issues raisedhere.

Expanding the Discussion on IRBs in theHumanities and Social and Behavioral Sciences

Editor’s note: Dr. Lattman is Dean ofResearch and Graduate Education atJohns Hopkins University. He submit-ted this article in response to IRBs andBehavioral and Social Science Research:Finding the Middle Ground, which waspublished in the Winter 2008 editionof AAHRPP Advance. The opinionsexpressed below are solely those ofthe author.

B Y E AT O N L AT T M A N , P h . D .

AAHRPP InvitesArticle SubmissionsAAHRPP encourages readers to share their perspectives and further the dialogue on topics covered in AAHRPP Advance. If you would like to submit an article, please send an e-mail to accredit@aahrpp.org, and we will provide submission guidelines.

AAHRPP ADVANCE 7

Coming EventsPlease save the dates for the followingAAHRPP events:

■ June 11, 2008: Half-day meetingfor voluntary health agencies interested in learning more aboutaccreditation.

■ February 22-24, 2009:Fifth Annual AAHRPP Conferenceat the Millennium Biltmore Hotel in Los Angeles. Registration willopen October 1, 2008.

Visit the AAHRPP Web site,www.aahrpp.org, for more detailsabout the Annual Conference. ContactKathleen Dougherty at (202) 783-1112or kdougherty@aahrpp.org for moreinformation about the meeting withvoluntary health agencies. Watch, too, for an announcement about asoon-to-be-scheduled meeting for organizational officials.

AAHRPP WelcomesTestimonials for Web Site

The AAHRPP Web site now featurestestimonials from representatives ofaccredited organizations who sharetheir experience with accreditation and the resulting benefits. The testimo-nials—from community hospitals, independent Institutional ReviewBoards, teaching hospitals, and universities—can be viewed atwww.aahrpp.org. Click on“Accreditation,” then “What Accredited Organizations Say.”

AAHRPP invites accredited organizations to help us expand thissection of the Web site. Testimonialsmay be submitted via e-mail toaccredit@aahrpp.org. Please be sure to include your name, title, and contact information for verification.

AHA Recommendationsfor Emergency Research

The American Heart Association(AHA) has published recommenda-tions for implementing the FDA’srequirements for community consulta-tion and public disclosure under theFDA’s exception from informed consentrequirements for emergency research.These recommendations were pub-lished in Circulation 2007; 116; 1855-1863 and can be found online athttp://circ.ahajournals.org/cgi/content/full/116/16/1855.

The AHA provides a method to analyze the risks imposed by emer-gency research and recommends thatthe level of community consultationand public disclosure be based on thedegree of risk. AHA also presents sever-al options for obtaining communityconsultation and providing public disclosure when research poses low,intermediate, or high risk.

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

President and CEO:Marjorie A. Speers, Ph.D.

Editor:Elisa GallaroClifton Park, NY

Design: Levine & Associates, Inc.Washington, DC

Printing: Todd Allan Printing Co., Inc.Beltsville, MD

Non-Profit Org.U.S. Postage

P A I DWashington, DCPermit No. 96