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Fall 2005, Vol. 2, No. 3

The Need for Accreditation in an Increasingly Complex Research Enterprise

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oday’s research enterprise bears little resemblance to that of 25 or so years ago. Back then, the primary model was simple: a single grant to a single investigator at a single site. The current model is far more complicated. While many studies are still conducted as single studies or grants, others are conducted at multiple sites, by multiple players, reporting to multiple regulators. (See The Clinical Research Enterprise Today, Page 4.) Once the predominant province of academic centers, research has expanded to community hospitals, private physician practices, and entities—such as clinical research organizations (CROs) and site management organizations (SMOs)—that didn’t even exist 25 years ago. This complex arena provides greater opportunity for collaboration and, ultimately, for progress. But it also presents a challenge to compliance that may lead to litigation, lack of transparency, and diminished public trust. In response has come widespread recognition of the need to raise standards, particularly for human research protection. At each level of the research enterprise, accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) can help accomplish this objective. Three different perspectives Felix A. Khin-Maung-Gyi, Pharm. D., MBA, CIP, is founder and CEO of Chesapeake Research Review (CRR), a private firm that provides independent Institutional Review Board (IRB) and human research protection consultation services in Columbia, Maryland. Donna L. Bennett, BSN, MS, is Administrative Director, Research Services at Catholic Medical Center (CMC), a community hospital in Manchester, New Hampshire. Robin Ginn, MBA, is Executive Director of Research 915 15th Street, NW

Suite 400

Washington, DC 20005

Informatics and Regulatory Affairs at Vanderbilt University, an academic research center in Nashville, Tennessee. Despite their different perspectives, all three agree that accreditation can play a vital role in raising the bar for research standards and in regaining public trust. CRR was awarded full AAHRPP accreditation in May 2004, CMC in December 2003, and Vanderbilt University in October 2004. They are in this issue: among 24 entities representing 84 organizations • the clinical that have earned accreditation from AAHRPP. research CRR sought accreditation, in part, to enterprise demonstrate its commitment to protecting today, 4–5 human research participants through the accreditation process and the required self• HRPP assessment. “It really does hold people innovations, 6 accountable,” Gyi explains. “It forces us to be honest with ourselves, to look at the standards • new liability and policies we have in place and make sure they insurance genuinely relate to human subject protection.” program Gyi is heartened by what he views as a available, 7 new, shared emphasis on protecting research subjects. “There is an understanding now that IRBs can no longer perform the gatekeeping by themselves—that human research protection is a responsibility that is shared by everyone in the research enterprise,” he says. “That represents a true sea change, and one that has occurred in just the past Who should seven to eight years.” consider Like CRR, CMC pursued accreditation to underscore a accreditation? commitment but, in this case, see Page 4 ... to the community it serves. One of the first to attain the AAHRPP recognition, the 330-bed community hospital has been engaged in research since 1984, has its own IRB, and conducts about 40 clinical trials per year.

Phone: (202) 783-1112

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From the

Executive Director Marjorie A. Speers, Ph.D.

Strengthening Each Link of the Research Enterprise

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egardless of our particular perspective, all of us They also expect that the advantages of accreditation will involved in the research enterprise have the same only increase as it becomes the industry standard. goals: to advance health and improve quality of We thank them for their insights and applaud their life through more effective prevention and treatment. We willingness—and that of their institutions—to be among recognize that, by its very nature, research involves risk. But accreditation’s pioneers. They have recently been joined by we believe that risks can be managed if we are committed four more entities: an independent, free-standing children’s to ethical practices that ensure the integrity of results hospital; an academic health center; an entity that includes and, above all, provide protection for human a university component and affiliated hospitals participants. and research institutes; and a comprehensive The AAHRPP Of course, as recent high-profile cases university whose portfolio covers biomedical, have demonstrated, commitment alone is not behavioral, and social science research. All accreditation enough. It must be backed by policies and attained full accreditation in June. (See Page 5.) procedures that ensure the highest standards at process seeks every level of the research process. Furthermore, AAHRPP as resource adherence to these policies cannot be assumed. not just to raise Throughout the accreditation process, Instead, systems must be in place to verify that the standards AAHRPP serves as a resource for applicants. every person and entity involved is following We provide a variety of print and online the same criteria and complying with the for human training tools to help organizations interpret regulations. accreditation standards and navigate the research, but In today’s research enterprise, that is no accreditation process. We also offer workshops small task. As the diagram on Pages 4 and 5 to do so in a to give applicants the opportunity to interact illustrates, the economic, regulatory, and legal one-on-one with AAHRPP staff. manner that landscape has given rise to a complicated, AAHRPP serves as a resource in other interdependent system in which a misstep ways, as well. A prime example is the Clinical encourages by any single entity can have repercussions Research Liability Insurance (CRLI) and Life well beyond its specific part in the research ongoing selfScience Liability Insurance (LSLI) program enterprise. In other words, the system is only as for those engaged in human research. (See assessment strong as its weakest link. Page 7.) We believe the program better serves That’s where accreditation comes in. The and selfthe needs of today’s research entities and AAHRPP accreditation process seeks not just And, as further proof of the value improvement. individuals. to raise the standards for human research, but of accreditation, the program offers a discount to do so in a manner that encourages ongoing to those with AAHRPP accreditation. self-assessment and self-improvement. It aims Finally, in yet another example of our role as a resource, to foster the communication and collaboration that have I call your attention to the second Annual AAHRPP become even more critical as the research enterprise has Conference, which will be held February 26-28, 2006 in grown in complexity. I am gratified to report that those that Phoenix, Arizona. Those of you who attended our first have attained AAHRPP accreditation say we are, indeed, conference this past March know that it was a vital source accomplishing these objectives. Starting on Page 1 in The of information, not just on accreditation but also on human Need for Accreditation in an Increasingly Complex Research research protections in general. We expect the second Enterprise, we share the perspectives of representatives of conference to provide more of the same, and we look three accredited entities: an independent IRB, an academic forward to seeing you there. § research institution, and a community hospital. All three feel strongly about the value of the accreditation process.

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3 The Need for Accreditation in an Increasingly Complex Research Enterprise, from Page 1 ...

• To researchers and other research professionals, accreditation serves as a “gold seal” of quality and an assurance that the same stringent requirements govern each phase of the research process. That, in turn, instills confidence in the accuracy of research results.

“Accreditation presented a golden opportunity to affirm our commitment to do the right thing,” Bennett says. That commitment is evident in the mandatory annual • To sponsors, accreditation offers a measure of protection education of CMC investigators, research staff, IRB for what has become an increasingly sizable investment. members, and others throughout the institution, as well as According to the Pharmaceutical Research and in CMC’s rigorous policies Manufacturers of America, regarding research ethics its members invested $38.8 Accreditation really helped us take a and disclosure of conflicts of billion in 2004 to research interest. more global perspective and fostered and develop new medicines. At Vanderbilt University, collaboration,” Ginn says. “Instead of Federal agencies also spend the AAHRPP accreditation process prompted a thorough looking at each department individually, billions each year on clinical research. assessment of the university’s we’re focused on how all the pieces work research protection “Accreditation is a tool to program and helped foster together for the common goal of human help measure quality,” says collaboration among different Ginn. “The more people research protection. departments. That is a key realize that, the more we will benefit at an institution that currently has about 3,000 see them seek accreditation and its benefits.” protocols underway involving human subjects. Bennett agrees. “In a sense, those of us who already are According to Ginn, at larger settings it’s not uncommon accredited are the pioneers,” she says. “It’s up to us, now, for research to become compartmentalized, with each to provide the necessary education and to move the agenda department concentrating on its own piece of the process. forward.” § “Accreditation really helped us take a more global perspective and fostered collaboration,” Ginn says. “Instead of looking at each department individually, we’re focused on how all the pieces work together for the common goal of human research protection.”

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Embracing higher standards One of the goals of accreditation is to expand the collaboration and common focus beyond individual institutions to all entities engaged in different phases of research, from sponsors and CROs to investigators and IRBs. “If we are truly committed to human subject protection, we have to embrace accreditation and its higher standards of compliance,” Gyi says. “Those of us who choose to become accredited are helping to build trust in the system. We are providing an assurance—to each other and the community—that we are doing the right thing.” Gyi, Bennett, and Ginn agree that, as organizations realize the benefits of accreditation those that are accredited will gain significant competitive advantages. • To patients, accredited entities demonstrate their commitment to human research participants, a key consideration at a time when many clinical trials are under-enrolled because of difficulties in attracting human subjects. In fact, according to CenterWatch, 80% of U.S. clinical trials are delayed at least one month because of unfulfilled enrollment.

The Impact of Research • •

Each year, several million Americans participate in clinical trials.1 Currently, there are more than 41,000 active industry- and government-sponsored clinical trials.1 83% of adults believe it is either “essential” or “very important” that prescription drugs and new treatments be tested on humans.2 In the 1960s, it took 8.1 years to develop a new drug. By the 1990s, that time frame had almost doubled, to 15.3 years.3 Annual operating costs for Institutional Review Boards (IRBs) range from $171,014 to $4.7 million, with a median cost of $741,920.4

CenterWatch Harris Interactive study, 2002 3 Association of Clinical Research Professionals 4 The New England Journal of Medicine, April 28, 2005 1 2

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Who Should Consider Accreditation?

ory Bodi ulat es g Re Food & Drug Administration

ent Funding B m n od r ve Department of Health & Human Services

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The Clinical Research Enterprise Today Go

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AHRPP accreditation provides an assurance of quality, consistency, and compliance. It serves notice—to the public, sponsors, and other research partners—that an organization has systems in place to ensure safe, ethical research. As such, it offers significant advantages. Following are just some of the types of entities that could benefit from accreditation: • Contract Research Organizations (CROs). These organizations are hired by pharmaceutical, medical device, and biotechnology companies to manage the clinical research that is required to bring a product to market. CROs oversee a broad range of services, from preclinical evaluation and study design to data collection and analysis. Each year, they enroll millions of research participants worldwide in clinical trials. AAHRPP accreditation signals that a CRO adheres to U.S. and international regulations for product research and testing, making the CRO more attractive to research sponsors and research participants. • Government Agencies. As both sponsors and investigators, state and federal agencies play a vital role in furthering clinical research. AAHRPP accreditation underscores these agencies’ adherence to the highest standards and their fundamental commitment to participant protection. It provides an added assurance to the public and sets an example for others engaged in clinical research. • Hospitals and Physician Practices. Hospitals and private physicians conduct clinical trials to offer individuals the opportunity to benefit from medical advances in their earliest stages. AAHRPP accreditation indicates that these entities have the experience, oversight, and commitment to quality that are required of research partners. It can enhance hospitals’ and private practices’ standing with research sponsors and instill confidence in patients. • Independent Review Boards (IRBs). These entities are responsible for monitoring and reviewing research to protect the rights and welfare of research participants. Institutions usually have their own IRBs, which are accredited as part of the larger organization. Researchers who do not have access to an institutional IRB can contract with outside or independent IRBs. AAHRPP accreditation helps IRBs achieve compliance with federal regulations. It can, therefore, help independent IRBs attract sponsors, research participants, investigators, and research institutions that are in need of IRB oversight. • Site Management Organizations (SMOs). Relative newcomers to the clinical research enterprise, SMOs provide management services—including clinical investigation, participant recruitment, and data

Department of Defense Department of Energy

Office of Human Research Protection

Department of Veterans Affairs Department of Homeland Security

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arch Settings Rese Industry Private Foundations

Hospitals Site Management Organizations

Government Agencies (intramural programs)

Research Institutes

Research Participants Contract/ Clinical Research Organizations

Physician Practices Universities

Others Auditing Companies Education Companies

Independent IRBs

Patient Recruitment Firms

Accrediting & Certifying Bodies

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Data Maintenance Firms Insurance Companies

collection and submission—at multiple research sites. With its assurance of quality and compliance, AAHRPP accreditation can help SMOs attract sponsors, CROs, investigators, and research participants. • Universities and Teaching Hospitals. The nation’s medical colleges and their affiliated teaching hospitals have long been centers of clinical research. Larger institutions often coordinate hundreds of trials simultaneously, enrolling individuals through their medical center as well as affiliated community hospitals and private physician practices. Trials may involve government or industry sponsors, or other academic institutions and research partners, with oversight provided by the university’s own IRB or external IRBs. AAHRPP accreditation can assist universities in attracting research sponsors, other research partners, and research participants. § For more information on the benefits of AAHRPP accreditation and the accreditation process, visit www.aahrpp.org. An Intricate, Connected System The clinical research enterprise has evolved into a complex, interdependent system of individuals and entities. As the diagram indicates, those engaged in virtually every aspect of research typically must answer to at least two sets of regulators. Because the environment has become increasingly collaborative, most also interact with other institutions and, therefore, must rely on one another for compliance and for ensuring the integrity of the research process.

Newly Accredited Organizations Announced The following organizations were awarded Full AAHRPP Accreditation at the June 17 meeting of the AAHRPP Council on Accreditation: • Children’s Hospital Boston, Boston, Massachusetts • Johns Hopkins Medical Institutions, Baltimore, Maryland • University of Arkansas for Medical Sciences, Little Rock, Arkansas • University of Louisville, Louisville, Kentucky The Council will meet again in September. Accredited organizations are listed at www.aahrpp.org.

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HRPP Innovations

An Interactive Parent Guide to Clinical Research at Children’s Hospital Boston

As part of its educational mission, AAHRPP periodically disseminates information on innovations encountered in accredited organizations. Children’s Hospital Boston he decision to participate in clinical research can be especially difficult when it involves a child. To help parents gather the necessary information and weigh their options, Children’s Hospital Boston (fully accredited by AARHPP as of June 17, 2005) designed an Interactive Parent Guide to Clinical Research. Available at www.bostonchild.vitalconsent.com, the guide takes an objective look at medical research, addressing topics such as common misunderstandings, the difference between research and medical therapy, potential conflicts of interest, research protections, and the responsibilities of parents. It also includes a feature that helps parents prepare for their meeting with the research team. “We wanted to take a neutral, balanced approach that addresses the benefits and potential risks of medical research, and makes it clear that there are lots of individual factors to consider,” explains Susan Kornetsky, Director of Clinical Research Compliance at Children’s Hospital Boston. “We view it as an educational tool—one that empowers parents to ask questions and get the information they need to make the right decision for their child.” Funded by the National Institutes of Health through the Human Subjects Research Enhancements Program, the user-friendly guide offers parents the opportunity to view the information via video or as text. It takes parents step by step from “Medical Research Basics” through “A Deeper Understanding” and “Your Child & Medical Research.” The interactive “Questions for Research Team” provides a comprehensive list of questions for parents to ask. It also includes features that let parents add their own questions, save and print the questions they’ve selected, or e-mail them directly to the research team. To complement and build awareness of the interactive parent guide, Children’s Hospital Boston includes the Web address on all of its informed consent documents. The hospital also has printed a pamphlet highlighting key points from the online guide. § Information: Susan Kornetsky, Susan.Kornetsky@childrens.harvard.edu, (617) 355-7052.

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Johns Hopkins: Setting the Standard for Conflict of Interest Reporting Johns Hopkins Medical Institutions Investigators at Johns Hopkins Medical Institutions (fully accredited by AAHRPP as of June 17, 2005) adhere to one of the most stringent, comprehensive conflict of interest policies to govern human subjects research. Adopted in 2002, the policy requires that all potential conflicts of interest be reported in advance and that they be reviewed by both the Committee on Conflict of Interest (CCOI) and the Institutional Review Board (IRB) overseeing the research. Because CCOI serves in an advisory capacity to the IRB, final authority for managing conflicts of interest rests with the IRB. Johns Hopkins was one of the first institutions to adopt such an advisory structure. The IRB may not modify CCOI recommendations except to strengthen them. “We view that as a key provision because it provides an additional protection,” explains Julie Gottlieb, Assistant Dean, Policy Coordination at Johns Hopkins University School of Medicine. “It guarantees that recommendations on conflict of interest cannot be watered down.” The conflict of interest policy applies to anyone who participates in research at Johns Hopkins: faculty, staff, trainees, post-doctoral fellows, students, administrators, and researchers. It governs new protocols and renewals, mandates the reporting of “all financial and fiduciary interests that might appear to present a conflict,” and clearly states that “there is no de minimis level below which a financial interest is exempt from reporting.” If a financial interest is introduced once research is underway, that interest must be reported and reviewed immediately. “Every proposal and every report is scrutinized through the lens of the policy and on a case-by-case basis,” Gottlieb says. “That is the only way to maintain the primacy of protecting human subjects.” To ensure compliance with the policy, Johns Hopkins offers a Web-based training module and assessment. Completion of the module is a prerequisite for submitting protocols and participating in research. § Information: Julie Gottlieb, jgottlie@jhmi.edu, (410) 516-4972.


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advancing human protection in research.

New Liability Insurance Program Available A flexible approach to managing risk By Walter H. Killian, Esq. On September 17, 1999, 18-year-old Jesse Gelsinger died, just days after receiving experimental gene therapy as part of a clinical trial at the University of Pennsylvania. His family settled with the university the following year. On June 2, 2001, 24-year-old Ellen Roche died as a result of her participation in a research experiment at Johns Hopkins University. Her family reached an out-of-court settlement with the university later that year. In many ways, these tragic cases served as a wake-up call for the clinical research enterprise. First and foremost, they drew attention to the need to strengthen human research protections. But they also highlighted the risks inherent in research and the challenges of managing those risks. To help address those challenges, two new insurance products were recently introduced—Clinical Research Liability Insurance (CRLI) and Life Science Liability Insurance (LSLI) for entities and individuals engaged in human research. Underwritten by Lloyd’s of London, the programs essentially are mirror images of each other. CRLI covers clinical research, and LSLI covers non-clinical research. Both are available throughout North America and reflect the current economic, regulatory, and legal climate. Rates vary with the class of insured, with a discount offered to AAHRPP-accredited entities in recognition of the value of accreditation. A more suitable option A review of the insurance coverage available for clinical research-related liability exposures revealed an approach that was generally lacking in flexibility. As a result, coverage has not been well-suited to the sweeping changes confronting research entities. Many policies were severely limited in the scope of coverage or in the classes of persons or entities that could purchase the insurance. The approach tended to be simplistic and did not reflect the challenges facing modern researchers. Finally, the review found that many medical professionals engaged in clinical research activities with no insurance protection at all, erroneously assuming that their medical professional liability policies would cover losses. The conclusion was that the time is right for a change from the traditional, static approach to one in which coverage is managed as part of an overall program that can respond—with flexibility, broad applicability, and

innovation—to the diverse situations found in the business and academic research worlds. CRLI/LSLI program overview CRLI/LSLI starts with traditional insurance coverages but links them in non-traditional ways. For example, CRLI provides medical professional liability coverage for investigators on the same policy form that covers their employer for errors and omissions. The program also is designed to meet the needs of the range of individuals and entities involved in human subject research. The same program can cover many classes of insureds, from an independently practicing clinical research associate to a mid-sized CRO, all the way up to a university or large academic medical institution with worldwide contracts. Another key feature of CRLI/LSLI is the suite of ancillary coverage that is available. The program acknowledges that exposure is not limited to matters easily categorized as claims or lawsuits. It currently provides coverage for the defense of administrative and regulatory proceedings, including FDA investigations, HIPAArelated actions, and billing- and reimbursement-related proceedings. Though it is not broken out as separate coverage, CRLI/LSLI also allows coverage for public relations consultation, at the discretion of underwriters’ representatives, when an insured faces a claim or regulatory action. The program will continually be evaluated to ensure that coverage keeps pace with the risk profile of those engaged in research and the evolving life science industry. Undoubtedly, there will be instances where the program, in its current form, may not meet the needs of prospective insureds, because of clients’ special circumstances or complicating factors. In such cases, special manuscripts may be prepared, further illustrating the flexibility of CRLI / LSLI. For more information on CRLI/LSLI, contact Walter H. Killian at whjkillian@msn.com (tel: 443283-1153) or Ian Thompson of Catlin Group, Ltd at ian.thompson@catlin.com (tel: +44 (0)20 7626 0486). § Walter H. Killian, Esq., is the principal architect of CRLI/ LSLI. A healthcare attorney and former hospital counsel, Mr. Killian concentrates his practice on the design of new insurance products to address the unique needs of the healthcare and biotechnology industries.

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Save the Date for Our Second Annual Conference 2006 AAHRPP Conference: Quality Human Research Protection Programs

February 26–28, 2006, Phoenix, Arizona * Pre-conference workshops on February 26

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AAHRPP Advance is published quarterly by the Association for the Accreditation of Human Research Protection Programs, Inc.® (AAHRPP®) Executive Director Marjorie A. Speers, Ph.D. Editor Elisa Gallaro Design Wieder Communications Printing Federation of American Societies for Experimental Biology (FASEB)

What you’ll learn ... • Innovative practices in human research protections • Expectations and practices related to accreditation • Information on resources needed to prepare for accreditation

Attention Exhibitors! If you are interested in exhibiting at the conference, contact the AAHRPP office at 202-783-1112 to receive our exhibitor prospectus.

Who should attend? Institutional officials, IRB professionals and chairs, project managers or inspectors, regulatory compliance professionals, researchers, sponsors, and patient group leaders. Where? Wyndham Phoenix 50 East Adams St. Phoenix, Arizona www.wyndham.com

Check www.aahrpp.org for details in the months ahead.

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www.aahrpp.org 915 15th Street, NW, Suite 400

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Fax: (202) 783-1113 Phone: (202) 783-1112 www.aahrpp.org accredit@aahrpp.org

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V2.3 - Advance - Fall 2005