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FALL 2007

The Role of the Organizational Official Unparalleled influence and responsibility As the research enterprise has changed, so has the role of the organizational official. As a result, few are as influential — or as accountable — as those charged with integrating and overseeing their organization’s human research protection program (HRPP). Today’s organizational official has more responsibilities than in the past, takes those responsibilities more seriously, and maintains a delicate balance among often competing objectives. In essence, the organizational official is advocate and enforcer, negotiator and educator, all rolled into one. When the job is performed well, the benefits are enormous and obvious. Strong, effective leadership by an organizational official translates into a sound, quality-driven HRPP. That, in turn, furthers research and the advances it makes possible. According to Richard W. Bianco, Associate Vice President for Regulatory Affairs at the University of Minnesota, the most successful organizational officials are those who take the broadest possible view of compliance and protection efforts. “It is no longer enough to focus just on the activities of the institutional review board (IRB),” Mr. Bianco says. “The IRB is essential, but it is also just one piece of what should be a comprehensive, centralized research protection program.” In fact, today’s HRPPs must integrate all components of research

compliance — including such areas as conflict of interest, research integrity, and environmental safety — with protections for participants. This is possible only if the organizational official is equipped with all of the following: ■

Broad authority over the organization’s research and compliance activities.

Extensive experience in research, regulations, and compliance oversight.

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

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

An understanding of the organizational culture and the ability to effect change within that culture.

A commitment to ongoing communication and education with and among investigators, IRB members, and others engaged in research — including research participants.

A fundamental appreciation of the importance of compliance, both to safeguard participants and to promote research.

Effective organizational officials also view compliance efforts as facilitative, not punitive, and welcome accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) as a

Officials point to benefits of accreditation PA G E 4 means of bolstering their efforts to build awareness and support for a culture of compliance. “Through accreditation, we have a constructive way to get people’s attention and involve them in improving and advancing research,” Mr. Bianco says. “AAHRPP’s application process is a form of self-inspection and introspection. At the University of Minnesota, that process gave us an appreciation of the scope of our program and how the pieces fit together to ensure quality research.” VOLUME 4 • NUMBER 3

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HRPP Innovations

Newly Accredited Organizations


Partners in Furthering Research To date, we have accredited 81 organizations. Without exception, those organizations that succeed — both in attaining accreditation and maintaining high-quality research programs — can trace their success to strong leadership from their organizational officials. As we point out in The Role of the Organizational Official on Page 1, these individuals bear the ultimate responsibility for their organizations’ human research protection programs (HRPPs). But their influence extends well beyond their own HRPPs. They are among the research enterprise’s most effective advocates — for compliance and protection and for the improved health and quality of life that society enjoys as a result of research. Organizational officials fulfill their responsibilities in many ways: building the infrastructure for research, protections, and compliance; encouraging innovation; supporting researchers and helping them navigate today’s increasingly difficult research environment; and recognizing that accreditation helps further research. Starting on Page 4, we introduce you to 12 organizational officials who discuss some of the benefits their organizations have realized as a result of accreditation. These individuals represent organizations large and small, from major teaching hospitals and research universities to community hospitals, independent review boards, and contract research organizations. (Additional testimonials will be posted on our Web site in the weeks to come.) We share these with you because we believe they provide valuable insights about accredited HRPPs, their organizational officials,

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and the positive effects of accreditation. Since registration is underway for our 2008 AAHRPP Conference, on Page 3 we present conference highlights. As in the past, we will be offering a combination of fascinating and thought-provoking plenary and breakout sessions. Also included in this issue is a Call for Abstracts from individuals at accredited organizations. Those of you who have attended our conferences in the past know that they afford a wonderful opportunity to learn more about accreditation, research trends, and challenges and to network with your peers. I look forward to seeing you in Minneapolis, February 24 – 26.

Revised Publication Schedule: Starting with this issue of AAHRPP Advance, we are adjusting our publication schedule to more closely coincide with our Council on Accreditation meetings. The schedule change will allow us to provide more timely recognition of organizations that are awarded accreditation by the Council. We will continue to publish quarterly, but in January, April, July, and October — in each case, approximately one month after the Council on Accreditation announces its decisions.

— Marjorie A. Speers, Ph.D.

Call for Abstracts for 2008 Conference Deadline for submission: November 1 AAHRPP invites accredited organizations to participate in its conference breakout sessions by sharing innovative practices and strategies for increasing research protections. We welcome abstracts on the following: ■

Education Programs

Outreach Programs for Research Participants

Reaccreditation

Orienting the IRB Toward Customer Service

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

Consent Processes

Institutional Conflict of Interest

General Issues Related to HRPPs

Submission guidelines are available at www.aahrpp.org. Send abstracts to kdougherty@aahrpp.org by November 1.


2008 AAHRPP Conference: Quality Human Research Protection Programs Don’t miss the fourth annual accreditation conference, which will be held in Minneapolis, Minnesota, February 24 – 26. The conference is geared to individuals from accredited and non-accredited organizations, as well as stakeholders — government, industry, voluntary health agencies, and community groups — that are concerned with promoting human research protection and quality research. Institutional officials, IRB professionals and chairs, compliance professionals, researchers, sponsors, and patient group leaders should attend. Conference dates: February 25 – 26. Pre-conference workshops: February 24. Information/Registration: www.aahrpp.org

Conference attendees will: 1. Learn the key aspects of the accreditation process and acquire the skills necessary to complete each phase. 2. Identify common problems that organizations experience in meeting the accreditation standards and ways to address them. 3. Become familiar with what others are doing to improve protections for research participants. 4. Learn about current challenges facing accredited organizations and strategies to address them.

MAIN CONFERENCE: Plenary Sessions ■ ■ ■ ■

Common Accreditation Findings and Distinctions Taming the Taboos: “_ism” and “_ability” Research — Have IRBs Gone Too Far? Incidental Findings in Research — What Are the Ethical Obligations? Current Issues Facing Federal Agencies

Breakout Sessions: Specialized breakout sessions cover topics designed for all interest groups. Examples include: For organizational officials ■ Addressing Tensions between IRBs and Researchers ■ Developing a Cohesive and Effective Relationship between the Organizational Official and the IRB ■ Managing the Full Array of Human Research Responsibilities

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Overseeing Biomedical Research Overseas — A Case Study in Mali The Common Rule — Is It Becoming Uncommon? Pursuing Accreditation When There Are No Dedicated Resources International Research Ethics — Issues in Prevention Trials Leveraging Accreditation within Your Organization The HRPP As Part of the Organization’s Integrated Compliance Program

For those new to the accreditation process ■ Conducting a Self-Assessment ■ Getting the Go Ahead to Seek Accreditation from Senior Officials ■ Writing a Response to an AAHRPP Report ■ Negotiating Contracts with Sponsors ■ Application Forms ■ Reviewer Checklists ■ Consent Templates ■ Putting Together the Application for Accreditation For behavioral and social science research programs ■ Challenges in Conducting and Overseeing Education Research ■ Practical Solutions to Ethical Issues Involved in Conducting Research over the Internet ■ Meeting the Ethical Challenges in International Research ■ Creating a Whole HRPP — Issues to Consider When Relying on an External IRB ■ Following DoD Regulations ■ Overseeing Research That Puts the Researcher at Risk: Whose Responsibility Is It?

For VA facilities ■ Identifying and Managing Institutional Conflict of Interest ■ Responsibilities of the Research and Development Committee and the IRB ■ Closing the Gap When Using an External IRB ■ What Activities Constitute Research, Research Involving Human Subjects, and Exempt Research Involving Human Subjects? Other breakout sessions of interest ■ ICH/GCP — Should Our Organization Commit to Following the Guidelines? ■ How Is Your IRB Doing? Metrics for IRBs ■ HIPAA and Research ■ Reaccreditation ■ Ethical Issues to Consider in Using Tissue Repositories ■ Orienting the IRB toward Customer Service ■ A Cohesive HRPP — The Organizational Official, IRB, and Researchers Working Together ■ Scientific Review — What Is It and When Is It Present? ■ Strategies to Enhance Communication among Committees That Contribute to Human Research Protection Programs — IRB, COI, Radiation Safety, and More ■ Community Hospitals ■ Writing a Policy on Unanticipated Problems Involving Risks to Participants or Others in the Context of the Recent OHRP and FDA Guidelines All breakout sessions are open to all attendees.

Pre-conference workshops (February 24): ■ ■ ■

Workshop I: AAHRPP: Getting Started Workshop II: Current Challenges for Social/Behavioral Research HRPPs Workshop III: Reaching Your Goal of Accreditation — Case Studies of Small HRPPs Workshop IV: Managing an Effective Human Research Protection Office

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AAHRPP Accreditation Results in Tangible Advantages for Organizations Officials cite improved protections, compliance, respect, and other benefits Organizations are seeking accreditation because it offers significant benefits both to research participants and to research protection programs. All accredited organizations benefit from higher standards; comprehensive systems, policies, and procedures; and the resulting improved compliance.

Meeting FDA Requirements Sandra J. Degen, Ph.D. Vice President for Research University of Cincinnati “We’ve only been accredited a short time, so most of the benefits we’ve seen are the result not of accreditation itself but of the self-assessment process. Even so, the benefits have been significant. For example, to meet the accreditation standards, we implemented a formal auditing and monitoring system — something that had not existed before. Subsequently, we were audited by the FDA, which found that the necessary safeguards were in place. I can honestly say that’s because of AAHRPP. We did what AAHRPP required, and that made the difference when the FDA came in. “We also believe that our accreditation status — and that of Cincinnati Department of Veterans Affairs Medical Center and Cincinnati Children’s Hospital Medical Center — will give a boost to our joint application for an NIH Clinical and

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As you can see from the comments below, organizational officials point to these and other — sometimes unexpected — advantages, ranging from additional opportunities for partnerships and collaboration to growing respect, within and beyond their organizations.

Translational Science Award (CTSA) grant. All three of us have received the AAHRPP stamp of approval, indicating that we’ve harmonized our human research protection programs and that we’re communicating with one another and working well together.”

The ‘Magnet’ Equivalent Ben H. Brouhard, M.D. Executive Vice President for Medical Affairs & Chief Medical Officer The MetroHealth System “For hospitals and health care systems, AAHRPP accreditation is the official designation of excellence — the HRPP equivalent of Magnet status. Like Magnet, accreditation requires a long-term commitment and is something that all organizations should be striving to achieve. “Many of the advantages of accreditation are actually realized during the self-assessment process because of the increased focus on policies and procedures. At MetroHealth, we’ve seen a heightened awareness and under-

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

A Centralized, Integrated Program Richard W. Bianco Associate Vice President for Regulatory Affairs University of Minnesota “What AAHRPP does particularly well is assess the entire research protection program, not just the role of the IRB or the activities of the investigators. Accreditation encourages organizations to develop a centralized, integrated program and to support that program with a culture of respect for compliance, from the president on down. “We have hundreds and hundreds of organizations in the United States that conduct research and, until now, there’s been no consistency. AAHRPP is changing that by requiring all accredited research programs to adhere to the same high standards.”


Competitive Advantages Through Partnerships Felix A. Khin-Maung-Gyi, Pharm.D., M.B.A., C.I.P., R.A.C. Founder / CEO Chesapeake Research Review, Inc. “We are starting to see some of the longer-term benefits of accreditation, such as the opportunity to partner with ethica Clinical Research, another accredited organization, for mutually beneficial outcomes. We believe that accreditation and this partnership make us more competitive because we can demonstrate — to our institutional and industry colleagues — that we’ve made a concerted commitment to excellence. “Everyone in our organization has embraced accreditation and its standards. Whenever we consider a change, we evaluate it with respect to accreditation standards. We are constantly cognizant of where the bar ought to be because accreditation has given us a visible, tangible target.”

On Par with Major Teaching Hospitals Leslie G. Selbovitz, M.D. Chief Medical Officer and Senior Vice President for Medical Affairs Newton-Wellesley Hospital “As a community teaching hospital, NewtonWellesley considers research to be a key component of physician training and patient care.

Our accreditation demonstrates that community hospitals can adhere to the same high standards — and conduct research of the same caliber — as the major medical centers. We can bring the advantages of research and the highest principles of protection directly to our community. “We recognized early on that everyone involved, from investigators to patients, would benefit if our HRPP were accredited. We decided to be among the first to seek accreditation, and we made that decision at a time when our program was expanding. We knew AAHRPP’s requirements would force us to develop and maintain the necessary protections.”

Aligning Sister Institutions Laurence J. Meyer, Ph.D., M.D. Associate Chief of Staff for Research and Development Department of Veterans Affairs Salt Lake City Health Care System “The accreditation process required us to work closely with our sister institution. We’ve always been fortunate to have a very cooperative, robust human research program with our academic affiliate, the University of Utah, but now our programs are better and are more closely aligned than before. The selfassessment made us aware of areas that needed improvement, and we improved them. It made us consider scenarios that we hadn’t experienced and required us to develop procedures to cover those scenarios. “Within our community of researchers, accreditation is highly respected. When they see the AAHRPP seal on our applications and our pro-

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

Respect and Collaboration Laura J. Jenski, Ph.D. Vice President for Research The University of South Dakota “A major benefit of accreditation is the respect that our program has gained from faculty. They appreciate the effort and input that went into attaining accreditation, and they realize its significance to our program and to the university. As a result, they have a better understanding of what we require of them, and why. “Accreditation also has provided valuable opportunities for us to network with other accredited organizations — to exchange information and collaborate with institutions that have similar experiences and face the same complex issues.”

Providing an Accredited Choice Sharon Hill Price, B.S.N., M.S. Founder and CEO Copernicus Group IRB “We sought accreditation because we recognized its potential to assure the best possible protections for research subjects. Once we attained accreditation, we felt an obligation not just to continue to improve our own processes but also to C O N T I N U E D O N PA G E 6

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Continuous Improvement

educate the public — to let them know that, increasingly, they will have a choice between accredited and non-accredited organizations. “Over the past three years, we’ve seen a growing awareness of AAHRPP and the value of accreditation. In fact, when people approach us about providing IRB services, one of the top five questions they ask is ‘Are you accredited?’”

Lynn A. Meyer, C.I.P., C.I.M. President IntegReview Ethical Review Board

Building Integrity, Confidence Chee Yam Cheng, M.B.B.S., F.A.M.S., F.R.C.P. (London), F.R.A.C.P. Assistant CEO (Clinical) National Healthcare Group, Singapore “The rigorous accreditation process resulted in system wide improvements that provide greater protection for research participants and ensure the integrity of the research conducted in our institutions. Because AAHRPP accreditation sets the highest standards for clinical studies, the pharmaceutical industry, academic drug developers, and regulatory bodies can have confidence in the quality of data they receive from studies conducted here. “With accreditation has come increased awareness of the importance of a robust HRPP. Consequently, we are allocating more resources to educate investigators and coordinators and to engage patients on their rights and safety. We are also building a pool of talented clinician scientists to support the growth of Singapore’s biomedical industry.”

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“AAHRPP’s emphasis on continuous process improvement is a significant benefit for our clients and for us. Accreditation provides an assurance of an ongoing commitment to ethics, standards, and quality. It requires us to stay on top of changes and additions to guidelines and regulations, and to incorporate them effectively into our policies and practices. “Already we’re seeing the impact of having the AAHRRP seal of excellence on our Web site and printed materials. We are being contacted by new clients who are interested in us because they know we’re accredited.”

Increased Awareness, Investment Juan M. Sanchez, Ph.D. Vice President for Research University of Texas at Austin “In my view, the accreditation process was the best thing that could have happened to our program. The process has raised the level of awareness of administrators, faculty, and students. It also has driven a significant increase in our investment in compliance. We now have an Office of Research Support and Compliance that coordinates human subjects research, animal care and

use, and biosafety. We have four coordinators for human subjects research, all of whom have a Ph.D. or medical degree. “The quality of our program has always been good, but now we put an even greater emphasis on training for everyone involved. One result is that our graduate students are more aware of research protections and better prepared as they move on to develop their own research programs.”

International Assurances Janice E. Parente, Ph.D. President ethica Clinical Research, Inc. “Our joint venture with Matrix Group in India would not have been possible if we weren’t accredited. Both Matrix Group and the Indian government wanted a partner they could count on to hold itself to high standards and minimize the risks to research volunteers. As the only contract research organization (CRO) in the world to have earned AAHRPP accreditation to date, ethica was in a unique position to provide what Matrix Group and the Indian government were seeking. “Having that seal of excellence from AAHRPP served almost as our letter of recommendation. It offered assurances that no other CRO could provide.”


USC: Moving Forward with a Fully Accredited HRPP For the University of Southern California (USC), AAHRPP accreditation represents an important step in an ongoing effort to remain among the nation’s leading human research protection programs (HRPPs). Even before the university was notified that it had been awarded full accreditation, Susan L. Rose, Ph.D., Executive Director of USC’s Office for the Protection of Research Subjects (OPRS), had developed an ambitious agenda for the 2007–2008 academic year, building upon the lessons learned during the accreditation process. At the heart of that agenda is a continued emphasis on innovation, collaboration, education, quality improvement, and communication. OPRS presented its plans to the USC community in the July issue of the OPRS newsletter, detailing a comprehensive, coordinated plan to

ensure continued adherence to the expectations set and promises made during the accreditation process. The newsletter is available at www.usc.edu/admin/provost/oprs/ news/archives/index.html. Click on Volume 3, Issue 4. “Accreditation is the gold standard, but that doesn’t mean we stop once we attain it,” Dr. Rose explains. “Instead, we view accreditation as a validation of our program and an incentive to push forward.” In the 2007– 2008 academic year, OPRS will collaborate with research professionals from the university’s Health Research Association, Health Sciences Campus, School of Pharmacy, and General Clinical Research Center to implement a continuous quality improvement program that will involve regulatory science students in designing and

conducting audits. In October, USC and the University of California, Los Angeles will host an IRB retreat featuring guest speakers and topics that go well beyond regulatory issues. As part of its education efforts, OPRS will continue to conduct monthly education sessions during the academic year and offer individual, classroom, faculty, and group sessions upon request. OPRS is also developing a first-of-its kind education guide for community members who serve on IRBs. Like all OPRS publications, the guide will be available for users nationwide. It is the next in a series of publications that target specific audiences, including students, investigators, and research participants. All OPRS efforts are designed to exceed the requirements and fulfill the intent of accreditation. “AAHRPP accreditation isn’t just about following regulations,” Dr. Rose says. “It’s about doing everything we can — often as innovatively as possible — to protect participants.” Information: Susan L. Rose, Ph.D., oprs@usc.edu, www.usc.edu/admin/ provost/oprs/, (213) 821-1154.

UK: Tapping International Consultants The University of Kentucky’s (UK) Office of Research Integrity maintains a list of international and cultural consultants to streamline the protocol review process, ensure that Institutional Review Board (IRB) decisions reflect cultural sensitivities, and provide maximum protection for research participants. Before it is submitted to the IRB, each research protocol is screened to determine whether an international or cultural consultant will be required. Consultants are selected, based on their expertise, from a list that is

continually updated to make sure it remains current and comprehensive. “The consultants qualify on the basis of their cultural or linguistic knowledge or training,” explains John V. Ryan, J.D., Professional Associate in UK’s Office of Research Integrity. “And, of course, there can be no conflict of interest or even appearance of impropriety.” UK developed the list and screening process, in part, in response to an increase in the number of research protocols, especially those involving international participants and indi-

viduals from geographic regions not represented on the IRB. “Identifying consultants is a challenge for IRBs everywhere,” says Ada Sue Selwitz, Director of UK’s Office of Research Integrity. “Our university’s Office of International Affairs is a valuable resource in identifying consultants. Others are recruited at the recommendations of investigators and IRB members. Once an individual is recruited, we ask permission to add them to our list for future reviews.” Information: John V. Ryan, J.D., john.ryan@uky.edu, (859) 257-2978. A A H R P P A D VA N C E

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Newly Accredited Organizations AWARDED SEPTEMBER 2007

AWARDED JUNE 2007

Full Accreditation

Full Accreditation

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Department of Veterans Affairs Huntington VA Medical Center, Huntington, WV Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Edward Hines Jr. VA Hospital and North Chicago, VA Medical Center, Hines, IL Harvard University Faculty of Medicine, Boston, MA Manchester Veterans Affairs Medical Center, Manchester, NH Marshall University, Huntington, WV The Board of Regents of the University of Oklahoma, Oklahoma City, OK The Department of Veterans Affairs New York Harbor Healthcare System, Brooklyn, NY The Memphis Veterans Affairs Medical Center, Memphis, TN University of Kansas Medical Center, Kansas City, KS VA Sierra Nevada Health Care System, Reno, NV Veterans Affairs Caribbean Healthcare System, San Juan, PR Veterans Affairs Medical Center, Oklahoma City, OK

AAHRPP

ADVANCE

is published quarterly by the Association for the Accreditation of Human Research Protection Programs, Inc. Executive Director: Marjorie A. Speers, Ph.D. Editor: Elisa Gallaro Clifton Park, NY Design: Levine & Associates, Inc. Washington, DC Printing: Todd Allen Printing Co., Inc. Association for the Accreditation of Human Research Protection Programs, Inc.® (AAHRPP®) 915 15th Street, NW, Suite 400 Washington, DC 20005 Phone: (202) 783-1112 Fax: (202) 783-1113 accredit@aahrpp.org www.aahrpp.org

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Cincinnati Children’s Hospital Medical Center, Cincinnati, OH Cincinnati Department of Veterans Affairs Medical Center, Cincinnati, OH Department of Veterans Affairs (VA) Salt Lake City Health Care System, Salt Lake City, UT IntegReview Ethical Review Board, Austin, TX The MetroHealth System, Cleveland, OH The University of Utah, Salt Lake City, UT The Veterans Affairs Pacific Islands Health Care System, Honolulu, HI University of Cincinnati, Cincinnati, OH University Hospitals Case Medical Center, Cleveland, OH University of Kentucky, Lexington, KY University of Rochester, Rochester, NY University of Southern California, Los Angeles, CA VA Palo Alto Health Care System, Palo Alto, CA Veterans Affairs Healthcare Network Upstate New York at Albany, Albany, NY Virginia Commonwealth University, Richmond, VA

Qualified Accreditation ■

Lexington VA Medical Center, Lexington, KY

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V4.3 - Advance - Fall 2007