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advancing human protection in research.

Summer 2005, Vol. 2, No. 2

Understanding—and Acknowledging— the Public’s Perspective The articles below feature three AAHRPP Board members who, as representatives of the public, have agreed to share their insights on how the public perceives research and its benefits. One article is a personal account of a patient who volunteers for clinical trials—and what she expects in return. The other highlights the advances made possible by cancer research and, despite those advances, the reluctance on the part of some to participate in clinical trials. Both underscore the influence AAHRPP accreditation can have on building public confidence in the safety of clinical trials, strengthening the partnership between scientists and participants and, ultimately, furthering research and the resulting breakthroughs.

An Alpha’s Story One woman’s experience as a research participant and Board member of AAHRPP t was the evening of May 8, 2001, and I was watching television, trying without success to ignore that it was getting more difficult for me to breathe. I hadn’t felt quite right since starting on a clinical trial of a new inhaled pulmonary medication two weeks previously, but this was more pronounced. Something was definitely wrong. I walked over to the oxymeter that always hangs from my treadmill. My suspicions were confirmed: My oxygen saturation had dropped from my usual norm of 96 to 82. I tried not to panic. Instead, I turned on my oxygen concentrator, jacked it up to 6 liters, and vowed to call my physician/investigator first thing in the morning. My name is Sarah Everett, and I have severe Alpha-1 Antitrypsin Deficiency (A-1AD). An inherited protein deficiency, A-1AD predisposes those it afflicts to lung and liver disease. It is a rare disorder affecting an estimated 100,000 persons in the United States, of which only 6,000 are diagnosed. I was diagnosed in 1993. Four years later, I joined the board of the Alpha1 Foundation. The Alpha-1 Foundation was established in 1995 by three Alphas (persons with A-1AD): John Walsh, Susan Stanley, and Sandy Lindsay. Their goal was to attract sponsors and research

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The Role of Trust in Furthering Cancer Research

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ver the past decade, five-year cancer survival rates have increased to 64 percent from 59 percent, according to the National Cancer Institute and Centers for Disease Control and Prevention. This improvement is a direct result of years of research, primarily via clinical trials. Yet despite such successes, few eligible adults opt to participate in research. In fact, according to the newsletter CenterWatch, of the 50,000 clinical trials underway in the United States, 80 percent are delayed at least one month because of unfulfilled enrollment. If even 10 percent of eligible cancer patients participated in clinical research, studies could be completed in one year, instead of the current three to five years. The reason for this reluctance can be summed up in one word: trust. AAHRPP seeks to build that trust both by offering accreditation to organizations engaged in research and by ensuring public representation on the AAHRPP Board. Five of the 23 Board members represent research participants and other community stakeholders. Two of the five work in the cancer field: Susan Weiner, President of the Children’s Cause for Cancer Advocacy, continued on Page 3 ...

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• NHC— serving our constituencies as a founding member, 5 • HRPP innovations, 6 • AAHRPP tips, 7


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Executive Director Giving Voice to Different Perspectives Marjorie A. Speers, Ph.D.

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Human Research Protection Programs. Nearly n the most fundamental level, research All [of 300 research professionals attended the meeting, is about the public. It is the public’s tax AAHRPP’s which took place March 13-15 in Atlanta dollars, after all, that fund many of our founding and featured plenary talks by the following nation’s most promising research efforts. It is the public who must volunteer to participate in members] are government and industry leaders: Raynard Kington, Deputy Director of the National research studies. And, ultimately, it is the public determined Institutes of Health; Deborah Holzman, Acting who will benefit from research discoveries. Deputy Associate Director for Science at the Given these vested interests, it’s only fitting to ensure for Disease Control and Prevention; that the public is represented, via patient and that research Centers Stuart Plattner, Human Subjects Research disease advocacy organizations, among the continues Officer, National Science Foundation; Bernard founders and Board of Directors of AAHRPP. In many ways, their view is the same as that of to grow and Schwetz, Director, OHRP; and Ted Roumel, Senior Adviser at Pharmaceutical Research and other founding members: the representatives flourish. All Manufacturers of America. Clearly, accreditation of universities, medical schools, and teaching hospitals; biomedical, behavioral, and social recognize that is regarded as a strong tool for quality and accountability. scientists; and IRB professionals. All are this will be improvement Because one of AAHRPP’s core values is determined to ensure that research continues to possible only education, the conference agenda followed three grow and flourish. All recognize that this will be possible only if research participants are assured if research tracks: innovative practices, common findings, aspects of the accreditation process. All were of the utmost protection. participants and designed to offer insights—from individual This commitment to the highest standards of are assured research organizations and collectively—into protection takes on a different level of urgency for those who participate in research studies or have of the utmost ways that organizations are building the best possible protection programs. We were gratified loved ones who serve as research participants. protection. to hear that attendees found these sessions For this reason, we thought it important to share helpful not just to prepare for the accreditation their perspective with you in this issue. Starting process, but also to learn of vital information about human on Page 1, we feature the first-person account of a Board research protections. member who, as an Alpha, willingly participates in clinical Another objective of the conference was to create an trials. We then highlight the experience of two individuals environment in which organizations that are already who have benefited from cancer research. All three of accredited could share their experiences with those still these individuals feel strongly that accreditation can play navigating the process. This networking occurred during a a key role in cementing the partnership between research devoted session as well as in informal settings, and we heard participants and practitioners. repeatedly how valuable these encounters were. We also provide two other perspectives on the We intend to offer similar opportunities at the 2006 importance of accreditation. On Page 5, we present conference, for which planning already is underway. the views of the National Health Council, a founding Your input is always welcome, so please send suggestions member that represents the interests of 110 health-related about any topics you’d like to see covered to us at organizations. On Page 8, Bernard Schwetz, Director of accredit@aahrpp.org. the Department of Health and Human Services Office for Finally, we’d like to express our appreciation to those Human Research Protections, shares OHRP’s reasons for organizations that worked with AAHRPP to make the encouraging accreditation. 2005 event so successful—our exhibitors, supporters of refreshments, and contributors of unrestricted educational Conference Update grants. We look forward to working with you again The advantages of accreditation were discussed at some next year. § length during our 2005 AAHRPP Conference: Quality

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3 The Role of Trust in Furthering Cancer Research, from Page 1 ... and Steven Friedman, Program Manager for IQ Solutions, which provides day-to-day operational support for the Cancer Therapy Evaluation Program’s Protocol and Information Office at the National Cancer Institute. Both have been touched by cancer and feel strongly that research must continue. Both also believe that accreditation can foster the trust that promote participation in clinical trials. “Accreditation can advance research by reassuring patients and families that accredited organizations conducting research meet clear and demanding ethical standards,” Weiner said. “AAHRPP lends a public face to accreditation and instills public confidence in the research enterprise.” Weiner is the parent of a child who survived cancer for 13 years before succumbing to the disease. After working for many years as an advocate for children with brain tumors and disabilities, in 1999 Weiner founded the Children’s Cause to give voice to the concerns of childhood cancer patients, survivors, and their families, and to empower them to assume leadership roles in pediatric cancer advocacy. She believes that as molecularly targeted therapies move into pediatric oncology trials, patients and families can continue to have confidence that the conduct of this clinical research meets the highest ethical standards. “Confidence derives directly from families’ trust in their physicians and in the institutions that enroll their children in therapeutic research,” Weiner explained. She is quick to emphasize the dramatic beneficial results of research, citing increased survivor rates for children with cancer and breakthroughs in treatment of testicular cancer. “Thirty years ago, adolescents afflicted with testicular cancer didn’t have a chance,” she said. Steven Friedman is proof of the progress that research has brought for those with testicular cancer. He was diagnosed in June 1995. Back then, he’d been married only a year and a half, and was working in health care while pursuing a master’s in Health Policy. Friedman was successfully treated that summer and fall at George Washington University, first with surgery and then chemotherapy. Using the five-year survival rate as the benchmark, he considers himself cured. “My treatment protocol was the result of the time and energy that researchers and patients devoted to the clinical trials process,” Friedman said. He views his involvement with AAHRPP as a chance to help cancer patients continue to benefit from the hope and advances that only research can provide. “My affiliation with AAHRPP allows me to promote a research environment that benefits patients and helps recruit more participants for clinical trials,” he said. “Such

an environment will allow for the more rapid development of effective treatments.” To him, there are clear and significant advantages to accreditation, for researchers and patients alike. “Every research organization that can demonstrate a sound, ethical research program through accreditation will have an edge in attracting participants for clinical trials,” Friedman said. “Participants will know that the investigator and research staff will protect them, that an unbiased third party has reviewed the ethics of the research protocol, and that the research team meets the highest ethical standards.” §

“Accreditation can advance research by reassuring patients and families that accredited organizations conducting research meet clear and demanding ethical standards.” —Susan Weiner President of the Children’s Cause for Cancer Advocacy

Summer 2005


4 An Alpha’s Story, from Page 1 ... scientists to stimulate research for a cure—something that can be difficult for rare disease groups. The founders began by building an infrastructure, including a board, half of whom must be Alpha-1 Antitrypsin Deficient; a medical and scientific advisory committee; a research registry; and an ethical, legal, and social advisory working group. To help ensure a steady stream of funding, the founders established AlphaNet, a not-for-profit health management company whose mission is to provide services to Alphas, with profits going to the Alpha-1 Foundation. Next, they sponsored a series of workshops involving research scientists in Alpha-1 and other related diseases. Last, but not least, they embarked on a fundraising campaign and began offering grants to researchers in Alpha-1. The Alpha-1 Foundation has succeeded beyond anyone’s wildest dreams. Our annual budget is over $5 million, and we have funded more than $15 million in Alpha-1 research. With that success, however, has come a new challenge: finding enough Alphas to volunteer for an ever-increasing number of clinical trials. The Alpha-1 Research Registry has helped enormously—to date we have registered over 2,800 Alphas and Alpha carriers. But fears over subject safety continue to be a problem, especially for those of us with severe lung and liver disease. To address those fears, the Alpha-1 Foundation Board supported my nomination to the AAHRPP Board of Directors as a public member. The Foundation also became the first patient group to ask potential research grantees whether their organization’s human research protection program is accredited. Almost by definition, participation in a clinical trial carries the risk of an adverse event. Yet Alphas are generally willing to step forward and volunteer because of their desire for better treatments and, ultimately, a cure—if not for themselves, then for their children and grandchildren. At the same time, they want every assurance that the risk of adverse events has been minimized. Furthermore, they want the assurance that procedures will be in place to immediately identify and treat adverse events should they occur. Fortunately, my personal story had a happy ending. My physician/investigator saw me first thing the next morning, ran a battery of tests, and temporarily suspended me from the trial. Two days later he repeated the tests and withdrew me from the trial permanently. Six weeks later, the tests were repeated and I was back to normal. Then, after a number of other subjects also experienced adverse events, the trial was suspended indefinitely. Clinical research today is a partnership between the research scientist and the research subject. In return for volunteering, the research subject expects not only better treatments and, hopefully, a cure, but also the best

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protections available. The AAHRPP Board reflects the research scientist-research subject partnership. Putting in place policies and procedures that maximize human research subject protections is what AAHRPP accreditation is all about. §

Newly Accredited Organizations Announced The following organizations were awarded accreditation at the March 13 meeting of the AAHRPP Council on Accreditation: • The University of New Mexico Health Sciences Center—Full AAHRPP Accreditation • Indiana University-Purdue University, Indianapolis—Qualified AAHRPP Accreditation. The Council will meet again in early June. A list of accredited organizations is available at www.aahrpp.org.

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News notes The Council of Accreditation is composed of nationally recognized individuals who represent IRBs, investigators, and the public. The Council is charged with making accreditation determinations. Five individuals were newly elected to the Council on Accreditation beginning March 13, 2005. John M. Falletta, M.D. Duke University Medical Center Karen N. Hale, R.Ph., M.P.H. The Ohio State University Karen Hansen Fred Hutchinson Cancer Research Center Moira A. Keane, M.A., C.I.P. University of Minnesota David Wynes, Ph.D. The University of Iowa The Alzheimer’s Association recently published an article in the journal Alzheimer’s Disease and Associated Disorders (2004, Vol. 18 No. 3) entitled, “Research Consent for Cognitively Impaired Adults: Recommendations for Institutional Review boards and Investigators.” The article outlines practical guidelines to help investigators and IRBs in the informed consent process.


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NHC: Serving Our Constituencies as a Founding Member

For more information on the National Health Council, visit www.nationalhealthcouncil.org.

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accreditation addresses allegations of carelessness and he National Health Council (NHC) is a founding corner-cutting by investigators and their institutions. It member of AAHRPP for a simple reason: to also helps avert potential suspension of clinical research safeguard the welfare and rights of human by the federal government (which occurred in some of the participants in research by ensuring a high level of ethical nation’s most prestigious academic medical centers) and and professional conduct among research institutions. ensures that research organizations will be as accountable Like our six co-founding organizations, NHC believes that to the public for human research as they strengthening the quality, integrity, and currently are for animal research. ethics of clinical research requires a total By encouraging research organizations institutional commitment that can best We believe that, to seek accreditation, NHC can help achieve voluntary accreditation. through active ensure the protection of those patients it NHC brings 110 member represents. Patient-based organizations organizations—representing millions of participation in play a vital role in this effort. In fact, as people—to the accreditation table. A part of their grant-making procedures, private, nonprofit umbrella organization the accreditation some now ask whether a researcher’s of national health-related organizations, process, research organization is accredited and, if not, we work to bring quality health care to whether the organization intends to seek all people, especially those with chronic institutions will accreditation. This simple step helps raise diseases or disabilities. help preserve awareness among investigators and their Our core membership includes 50 research institutions. It also sends a clear of the nation’s leading voluntary health the public’s message that patient-based organizations agencies (patient-based organizations). take the protection of human participants Together, they represent approximately confidence in seriously. 100 million people. Some help recruit the research that As accreditation becomes more participants for clinical research and widespread, patient-based organizations maintain patient registries of potential holds so much will enjoy increased confidence that their research participants. All deeply research funds are going to organizations understand that clinical research is potential to with high-quality protection programs— essential if we’re to find relief from, and improve health those that are dedicated to ethical perhaps a cure for, specific illnesses. Other NHC members include professional and quality of life. research and human safety, and compliant with federal and state regulations. and membership associations, nonprofit Public trust in and support for organizations with an interest in health, research are critical and depend on research organizations and representatives of business and industry. providing increased accountability. NHC believes that We believe that through active participation in the patient-based organizations and the communities they accreditation process, research institutions will help preserve serve will be able to rely on accreditation as a signal that the public’s confidence in the research that holds so much researchers and their institutions regard human safety as a potential to improve health and quality of life. In addition paramount concern. § to promoting the protection of research participants, such

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AAHRPP founding members: Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Association of State Universities and Land-Grant Colleges, National Health Council, and Public Responsibility in Medicine and Research. Summer 2005


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HRPP Innovations

As part of its educational mission, AAHRPP periodically disseminates information on innovations encountered in accredited organizations.

IUPUI’s Tracking Log for Non-Reportable Events Checklists for Vulnerable Populations at UNMHSC

Checklists for Vulnerable Populations at UNMHSC IUPUI’s Tracking Log for Non-Reportable Events IRB staff at The University of New Mexico Health Faced with a large volume of reports on non-reportable Sciences Center (UNMHSC)—which was awarded Full events, the IRB at Indiana University-Purdue University, AAHRPP Accreditation in March—have developed a series Indianapolis (IUPUI)—which received Qualified AAHRPP of checklists to guide deliberations on research involving Accreditation in March—devised a solution, which ensures vulnerable populations. that both adverse and non-adverse events receive the Checklists take into account all regulatory attention they deserve. requirements. They have been in place for Under the IUPUI policy for reporting During IRB about a year on the following topics: adverse events, only events that are serious, unexpected, and likely related to the research meetings, the • Research Involving Children Subpart D procedures must be reported to the IRB. • Research Involving Devices checklists are But due in part to sponsor expectations that • Research Involving Neonates projected on investigator reporting be thorough, IUPUI • Research Involving Pregnant Women was experiencing an over-reporting problem. a screen via • Research Involving Prisoners “Our IRB, of course, needs to be properly laptop and serve • ICD and HIPAA Waiver notified of serious or potentially serious “During IRB meetings, the checklists are events,” said Shelley Bizila, MS, CIP, Director as a guide for projected on a screen via laptop and serve as of Research Compliance Administration at discussion. This a guide for discussion,” said Linda Petree, IUPUI. “But as the number of reports reached Senior Human Research Review Analyst. new procedure 6,000 in a year, it was becoming a huge “This new procedure ensures that research administrative burden.” ensures that trials are held to a consistent, high standard. What’s more, there was the potential research trials By making certain that all relevant protocols for the administrative problem to affect are covered during discussion, the checklists participant protections. “If the IRB receives are held to a also reduce the need for the follow-up 100 reports a week, but only one meets the consistent, high investigations that were common—and time reporting requirements as a serious, adverse consuming—in the past.” standard. event, it’s easy for that one to get lost in the Comments from two primary reviewers are shuffle,” Bizila said. recorded during meetings. According to Dr. To prevent that from happening, IUPUI devised a William Reed, Executive Chair of the IRBs at UNMHSC, Tracking Log for Non-Reportable Events. Instead of the reviewers find the checklists extremely helpful. “There submitting separate, detailed reports on each non-reportable are so many regulations to be taken into account on these event, investigators list them in the log, where IRB staff types of protocols,” he explained. “Having the checklists as reviewed and acknowledged them. Actual IRB review a visual reminder guides members’ thinking and results in a is reserved only for those events that meet the “adverse” more organized review.” criteria. In part because of the positive reception to the “Now, everyone’s needs are being met,” Bizila said. checklists, IRB staff have also developed one for reviewing “Sponsors know that every ‘i’ is dotted and every ‘t’ crossed, waivers. “IRB members don’t deal with a lot of waivers, and the IRB enjoys the benefits of a more streamlined and so the checklist helps provide the groundwork for their accurate process.” § discussion,” Petree said. § Information: Shelley Bizila, sbizila@iupui.edu, Information: Gary Cseko, M.S.P.H., M.B.A., (317) 274-8289. gcseko@salud.unm.edu, (505) 272-1492.

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advancing human protection in research.

tip sheet Human Research Protection Program Plan Related Accreditation Elements: I.1.A, I.2.A, I.2.B, I.3.B, I.3.M, 2.1.D, and 5.2.B A human research protection program should have a written plan that describes the organization’s overall strategy to protect participants. A written plan is analogous to a strategic plan, a business plan, or a corporate compliance plan. The plan may be a comprehensive document or a single document that references other policies and procedures. The plan should be approved at the level of the organizational official or higher.

Recommended Content Suggested elements of a human research protection plan: a) The governing principles and standards for the human research protection program i.

The organization’s mission or goal statement regarding the protection of research participants

ii. The ethical principles that the organization follows to govern the conduct of human research iii. Applicable laws that govern the conduct of human research and when they are applied b) A description of the research overseen by the human research protection program i.

Criteria for defining when an activity is considered subject to the human research protection program. Such criteria should include all activities the organization is legally obligated to cover (e.g., DHHS and FDA regulations). Note: These criteria differ from those for whether a protocol must be reviewed by the organization’s IRB.

ii. The types of research typically overseen by the organization and the categories of participants typically involved in research c) The overall organizational structure for protecting research participants i.

Designation of who has overall responsibility for the human research protection program and the authorities granted to this person

ii. The components of the organization and the relationships among them that are involved with the conduct or oversight of human research protection iii. The roles and responsibilities for each component d) The organization’s activities that enhance compliance with regulations and the requirements of the human research protection program i.

The actions taken so that activities do not commence until the research has received all required approvals

ii. How employees or agents of the organization may communicate concerns or suggestions to the organizational official, and how those concerns and suggestions are addressed iii. How employees or agents of the organization may communicate allegations of coercion or undue influence to the organizational official, and how those allegations are handled iv. Plans for periodic review of the human research protection program, including, but not limited to, resources, policies and procedures, personnel, composition and number of IRBs, and participant outreach v. Other activities designed to enhance compliance

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OHRP Thoughts on Accreditation By Bernard A. Schwetz, Director, DHHS Office for Human Research Protections

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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)

ll activities that will potentially increase the protection of human subjects of research are important. Accreditation of Human Research Protection Programs (HRPPs) at organizations that review, conduct, or sponsor research is one of those activities that hold real promise to enhance the protection of research subjects. A considerable number of institutions have now been accredited, and many more have made the commitment to become accredited in the near future. Among federal agencies and offices that conduct research involving humans, accreditation is voluntary except for the Department of Veterans Affairs, where it is mandatory. Over half of the 116 research facilities of the VA are now accredited. Regarding HRPPs outside of the government, we hope that if enough institutions become accredited there may be a positive effect for the whole research community, not just for those that have achieved accreditation. Accreditation and peer pressure can encourage institutions that are operating below the floor of regulatory compliance to become

compliant, thereby enhancing the protection of human subjects throughout the entire research enterprise. The real cost of becoming and remaining accredited cannot be ignored, especially at a time when so many research units are already financially strapped. However, conducting research below the compliance threshold creates an environment of risk for human subjects and the threat of additional expenses for institutions. Accreditation should decrease the likelihood that an institution will have compliance problems that represent risk to research subjects. Accreditation isn’t the only way to enhance the protection of human subjects of research, but it certainly has the potential to be an important way. As accreditation moves forward, good documentation of the benefits and costs of this endeavor will enable refinement of this tool so that we can use it more effectively in our efforts to protect human subjects and the human research enterprise. §

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V2.2 - Advance - Summer 2005