APA's Science Policy Insider News June 2002

[ Subscribe to SPIN]  Friends of NICHD Testify on Capitol Hill Each year, representatives from various organizations and coalitions are allowed to appear in person before the congressional committee that determines the funding allocation for the National Institutes of Health (NIH). PPO’s Karen Studwell testified on May 2nd on behalf of the Friends of NICHD Coalition (a coalition of scientific and patient organizations that advocates increasing the budget of the NICHD, the National Institute of Child Health and Human Development) before the House Appropriations Subcommittee on Labor, Health and Human Services and Education. The Friends Coalition supports a 15% increase in NICHD funding for FY 2003, a level commensurate to the overall NIH budget increase proposed by the Administration. The Subcommittee chairman, Rep. Ralph Regula (R-OH), presided over the hearing. The complete Friends of NICHD testimony can be read at: http://www.apa.org/ppo/issues/snichdtestfy03.html. The Committee is currently in the process of determining how much money will be apportioned to the various agencies under its jurisdiction for FY 2003, including the NIH. The President has requested $27.3 billion for NIH for FY 2003, a 15% increase that would complete the bipartisan effort to double NIH’s budget over five years that began in FY 1998. However, the President has only proposed a nine percent increase for NICHD for FY 2003. The Friends request would increase NICHD’s budget to $1.284 billion. The Friends Coalition also sponsored a Capitol Hill Day on May 29th, where representatives of various coalition member organizations met with congressional staff to highlight the advances made by NICHD scientists, not only in areas of behavioral research, but also in vaccine research, infertility, medical rehabilitation, and genetics. Also highlighted were NICHD’s planning and development activities for several large studies, including the National Children’s Study. This proposed longitudinal study of pre- and post-natal growth and development seeks to uncover the contributions of the conditions and milieu in which children grow and develop. To fully fund the study, NICHD will require substantial congressional support in the coming years. More information on the National Children’s Study can be found at: http://www.nationalchildrensstudy.gov Tenth Annual Science Advocacy Training Workshop Each year, the science policy staff in PPO invites expert psychologists to come to Washington to participate in an advocacy training workshop. Attendees discuss and formulate a position on a particular policy issue that may impact psychological research or psychological scientists. They receive advocacy and media training and typically visit members of Congress or the Administration to advocate on behalf of psychological science. This year, participants were invited to discuss the potential local impact of certain provisions of the recently enacted No Child Left Behind Act, as well as other regulatory and community changes on school-based research. The workshop focused on developing strategies for overcoming barriers to high quality school-based research, because the social, legal and regulatory landscapes for conducting research in U.S. schools are changing.Social changes include the increasing number of active stakeholders in schools—including parents and community members-- who want the right to inspect the content of non-curricular surveys and have in many communities raised issues about documentation of informed consent. Legal changes include the No Child Left Behind Act (PL 107-110), which requires each local educational agency (LEA) to develop a policy to protect student privacy when surveys are given in schools on such subjects as violence, substance abuse and health behaviors. The same law requires each state to implement annual accountability testing for Grades 3 through 8 beginning in 2006. Changes in the regulatory landscape include added scrutiny by institutional review boards (IRBs) of social science research conducted with children, which has in many cases led to increased barriers to and costs of some survey research. The federal regulations to protect human participants in research are facing increased legislative and administrative review. In some states (e.g., New Jersey), state law now addresses such issues as documentation of informed consent. Workshop participants discussed these issues with representatives of the American Educational Research Association, National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, National Science Foundation, U.S. Department of Education, White House Office of Science and Technology Policy, Department of Health and Human Services Office of Human Research Protections, National School Boards Association, and Institute for Educational Leadership. Participants discussed how researchers are handling requirements for prior, written parental permission versus ‘passive’ parental permission, confidentiality, and privacy regulations. The group also discussed the important issue of what schools should receive in exchange for the disruption that may accompany non-curricular research. The speakers encouraged scientists who conduct risk behavior research to collaborate with educational researchers who may already have good, working relationships with schools and school districts. They were also encouraged to help educate their IRBs about social science research. Merry Bullock and Kurt Salzinger from the APA Science Directorate encouraged the group to share success stories about interactions with Institutional Review Boards to help with the Directorate's project on best practices in researcher-IRB relations. Participants are collaborating to produce a sample school board policy that would protect the privacy of students while permitting access for school-based research when appropriate. They will also work to produce a "Best Practices in School-based Research" document which may take the form of a journal article or special issue. Representatives from the National Institutes of Health indicated an interest in holding a conference to explore more fully the difficulties faced by school-based researchers who survey students about illegal and other sensitive behaviors. Science-PPO staff will follow up with the workshop participants to produce these products. Thirteen scientists whose research has been conducted in elementary and secondary schools participated:  Patricia Alexander, University of Maryland; Gwyn Boodoo, Educational Testing Services, Princeton, NJ; Ronald Brown, Medical University of South Carolina; Eric Bruns, University of Maryland School of Medicine; Jenifer Cartland, Children’s Memorial Medical Center, Chicago, IL; Kevin Chen, University of Medicine & Dentistry of New Jersey; Susanne A. Denham, George Mason University; Constance Flanagan, Pennsylvania State University; Linn Goldberg, Oregon Health Science University; Deborah Land, Johns Hopkins University; John Schulenberg, University of Michigan; Edward Seidman, New York University; Thomas Wills, Yeshiva University-Albert Einstein School of Medicine. The group is pictured here: http://www.apa.org/ppo/issues/10thadvtrainpics.html [back to top] Advocating for NSF’S New Science of Learning Centers Following up Nora Newcombe’s successful April testimony in support of National Science Foundation (NSF) funding, PPO invited an NSF-funded adult learning and memory researcher, Daniel Willingham, to further advocate for the new Science of Learning Centers on May 14th. Willingham, PPO’s Heather Kelly, and Executive Director of the Consortium of Social Science Associations, Howard Silver, met with the head Republican staffer on the House Appropriations Subcommittee to discuss congressional support for the NSF program, first detailed in the President’s FY03 budget. For the full story, go to: http://www.apa.org/ppo/issues/newcombepsa.html. SPIN readers can also visit the NSF Web site at: http://www.nsf.gov/bfa/bud/fy2003/overview.htm to read more about the new Science of Learning Centers, by scrolling down to the section on "Learning for the 21st Century Workforce.” Showcasing Behavioral Research at Capitol Hill Reception On May 15th, Dr. Roxane Silver of the University of California, Irvine, represented APA at the annual Capitol Hill Exhibition and reception highlighting NSF research. Silver’s national, longitudinal study of coping in the wake of September 11th was a powerful draw for members of Congress that evening, including Rep. Lois Capps (D-CA), Rep. Bob Etheridge (D-NC), Rep. Rodney Frelinghuysen (R-NJ), and Rep. David Price (D-NC). PPO staff also arranged meetings for Silver with her California delegation, including Sen. Dianne Feinstein (D-CA) and Rep. Christopher Cox (R-CA), who chairs the House Republican Policy Committee, as well as staff from the Administration’s Office of Homeland Security. In all of these meetings, Silver discussed real-world implications and applications of her research while highlighting the importance of continuing to support NSF’s basic research program. See http://www.apa.org/ppo/issues/02cnsfexhibit.html for photos of the exhibit and a summary of Silver’s study. Ten Psychologists on the Hill in Nine Days — This May be a Record In a remarkable nine-day period in mid-May, 2002, eight psychologists were invited to present expert testimony to six congressional committees and two other psychologists participated in a congressional science exhibit. We don’t know whether this is a record-- but the confluence of independent invitations provides a striking example of policymakers’ recognition that scientific psychologists have important and relevant information to share. Consider the schedule: May 15: Mark Goldman of the University of South Florida, co-chair of the Task Force on College Drinking of the National Institute on Alcohol Abuse and Alcoholism, presented data on prevention of college drinking at a Senate Governmental Affairs hearing. His testimony is available at: http://www.senate.gov/~gov_affairs/051502goldman.htm. To view photos of hearing go to: http://www.apa.org/ppo/issues/collegedrinkpics.html. More information on the NIAAA Report on College Drinking can be found at: http://www.apa.org/ppo/issues/call2action.html. May 15: Roxane Cohen Silver of the University of California, Irvine was invited by APA to represent us at the annual congressional ‘science exhibition’ sponsored by the Coalition for National Science Funding. Developmental psychologist Steve Ceci was invited by Cornell University to showcase his National Science Foundation-funded research at the same event. May 16: Health psychologists David Abrams of Brown University School of Medicine and Karen Matthews of the University of Pittsburgh were asked by Sen. Arlen Specter (R-PA) to present testimony before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education. Psychologist Peter Kaufmann of the National Heart, Lung and Blood Institute testified on behalf of NIH. Their statements appear on the PPO Web site at: http://www.apa.org/ppo/issues/call2action.html. May 21: Kelly Brownell of Yale University testified at a hearing on nutrition and physical activity called by the Senate Committee on Health, Education, Labor and Pensions. May 22: Psychologist Alan Leshner, Chief Executive Officer of the American Association for the Advancement of Science, testified before the Senate Commerce, Science and Transportation Committee about the need to double the budget of the National Science Foundation. His statement appears at: http://commerce.senate.gov/hearings/052202leshner.pdf. May 22: Substance abuse researcher Charles Schuster of Wayne State University provided testimony to the Senate Judiciary Committee on the disparity in sentencing between persons convicted of crack cocaine and powder cocaine sale or use. His full statement appears on the Committee’s Web site: http://judiciary.senate.gov/testimony.cfm?id=267&wit_id=579. May 23: Health psychologist Jessie Gruman, Ph.D., President of the Washington, DC-based Center for the Advancement of Health, testified before the House Energy and Commerce Subcommittee on Government Oversight on ways in which the Medicare program can take a larger role in the translation of behavioral research to practice. Her statement appears on http://energycommerce.house.gov/107/hearings/05232002Hearing573/Gruman985.htm. In some of these cases, PPO staff helped brief psychologists who were asked to testify, and offered help with their statements. In other cases, PPO staff had suggested names of prominent scientists as witnesses, and the congressional committees acted on some of the suggestions. And in several cases, we, in PPO, weren’t involved at all. While it’s good when one or more organizations can make opportunities for psychologists to testify, it’s even better when policymakers already know about the contributions of psychology or specific psychologists—when the data speak for themselves and no selling is necessary. Science PPO Supports NIMH, NIDA, and NIAAA Funding Increases APA is active in supporting funding increases for a variety of mental health research and mental health services programs within the Department of Health and Human Services (DHHS). On May 17th, PPO’s Karen Studwell participated in the Mental Health Liaison Group’s advocacy visits to educate congressional staff about the need for increased funding for mental health research, as well as mental health services programs. The Mental Health Liaison Group is a coalition of national organizations representing consumer, family members, advocates, professionals and providers. Each year, the MHLG Budget and Appropriations Subcommittee produces a comprehensive budget document recommending specific funding levels for the mental health services and research programs within DHHS. The MHLG appropriations document can be found at: http://www.mhlg.org/page5.html. Planning Underway for October 2002 FDA Abuse Liability Assessment Conference Evaluating the abuse liability of new and existing medications is a tricky business coordinated by the Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA). For nearly two decades, those government entities relied on the advice of leaders in psychopharmacology and substance abuse research to guide those evaluations in the form of the Drug Abuse Advisory Committee (DAAC). However, in the fall of 2000, much to the dismay of the external scientific community, the FDA dissolved the DAAC. APA’s letter to the FDA and FDA’s response can be viewed at: http://www.apa.org/ppo/issues/daacletters.html. Following a year and a half of negotiations, representatives from several organizations interested in scientific assessments of abuse liability met with FDA staff on May 20 to plan a fall conference that will provide a framework for research and development as it relates to the changing landscape of medications development. The meeting, organized by the College on Problems of Drug Dependence (CPDD), was led by APA Fellow, Charles "Bob" Schuster and was hosted by APA Fellow Jack Henningfield at the Bethesda offices of the health research/policy consulting firm of Pinney Associates, Inc. Representatives from several other organizations were either at, or had provided input prior to, the meeting including: APA, the American Academy of Addiction Psychiatry, American College of Neuropsychopharmacology, American Psychiatric Association, American Society of Addiction Medicine, American Society of Pharmacology and Experimental Therapeutics, Research Society on Alcoholism, and Society for Research on Nicotine and Tobacco. The planned conference comes 14 years after a CPDD sponsored conference on abuse liability assessment held in Princeton, New Jersey. That meeting was co-sponsored by the FDA, DEA, and NIDA and is summarized in NIDA Monograph 92, Testing for Abuse Liability Assessment of Drugs in Humans. This monograph provided a scientific foundation for two abuse liability guidance documents that have served FDA, researchers and pharmaceutical developers for the past decade: the Draft Guidelines for Abuse Liability Assessment (1990, G.E. Bigelow et al.), and the Draft Guidelines for the Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use Disorders (1992, G. E. Woody et al.). It was clear to many in the field that another such conference was overdue and, with the FDA's efforts to develop new guidance for drug abuse liability assessment, that convening such a meeting was particularly timely. Those in scientific leadership positions recognized the importance of involving FDA to the greatest extent possible in both its planning and attendance as it is among the major stakeholders with an interest in a thoroughly evaluated framework for abuse liability assessment. The FDA and other agencies involved in abuse liability assessment, researchers, NIDA and other NIH institutions that fund relevant research, and pharmaceutical companies, have a common interest in the following two main objectives of the meeting: To establish a practical framework for abuse liability assessment that will enable pharmaceutical developers and NIH to meet regulatory requirements issued by FDA and DEA; and To identify research needs and priorities that will serve researchers and research funding institutions. Further, the FDA Controlled Substance staff have identified several specific areas for potential research including the following: Abuse liability assessment in clinical efficacy trials, including methodology to identify abuse, dependence, misuse, and diversion across different potential patient populations. Reassessing methodological aspects of human abuse liability studies, including scale validation, selection of primary endpoints and of appropriate controls, and determination of appropriate statistical analyses to enable more thorough understanding and interpretation of the data. Post-marketing surveillance methodology, including operational definitions of abuse, misuse, and diversion. Determining appropriate data sources, signal recognition and limitations on putative data sources is needed, as is determination of appropriate methodology to estimate iatrogenic addiction outside of the closed medical settings. The relative significance and importance of pre-clinical behavioral studies warrants discussion. For example, what is the predictive value of behavioral tests across drug classes and how does the treatment history of subjects and other methodological factors influence the generality of the findings. [back to top] Results of Planning Meeting At the May 20 planning meeting, several preliminary decisions were made regarding the conference format, content, timing (October 28-29) and logistical considerations. The meeting will be structured to maximize active participation by attendees representing federal agencies, academia and industry. Commissioned background papers will be disseminated before the meeting with an October 1 target date for distribution. The background papers will likely include the following topics: an introduction to the meeting and needs for abuse liability guidance;  legislative history of the development and application of past guidance; and  summary and analysis of existing guidelines and reviews;  description of the types of drugs being addressed with emphasis on challenges posed by new entities, delivery systems and combinations;  methodological issues relevant to more than one drug class;  how clinical trials might more effectively provide data relevant to abuse liability assessment and abuse mitigation and;  post-marketing activities options to balance control of abuse with medical need.   Appropriate experts will be recruited to develop each background paper. In most cases, it was concluded that several persons might be involved in developing the papers to help ensure adequate coverage of the diverse and cross cutting topics. The presentations at the conference will focus on the recommendations and points for discussion from each individual paper to foster discussion that may enable the expert core advisory group (likely composed of previous DAAC Chairs and other agreed-upon experts) to produce a credible and practical framework document. Beyond the expert core advisors, liaisons from the federal agencies will be available to provide information and consultation to the extent allowable in their role as federal employees. In addition, a representative from the World Health Organization will provide an international perspective. As this issue of SPIN went to press, an abuse liability workshop was being held at the annual CPDD meeting in Quebec City to provide the basis for final resolution of papers, authors, and format for the October conference. Animal Learning Research at NSF On May 29th, a contingent of staff from APA and American Psychological Society joined leaders in the field of animal learning research to meet with the Directors of the Biological Sciences and Social, Behavioral and Economic Sciences Directorates at the National Science Foundation (NSF). The meetings, organized by APA Senior Scientist, Susan Brandon, were meant to raise awareness within the NSF of concerns in the scientific community about the decreasing support of research in animal learning and cognition. The group convened two separate meetings, one with Norman Bradburn, NSF, Assistant Director of the Social Behavioral, & Economic Sciences, and Philip Rubin, Director, Division of Behavioral and Cognitive Sciences, and a meeting with Mary Clutter, NSF, Assistant Director of the Directorate for Biological Sciences, Frank Greene, Director, Division of Integrative Biology & Neuroscience, and Joann Roskoski, Executive Officer, Biological Sciences. Present at both meetings were Peter Balsam, Samuel R. Milbank Professor of Psychology, Barnard College and Columbia University; Thomas Carew, Bren Professor and Chair, Department of Neurobiology and Behavior, University of California, Irvine; Karen Hollis, Professor of Psychology, Mount Holyoke College; Richard Thompson, Keck Professor of Psychology & Biological Sciences, University of Southern California; Edward Wasserman, Stuit Professor of Experimental Psychology, University of Iowa; Alan Kraut, Executive Director, American Psychological Society; Barbara Wanchisen, Executive Director, The Federation of Behavioral, Psychological, and Cognitive Sciences; APA’s Kurt Salzinger, Executive Director for Science; APA’s Geoffrey Mumford, Director of Science Policy; and APA’s Susan Brandon, Senior Scientist. A group picture can be found at: http://www.apa.org/ppo/issues/animalgrp-pic.html. The visitors presented arguments and evidence that good science in animal learning and cognition is not being supported by the NSF, that this science is vital nonetheless, and that this science remains critically important to allied disciplines, (an example of which is the importance of the systematic analysis of natural and artificial intelligence systems to behavioral neuroscience, and to behavioral ecology). The research in animal learning and cognition fits within the NSF mission to "promote the progress of science." One outcome of the meeting was to develop suggestions about how this science can be better represented and receive secure funding from the NSF. The meeting resulted in several short-term action items for participating organizations, including: Work with NSF Program staff to suggest how the Science of Learning Centers program announcements can be written so as to make it clear that basic research in fundamental mechanisms of animal learning and cognition will be supported by these Center programs. Send names (with CV and contact information) of psychologists who are willing to be actively involved in programs relevant to animal learning and cognition by serving as Division Director, Integrative Neurobiology Division (BIO), Program Director and Panelists for the Animal Behavior Program (IBN/BIO), Program Director and Panelists for the Cognitive Neuroscience Program (BCS/SBE), and Panelists for Science of Learning Center grant proposals. Longer-term action items included: Submitting a proposal for a workshop (to either SBE or BIO) for "The Science of Learning and Cognition in the 21st Century" that will serve to develop ways in which research in the fundamental mechanisms of behavior and cognition will remain as a cornerstone of both the behavioral and biological sciences. Participating in a workshop that is currently under development, being organized by the NSF that is designed to explore ideas about how computational neuroscience, neurobiology and behavioral science can be better supported (under the umbrella of "systems cognition and neuroscience") by the NSF. Participating in programs supported by a virtual division under development alternately called "Emerging Frontiers" or "Integrative Research Challenges in 21st Century Biology." Whatever it is eventually named, this will be a cross-directorate (SBE, BIO, and HER) initiative to support "radical and risky" research that is "falling through the cracks" via proposals and planning grants. Encouraging researchers to submit proposals to the Science of Learning Centers initiative, which is soon to be announced. Some unique opportunities are presenting themselves from which the animal learning and cognition community will benefit.  These include: a possible restructuring of the Biological Directorate, along with a desire within the Directorate to recognize how research in animal behavior and cognition serves as "sticky ends" between biology and behavior; the emphasis within the NSF generally, and within both the SBE and BIO Directorates specifically, to work collaboratively across disciplines; the recognition on the part of NSF Director Rita Colwell and the larger Washington policy community of the importance of social and behavioral science research. Assistant Directors Bradburn and Clutter both view an important part of their role at the NSF as being tuned to the excitement and needs of the research community. The reception of the visitors to the NSF was gracious, and the meetings were mutually informative and progressed in the spirit of working together on problems of collective concern. The usefulness of the meeting will depend on what actions are taken next, and on the ability of scientists within and outside of the NSF to continue to work together to address the needs of each. For more information or to offer assistance in this effort please contact Susan Brandon or Geoff Mumford. [back to top] Any questions? If you have any questions regarding SPIN or specific science policy issues, please feel free to contact any of APA’s Science PPO staff. Geoff Mumford, Ph.D., Director of Science Policy Pat Kobor, Senior Science Policy Analyst Heather O'Beirne Kelly, Ph.D., Senior Legislative and Federal Affairs Officer Karen Studwell, J.D., Legislative and Federal Affairs Officer LaTonya Wesley, Legislative Assistant

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