August 9, 2010 Volume 29- Issue 15
Cora Marrett Nominated as NSF's Deputy Director
In the early 1990s, she was the first Assistant Director for the National Science Foundation's (NSF) Social, Behavioral and Economic Sciences directorate. She returned to NSF in 2007 to serve as the Assistant Director for the Education and Human Resources Directorate. In early 2009, she became NSF's Acting Deputy Director. She has been serving as the Acting Director of NSF since May, when Arden Bement left to return to Purdue.
On August 6, President Obama nominated Cora Marrett to become the Foundation's Deputy Director. She now faces Senate confirmation, not an easy task these days. The President nominated Subra Suresh as the new NSF director on June 8, 2010. He has not been confirmed yet. On March 24, 2010 Carl Wieman was nominated as the Associate Director for Science at the White House Office of Science and Technology Policy. The Senate has not confirmed him either.
In between her stints at NSF, Marrett served as the Senior Vice President for Academic Affairs and Professor of Sociology at the University of Wisconsin System, as the Vice Chancellor for Academic Affairs and Provost of the University of Massachusetts, Amherst, and on the COSSA Board of Directors.
Prior to arriving at NSF in 1992 to head the SBE Directorate, she taught Sociology at Wisconsin, Western Michigan University, and the University of North Carolina. She has also served on advisory committees for the Ford Foundation, the Andrew W. Mellon Foundation, the National Academy of Sciences' National Research Council, and was a member of President Carter's Commission on the Accident at Three Mile Island.
Marrett is a fellow of the American Association for the Advancement of Science, Sigma Xi, and the American Academy of Arts and Sciences. She holds a B.A. from Virginia Union University, and an M.A. and a Ph.D. in Sociology from the University of Wisconsin.
Robert Kaplan Appointed NIH Associate Director for Behavioral and Social Sciences Research
On July 29, National Institutes of Health (NIH) Director Francis S. Collins announced the appointment of Robert M. Kaplan as Director, Office of Behavioral and Social Sciences Research (OBSSR) and NIH Associate Director for Behavioral and Social Sciences Research. Kaplan is expected to officially join the agency in early 2011.
Kaplan is currently at the University of California, Los Angeles (UCLA), where he is the distinguished professor in the Department of Health Services at the School of Public Health and the Department of Medicine at the David Geffen School of Medicine. He is the Principal Investigator of the UCLA/RAND Center for Disease Prevention and Control (CDC) Prevention Research Center and Director of the UCLA/RAND Health Services Research training program. Kaplan was formerly professor and chair of the Department of Family and Preventive Medicine at the University of California, San Diego School of Medicine.
When announcing Kaplan's appointment, Collins pointed out that the "NIH will benefit from Dr. Kaplan's longstanding proven expertise in high priority behavioral health areas such as tobacco-induced lung disease. His commitment to evidence-based behavioral research and his broad knowledge of health services research and epidemiology will be a significant asset to OBSSR and all of NIH."
His research interests include behavioral medicine, health services research, health outcome measurement and multivariate data analysis. He is a past President of several organizations, including the Society for Behavioral Medicine (SBM), the American Psychological Association's (APA) Division of Health Psychology, Section J of the American Association for the Advancement of Science (Pacific), the International Society for Quality of Life Research, and the Academy of Behavioral Medicine Research. He is a Past Chair of the Behavioral Science Council of the American Thoracic Society.
Kaplan is editor-in-chief of the APA's journal Health Psychology and received the APA's Division of Health Psychology's annual award for outstanding scientific contribution as a junior scholar in 1987 and as a senior scholar in 2001. He also received the SBM's national leadership award in 2004 and distinguished research mentor award in 2006. He was elected as a member of the Institute of Medicine in 2005. Kaplan is the author, co-author or editor of more than 18 books and approximately 450 articles or chapters. The ISI includes him in the listing of the most cited authors in the world (defined as above the 99.5th percentile).
Kaplan has an A.B. from San Diego State and earned an M.A. and Ph.D. in Psychology from the University of California, Riverside.
Congress Recesses for Summer: Spending Bills Continue to Emerge from Committees
The House left town on July 30. After confirming Elena Kagan to the Supreme Court, the Senate recessed on August 6. Aside from a two-day callback on August 9-10, when the House expects to agree to the Senate's legislation providing aid to the States to help retain school teachers and fund Medicaid, the Congress will not meet again until September 13. With political experts suggesting that control of the House and possibly the Senate are in play in this year's congressional elections, those seeking a seat in the 112th Congress in 2011 will have a busy recess.
Before leaving, the parade of FY 2011 spending bills emerging from Committees and in two cases from the House floor continued. On July 28, the House of Representatives passed the Military Construction/Veterans' Affairs spending bill and the following day it gave approval to the Transportation/HUD bill. Nine of the twelve spending bills have passed through the Senate Appropriations Committee. The House has moved its other ten spending bills through the Subcommittee level.
In addition, with the continued emphasis on reducing the deficit, there are reports that Senate Majority Leader Harry Reid (D-NV) might acquiesce to Senate Republican demands to drop the overall FY 2011 spending by another $6 billion. This would put the Senate number $19 billion below the President and $13 billion below the House.
Despite all this activity, the expectation is that most of the FY 2011 funding for agencies and programs of the federal government will end up in an omnibus bill following the election.
NIH Receives $1 Billion Increase from Senate Panel, same as House Subcommittee
The Senate Appropriations Committee in its version of the FY 2011 Labor, Health and Human Services, Education Appropriation bill recommended $32 billion for the National Institutes of Health (NIH); a $1 billion or 3.2 percent increase over the FY 2010 level. This is the same number as the President's request and the House Labor, Health and Human Services, Education Appropriations Subcommittee number and is equal to the rate of biomedical inflation.
In the report accompanying the bill, the Committee "recognizes that the NIH faces an imposing 'funding cliff' following the historic increase" -- nearly $10.4 billion - provided via the American Recovery and Reinvestment Act of 2009. "Negotiating the softest possible landing is critical to maintaining the scientific momentum gained over the past two years and ensuring that young investigators in particular can find a bright future in the field of biomedical research." The Committee acknowledges the 3.2 percent increase is less than what would have been desired in stronger economic times. It "hopes that this will mark the first of several years of growth for the NIH that, if not spectacular, are at least steady and predictable."
For the National Children's Study, the Committee includes $194.4 million to continue the study. The Committee expressed its appreciation for the improvement in management and oversight of the study that have occurred in the past year. "While the implementation of the main study has been delayed, the Committee believes this will allow more time to evaluate the project's scope and cost, and allow the NIH and the Congress to make better-informed decisions about its future."
The Committee report accompanying the bill also includes language affecting research agendas for social and behavioral science studies.
Committee Report Applauds OppNet
The Committee noted that it is pleased that the Basic Behavioral Opportunity Network (OppNet) was launched in FY 2010 with the support of 24 Institutes and Centers (ICs) and the NIH Director (see other story). The Committee further noted that it "has addressed basic behavioral science in many previous reports, and it applauds NIH's recognition that basic behavioral research is essential in efforts to improve the Nation's health." It understands that OppNet represents a minimum of a five-year, "cross-NIH initiative designed to fill critical gaps in the NIH's basic behavioral research enterprise." It requests an update on OppNet's progress in the FY 2012 congressional budget justification.
The report has language applauding the National Institute of General Medical Sciences for its leadership role in OppNet. The Institute is also encouraged to support basic behavioral research to its fullest potential, and to incorporate basic behavioral training in its forthcoming training plan.
Noting that women of racial and ethnic minorities face higher rates of disease including obesity, cancer, diabetes, heart disease, and HIV/AIDS when compared with white women, the Committee encourages the Office of Research on Women's Health (ORWH) to support research into the causes of health disparities and develop and evaluate interventions to address these causes. The Committee also underscored the need for continued and expanded collection of data capturing racial and ethnic information that is essential to understanding and reducing disparities.
Expressing its strong support for the Clinical and Translational Science Awards (CTSAs), the Committee states that it believes that greater involvement from all 27 ICs would help the program reach its full potential. Therefore, the Committee requests that the Director consider developing a formal, NIH-wide plan on how to align the CTSAs with the programmatic and funding priorities of the ICs.
The Committee stressed its concern regarding diabetes and noted that it "recognizes that more research and education is needed on the disparate effects of diabetes on minority populations."
Accordingly, the Committee urges the NIH to expand, intensify, and support ongoing research and other activities with respect to pre-diabetes and diabetes in minority populations, including research to identify clinical, socioeconomic, geographical, cultural, and organizational factors that contribute to diabetes in such populations. Specifically, the Committee encourages NIH to support studies on behavior and obesity; environmental factors that may contribute to the increase in type 2 diabetes in minorities; and environmental triggers and genetic interactions that lead to the development of type 2 diabetes in newborns.
The NIH is also strongly encouraged to develop a trans-Institute strategy for increasing funded research in palliative care for persons living with chronic and advanced illness. According to the Committee, research is needed on: treatment of pain and common non-pain symptoms across all chronic disease categories, which should include cancer, heart, renal and liver failure, lung disease, Alzheimer's disease and related dementias; methods to improve communication about goals of care and treatment options between providers, patients, and caregivers; care models that maximize the likelihood that treatment delivered is consistent with patient wishes; and care models that improve coordination, transitions, caregiver support, and strengthen the likelihood of remaining at home.
The agency is urged to support behavioral research aimed at reducing the likelihood of HIV infection by determining risk factors in various populations as well as the ways in which interventions need tailoring for specific populations at greatest risk of becoming infected.
Concern About Cancer in Adolescents
The National Cancer Institute (NCI) is encouraged to give additional consideration to adolescents, whose overall risk of contracting most cancers is lower than for adults, but who, because of factors peculiar to adolescence, are less likely to participate in clinical trials and often diagnosed at later stages. In particular, the Committee encouraged the Institute to focus research efforts on health communications strategies for adolescents, their families, and their health providers.
The Committee noted that NCI's research on smoking cessation, smokeless tobacco and collaborations with the National Institute on Drug Abuse (NIDA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Heart, Lung, and Blood Institute (NHLBI) are critical to building knowledge to reduce the use of tobacco in adolescents. The Committee believes that behavioral science should facilitate FDA regulation of tobacco, including consumer perceptions, development of warning labels, product development and response, risk communication, and cultural effects, and recommends that the NCI support such research.
The Committee also encouraged the NCI to fund research on how social media can be used to promote health behaviors and social support. Meanwhile, noting that social network analysis can be used to study the transmission of viral infections, behaviors, attitudes, information, or the diffusion of medical practices within social networks, NHLBI is commended for contributing to a recent trans-NIH initiative on social networks.
The National Institute of Dental and Craniofacial Research (NIDCR) is applauded for its recognition of behavior as a critical factor in oral health. The Committee encourages NIDCR to support research on the development of educational and behavioral oral health promotion interventions to improve maternal and infant oral health.
NICHD is recognized by the Committee for its "historic support for demographic research on the non-aged population" which has yielded "landmark scientific findings, confirming how health and well being in the early years affect long-term health and socioeconomic outcomes." The report noted NICHD's investment in large-scale, longitudinal studies, such as the National Longitudinal Study of Adolescent Health and Child Development Supplement to the Panel Study of Income Dynamics, and interagency data collections, including the National Survey of Family Growth and National Longitudinal Survey of Youth. The Committee states that it expects NICHD to sustain its support for these studies and "reaffirm its commitment to supporting research on how maternal factors before and during pregnancy and early life events affect health and well being in later life."
The Committee also noted that it is pleased that the NICHD supports a broad spectrum of behavioral neuroscience research, particularly as it relates to real-world problems. NICHD is further encouraged to support work on the effects of socioeconomic adversity on children's brain development. The Institute is encouraged to develop a program of research to better understand the immediate and long-term effects of stress in children, in contexts including families of deployed military personnel, and experiences in natural disasters and war zones.
Support Expressed for NIA Behavioral Economics Funding
The Committee expressed its support for the National Institute on Aging's (NIA) focus on the emerging research area of behavioral economics. The Committee encourages additional work on the topic. NIA is also urged to continue investments in its demographic research portfolio, particularly large-scale longitudinal studies such as the Health and Retirement Study. The Institute is also urged to continue working with other Federal agencies, including the Fogarty International Center, to support and expand its investment in national and international demographic projects. The Committee also backed NIA's continued support of the Roybal Centers for Translational Research on Aging.
The National Institute on Drug Abuse (NIDA) should continue its investment in behavioral genetics, especially in studies that combine genetic and behavioral approaches. The Committee "particularly commends research on the relationships among behavior, genetics and nicotine addiction, and how they impact cognitive function." NIDA should also maintain its investment in comparative effectiveness research "so that proven models of drug abuse prevention and treatment can be further refined." The Committee expressed concern about drug abuse and HIV/AIDS in criminal justice populations. It supports research efforts to empirically test the "seek, test, and treat," paradigm. NIDA "should continue its initiative in this area, which will yield important linkages to appropriate health services and effective HIV prevention, intervention, and treatment in those populations."
NIDA is recognized for its joint work with the Veterans' Affairs Department and other NIH Institutes to support research on substance abuse and associated problems among U.S. military personnel, veterans, and their families. The Committee noted that there has been very little research on how to prevent and treat the unique characteristics of wartime-related substance abuse issues. It notes that many returning military personnel need help confronting a variety of war-related problems including traumatic brain injury, post-traumatic stress disorder, depression, anxiety, sleep disturbances, along with substance abuse, including tobacco, alcohol, and other drugs. The Committee commends NIDA for this "crucial work" and asks for an update in the FY 2012 congressional budget justification.
The Committee recognized that immigrants in the U.S. experience unique stresses, prejudice, and poverty, and urges the National Institute of Mental Health to direct research on the adaptation, development, health, and mental health needs of diverse immigrant populations.
The National Institute on Minority Health and Health Disparities is encouraged by the Committee to support a new network of urban-based academic institutions focused on, and with demonstrated commitment and capacity to, addressing recruitment and training needs of minority and urban underserved populations and reducing health disparities in these urban communities.
Finally, the Committee provides $50 million to create the Cures Acceleration Network (CAN) which was authorized in the Patient Protection and Affordable Care Act. CAN will be administered under the NIH Office of the Director and is authorized to make grants to biotech companies, universities, and patient advocacy groups to target new discoveries that have shown potential at the laboratory level but have not advanced far enough to attract significant investments from the private sector.
Education Funding: Increases for Research and Statistics
The Senate Committee allocated $722.8 million for the Institute of Education Sciences (IES) in FY 2011, representing a $63 million boost over FY 2010, but $16 million below the request. The Committee recommended $240.7 million for the education research, development and national dissemination account; $40.5 million above FY 2010 and $20 million below the request. In the Committee's report accompanying the bill, it focuses IES' attention on the National Academies' report, Preparing Teachers: Building Evidence for Sound Policy, and asks IES to "help address the knowledge that the report identified." As in previous years, the Committee continued to express concern about the under-utilization of the What Works Clearinghouse.
The Committee provided $118 million for the data gathering and statistical analysis activities of the National Center for Education Statistics [NCES]; about $9.5 million above FY 2010 funding and a $1 million boost over the request. The panel wants NCES to "update the report, Condition of America's Public School Facilities: 1999."
The Regional Education Laboratories received a $2 million boost for FY 2011 to $72.7 million, while the Assessment account was allocated $143.8 million, the $5 million raise over last year requested by the Administration.The panel provided another $65 million for the development of statewide data systems "to design, develop, and implement statewide, longitudinal data systems to manage, analyze, disaggregate, and use individual data for students of all ages."
The Senate panel provided $127.9 million for the Title VI and Fulbright-Hays international education and foreign language program. This is a $2 million increase over the FY 2010 level and the President's request that will fund new undergraduate study abroad awards to be made "on a competitive basis to institutions of higher education individually or as part of a consortium and consistent with the recommendations of the Commission on the Abraham Lincoln Study Abroad Fellowship Program."
As they have been for many years now, the Javits Graduate Education Fellowship program and the Graduate Assistance in Areas of National Need (GAANN) were level funded. Javits received $9.7 million and GAANN a little over $31 million. The Thurgood Marshall Legal Educational Opportunity Program obtained $3 million for FY 2011 from the Committee, same as last year.
The Committee recommended $634.9 million for the Bureau of Labor Statistics (BLS); a $23.5 million boost over FY 2010 but $10 million below the request. The Committee report noted that the funding "includes resources to continue BLS efforts to: strengthen the current BLS examination of the differences between workers' compensation information and BLS survey data; better understand employer injury and illnesses recording practices; and conduct a pilot study of using multiple data sources to capture injury and illness data." The report also accepted BLS' request to restructure the current employment survey program and to develop an alternative source of data for locality pay surveys. The Committee also eliminated bill language included last year that required the BLS to continue the women worker series within the current employment statistics program. "The Committee understands BLS will continue this data collection as it currently exists; therefore, this bill language is unnecessary," the report indicated.
Obama Administration Outlines S&T Priorities for FY 2012 Budget
Despite an earlier memo advising agencies to prepare FY 2012 budgets with five percent reductions from the FY 2010 levels (see Update, June 14, 2010
), the Obama Administration through its Office of Management and Budget (OMB) and its Office of Science and Technology Policy (OSTP), has outlined its "Science and Technology (S&T) Priorities for the FY 2012 Budget."
In a July 21st memo from then-OMB director Peter Orszag and OSTP Director John Holdren, the Administration again makes the case that: "Scientific discovery, technological breakthroughs, and innovation are major engines for expanding the frontiers of human knowledge and are indispensable for promoting sustainable economic growth, improving the health of the population, moving toward a clean energy future, addressing global climate change challenges, managing competing demands on the environment, and safeguarding our national security." The Administration also maintains its long-term goal that research and development investment, both public and private, should reach three percent of the Gross Domestic Product.
The memo encourages new approaches to supporting multidisciplinary research and for accelerating technology commercialization and innovation, including incentive prizes, university-industry partnerships, proof-of-concept centers, and regional innovation clusters. Inter-agency coordination and international cooperation are two other important themes.
The Administration also stresses developing and sustaining datasets "to better document Federal science, technology, and innovation investments," part of the Science of Science and Innovation initiative led by the National Science Foundation and initiated by the previous science adviser John Marburger. Agencies should make the data collected "open to the public in accessible, useful formats" and "regularly update their data sharing policies for researchers."
The memo concludes that "agencies are expected to conduct programs in accordance with the highest standards of ethical and scientific integrity and to have clear principles, guidelines, and policies on such issues as scientific openness, scientific misconduct, conflicts of interest, protection of privacy, and the appropriate treatment of human subjects."
With regard to S&T challenges and areas that need strengthening in FY 2012, the Administration focuses on six:
*Promoting sustainable economic growth and job creation, which means supporting R&D on advanced manufacturing, a 21st century "bio-economy," and efforts to improve the value of enormous quantities of data;
*Defeating dangerous diseases and achieving better health outcomes while reducing health care costs, which calls for prioritizing research investments in biotechnologies and vaccine development;
*Moving toward a clean energy future by R&D investments in solar energy, next-generation biofuels, sustainable green buildings, and advanced vehicle platforms;
*Understanding, adapting to, and mitigating the impacts of global climate change by supporting interagency investments on climate change science, impacts, vulnerabilities, and response strategies, including mitigation and adaptation;
*Managing the competing demands on resources by integrating ecosystem management "that brings together biological, chemical, and human uses data into forecast models, assessments, and decision support tools;" and
*Developing the technologies to protect U.S. troops, citizens, and national interests by supporting cybersecurity R&D, verification technologies to help make the world free of nuclear weapons, and chemical and biological defense agents.
To achieve these objectives the Administration will: continue to strengthen Science, Technology, Engineering and Mathematics (STEM) education; protect the vitality and productivity of U.S. research universities and sustain support for fundamental research [this usually means the NSF budget]; boost the capacity and robustness of the nation's information and physical infrastructure; encourage partnerships among researchers, the private sector, civil society, and international entities; maintain capabilities in space; and promote "an economic and policy environment that promotes and rewards research, entrepreneurship, and innovation."
House Passes Bill to Establish a National Criminal Justice Commission
On July 27, the House of Representatives passed legislation, H.R. 5143, to establish a National Criminal Justice Commission. Sponsored by Rep. William Delahunt (D-MA), the bill asks the commission to "undertake a comprehensive review of the criminal justice system." A companion bill, S. 714, sponsored by Sen. James Webb (D-VA), has emerged from the Senate Judiciary Committee and awaits Senate action.
Supporters of the legislation hope the commission will produce a report comparable to The Challenge of Crime in a Free Society, issued by the President's Commission on Law Enforcement and Administration and Justice during the Lyndon Johnson Administration. That report led to the creation of the predecessor agency of the current National Institute of Justice and Bureau of Justice Statistics.
In making the case to the House for passage, Rep. Bobby Scott (D-VA), while noting the very high rate of incarceration in this country, declared: "The United States depends on the criminal justice system to maintain our safety and security and we expect it to be reliable, fair and effective. It must provide a sense of justice for all Americans, and must treat victims and their families with compassion."
For Delahunt, who retires at the end of this Congress, the goal of the legislation "is how do we deal with crime in America in a way that makes us safer, but saves us money, while still protecting fundamental American liberties and values?" At the same time, the commission, according to Delahunt, "will be tasked with improving the cost-effectiveness of the criminal justice system, so that tax dollars are not wasted on inefficient, ineffective programs."
The bill also garnered bipartisan support, with Rep. Lamar Smith (R-TX) and Tom Rooney (R-FL) speaking on behalf of the bill's enactment. Smith proclaimed that "passage of this bill represents an historic opportunity to undertake a bipartisan, thorough, and comprehensive review of what works and what does not work at every level of the criminal justice system."
According to the bill, the Commission shall have 14 members appointed by the President and Congress, four of whom will be State and local representatives. The individuals who serve should include people who are "nationally recognized for expertise, knowledge, or experience in such relevant areas" as: law enforcement, criminal justice, national security, prison and jail administration, prisoner reentry, public health, victims' rights, civil liberties, court administration, social services, and state, local and tribal government. The Commission will have a staff headed by an Executive Director.
The legislation calls for the submission of a final report 18 months after its formation. The bill's authors also hope "that given the national importance of the matters before the Commission, [it] should work toward unanimously supported findings and recommendations."
Children's Study Gets Continued Scrutiny
On July 21, the National Children's Study Federal Advisory Committee (NCSAC) met to continue its discussion surrounding the implementation of the National Children's Study (NCS). The NCS is led by a consortium of federal partners: the U.S. Department of Health and Human Services (HHS) [including the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC)], and the U.S. Environmental Protection Agency (EPA). The meeting was held in conjunction with the NCS' program office.
NCSAC's Interim Chair Carol Henry, George Washington University, welcomed the committee and recapped the NCSAC April meeting, both open and closed sessions, which included discussions regarding: clarifying roles of various advisory groups (Data Access and Confidentiality Committee, Federal Consortium, Independent Study Monitoring and Oversight Committee, Interagency Coordinating Committee, National Children's Study Federal Advisory Committee), the structure of the NCSAC meeting to allow for adequate discussion, a detailed Study data update, recruitment challenges, retention at future meetings, a summary of the NCS translation policy and how the NCSAC can publically support the NCS.
At the June 3rd, 2010 National Advisory Child Health and Human Development Council (NACHHD) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) then Acting Director Alan Guttmacher explained that implementation of the NCS' Main Study has been postponed until FY 2011. According to Guttmacher, the data from the first seven Vanguard Centers show that some of the initial assumptions about the Study recruitment were inaccurate. It appears that the recruitment strategies utilized by the Vanguard Centers have led to lower than expected enrollments. Accordingly, this would also result in an increase in costs to implement the study across the Main Study sites.
NCS Program Office's Acting Director Steven Hirschfeld updated the NCSAC members on the activities since their last meeting. Hirschfeld informed the Committee that their most valuable contribution at this stage is to bring their varying points of view to the continued planning for implementation. Accordingly, the NCSAC is meeting every 90 days. He echoed Guttmacher in noting the study is in transition as a result of a lack of specificity of outcomes anticipated from the Vanguard sites.
Recruitment Strategies Still Under Discussion
According to Hirschfeld, since October 2009 the NCS has been discussing three alternative recruitment strategies: 1) Provider-based recruitment (relies on health care providers for assistance in participant identification and recruitment), 2) Enhanced household enumeration (builds on the lessons learned in the existing Vanguard Study by enhancing enumeration techniques and employing a more streamline recruitment process), and 3) Two-tier high intensity, low intensity (relies on larger secondary sampling unites to increase the number of geographically-eligible women in a given area, and allows for both higher-intensity and lower-intensity forms of data collection.) Using the 36 study centers under contract, each with multiple locations under their jurisdictions, NCS has held three kick-offs to implement the strategies. Hirschfeld emphasized that the centers are only asking questions based on those they have been asking over the last year and a half. The primary outcome measures are recruitment and retention rates for the three proposed recruitment strategies.
The NCS has reframed the Vanguard Study scope of activity to focus on feasibility, acceptability, and cost of the elements that will form the NCS Main Study. Consequently, operational and performance data are presently the primary interest in the Vanguard Study. In February, NCS released the third in a planned series of announcements for letters of interest to augment Vanguard Study activities with efforts that will accelerate development and deployment of the Main Study. Hirschfeld emphasized that the Vanguard Study is designed to validate the activities that will be implemented in the Main Study. He noted that the first round of formative research proposals is ready to initiate. A second round of formative research proposals will begin in August, Hirschfeld informed the NCSAC.
This most recent call for Letters of Interest included opportunities to develop and enhance real-time assessments that can be shared with participants and communities; to analyze and enhance study logistics by understanding NCS' efforts to date; to enhance the Study's infrastructure with new tools and methods, and to augment toolsets for biospecimen collection and processing, environmental sample collection and processing, physical measures, and questionnaires, to develop enhance study visit assessments; to develop methods to analyze and augment the utility of data collected through the Study; and to test promising methods in pilot studies or formative research with Study participants for possible inclusion in the Main Study.
Federated IRB Approved
Hirschfeld announced that a Federated Institutional Review Board (IRB) was recently approved in July, which consists of a set of three documents that have been made available to the study centers: a compact outlining principles, processes and performance goals for a memorandum of understanding; and questions and responses. The NIH Deputy Director for Intramural Research is the designated official and will sign bilateral agreements with participating study centers. The Federated IRB is an intramural IRB. According to Hirschfeld, NCS is seeking have the NICDH IRB as the IRB of record. He observed that other NIH programs and studies have expressed an interest in adopting the Federated IRB model.
Presently, there are not clear best practices for revealing clinically relevant and actionable findings to individual participants, which is seen as an ethical obligation, for longitudinal cohort studies and biobanks. The NCS has operationalized the definition of "clinically relevant and actionable" as requiring the existence of a national or other widely recognized threshold or regulatory standard.
According to NCS, current NCS Policy and Practice on the Return of Research Results is that "anthropometric measurements such as height, weight, and blood pressure," would be shared immediately with participants, but that analyses from environmental samples and biological specimens would be indefinitely in storage and if and when samples would be assayed would be on a de-identified basis so that there should be no expectations of sharing results of laboratory analyses. The introduction of real time analysis may introduce additional considerations for the NCS Policy and Practice on the Return of Research Results. The NCS wants input from the NCSAC on what, if any, adjustments may be recommended. An excerpt of the NCS Policy and Practice on the Return of Research Results is available at: http://www.nationalchildrensstudy.gov/about/organization/advisorycommittee/Pages/NCS-Policy-and-Practice-on-the-return-of-research-July-2010.pdf.
The NCS noted in the discussion questions prepared for the meeting and its subsequent discussion, the ability to link to individual records does exist within the NCS and is integrated into the current process. See http://www.nationalchildrensstudy.gov/about/organization/advisorycommittee/Pages/NCSAC-Discussion-Questions-7-13-10.pdf. There is, however, an unknown temporal lag between collection and analysis and an inability to define which potential analytic results may be relevant to participants. Due to this lack of certainly, the Independent Study Monitoring and Oversight Committee (ISMOC) was developed to independently review analytic plans and make recommendations regarding the advisability of reporting of specific results to participants.
Issues and Questions Raised
The Committee and those interested in the NCS were asked to contemplate the following issues and questions:
*Is the current NCS Policy and Practice on the Return of Research Results sufficient if real time analysis is instituted? What additional policies or clarifications, if any, should be incorporated into this NCS policy? Specifically, the NCS real time analysis would be performed in research laboratories with equipment dedicated to research, and would not be clinical grade or CLIA certified. What are the possible downsides/risks of sharing research laboratory data in an observational study enrolling a broad population and how can we minimize those risks?
*If the NCS policy for incidental findings follows other longitudinal study policies for incidental findings, health care providers would be informed. What recommendations would you make about the nature and extent of information provided to health care providers? In your opinion, how prepared are health care providers to use research findings, particularly from environmental measurements or genetic analyses, in interactions with potential study participants? What recommendations would you make if a health care provider cannot be identified or contacted?
*Under what circumstances, if any, would you recommend that community organizations or authorities be informed of environmental findings; for example if known toxins or carcinogens are found that appear to exceed allowable limits?
*If genetic analyses are performed, under what circumstances, if any, should results be shared with participants? Should results be shared only for health related information, that is, no information about ancestry, physical traits, etc.? Should results be shared if requested by the participant? Should Health-related information be restricted to those conditions included for newborn screening?
*For each scheduled visit, current NCS policy is to provide participants prior to the visit a information sheet as a guide to the contents of the visit. As assays and analyses are identified as potentially yielding results that could be conveyed to participants and critical values are determined; should the NCS prospectively incorporate language within these forms, in addition to the general language in the protocol and consent forms, to better communicate the possibility of sharing findings with either participants or health care providers?
The next NCSAC is scheduled for October 14, 2010. For more information on the NCS see www.nationalchildrensstudy.gov.
OBSSR Establishes Network on Inequality, Complexity and Health to Address Health Disparities
On August 5, the National Institutes of Health (NIH) announced the formation of a multidisciplinary Network on Inequality, Complexity, and Health (NICH), to explore new approaches to understanding the origins of health disparities, or differences in the burden of disease among population groups. The new Network's objective is to use state-of-the-science conceptual and computational models to identify important areas where interventions or policy changes could have the greatest impact in eliminating health disparities. The NIH Office of Behavioral and Social Sciences Research (OBSSR) is contracting with the University of Michigan's School of Public Health to establish NICH.
"NICH brings together scientists from many different disciplines to create a new conceptual approach for examining the behavioral, social and biological factors which interact to cause inequalities in health," explained Acting OBSSR director Deborah H. Olster. The Network will consist of scientists with expertise across multiple disciplines, including economics, biology, ecology, computer science, education, sociology, mathematics and epidemiology.
NICH will be the first network to apply systems science approaches to the study of health inequities. Systems science methods enable investigators to examine the dynamic interrelationships of variables at multiple levels of analysis (e.g., from cells to society) simultaneously. It will also study the impact on the behavior of the system as a whole over time.
George A. Kaplan of the University of Michigan's School of Public Health is the Network's chair and principal investigator. When announcing NICH, Kaplan explained that "Much of the health disparities research conducted to date took place within single disciplines, and therefore could not comprehensively approach the multitude of factors that are involved. NICH will fundamentally change this approach by embracing perspectives from the biological to the societal, while employing cutting-edge simulation methods from computer science."
NICH will produce reports and publications, including possible books or special journal issues, on the collaborative work of network members and other experts. Publications will focus on breaking new ground by illustrating, explaining, promoting and translating the application of complex systems approaches to critical health disparities areas that require transdisciplinary development.
For more information on NICH see: http://obssr.od.nih.gov/scientificin_health/health_disparities/index.aspx#NICH.
Making Teachers More Accountable Subject of Report and Briefing
The Center for American Progress (CAP) recently released its new report, Measuring What Matters: A Stronger Accountability Model for Teacher Education, and on July 29 held a briefing to discuss the report's findings.
The report found that most states fail to hold teacher preparation programs accountable. Cynthia Brown, Vice President for Education Policy at CAP, said at the briefing that "this lack of state accountability would not matter so much if these programs were consistently producing excellent teachers. But they aren't. Many teacher education programs are not selective about who they admit, lack a rigorous curriculum, and don't give teachers sufficient clinical practice."
Ed Crowe, an education consultant and author of the CAP report, believes there must be greater accountability for both traditional and alternative teacher preparation programs. He stated that currently there are no meaningful sanctions or repercussions for consistently poor performing programs. He called on states to impose serious consequences on these programs, "if we want to improve teacher preparation, states will need to step up to the bar in a way they haven't done before."
Kate Walsh, president of the National Council on Teacher Quality, agreed that states and universities need to take greater ownership of their programs, noting that there is no coherent policy in how universities prepare teachers. According to Walsh, curricula vary widely with major differences between states and even within states. She believes it "malpractice" that teachers can graduate from programs without even the most basic skills needed to make them effective.
Brown noted that in many countries with high performing educational systems teacher preparation programs are often very selective and students are put through rigorous training. Crowe agreed, stating that the teaching profession cannot continue to admit everyone who applies to a program. Despite the negative attitudes towards the Teach for America program from many teachers, Walsh believes that the profession needs bright talented people, and that GPA and test scores do matter, that "it is not enough to just love kids."
However, Jane West, of the American Association of Colleges for Teacher Education, countered that it would be hard for a country the size of the U.S. to become more selective like Finland or South Korea in recruiting their teachers. She said it's easier for smaller countries, but America has about three million teachers and can't afford to only admit the top ten percent of each class.
U.S. school systems hire 200,000 teachers each year and spend $7 billion a year to train and prepare them. However, they don't track them to see how effective they are as teachers or how long they stay in the profession. West said teacher preparation schools need to learn more about how their graduates are doing once they are in the classroom, and they need to start gathering data and using that data to improve their programs and develop more effective teachers.
Very often teacher preparation is an afterthought in discussions of school reform. Crowe declared that the will-to-change is not a gift politicians can bestow. Teacher preparation programs can't just wait for politicians to make changes for them, they must decide to make them on their own.
Click here to view the report.
OppNet Seeks Applications for Research on Sleep and Social Environment and Basic Biopsychosocial Processes
The National Institutes of Health (NIH) Basic Behavioral and Social Sciences Research Opportunity Network (OppNet) is seeking applications designed to investigate the reciprocal interactions of the processes of sleep and circadian regulation and function with behavioral and social environment processes. The funding opportunity announcements (FOA) (RFA-HD-11-101) and (RFA-HD-11-102) recognize that sleep is a complex biological phenomenon that is essential to normal behavioral and social functioning, as well as optimal health. Despite sleep's vital nature, the mechanisms by which influences in the social environment affect sleep behavior patterns have not been studied systematically, particularly within the context of individual vulnerability, resilience, and adaptation. Letters of Intent are due on September 8, 2010. Applications are due on October 8, 2010.
OppNet is a trans-NIH initiative that funds activities that build the collective body of knowledge about the nature of behavior and social systems, and that deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance a targeted domain of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and lifecourse-related research.
According to the FOAs, chronic and acute sleep loss and sleeping outside of the optimal circadian phase can result in persistent alteration in behavior and mechanisms regulating behavior. Investigators have established connections between disrupted circadian regulation, disordered sleep, and neuropsychiatric disorders as well as changes in metabolic regulation, inflammation, and immune response. Furthermore, mutations in genes involved in regulation of circadian rhythms have been shown to have effects on behavioral outcomes including cognition (e.g., learning and memory), addictive behavior, and mood (e.g., aggression). It is not known how choosing not to sleep in favor of engaging in optional activities for enjoyment may affect the rewards expected to be derived from these activities. Alterations in social systems and social learning and behavior are also generated by altered sleep processes, such as sleep deprived parents who exhibit less sensitivity and lower frustration tolerance to their infants. Broader consequences of less than optimal sleep include safety incidents and traffic fatalities. Among the most dramatic of consequences, the loss of the Space Shuttle Challenger has been attributed partly to impaired decision making and "group think" arising from sleep deprivation among the NASA engineer team.
The FOAs provide a unique opportunity to link social environment factors that shape sleep behaviors with the direct neurobehavioral and circadian biology effects of sleep processes on individuals in the context of their social milieu. The research gap to be addressed lies between the understanding of the behavioral choices of individuals and social units, such as families and work groups, that determine sleep and circadian regulation (e.g., 24/7 media content, artificial light exposure, self imposed sleep debt) and individual susceptibility to decrements in neurobehavioral and social functioning arising from phenotypic, genotypic, and gene by environment interactions.
The FOAs is designed to stimulate research that will investigate the biopsychosocial mechanisms underlying the reciprocal and dynamic relationships between behavioral and social environment factors on the one hand and basic sleep and circadian regulation and function on the other. Two broad categories of proposals are responsive to this initiative: 1. Human or animal studies of the biological sequelae of changes in basic behavioral patterns of sleep duration and timing as a function of determinants from the social environment; 2. Human or animal studies of the dynamic relationships of individuals' behaviors in social interactions as a function of sleep or circadian rhythms.
OppNet intends to commit up to $1 million in FY 2011 to fund 5-6 applications submitted in response to this FOA, pending the number and quality of applications and availability of funds. For more information on the FOA see http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-11-102.html. For more information about OppNet and all its funding opportunities, see http://oppnet.nih.gov.
Editor's Note: Update on Hiatus
With Congress on its summer recess, Update will take a break too and return on September 13. Have a wonderful end of summer!
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