Volume 20, Number 12                 Celebrating 20 Years of Advocacy             July 2, 2001


CONGRESS BEGINS TO MOVE APPROPRIATIONS BILLS


As it heads into the Independence Day work period, Congress has begun to mark up and even pass some of the 13 spending bills for Fiscal Year 2002. Having started late because the President's budget wasn't released until April, Congress needs to proceed quickly if it is to complete the process by the beginning of the new fiscal year on October 1. The switch of the Senate to Democratic control may complicate this, but, at least at the committee level, bipartisanship is still working.

The House has passed three bills: Interior and Related Agencies (which includes funding for the National Endowment for the Humanities), Energy and Water Development, and Transportation. Before it recessed, the House began consideration of the Agriculture and Rural Development bill (see below). The Commerce, Justice, State and the Judiciary Appropriations Subcommittee has marked up its bill, which includes funding for the Census Bureau, the National Institute of Justice and the Bureau of Justice Statistics, and the Educational and Cultural Exchange programs of the Department of State. In addition, the Foreign Operations spending bill has emerged from subcommittee.

On the Senate side, the process began with subcommittee and full committee markup of the Interior and Related Agencies appropriation. The National Endowment for the Humanities (NEH) received $123.5 million from the House and $125.5 million from the Senate panel. The President had requested $120.5 million, a slight increase over the $120 million NEH received last year.

The VA, HUD, Independent Agencies Appropriations Subcommittee, whose bill includes funding for the National Science Foundation, HUD, EPA, NASA, and other agencies, had scheduled its markup for June 25. That has now been postponed until July 10. The massive Labor, Health and Human Services, and Education appropriations bill, as in many recent years, will probably be one of the last of the 13 to receive consideration.

House Panel Keeps Most Rural Research Programs at 2001 Levels

The House Agriculture and Rural Development Appropriations Subcommittee made its allocations on June 6, with the full Appropriations Committee ratifying these decisions on June 13. The full House will continue debate on the bill when Congress returns on July 9.

Although the Agricultural Research Service received a $79.4 million increase over last year on its close-to $1 billion budget, most of the rest of the programs funding research in the Department were level-funded or received minimal enhancements over last year.

The National Research Initiative Competitive Grants program (NRI), after being cut by over 11 percent to $105.8 million in FY 2001, did not receive an increase for FY 2002. The House also prohibited future spending on two other programs that make competitive awards: the Fund for Rural America and the Initiative for Future Agriculture and Food Systems. The House has done this in the past, and the Senate has subsequently rescued the programs.

The Committee also ignored, as they have with other chief executives, President Bush's attempt to rein in spending on special grants for projects the appropriators deem worthy. The President had asked for only $2.8 million (as defined by the appropriations committee) in special grants. The House Committee provided $82.4 million. Included in these special grants are $700,000 for Rural Development Centers, up from $522,000 in FY 2001, and $1.3 million for the Rural Policy Institutes, up from $820,000.

Hatch Act formula funds were also unchanged from last year and the President's request at $180.1 million. The National Agricultural Statistics Service received a $13.4 million increase over FY 2001 from the Committee, to $114.5 million. Most of the increase goes to help fund the Census of Agriculture, which receives a total of $25.5 million. The Committee appropriated $67.2 million for the Economic Research Service (ERS), less than a million-dollar boost over FY 2001. It provided a $3 million transfer to the Food and Nutrition Service for food studies and evaluation and expects ERS to spend $9.3 million for research and evaluation in these areas.

House CJS Restores Much Justice Funding

The House Commerce, Justice, State, and the Judiciary Appropriations Subcommittee marked up their FY 2002 spending bill on June 27. The bill funds the Department of Justice at a level significantly higher than the President's request.

If the bill clears the full committee, the Justice Department will be funded at $21.5 billion, $672 million more than FY 2001 and $623 million more than the President's request.

For Violence Against Women Act programs, the bill provides $391 million, $103 more than FY 2001. The Community Oriented Policing Services (COPS) program would receive $1.01 billion, $158 million more than the President's request and $17 million less than last year. This includes $150 million to provide local law enforcement with the latest technologies to reduce crime. Juvenile Justice programs would receive $298 million, the same as last year and the President's request.

Funding levels for other agencies and programs, such as the National Institute of Justice and the Bureau of Justice Statistics, will not be released until the full committee marks up the bill.

Periodic Censuses and Programs at the Census Bureau would be funded at $375.3 million, which includes $25 million from the previous year.


ELECTION REFORM DISPUTE PUTS STATISTICIANS FRONT-AND-CENTER AT HEARING


Statisticians working for rival members of the United States Commission on Civil Rights squared off as part of a heated exchange during last Wednesday's Senate Rules Committee hearing on election reform, chaired by Senator Chris Dodd (D-CT). At issue was whether African Americans were more likely to be disenfranchised than white voters in last November's Florida presidential election.

The first witness to testify was Mary Frances Berry, Chair of the Commission and a professor of American social thought, history, and law at the University of Pennsylvania. She focused her testimony on the report on Florida voting irregularities that the Commission approved by 6-2 earlier this month. The study found vast inconsistencies in election administration in disparate sections of the state, and that state officials, from the Governor down, failed to fulfill their obligation to protect the rights of voters.

Most strikingly, however, the report concluded that African Americans were ten times as likely as whites to be disenfranchised and that while blacks comprise only 11 percent of Florida's voter pool, they cast 54 percent of rejected ballots voted across the state. These inferences were based on a statistical analysis conducted by Allan Jay Lichtman, Chairman of the Department of History at American University in Washington, D.C.

Following Berry, Abigail Thernstrom, a political scientist at the Manhattan Institute and one of only two Republican appointees currently serving on the Commission, took issue with Berry's testimony and Lichtman's analysis. Thernstrom began by stating that Lichtman has close ties to former Vice President Gore, and that he failed to practice "scholarly convention" by denying her his data. After Berry retorted that this was an outright lie, Thernstrom went on to present her dissent to the Commission's report, which included statistical analysis conducted by John Lott of the Yale Law School.

Lott asserted to the Committee that a major factor in the "disenfranchisement" discussed by Berry was voter error. He stated that many of the African-Americans who had their ballots discounted were first time voters, who are more prone to make mistakes. In a heated exchange with Senator Charles Schumer (D-NY), however, Lott was forced to admit that a greater percentage of minorities were turned away from the polls than whites.

In other testimony, Larry Sabato, professor of Political Science at the University of Virginia, presented the Committee a detailed analysis of voter fraud issues facing the nation. He pointed out that fraud is becoming more feasible as we "make it easier for people to register and vote." To back his claim, Sabato cited several examples from the 2000 election, including the casting of several thousand illegal ballots in Florida by convicted felons and others, in a presidential contest that was decided by a mere 537 votes.

Dodd scheduled the hearing to keep election reform on the Senate's mind as the July 4 recess approached. Legislators will debate several bills on the issue, including two that were discussed extensively at the hearing. One is sponsored by Dodd and supported by a large group of Democrats, while the other is championed by Ranking Member Mitch McConnell (R-KY) and Senator Schumer and has been endorsed by 70 other senators. The House is also set to take up election reform later in the year.


JUVENILE JUSTICE BILL CLEARS PANEL; RESEARCH DISCUSSED


The House Subcommittee on Select Education, chaired by Rep. Michael Castle (R-DE), heard testimony on The Juvenile Crime Control and Delinquency Prevention Act of 2001 on June 6. The bill, which would reauthorize the Juvenile Justice and Delinquency Prevention Act of 1974, sailed through the Subcommittee on June 21.

Sponsored by Rep. Jim Greenwood (R-PA) and co-sponsored by Rep. Bobby Scot (D-VA), the bill consolidates five federal juvenile justice programs into one Prevention Block Grant. The bill elicited strong bipartisan support.

H.R. 1900 "successfully strikes a balance in dealing with children who grow up and come before the juvenile justice system who are already vicious and dangerous criminals and other children who come before the . . . system who are harmless and scared and running away from abuse at home," Greenwood said.

The punitive side of juvenile justice legislation in the House is contained in H.R. 863, The Consequences for Juvenile Offenders Act of 2001, which authorizes the Juvenile Accountability Incentive Block Grant (JAIBG) program. The grants would promote graduated sanctions for juvenile offenders and fund juvenile facilities and programs. That bill cleared the House Judiciary Committee in late March. It would authorize appropriations of $500 million for fiscal years 2002 to 2004; of that amount, the Attorney General may spend up to two percent on research, evaluation, and demonstration. The Senate will probably not take up its juvenile justice legislation until late summer.

Improving the Research

Among criminal justice experts who testified at the hearing was Edward Mulvey, a psychiatrist at the University of Pittsburgh School of Medicine. Reiterating a message that has been heard by policymakers many times, Mulvey asserted that useful research "has and can be done regarding juvenile delinquency and the juvenile justice system." Unfortunately, he pointed out, "the system is usually ruled more by fads than empirical findings."

"By looking at and pursuing sound empirical information, we can move out of this wasteful cycle and greatly increase the chance of making incremental progress toward a more just and effective system." Testing the assumptions underpinning broad policy positions in the field of juvenile justice, Mulvey said, is one way that research can make a clear contribution.

We already know several aspects of effective programming for adolescent offenders, Mulvey declared.

· First, the earlier the better. Preventive intervention with families with young children can have positive effects on later delinquency.

· Second, different things work at different times in development. The factors that contribute to risk change over time must be addressed in different ways at different ages. Juvenile crime can only be addressed effectively by having a balanced portfolio of approaches to prevention and intervention.

· Third, the most effective programs with adolescent offenders are comprehensive, theory-based, and use structured methods for building skills.

A coherent strategy for research, Mulvey said, requires a central body overseeing and promoting work in juvenile justice that "contributes to a balanced portfolio of approaches." Comparing juvenile justice research to the medical field, he reminded the panel that building a useful body of knowledge requires vision and patience, expecting "good science and pragmatic answers over time."

"We do not and would not expect to generate knowledge about treating complicated medical disorders piecemeal or in a time frame that serves our immediate funding cycle. Yet we somehow think that this can be done with the complicated processes underlying antisocial and violent behavior in adolescence."

Without a coherent, balanced, and rational approach to improving policy and practice in juvenile justice, Mulvey warned, we will "keep following the newest fad and getting disappointed when it goes out of style."


HUMAN SUBJECTS: FOCUS ON SOCIAL AND BEHAVIORAL SCIENCE


On June 28 and 29, the Panel on Institutional Review Boards, Surveys, and Social Science Research held its first meeting commencing an 18-month study by the Committee on National Statistics (CNSTAT), in collaboration with the Board on Behavioral, Cognitive, and Sensory Sciences and coordinating with the Institute of Medicine (IOM). Cora Marrett, former Assistant Director for the Social, Behavioral, and Economic Sciences at the National Science Foundation, is the panel's chair. Marrett is currently in transition from the Vice-Chancellor of Academic Affairs and Provost at the University of Massachusetts-Amherst (until August 1) before moving on to become the President of the University of Wisconsin system.

The Panel on Institutional Review Boards, Surveys, and Social Science Research will review current and proposed methods of human subjects protection in social science data collection. A focus will be on the structure, function, and performance of the Institutional Review Board (IRB) system designed by the Department of Health and Human Services "largely to guide clinical and biomedical research but that also affects social science researchers."

This study will complement the IOM study, Assessing the System for the Protection of Human Research Subjects, that is examining the structure, function, and performance of human subjects protection activities with a focus on clinical and biomedical research (see Update, January 29, 2001). Although the CNSTAT study will inform the IOM study, its findings will also be published in an independent report. The report will provide recommendations to assure the protection of human participants in social science research that can accommodate differences between social/behavioral and clinical/biomedical research.

In a letter to Marrett, Daniel Federman, chair of the IOM study, noted that "to ensure that research is getting a fair and technically informed review is an issue regardless of whether oversight is linked to accreditation, federal regulation, or any other mechanism. . . How best to oversee IRBs that review mainly or exclusively survey and population studies is an issue that we hope you can take up, as well as how to ensure sound review at institutions (or IRBs within them) that review mainly clinical or other research, but occasionally encounter social, behavioral, and population research protocols."

Marrett acknowledged that within the limited time period given for the study, the panel needs to ensure that it is having the best kind of impact. She invited panel members and the social and behavioral science community to share, in addition to their comments on what issues and topics should be discussed by the panel, what should not be on the agenda.

Assessing the System

Roderick Little, professor of Biostatistics at the University of Michigan and a member of the IOM study and CNSTAT, noted that phase I of the IOM's two-phase study "cautiously accredited accreditation." The IOM panel, he observed, is aware of the sensitivity of the social and behavioral science community. That panel, he said, does not have the breadth and knowledge needed to do justice to behavioral and social science research. The prospect for collaboration is excellent for the two panels, said Little. The CNSTAT panel is an "extremely important venture."

Jeffrey Cohen, director of the Office of Human Research Protection's (OHRP) division of Education and Development, observed that there are currently three other groups in addition to the CNSTAT panel addressing the issues of the social and behavioral sciences.

The first is the National Human Research Protection Advisory Council (NHRPAC) to OHRP that has a Social and Behavioral Science Working Group, co-chaired by Cohen and Felice J. Levine, Executive Officer of the American Sociological Association. This workgroup has two core goals: "to develop guidelines to help IRBs more effectively administer the human subjects protection system, and to make specific recommendations regarding additions or changes to the Common Rule with respect to the social and behavioral sciences."

The second group looking at this issue is the Human Subjects Research Subcommittee of the Committee on Science at the National Science and Technology Council, chaired by OHRP Director Greg Koski. It is the interagency committee for those 17 federal agencies that are involved in the Common Rule.

The third is the National Science Foundation's Advisory Committee for Social, Behavioral and Economic Sciences (SBE) Subcommittee for Human Subjects. According Norman Bradburn, Assistant Director of the SBE, NSF is circulating an agenda to explicate the differences between behavioral and social science and the medical model. Bradburn stated that NSF would like to end up with a set of specific guidelines for interpreting specific cases, stressing the flexibility of IRBs.

Cohen emphasized that OHRP does not want four separate sets of recommendations. Director Koski has said he wants to make a concerted effort to come up with a single set of recommendations.

Cohen announced that there was still room at a workshop being sponsored by OHRP and the University of Southern California, July 16-17, on "Informed Consent, Cultural Values, and Regulatory Overview: A Closer Look at Behavioral Issues in Biomedical and Social Science Research." OHRP, he said, plans to continue doing workshops and outreach to the behavioral and social science community. For more information see www.usc.edu/dept/law/Pacific_Center/workshop.

It is OHRP's position that the Common Rule provides sufficient flexibility for the oversight of behavioral and social science research. Cohen said, however, that more guidance is needed for IRBs and researchers. Accordingly, OHRP is developing guidance for the social and behavioral sciences, including the creation of a new set of decision charts. The Office is seeking the input of the behavioral and social science community before posting them on the agency's website. For more information see http://ohrp.osophs.dhhs.gov/.

Look Beyond the IRBs

Belinda Seto, Deputy Director of the National Institutes of Health's Office of Extramural Research, observed that NIH has large investments in behavioral and social science research. She urged, as she had the IOM panel, that the CNSTAT panel broaden its focus beyond the IRBs. While IRBs are a critical part of the system to protect human subjects, there are other components, Seto emphasized.

The education of investigators is also important, Seto said. There is a need for the elevation of general knowledge of human subjects research. She informed the panel that beginning October 1, NIH will require investigators to document that they have taken a course in human subjects protection. NIH will leave it to the researcher to decide how to fulfill this requirement.

A second component of the human subjects protection system, said Seto, is data and safety monitoring boards (DSMBs), which play an important role in protecting human subjects. An independent evaluation of DSMBs is important for the behavioral and social sciences.

A third component is how to protect the rights and interests of third parties about whom investigators learn private information during the course of doing research. Under the current regulatory interpretation, these individuals become human subjects. The NIH, working with OHRP, has created a working group that is drafting guidance to address this issue, Seto said.

NIH would also like the CNSTAT panel to consider the area of data protection - to the extent that one can require an investigator to be sensitive to data issues. Finally, Seto urged consideration of conflict of interest issues for investigators, institutions, and IRBs.

Professional Associations

The panel also heard from professional associations, including COSSA members.

Rob Hauck, Deputy Director of the American Political Science Association, told the panel that it is "important to distinguish between the provisions of the Common Rule and the selective interpretation of the Common Rule by Institutional Review Boards." The confusing and often contradictory application of the Common Rule by local IRBs undermines its flexibility, said Hauck.

He emphasized that over time, institutions have unilaterally expanded the scope of IRB oversight to include all research involving human participants regardless of sources of funding, extended the review requirement to previously exempted research, favored full over expedited review, and abandoned the differentiated assessment of risk in favor of standardized consent requirements.

Hauck cited as an example two political scientists from major research universities on the west coast who underwent a nine-month IRB review although their project involved nothing more than asking participants to guess the outcome of a coin toss.

In practice IRBs are reluctant to alter or waive the active consent requirement even though it may be inappropriate to the research method or setting. For political science research conducted abroad, the written requirement may be at odds with cultural and social norms, he explained.

Mary Margaret Overbey, Director for Government Affairs at the American Anthropological Association, explained to the panel that anthropology involves four subfields: archaeology, cultural anthropology, biological or physical anthropology, and linguistic anthropology. Most anthropological research, said Overbey, is generally low-risk.

What we need is massive education at all levels of the research process, said Merry Bullock, Associate Director for Science, American Psychological Association. Some behavioral research is very similar to prototypical clinical/ biomedical research; other behavioral research is closer to prototypical social science research. Very little attention is paid to the difference. The regulations are very general and can be applied quite flexibly, said Bullock.

According to Bullock, challenges include:

· Providing adequate guidance - guidance is inadequate in such areas as risk-benefit analysis (e.g., identification of potential harm, determination of probability of that harm, and determination whether adequate steps taken to minimize that harm)

· Increasing IRB expertise - there is a lack of content knowledge which hinders realistic risk assessment, leading to rigid and conservative interpretation of regulations

· Reducing researcher naiveté - researchers often lack knowledge about regulations, how the regulations apply to their research, and about IRB processes and what information is relevant in a protocol

Potential solutions, said Bullock, include: the education of researchers regarding regulations and their applicability, guidance for IRBs (especially on risk assessment and informed consent) and more involvement of behavioral and social science researchers in IRBs.


SOURCES OF RESEARCH SUPPORT


COSSA provides this information as a service and encourages readers to contact the sponsoring agency for further information. Additional application guidelines and restrictions may apply.

Fogarty Addresses the Issue of Tobacco-Related Illness

On June 27, the Fogarty International Center (FIC) announced a new program to address the increasing incidence of tobacco-related illness and death in the developing world. According to Director Gerald Keusch, FIC's aim is to provide a framework of support for the development of data necessary to inform decision-making.

The goal of the new research and training program is to reduce the burden of tobacco consumption in low- and middle-income nations by conducting observational, intervention, and policy research of local relevance and building capacity in these nations in epidemiological and behavioral research, prevention, treatment, communications, health services, and policy research.

FIC, in collaboration with NCI, NICHD, NIDA, NIMH, NINR, and in cooperation with the World Health Organization's Tobacco Free Initiative (WHO-TFI), encourages applications linking behavioral science, social science, and basic science with clinical and operational aspects of health care research. Five key research areas are targeted:

1) epidemiological and surveillance research, 2) susceptibility and risk for smoking uptake, 3) biobehavioral and social research, 4) intervention research, and 5) policy-related research. Additionally, the program may provide support for projects that examine tobacco tax policies, marketing and advertising strategies, campaigns that promote a smoke-free norm, and prevention strategies targeted at young people.

Applications are due by October 26, 2001. Letters of Intent to apply are due by September 4, 2001. For more information: http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-02-005.html.

Crime Mapping Research:  Funding for Spatial Data Analysis

The National Institute of Justice's Crime Mapping Research Center (CMRC) requests proposals for research that utilizes and/or develops leading-edge spatial analytic methods. A wide variety of research topics that explore the use of spatial data analysis for criminal justice research and practice are anticipated.

Established in 1997, the goal of the CMRC is the promotion, research, evaluation, development, and dissemination of GIS (geographic information systems) technology and the spatial analysis of crime. Toward that goal, approximately $300,000 is being made available for this solicitation to support between five and seven awards.

NIJ is particularly interested in innovative proposals that address continued development of spatial crime-forecasting models; spatial analysis techniques for discrete criminal events; innovative uses of spatial analyses to assess criminal justice system policies and practices; and others. See www.ncjrs.org/txtfiles1/nij/crimemap.txt for more information.

Application deadline is September 17, 2001.


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