Volume 20, Number 20            Celebrating 20 Years of Advocacy        November 5, 2001

 

·         Speakers Weigh Social Science’s Impact, Celebrate 20 Years of COSSA

·         Leshner, Hyman Continue Exodus at NIH

·         Marburger Confirmed

·          Discussion Progresses on Public-Use Data Files and Third Parties

 

 

speakers weigh social science’s impact, celebrate 20 years of cossa

 

        “A fiery intellectual agenda” is reflected in the COSSA’s 20th anniversary events, remarked keynote speaker David Ward at COSSA’s annual meeting October 29 in Washington, D.C.  Over 80 social and behavioral science researchers, government officials, association leaders, and representatives of COSSA’s members converged to celebrate the influence of social and behavioral science on public policy and look to the future.

 

        Originally booked for the Library of Congress, the meeting was moved to the Hyatt on Capitol Hill which, unlike the Congressional buildings, was not closed for anthrax clean-up. 

 

        Ward, President of the American Council on Education, kicked off the all-day meeting by referring to the contents of Fostering Human Progress:  Social and Behavioral Science Research Contributions to Public Policy, produced by COSSA for the occasion.  He contrasted the research agenda of the social and behavioral sciences outlined in the book with the management structure of universities.  To the social scientists, he said “You’re attacking problems, not pursuing disciplines.”

 

        The current management structure of universities is not ideal for solving the problems of society, Ward suggested.  Despite the importance of universities in tackling these problems, Ward observed, there is little careful study of higher education as an industry.  The institutions of higher education (what he termed “the knowledge industry”), should be an area of study just as other industries are, he argued – they are the “oil wells of the 21st century.”

 

Foreign Policy, Justice, Health, Fairness

 

        The morning’s first panel began with Stephen Krasner, Professor of International Relations at Stanford University, considering the contributions of social science to international affairs.  He challenged the audience directly:  “If social science research were really useful to government [officials], they’d seek it out more.”

 

        Krasner contrasted the impact of international relations and foreign policy research with other social sciences, which he credited with better success at establishing cause and effect relationships.  Economics does this well, he said.  International Relations, he lamented, does not.

 

        Krasner conceded that there are some robust findings in the field, like the observation that democracies tend not to fight each other.  However, it is often hard to translate academic findings into public policy.  Sometimes, he said, social science research rationalizes foreign policy and provides a theoretical basis, as in the case of deterrence theory.  Although this simply explains pre-existing policy, it can help to make better sense of it.

 

        Social science has had a much more significant impact over the past 30 years on reducing crime, argued Sally Hillsman, Deputy Director of the National Institute of Justice.  Not only have empirical studies yielded important findings, she observed, but the analytic insights of criminal justice research have been integrated into the operations of the justice system, especially at the state and local levels.

 

        Has research actually reduced crime?  Various studies tell us what is effective in controlling crime, Hillsman observed, but it is difficult to credit a crime drop directly to research.  Research has, however, made leaders more results-oriented, and policymakers are now “on the hook,” she said.  We have made great strides, Hillsman asserted, but we have a long way to go.

 

        A similar assessment for the field of health was made by Raynard Kington, Associate Director of the National Institutes of Health.  One of the major contributions of social and behavioral science to improving health, Kington said, is a reduction in public smoking levels.

 

        One of the current challenges for science is the significant disparities in health between different racial groups – great improvements in health might be achieved if the causes of those disparities are attacked, he observed.

 

        Looking to the future, Kington pointed to the need for greater interdisciplinary study and work in the health field, as well as more social and behavioral science work in the field of bioterrorism.

 

        Promoting fairness, another goal of social science research, was addressed by Deborah Merritt, Director of the John H. Glenn Center for Public Policy at Ohio State University.  She pointed to some specific instances in which social science evidence has played an important role in promoting equality and fairness, including several key Supreme Court cases, most notably Brown v. Board of Education.

 

        Although marked progress has been made in the past 50 years, the challenge, according to Merritt, is to continue that progress in all areas.  “How can we keep it going?” she challenged.

 

Prosperity, Education, the Environment

 

        The day’s second panel addressed three more areas in which social and behavioral science is making strides.  Carl Christ, of Johns Hopkins University and the National Bureau of Economic Research, considered his field of economics and how its research helps to advance prosperity.

 

        The first and most obvious way, he said, is that economists provide data to people with the power to guide the economy.  As a result, Christ claimed, we are able to control inflation, smooth out business cycles, and understand economic growth more generally.

 

        Christ then commented on proactive economic policy, cautioning that although affecting the distribution of wealth is sometimes desirable, we must be careful not to “kill the goose that lays the golden egg.”

 

        Unlike in economics, there is no climate for the use of education research, lamented Susan Fuhrman, Dean of the Graduate School of Education at the University of Pennsylvania.  Fuhrman did recognize some significant policy contributions of education research, such as standards reform and the analysis of the TIMSS (Third International Mathematics and Science Study).

 

        Fuhrman soon noted, however, some of the weaknesses in education research, such as unsuitable research designs for policy questions and the lack of longitudinal studies.  Considering the future, she acknowledged the Campbell Collaboration, which systematically reviews existing research to identify and make accessible good education research.  More such syntheses of research are needed, she argued.

 

        Michael Toman, of the think tank Resources for the Future, compared research on the environment to that on education in that “philosophy often trumps research.”  Nevertheless, he maintained, social scientists have important contributions to make towards protecting the environment.

 

        An important area of research is climate change, Toman said, and while scientists are studying its biochemical consequences, that knowledge is inadequate without the human dimension.  The economic study of the costs and benefits of environmental protection, he argued, can greatly improve the “bang for the buck” that we receive from, for example, reducing emissions.

 

        Looking beyond economics, Toman recognized the importance of other fields, such as psychology, sociology, and geography.  He asserted that we need to know more about how to implement policies and that we need to recognize the interrelations between economic growth, demographic change, and environmental change.

 

History for Lunch

 

        Bad times are often good for social science, and vice-versa, said Ernest May, Professor of American History at Harvard’s John F. Kennedy School of Government, provoking some lunchtime thought.  Referring in part to the recent terrorism, May asserted that challenging times often call on social scientists to help make sense of unprecedented events.

 

        May discussed the uses, and misuses, of historical research in political decisionmaking.  Studies on nuclear weapons, for example, led to a focus on arms control, he observed. 

 

        May also described the role of historians more generally in influencing society.  First, historians are important to other social scientists, prodding them to look harder and more skeptically at data and events.  Second, he said, they can raise questions about generalizations that appear plausible, such as the idea that relations between democratic nations are naturally peaceful.  Third, May observed, historians help people in public life look at the way they use history.  For example, historians can evaluate the appropriateness of the Pearl Harbor analogy to the recent terrorist strikes, and suggest policies based on knowledge of past events.

 

Social Science and Public Policy

 

        After lunch, William Julius Wilson, Professor at Harvard University, spoke on expanding the domain of policy-relevant scholarship in the social sciences.  He first discussed research on education and the job market, observing that lower-paid workers face income stagnation and job loss.

 

        However, a strictly economic perspective, he said, is insufficient to explain the link between employment and inflation.  Between 1993 and 1997, Wilson pointed out, worker anxiety increased despite the favorable job market.  This arose in part out of concern that jobs were going overseas.  Wilson cited Paul Krugman, who said that wage demands and therefore wages may have been moderated as a result.  The paradox is the simultaneous presence of more or less full employment and worker anxiety.

 

        There is a strong resistance, Wilson maintained, to the practical application of such social science research; some feel that social science should not try to influence policy until there is “adequate data.”  But, he countered, policy will happen anyway – better that it be informed by what research can tell us.  Research, he said, can point out the weakness of a policy focus, such as the preoccupation with the effects of welfare on single-parent families – it is more complex than this, Wilson asserted.

 

        The application of social science research, he explained, suffers from the “formalistic fallacy” – the idea that data for policy must come from established techniques, which can exclude the qualitative.  Many argue that ethnography, for instance, is appropriate only for discovery, and that quantitative techniques are necessary for validation, said Wilson. 

 

        However, he argued that qualitative participant observation can be used to test hypotheses.  Furthermore, social science techniques can be used not just to measure conditions, but to realize that processes may occur in ways we have not yet imagined.

The Future

 

        Norman Bradburn, Assistant Director for the SBE Directorate at the National Science Foundation, kicked off the final panel of the day, touching on a host of tools that are gaining prominence and helping social scientists tackle society’s problems.  Neuroimaging, collaboratories, wireless computers, web-based surveys, geographic information systems,  and statistical techniques like data mining and hierarchical analysis, are already in use and being further refined.

 

        Particular fields within social science, Bradburn observed, are growing rapidly.  Research in communication and language, human and natural systems, and symbolic systems is on the rise.

 

        What does this mean for people? Bradburn asked.  We need better training in mathematics, statistics, and computer science.  Social scientists need to know how to work with biologists and physical scientists, he argued.  The solutions to the problems of the future will require such interdisciplinary thinking, Bradburn remarked, and we must continue to develop multidisciplinary research centers and institutes.

 

        Touching on the recent terrorist strikes, Barbara Torrey, Executive Director of the Division of Behavioral and Social Sciences and Education at the National Academies of Science, agreed with May that hard times are good for social science.  “People want to know the root causes of today’s terrorism,” she said.  Social scientists can address this in many ways.  In considering how to encourage stable governance in central Asia, for example, we can find out what kinds of democracies work in what kinds of places.

 

        One area of strength is social network analysis, Torrey asserted, which may have a broad array of applications.  Ecologists, she said, are turning to social scientists because they are coming to realize the importance of networks in the ecological world.  Torrey predicted the 21st century will be “our time.”

 

        Finally, David Featherman, Director of the University of Michigan’s Institute for Social Research, discussed data and infrastructure issues as he looked to the future of social science.

 

        As the quantity and complexity of data grows immense, we will need better data mining and visualization tools and more effective partnerships with engineers.  Furthermore, social scientists, he said, will need our own supercomputers.  Featherman pointed out that we currently do not have a collaborative oversight system for data infrastructure, and that we should begin to develop it.

 

        Stepping back from the data of our inquiries to the very nature of our thinking, Featherman anticipated significant shifts.  We may move away from current paradigms, such as the tendency to see systems as seeking an equilibrium, or relationships as simply cause and effect, he predicted.  He also suggested a possible post-positive shift in research, where some of the qualitative methods discussed by Wilson may become significant.

 

        Having a fair amount of intellectual fat on which to chew, the speakers and attendees regrouped at the post-meeting reception, where they and friends of COSSA had a chance to celebrate 20 years of social and behavioral science advocacy.  The reception was graced by, among others, current NSF Director Rita Colwell, a strong supporter of the social sciences.

 

Due to high demand, COSSA will transcribe the day’s speeches and post them on our website (www.cossa.org).  They should be available by the end of the month.

 

LESHNER, HYMAN CONTINUE EXODUS AT NIH

 

Since 2001 began, five Institute directors at the National Institutes of Health have left or announced they are leaving.  In each individual case there are good reasons for the departures.  However, one cannot help but wonder if the probable conclusion of the glory days of double digit budget increases, and the continued lack of an appointed director have also made the alternatives for these distinguished scientists more attractive.  In three of the situations, the Bush administration’s failure to reward their rumored ambitions to replace Harold Varmus as NIH director may also have played a role in their moving on.

 

Alan Leshner, who has led the National Institute on Drug Abuse since 1994, will become the new Chief Executive Officer of the American Association for the Advancement of Science (AAAS) and publisher of its journal SCIENCE on December 3, 2001.  He replaces Richard Nicholson, who is retiring from the position he has held since 1989.  Leshner has also served as Acting Director and Deputy Director of the National Institute of Mental Health and in several senior positions at the National Science Foundation, including Deputy Director of the old Biological, Behavioral and Social Science Directorate.

 

Leshner began his professional career as a professor of psychology at Bucknell University after receiving his Ph.D. in physiological psychology from Rutgers University.  A member of the Institute of Medicine, Leshner delighted the attendees of the 1999 COSSA Annual Meeting with his lively and informative luncheon address.

 

Steven Hyman, director of the National Institute of Mental Health since April 1996, has announced that he will return to Harvard University as Provost.  He had previously studied, taught, and directed several programs there, including the Interfaculty Initiative on Mind/Brain/Behavior.  Earlier this year, Hyman was said to be strongly interested in replacing Harold Varmus as NIH’s director.

 

Richard Klausner stepped down as head of the National Cancer Institute (NCI) on September 30, 2001.  He had led the NCI since 1995.  Klausner has accepted the position of president of the Case Institute of Health, Science and Technology, a new philanthropic enterprise launched by the Case Foundation.  Alan Rabson, NCI’s Deputy Director and husband of NIH Acting Director Ruth Kirschstein, has been named Acting Director.  Klausner too was rumored to be a candidate for NIH’s top job.

 

In early October, Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism, announced his retirement.  Gordis, who is 71, had led the institute since 1986.  Before his appointment, he was Professor of Clinical Medicine at Mount Sinai School of Medicine and founder and Director of Elmhurst Hospital’s alchoholism program.

 

Earlier in the year, Gerald Fishbach left his position as Director of the National Institute of Neurological Disorders and Strokes to become the head of the neurobiology department of Harvard Medical School.  Audrey Penn has been named Acting Director.  Fishbach was yet another Institute director rumored to be interested in the top job.

 

 

Marburger Confirmed

 

With all these departures, there is good news on the Office of Science and Technology Policy (OSTP) front.  The Senate unanimously confirmed John Marburger as OSTP director on October 23.  For some of his first duties, Marburger has been charged by the White House with assisting the Office of Homeland Security to research how to safeguard the mail and with developing technology to help better track international students in the U.S.

 

 

discussion progresses ON PUBLIC-USE DATA FILES AND THIRD PARTies

 

The National Human Research Protections Advisory Committee (NHRPAC) continued the discussion at its October 30-31 meeting on public-use data files and whether the collection of data about third parties requires informed consent.   NHRPAC is the advisory body to the Department of Health and Human Services’ Office of Human Research Protections.

 

Public-Use Data Files

 

At the July meeting, the NHRPAC Social and Behavioral Science (SBS) Working Group, co-chaired by Felice Levine (Executive Officer of the American Sociological Association) and Jeffrey Cohen (Director of Education at the Office of Human Research Protections in the Department of Health and Human Services) explained the problem surrounding public-use data files to NHRPAC (see Update, August 13, 2001).  Institutional Review Boards (IRBs), they said, have increasingly sought to review research involving public-use data files.  At the same time,  IRBs have been uncertain about whether they should review protocols from secondary users of such files and unclear about the differences between various types of data that might be supplied or used. 

 

This is a significant issue for the social and behavioral science community because a great deal of social science research involves analysis of data files intended for public use.  But among non-social scientists and in the human subjects protection system, there is a fair amount of confusion about the analysis of data from public-use files and what requires Institutional Review Board (IRB) review.

 

Seeking to advance the group’s recommend-ations, none of which require changes in the Code of Federal Regulations (C.F.R.), Levine and Cohen updated the full committee on the group’s efforts.  According to Levine, the recommendations were revised to reflect the feedback from the research community, discussions with the working group, and comments from NHRPAC members (see www.asanet.org/public/humanresearch for the original recommendations).  The suggestions charge OHRP with issuing guidance to IRBs and investigators about public-use data files, the protection of human subjects, and the applicability of the Regulations to this class of social and behavioral science research. 

 

The next step involves Levine, Susan Kornetsky (Director of Clinical Research Comp-liance), and Elliot Dorff (Rector and Distinguished Professor of Philosophy at the University of Judaism) putting the group’s recommendations in a form upon which NHRPAC can act.

 

Third Parties

 

NHRPAC is also examining what many  consider a more controversial issue – whether third parties should be considered research subjects.  NHRPAC’s Working Group on Third Parties is chaired by Mary Kay Pelias, Professor of Genetics at Louisiana State University.  The SBS Working Group is also considering the issue as it relates to social and behavioral science, and the two groups are collaborating.

 

Pelias opened the discussion on third parties by emphasizing that “the public good has been well served by inquiries into the social context, relationships, and family histories of research subjects.”  The foundation of genetics research is the documentation of family histories in order to find and track genes as they are transmitted through generations of the same family.  Research in the social and behavioral sciences examines individuals, groups, organizations, and institutions.  This requires understanding people in their social contexts, she explained.

 

All agree that both family history information and information collected by an investigator about human subjects or from them about other parties should be treated with the highest standards of confidentiality.

 

Despite devoting considerable attention to the definition of human subjects as it relates to third party status, Pelias says the group remained divided on the issue.  Some members recommend that the definition of human subjects in the Regulations should make clear that third parties are not human subjects.  Others contend that virtually all third parties should be considered human subjects, in the context of the definition in the current regulation, said Pelias.

 

What the group could agree upon is that IRBs need guidance on how to evaluate the risks to human subjects on a protocol-to-protocol basis.  The group recommended a change in the C.F.R. or, absent such change, guidance issued to IRBs.  The group also agreed that IRBs are the appropriate bodies to make determinations of third party status and special circumstances related to the issue of seeking or waiving the need for informed consent.

 

Third Party and Informed Consent

 

Pelias observed that in genetics research, a third party may consent to be contacted either through the family member who is already a subject or through a health care professional who has professional contact with the third party.  A third party may even volunteer after learning of the study.  “In any event, a third party who establishes, or who consents to establish, contact with an investigator becomes a human subject when that contact is established.”

 

In the social and behavioral sciences,  information offered by human subjects about third parties seldom results in personal contact between the researcher and the third parties.  Usually in social and behavioral science research, “the investigator is interested in the research subjects’ perceptions, experiences, or interactions with third parties,” Pelias elaborated.

 

In some instances, she noted, an investigator may use snowball sampling to identify other potential subjects for research.  Under such circumstances, the protocol submitted for IRB consideration should address how all persons, including those contacted by virtue of information provided by human subjects, will have protections of informed consent and, if they enter a study as a human subject, how identifiable information will be secure and confidential.

 

“It is the overall view of both working groups that investigators’ relationship with research subjects should be the utmost concern,” Pelias maintained. 

The Third Party Working Group made five recommendations:

 

Rec. 1:  The definition of “human subject” in the code of regulations should be clarified through guidance issued by ORHP:  when human subjects provide information about others, these other persons do not then necessarily become human subjects. 

Rec. 2:  OHRP should clarify that “identifiable private information” in the context of the Federal Regulations should be understood as not only private information provided by human subjects themselves but also private information provided by human subjects that is both relevant to them and any other identifiable individuals.

Rec. 3:  The requirement for consent to participate in research should be determined by the IRB considering individuals who may decide to participate in the research and third parties about whom human subjects might provide identifiable private information.

Rec. 4:  OHRP should clarify that, when investigators see information directly from third parties in a research study, these persons become human subjects.  OHRP should issue guidance on what constitutes research and how human subjects are defined by the current regulations.

Rec. 5:  Some research projects, protocols, and methodologies are of such specialized nature that it may be unclear to the IRB whether the information collected about others is directly relevant to the study or whether a given type of potentially identifying information is necessary to achieve the goals of the study.  In such instances, the IRB has the discretion to “invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.”

After considerable discussion over the language of suggested guidelines for OHRP, a subcommittee, which included Levine, met again to revise language for a consensus document that would be suitable for posting on NHRPAC’s website.  After further editing, it will be available at http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm for public comment.

 

Risk, Harm, and the Nature of Minimal Risk

 

Levine reminded NHRPAC that the SBS Working Group views itself as “helping and giving guidance to NHRPAC on a number of issues.  The group is now preparing to discuss risk and harm and the nature of minimal risk. 

 

There is concern in the social and behavioral science community that minimal risk as set forth may not be sufficiently understood in practice by IRBs and researchers.  IRBs in recent years have been under increased scrutiny about whether they are adequately assessing risk and harm.  As a result, they have too frequently operated unaware of the nature of social and behavioral science research involving human subjects, the likely risks and harms associated with such research, and the best procedures for protecting subject populations involved in such research. 

 

The group advises OHRP to:  1) issue guidance to IRBs regarding the definition of minimal risk; 2) clarify that much of the research in social and behavioral sciences involves minimal risk – low-level harms that are transient in nature and easily ameliorated by either the passage of time, adequate debriefing, or both; 3) clarify that, in most social and behavioral science, the most serious harm that could occur to subjects would result from a breach of confidentiality.  The group expects to make final recommendations in this area at NHRPAC’s January meeting. 

 

SBS is also examining other issues, including the issues of consent and confidentiality.  According to Levine, group members are currently preparing draft reports and recommendations on these topics.  They plan to provide initial reports to NHRPAC on these two subjects in January. 

 

SBS has created a new website to extend its capacity for input:  http://www.asanet.org/public/ humanresearch.