Beyond conflict of interest: the responsible conduct of research

This paper reports data and scholarly opinion that support the perception of systemic flaws in the management of scientific professions and the research enterprise; explores the responsibility that professional status places on the scientific professions, and elaborates the concept of the responsible conduct of research (RCR). Data are presented on research misconduct, availability of research guidelines, and perceived research quality. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland, 5–6 April, 2002. The opinions expressed herein are those of the author and do not necessarily represent the views of the Office of Research Integrity, the U.S. Department of Health and Human Services, or any other federal agency.     

Confronting misconduct in science in the 1980s and 1990s: What has and has not been accomplished?

In 1985, after nearly a decade of inconclusive professional response to public concern about misconduct in research, Congress passed legislation requiring action. Subsequent to this legislation, federal agencies and research universities adopted policies for responding to allegations of misconduct in research. Conferences, sessions at professional meetings, and special publications were organized. New educational initiatives were begun, many in response to a 1989 National Institutes of Health/ Alcohol, Drug Abuse, and Mental Health Administration requirement to include ethics instruction in training grants. Notwithstanding a few key unresolved issues, such as the lack of a uniform federal definition of misconduct in research, the years since 1985 have witnessed a marked change in the professional response to misconduct in research. This paper evaluates the change since 1985 from the perspective of three key goals: 1) confronting misconduct, 2) promoting integrity and 3) ensuring integrity. While significant progress has been made in achieving the first two goals, the third remains largely unaddressed. The latter is due to the fact that researchers have not been interested in studying the integrity of their own profession. It is therefore suggested that studies are needed of routine or normal research practices and their impact on integrity for use in making decisions about research conduct policy. An earlier version of this paper was presented at the symposium entitled “Misconduct in Science: A Decade of Progress or Merely Years of Controversy” held during the Annual Meeting of the American Association for the Advancement of Science, Philadelphia, Pennsylvania, 13 February, 1998.     

Use and misuse of metrics in research evaluation

This paper addresses some critical issues in the applicability of quantitative performance measures (including bibliometric, economic, and co-occurrence measures) to the assessment of basic research. The strengths and weaknesses of metrics applied as research performance measures are examined. It is concluded that metrics have a useful role to play in the evaluation of research. Each metric employed, whether bibliometric, economic, co-occurrence, or others, brings a new dimension of potential insight to the complex problem of research assessment. However, when used in a stand-alone mode, metrics can be easily misinterpreted and result in misleading conclusions. Metrics should be an integral part of a more comprehensive approach to research evaluation, in which the leading role is assumed by expert peer review. Under this structure, the reviewers must be broadly constituted, so that the technical correctness of the research approaches being taken (doing the job right) can be evaluated by technical experts and the correctness of the research target (doing the right job) can be evaluated as well. This comprehensive approach insures quality in the implementation of existing research paradigms and allows the introduction of revolutionary new research paradigms as well. The views contained in this paper are solely those of the author and do not represent the views of the Department of the Navy. Ronald Kostoff received a Ph.D. from Princeton University, performed technical and economic research at Bell Laboratories, managed energy programs at U.S. Department of Energy, was Director of Technical Assessment at the Office of Naval Research for many years and presently manages the Navy’s In-House Laboratory Independent Research Program.     

North-South research partnership: Is collaboration possible between unequal partners?

Scientific cooperation between the Industrialized Countries (ICs) and the Less Developed Countries (LDCs) has evolved greatly over the last three decades and has involved a number of varied mechanisms ranging from technical assistance to collaborative research partnerships. After a brief historical review of these mechanisms and of the conceptual debates around them, this paper considers the main programs that have been established during the last 10–15 years to promote North-South scientific collaborative partnership. One of the main problems encountered in the implementation of collaborative research programs relate to the asymmetry of the collaboration and the dominance of the partners in the North. While recognizing that conditions for success may differ depending on the main objectives of the collaboration, a list of ingredients for successful collaboration is proposed in the conclusion. This is based on the experience of the programs under review. This paper was prepared while the author was a Visiting Fellow at the Center for International Science and Technology Policy, Elliott School of International Affairs, George Washington University, Washington D.C.     

Scientific misconduct: The lessons of time

Conclusions Pascal’s paper indicates how far we have come. Now as then, however, there is a need to reflect from outside the cocoon of our agencies, institutions, and disciplines to behold the enterprise that shapes both our behavior and our interpretations of it. For the boundary separating propriety from impropriety continues to move. Just as science, and the knowledge it begets, continues to evolve, so must our collective standards. The lessons of time include this: ORI or biomedical research is no island; each is connected to a body of practitioners who are accountable to a society that is ever-more skeptical of expert knowledge and the institutions entrusted with its development. We are participants in a process of “continuous improvement”, not occupants of a state of grace. For the good of the enterprise we cherish, it is best that we all remember that. The views expressed here are the author’s own and reflect neither those of NSF nor of the National Science Board.     

Pre-arrest diversion of people with mental illness: Literature review and international survey

Mental health diversion is a process where alternatives to criminal sanctions are made available to persons with mental illness (PMI) who have come into contact with the law. One form of mental health diversion is pre-arrest, in which the police use their discretion in laying charges. Concomitant with the growth of pre-arrest diversion programs is a growing body of research devoted to the phenomenon. The purpose of this paper is to review the existing literature of pre-arrest diversion, and to report the results of an international survey of pre-arrest diversion programs we conducted to identify evidence-based practices. On the basis of our review and survey, we note that successful pre-trial programs appear to integrate relevant mental health, substance abuse and criminal justice agencies by having regular meetings between key personnel from the various agencies. Often, a liaison person with a mandate to effect strong leadership plays a key role in the coordination of various agencies. Streamlining services through the creation of an emergency drop-off center with a no-refusal policy for police cases is seen as crucial. While there is some indication that mentally ill offenders benefit from their participation in this form of diversion, the evaluative literature has not yet achieved the "critical mass" necessary to create generalizable, evidence-based knowledge. The absence of generally agreed-upon outcomes could lead to the inequitable application of basic principles of diversion. We suggest that indicators, benchmarks, and outcomes must be agreed upon if a comprehensive understanding of pre-arrest programs is to emerge.     

Conflicts of interests and access to information resulting from biomedical research: an international legal perspective

Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedical research. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Knowledge management: A re-assessment and case

The authors are building a knowledge management system (KMS) for use by several U.S. federal agencies. Its use must harmonize with multiple agency and disciplinary cultures, and also link with the efforts of at least one international agency. In this paper, we present the KMS project’s technological contributions and implementation considerations as a case in knowledge management (KM). We link the public-sector case with our assessment of KM’s current status and future prospects. We find the challenges for KM’s future are in theory, interactivity, integration, the recognition of cultural differences, and the design of marketing programs that respect these differences. His research focuses on technology management and technology entrepreneurship. Dr. Delcambre’s research focuses on object-oriented and other database data models. developed the Metadata++ software discussed in this paper. With Lois Delcambre, he has been exploring models for terms or keywords that are used in a digital library.     

Funding,objectivity and the socialization of medical research

There has been a sharp rise in private funding of medical research, especially in relation to patentable products. Several serious problems with this are described. A solution involving the elimination of patents and public funding administered through extended national health care systems is proposed. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Four observations about “six domains of research ethics”

Stimulated by Kenneth Pimple's "Six Domains of Research Ethic", this paper examines four aspects of the responsible conduct of research and scientists' social responsibilities. I argue that scholars and decision-makers concerned with the responsible conduct of research should take notice of the rapidly growing body of scholarship on the social organization of science and the behavior of scientists, integrating that work with ethical principles. Of particular concern are the increasing heterogeneity and interdisciplinary of research, the ambivalences in the practice of peer review, the social tensions of research life, and the heightened concern for social and economic returns from federal research investments. In all, the paper echoes and develops Pimple's call for integrative thinking about the responsible conduct of research.     

Scientific misconduct: Present problems and future trends

Substantial progress in handling scientific misconduct cases has been made since the first cases were investigated by the NIH Office of Scientific Integrity in 1989. The successor Office of Research Integrity (ORI) has simultaneously reduced the backlog of cases and increased the professionalism with which they are handled. However, a spate of lawsuits against universities, particularly those brought under the federal False Claims Act, threatens to undermine the ORI by encouraging use of the courts as an alternate route for resolving claims of research misconduct. Next steps should include establishing a government-wide definition of scientific misconduct, providing immunity from lawsuits for institutions that follow proper procedures in investigating charges of scientific misconduct, and participating in the development of international guidelines for maintaining scientific integrity. An earlier version of this paper was presented at the symposium entitled “Misconduct in Science: A Decade of Progress or Merely Years of Controversy” held during the Annual Meeting of the American Association for the Advancement of Science, Philadelphia, Pennsylvania, 13 February, 1998.     

The gap between law and ethics in human embryonic stem cell research: Overcoming the effect of U.S. Federal policy on research advances and public benefit

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. The opinions expressed in this article are the author’s own, and are not necessarily the opinions of others, including Children’s Hospital Boston. Portions of earlier versions of this article were previously published by the American Bar Association and the New York State Bar Association.     

Moral duties of parents and nontherapeutic clinical research procedures involving children

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children.     

The Essential Need for Research Misconduct Allegation Audits

Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and the Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards (GAGAS/Yellow Book), if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct.     

Public Health Asks of Community Psychology…

As the field of public health has increasingly recognized the social and behavioral aspects of the changing epidemiology of diseases and injuries, it has added social and behavioral scientists to the faculties of schools of public health and most federal and state public health agencies. Community psychology can play a crucial role in helping to bridge the dominant psychological theories with the family and community contexts in which individuals are conditioned and reinforced in their tendencies toward violent behavior. Public health asks of community psychology a helping hand in bridging the clinical endpoints of most NIH-sponsored behavioral research with the community endpoints of most CDC-sponsored programs such as injury control.     

Special Feature: Research,training, and demonstration funds for guidance and counseling

The support programs of federal, state, and private agencies are reviewed so that educators may know some of the sources of financial aid for all levels of education. Federal legislation provides the most funds whether the programs are administered by federal or state agencies. Several basic sources of additional information on available programs are also presented.     

Evolving research misconduct policies and their significance for physical scientists

Scientific misconduct includes the fabrication, falsification, and plagiarism (FFP) of concepts, data or ideas; some institutions in the United States have expanded this concept to include “other serious deviations (OSD) from accepted research practice.” It is the absence of this OSD clause that distinguishes scientific misconduct policies of the past from the “research misconduct” policies that should be the basis of future federal policy in this area. This paper introduces a standard for judging whether an action should be considered research misconduct as distinguished from scientific misconduct: by this standard, research misconduct must involve activities unique to the practice of science and must have the potential to negatively affect the scientific record. Although the number of cases of scientific misconduct is uncertain (only the NIH and the NSF keep formal records), the costs are high in terms of the integrity of the scientific record, diversions from research to investigate allegations, ruined careers of those eventually exonerated, and erosion of public confidence in science. Existing scientific misconduct policies vary from institution to institution and from government agency to government agency; some have highly developed guidelines that include OSD, others have no guidelines at all. One result has been that the federal False Claims Act has been used to pursue allegations of scientific misconduct. As a consequence, such allegations have been adjudicated in federal courts, rather than judged by scientific peers. The federal government is now establishing a first-ever research misconduct policy that would apply to all research funded by the federal government regardless of which agency funded the research or whether the research was carried out in a government, industrial or university laboratory. Physical scientists, who up to now have only infrequently been the subject of scientific misconduct allegations, must nonetheless become active in the debate over research misconduct policies and how they are implemented since they will now be explicitly covered by this new federal wide policy. Disclaimer: The authors are grateful for the support for conduct of this research provided by the United States Department of Energy (DOE). The views expressed in this paper are solely those of the authors and were formed and expressed without reference to positions taken by DOE or the Pacific Northwest National Laboratory (PNNL). The views of the authors are not intended either to reflect or imply positions of DOE or PNNL.     

Governmental research funding and economic distortion

Science and technology are “good” things. Still, there are many good things that should not be done by government and there are many other things that the private sector does far better. Government-funded research and development (R&D) falls into both these categories. Research funding is big business. In 1998, the Department of Health and Human Services received $13.1 billion, the National Aeronautics & Space Administration $9.3 billion, the Department of Energy $5.6 billion, and the National Science Foundation $2.3 billion. Newt Gingrich, still adhering to the Progressive dictum that “government does it better,” is now calling for a doubling of current federal research expenditures. This article will assess the theoretical arguments for government-funded research and examine specific research programs of the Department of Energy and the Environmental Protection Agency. Throughout, I will argue that private property rights, the rule of law, and free markets are the greatest incentives to conduct scientific research; under-investment in R&D is due not to market failure but to the failure to have markets. a public interest group active in economic and environmental public policy issues. Located in Washington, D.C., CEI has a web site at http://www.cei.org. Mr. Smith has debated free-market approaches to public problems as a guest on MacNeil/Lehrer, Crossfire, and 20/20. This article began as testimony before the Subcommittee on Energy and Environment, House Committee on Science, 25 March 1998. National Science Foundation website.