COI Policies: Tax Dollars Should Not Be Used to Fund U.S. Institutions Not Making the Grade

Over two billion dollars was awarded by the U.S. Department of Health and Human Services (HHS) in research funding from 2010 to March 2012 to institutions receiving a grade of "C," "D," or "F" on their conflict of interest policies, as determined by the American Medical Student Association's scorecard on conflict of interest policies. More institutional oversight is needed with regard to assuring conflict of interest policies at U.S. research institutions are adequate. As stewards of public funds, HHS should require a minimum standard which institutional conflict of interest policies should meet, beyond current regulatory requirements, before granting funding.     

Research Misconduct Definitions Adopted by U.S. Research Institutions

In 2000, the U.S. federal government adopted a uniform definition of research misconduct as fabrication, falsification, or plagiarism (FFP), which became effective in 2001. Institutions must apply this definition of misconduct to federally-funded research to receive funding. While institutions are free to adopt definitions of misconduct that go beyond the federal standard, it is not known how many do. We analyzed misconduct policies from 183 U.S. research institutions and coded them according to thirteen different types of behavior mentioned in the misconduct definition. We also obtained data on the institution’s total research funding and public vs. private status, and the year it adopted the definition. We found that more than half (59%) of the institutions in our sample had misconduct policies that went beyond the federal standard. Other than FFP, the most common behaviors included in definitions were “other serious deviations” (45.4%), “significant or material violations of regulations” (23.0%), “misuse of confidential information” (15.8%), “misconduct related to misconduct” (14.8%), “unethical authorship other than plagiarism” (14.2%), “other deception involving data manipulation” (13.1%), and “misappropriation of property/theft” (10.4%). Significantly more definitions adopted in 2001 or later went beyond the federal standard than those adopted before 2001 (73.2% vs. 26.8%), and significantly more definitions adopted by institutions in the lower quartile of total research funding went beyond the federal standard than those adopted by institutions in the upper quartiles. Public vs. private status was not significantly associated with going beyond the federal standard.     

Credit and Authorship Practices: Educational and Environmental Influences

A survey on credit issues of academic chemists in U.S. Ph.D.-granting institutions was conducted. The respondents rated 15 criteria for authorship of scientific publications; core intellectual contributions received the highest ratings although making a single suggestion that was essential to the successful completion of the project was rated very low. Acquisition of data was also rated highly. The respondents rated eight potential influences on their own “policy” toward giving credit; doing what “seems to be the right thing” was the highest rated influence followed by graduate educational experiences; professional society or other responsible conduct of research (RCR) institutional policies were rated, by far, the lowest.     

An International Study of Research Misconduct Policies

Research misconduct is an international concern. Misconduct policies can play a crucial role in preventing and policing research misconduct, and many institutions have developed their own policies. While institutional policies play a key role in preventing and policing misconduct, national policies are also important to ensure consistent promulgation and enforcement of ethical standards. The purpose of this study was to obtain more information about research misconduct policies across the globe. We found that twenty-two of the top forty research and development funding countries (55%) had a national misconduct policy. Four countries (18.2%) are in the process of developing a policy, and four (18.2%) have a national research ethics code but no misconduct policy. All twenty-two countries (100%) with national policies included fabrication, falsification, and plagiarism in the definition of misconduct, but beyond that there was considerable diversity. Unethical authorship was mentioned in 54.6% of the misconduct definitions, followed by unethical publication practices (36.4%), conflict of interest mismanagement (36.4%), unethical peer review (31.8%), misconduct related to misconduct investigations (27.3%), poor record keeping (27.3%), other deception (27.3%), serious deviations (22.7%), violating confidentiality (22.7%), and human or animal research violations (22.7%). Having a national policy was positively associated with research and development funding ranking and intensiveness. To promote integrity in international research collaborations, countries should seek to harmonize and clarify misconduct definitions and develop procedures for adjudicating conflicts when harmonization does not occur.     

Morality policy processes in advanced industrial democracies

In recent years, several countries have experienced widespread, intense debates about morality issues such as the death penalty, abortion, ART/stem cell research, same-sex marriage, and euthanasia. Assuming the distinctiveness of morality policies from other policy fields, this article analyses three alternative institutional models for explaining variations in the amount of conflict over these morality issues across 24 Western democracies. Is either the US-developed “policy type” model or the European-developed “two worlds” of morality politics, based on religious and secular party systems, applicable more broadly? Are there regional patterns (Europe and non-Europe) to any institutional findings? How does each model contribute to our understanding of morality policy comparatively across Western democracies? We find broader cross-national support for the policy type model, with the two worlds model largely restricted to Europe. The US has more morality policy conflict because of its unusual combination of a political party targeting religiously oriented voters within an institutional framework of multiple venues. The US and other non-European countries have similar patterns of institutional deliberation through decentralization, and the US also has similarities in multiple venues with religious party systems in Europe. Secular European party systems with centralized institutions have the fewest venues for morality policy debate.     

Comparison of Conflict of Interest Policies and Reported Practices in Academic Medical Centers in the United States

The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.     

Comparison of conflict of interest policies and reported practices in academic medical centers in the United States

The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.     

When the research is not reproducible: the importance of author-initiated and institution-driven responses and investigations

Important and potentially useful findings in the sciences are under more intense public scrutiny now more than ever. Other researchers in the field dive into replicating and expanding the findings while the media swamps the community and the public with peripheral reporting and analyses. How should authors and the hosting/funding institutions respond when other workers in the field could not reproduce or replicate their published results? To illustrate the importance of author-initiated and institution-driven investigations in response to outcries of research irreproducibility, I draw on comparisons between three recent and well-publicized cases in the life sciences: betatrophin, Stimulus-Triggered Acquisition of Pluripotency (STAP) cells, and Natronobacterium gregoryi Argonaute (NgAgo). Swift, transparent responses and investigations facilitate activation of the self-correcting mechanism of science and are likely also critical in preserving the community’s resources, public trust, and the reputation of the institutions and individuals concerned. Operational guidelines for “author and institutional responses” towards external reports of irreproducibility should therefore be in place for all research intensive institutions.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

Current issues in clinical research and the development of new pharmaceuticals

As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the “common rule”; if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients’ rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo‐controlled clinical trials may adversely impact drug development     

The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada’s current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of “frequently asked questions” about the proposed agency design such as “What about ‘local context’?” and “Why not have a system of accreditation of institutional REBs instead?” In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

美国反垄断法的演变轨迹——政治博弈的视角

美国反垄断法的历史演变呈现出了典型的“钟摆式”运行轨迹,与其不断“经济学化”的主流解释存在抵牾。经济学理论、政党政治以及经济和战争危机等因素确实对美国反垄断法的演变有影响,但是这些解释都不尽周延。以生产者团体和消费者团体为代表的利益团体之间的“政治博弈”,是导致美国反垄断法钟摆式演变的根本原因。这种博弈塑造了美国的反垄断政策,并不断引导美国反垄断法的发展和演变。     

Credit and authorship practices: educational and environmental influences

A survey on credit issues of academic chemists in U.S. Ph.D.-granting institutions was conducted. The respondents rated 15 criteria for authorship of scientific publications; core intellectual contributions received the highest ratings although making a single suggestion that was essential to the successful completion of the project was rated very low. Acquisition of data was also rated highly. The respondents rated eight potential influences on their own "policy" toward giving credit; doing what "seems to be the right thing" was the highest rated influence followed by graduate educational experiences; professional society or other responsible conduct of research (RCR) institutional policies were rated, by far, the lowest.     

Evaluating research misconduct policies at major research universities: A pilot study

This pilot study evaluates the accessibility and usefulness of the research misconduct (RM) policies at the top-25 universities as ranked by NIH and NSF grant awards. Measuring accessibility demonstrates how readily-available policies are to the people they affect. Evaluating the range of policy content indicates whether policies and procedures on research misconduct are “useful” as opposed to merely “minimal” (Rhoades, 2003 Rhoades, L. J. Policies and Procedures: Minimal or Useful. Presentation to the introductory workshop for institutional research integrity officers. University of Connecticut Health Center.  [Google Scholar]). On average, it took five clicks to get from a university's home page to its RM policies. Only nine policies were accessed within three or fewer clicks. Policy information was coded into categories comprising a total of 20 topic areas, which were then grouped into five content domains. The policies reveal a broad range of usefulness. Some provide relevant details on almost every topic area, while others leave most questions unanswered. Three of the 20 topic areas are almost universally covered in the policies analyzed. In contrast, five other topic areas average less than half of the information which could have been included. These policies, from elite U.S. research universities, may serve as role models; as such they should perhaps be held to the highest standards. If the message sent by a policy lacks clarity and precision, it should be revised to include an appropriate level of detail.     

National Identity,Citizenship and Immigration: Putting Identity in Context

In this paper we suggest that there is a need to examine what is meant by “context” in Social Psychology and present an example of how to place identity in its social and institutional context. Taking the case of British naturalisation, the process whereby migrants become citizens, we show that the identity of naturalised citizens is defined by common‐sense ideas about Britishness and by immigration policies. An analysis of policy documents on “earned citizenship” and interviews with naturalised citizens shows that the distinction between “elite” and “non‐elite” migrants is evident in both the “reified” sphere of policy and the “common sense” sphere of everyday identity construction. While social representations embedded in lay experience construct ethno‐cultural similarity and difference, immigration policies engage in an institutionalised positioning process by determining migrants' rights of mobility. These spheres of knowledge and practice are not disconnected as these two levels of “managing otherness” overlap—it is the poorer, less skilled migrants, originating outside the West who epitomise difference (within a consensual sphere) and have less freedom of mobility (within a reified sphere). We show that the context of identity should be understood as simultaneously psychological and political.     

Drafting “better regulation”: The economic cost of regulatory complexity

Different public agencies are seeking to draft “better regulation”. Complex or poorly drafted norms are more difficult for economic agents to implement, tending to erode economic efficiency. The literature has so far concentrated on the analysis of regulatory complexity as a phenomenon related to the “quantity” of norms. This article guides the process of adopting new regulations, taking into account that norms can also be complex due to new “qualitative” reasons such as linguistic ambiguity or relational structure (references between legal documents). To perform the analysis, we develop new indicators for legibility and regulatory interconnectedness. Specifically, we construct a new database (RECOS – REgulation COmplexity in Spain) by extracting information from 8171 norms (61 million words) which comprise the regulations of all the Spanish Autonomous regions. Our analysis reveals the relationship between measures of “qualitative” complexity and relevant economic (productivity) and institutional (judicial efficacy) variables. This research shows that the new dimensions of regulatory complexity matter, yield significant results and should be taken into account in governments’ “better regulation” policies.     

A U.S. Holy War? The Effects of Religion on Iraq War Policy Attitudes*

Objective. Throughout the course of the Iraq War, the Bush Administration has consistently framed its war policy in religious language. Therefore, we investigate the extent to which public religiosity predicts neoconservative foreign policy attitudes. Method. We use the 2005 Baylor Religion Survey to estimate OLS models predicting the effects of religious measures on support for a neoconservative Middle East foreign policy. Findings. We find that support for U.S. Iraq policy is partially an outcome of what we call “sacralization ideology,” as measured by the belief that religious and secular institutions should be more closely in collaboration. Conclusion. We argue that the religious framing of U.S. foreign policy appeals to a certain religious type who is not fully Republican or conservative evangelical.     

Federal research spending and innovation in the U.S. economy

This paper provides a better understanding of federal funding and its impact on the production process of patentable ideas in the U.S. economy. In this study, I develop an expansion of the Marshallian Macroeconomic Model (Ngoie and Zellner, 2012, forthcoming), which is applied to the U.S. science sector and, among other things, compare the return of federal spending on the three components of research activities mainly (1) basic research, (2) applied research, and (3) development research. The findings presented in this study clearly outline that federal funding channeled toward applied research carries a much larger return than research funding assigned to basic or development research. The return on research spending is measured using the number of patents awarded. Furthermore, this study investigates the transformation of patented ideas into new products and the related implications on sectoral economic growth.     

Popular economic narratives advancing the longest U.S. expansion 2009–2019

The U.S. economic expansion since 2009 is the longest on record since 1854, according to the National Bureau of Economic Research Business Cycle Dating Committee. This paper seeks to understand this phenomenon better by looking at the time paths of popular narratives over this interval, of stories that people have been telling that offer clues into their economic behavior. Six constellations of narratives are studied, identified by keywords “Great Depression,” “secular stagnation,” “sustainability,” “housing bubble,” “strong economy,” and “save more.”