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Student projects in medicine: a lesson in science and ethics.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K., where there are periodic calls to change it. My main claim is that there seems to be no good reason for treating student projects differently from projects led by qualified and more experienced scientists and hence no good grounds for changing the current system of ethics review. I first suggest that the educational objectives cannot be met without laying down standard...
Source: Accountability in Research - October 30, 2009 Category: Medical Ethics Authors: Edwards SJ Tags: Account Res Source Type: journals

Dealing with misconduct in biomedical research: a review of the problems and the proposed methods for improvement.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The increasing complexity of scientific research has been followed by increasing varieties of research misconduct. Dealing with misconduct involves the processes of detection, reporting, and investigation of misconduct. Each of these steps is associated with numerous problems which need to be addressed. Misconduct investigation should not stop with inquiries and disciplinary actions in specific episodes of misconduct. It is necessary to decrease the personal price paid by those who expose misconduct and to protect the personal and professional interests of honest researchers accused of misconduct unfairly or mistakenly...
Source: Accountability in Research - October 30, 2009 Category: Medical Ethics Authors: Kumar MN Tags: Account Res Source Type: journals

Editors' malpractice: forward submitted letters (to the concerned authors), then reject them.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
It seems that editors still enjoy an almost absolute power in deciding "what gets published" and are barely accountable. The rejection of two "Letters to the Editor" submitted by myself to different journals leads me to expose here the editors' confidentiality breach inherent to improperly sharing unpublished manuscripts with the challenged authors. Although the scientific relevance of the issues raised here is virtually null, these experiences are consistent with the view that full peer review starts only after publication, highlight certain editorial malpractices, and stress that we all should promote scientific inte...
Source: Accountability in Research - October 30, 2009 Category: Medical Ethics Authors: Rivera H Tags: Account Res Source Type: journals

An analysis of toxicology and medical journal conflict-of-interest polices.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The objective of this article is to compare the criteria, specificity, and scope of COI polices in toxicology and medical journals. We studied the COI policies of 47 toxicology and 180 medical journals catalogued in Ulrich's International Periodicals Directory for criteria of competing interests, types of submissions covered, monetary or time thresholds for reporting, and penalties for violations. Indicators were constructed for rating policy specificity, author discretion, and policy scope. Written COI policies were found in 87% if the toxicology and 84% of the medical journals; 15% and 28% of the toxicology and medical j...
Source: Accountability in Research - September 18, 2009 Category: Medical Ethics Authors: Krimsky S, Sweet E Tags: Account Res Source Type: journals

Research misconduct policies of scientific journals.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of this study was to gather information on the misconduct policies of scientific journals. We contacted editors from a random sample of 399 journals drawn from the ISI Web of Knowledge database. We received 197 responses (49.4% response rate): 54.8% had a policy, and 47.7% had a formal (written) policy; 28.9% had a policy that only outlined procedures for handling misconduct, 15.7% had a policy that only defined misconduct, 10.2% had a policy that included both a definition and procedures; 26.9% of journals had a policy that was generated by the publisher, 13.2% had a policy that was generated by the journa...
Source: Accountability in Research - September 18, 2009 Category: Medical Ethics Authors: Resnik DB, Peddada S, Brunson W Tags: Account Res Source Type: journals

Ethics instruction increases graduate students' responsible conduct of research knowledge but not moral reasoning.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of this study was to assess the short-term effectiveness of ethics courses in enhancing responsible conduct of research (RCR) knowledge and moral judgment among graduate students in health-related disciplines. Forty-eight graduate students completed a questionnaire about research experience, knowledge and judgments about appropriate research practices, and a standardized test of moral judgment at the beginning and end of a semester-long ethics course. Knowledge about RCR but not moral judgment increased significantly in some areas. The results are discussed in terms of implications for RCR instruction and o...
Source: Accountability in Research - September 18, 2009 Category: Medical Ethics Authors: Schmaling KB, Blume AW Tags: Account Res Source Type: journals

Editorial.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19353386 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - April 1, 2009 Category: Medical Ethics Authors: Krimsky S Tags: Account Res Source Type: journals

Prevalence of industry support and its relationship to research integrity.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators' first hand knowledge of the effects of industry sponsorship on research. Here we show first-hand knowledge that compromises occurred in: research participants' well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) be...
Source: Accountability in Research - April 1, 2009 Category: Medical Ethics Authors: Tereskerz PM, Hamric AB, Guterbock TM, Moreno JD Tags: Account Res Source Type: journals

Supervisor-student relations: examining the spectrum of conflicts of interest in bioscience laboratories.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Much attention has been given to financial conflicts of interest (COIs) in bioscience research. Yet to date, surprisingly little attention has focused on other COIs that arise in supervisor--student relations. We examine a spectrum of related situations, ranging from standard graduate supervision through to dual relationships sometimes found in research with commercial potential. We illustrate some of the less-obvious factors that can bias supervisory judgment, and situate financial COI along a spectrum of forces that are deserving of recognition. We conclude by providing two sets of recommendations: one for individual...
Source: Accountability in Research - April 1, 2009 Category: Medical Ethics Authors: Macdonald C, Williams-Jones B Tags: Account Res Source Type: journals

Effect of bibliographical classification on the impact factor of science- and engineering-based journals.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this study, the JIF computation of eight top ranked journals from four different subject categories was analyzed. The analysis reveals that most of the published items (>65%) in the science disciplines were nonresearch items while fewer such items (<22%) were observed in engineering-based journals. The single regression analysis confirmed that there is correlation (R(2) >/= .99) in the number of published items or citations received over the two-year period used in the JIF calculation amongst the eight selected journals. A weighted factor computation is introduced to compensate for the smaller journals and jour...
Source: Accountability in Research - January 1, 2009 Category: Medical Ethics Authors: Foo JY Tags: Account Res Source Type: journals

Cost of the NSERC Science Grant Peer Review System Exceeds the Cost of Giving Every Qualified Researcher a Baseline Grant.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Using Natural Science and Engineering Research Council Canada (NSERC) statistics, we show that the $40,000 (Canadian) cost of preparation for a grant application and rejection by peer review in 2007 exceeded that of giving every qualified investigator a direct baseline discovery grant of $30,000 (average grant). This means the Canadian Federal Government could institute direct grants for 100% of qualified applicants for the same money. We anticipate that the net result would be more and better research since more research would be conducted at the critical idea or discovery stage. Control of quality is assured through ...
Source: Accountability in Research - January 1, 2009 Category: Medical Ethics Authors: Gordon R, Poulin BJ Tags: Account Res Source Type: journals

Moral disengagement in the corporate world.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We present possible safeguards designed to protect the integrity of research. PMID: 19247852 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - January 1, 2009 Category: Medical Ethics Authors: White J, Bandura A, Bero LA Tags: Account Res Source Type: journals

Introduction: accountability in neuroethics.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 18972262 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Illes J, Pierce R Tags: Account Res Source Type: journals

The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain f...
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Carter A, Hall W Tags: Account Res Source Type: journals

Disclosure issues in neuroscience research.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Issues of disclosure arise in neuroscientific research during the informed consent process, whenever incidental findings are identified, and when study results are generated. The possibility of disclosure of incidental findings and/or research results may raise informational expectations on the part of subjects and may alter a study's risk:benefit ratio. We recommend that the informed consent process address this potential consequence of research participation, and specify the conditions under which particular types of information will be offered, the conditions under which information may not be disclosed, and any pro...
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Parker LS, Kienholz ML Tags: Account Res Source Type: journals

Incidental findings: a common law approach.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Federal regulations governing human subjects research do not address key questions raised by incidental neuroimaging findings, including the scope of a researcher's disclosure with respect to the possibility of incidental findings and the question whether a researcher has an affirmative legal cuty to seek, detect, and report incidental findings. The scope of researcher duties may, however, be mapped with reference to common law doctrine, including fiduciary, tort, contract, and bailment theories of liability. PMID: 18972265 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Tovino SA Tags: Account Res Source Type: journals

What a tangled web we weave: ethical and legal implications of deception in recruitment.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing...
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Pierce R Tags: Account Res Source Type: journals

Perspectives on engaging the public in the ethics of emerging biotechnologies: from salmon to biobanks to neuroethics.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In anticipation of increasing interest in public engagement, this article seeks to expand the current discussion in the neuroethics literature concerning what public engagement on issues related to neuroscience might entail and how they could be envisioned. It notes that the small amount of available neuroethics literature related to public engagement has principally discussed only communication/education or made calls for dialogue without exploring what this might entail on a practical level. The article links across three seemingly disparate examples-salmon, biobanks, and neuroethics-to consider and clarify the need ...
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Secko DM, Burgess M, O'Doherty K Tags: Account Res Source Type: journals

Biomedical Research and the Commercialization Agenda: A Review of main Considerations for Neuroscience.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article reviews a range of issues associated with the commercialization of biomedical research and speculates on how these issues might apply to the neuroscience context. Drawing on existing studies of the impact of research commercialization activities on various areas of biotechnology research, the authors explore normative benchmarks for assessing and resolving issues likely to arise from the commercialization of neuroscientific research, including such topics as patenting, marketing pressures, and representations of research prospects. PMID: 18972268 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - October 1, 2008 Category: Medical Ethics Authors: Caulfield T, Ogbogu U Tags: Account Res Source Type: journals

The therapeutic misconception: a threat to valid parental consent for pediatric neuroimaging research.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article revierws the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research...
Source: Accountability in Research - July 1, 2008 Category: Medical Ethics Authors: Hadskis M, Kenny N, Downie J, Schmidt M, D'Arcy R Tags: Account Res Source Type: journals

Industry-sponsored ghostwriting in clinical trial reporting: a case study.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message. PMID: 18792536 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - July 1, 2008 Category: Medical Ethics Authors: McHenry LB, Jureidini JN Tags: Account Res Source Type: journals

Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in res...
Source: Accountability in Research - July 1, 2008 Category: Medical Ethics Authors: Amin SB, McDermott MP, Shamoo AE Tags: Account Res Source Type: journals

The expanding purview: institutional review boards and the review of human subjects research.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review. PMID: 18792538 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - July 1, 2008 Category: Medical Ethics Authors: Borenstein J Tags: Account Res Source Type: journals

Brain-Computer Interface devices: risks and Canadian regulations.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article provides an overview of the research, developments, design issues, and risks in BCIs and an analysis of the adequacy of the regulatory framework in place for the approval of medical devices in Canada, emphasizing device investigational testing. The article concludes that until better safeguards are in place, to best protect potential research subjects, BCIs should not be approved for investigational testing in Canada. PMID: 18593098 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - April 1, 2008 Category: Medical Ethics Authors: Alpert S Tags: Account Res Source Type: journals

Responsible Conduct of Research Measure: initial development and pilot study.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Although much discussion has been focused on research misconduct (RM) and questionable research practices, to date no self-report measures exist to examine this phenomenon. To help fill this void, the authors developed the Responsible Conduct of Research Measure (RCRM) through multiple pilot study waves involving researchers in the social and behavioral sciences. Preliminary results reveal adequate validity and reliability. The authors discuss limitations of the study as well as some possible directions for future research on this topic. PMID: 18593099 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - April 1, 2008 Category: Medical Ethics Authors: Wester KL, Willse JT, Davis MS Tags: Account Res Source Type: journals

Ethical and legal considerations regarding disputed authorship with the use of shared data.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article analyzes how the ethical guidelines from the American Psychological Association (APA), the Office of Research Integrity (ORI), and the American Educational Research Association (AERA) can inform common disputes in this area. Additional insights about the nature of the research relationship are derived from contract and copyright law. Practice guidelines are proposed to safeguard student and faculty welfare in research collaboration, and recommendations are provided to help prevent and resolve disputes between students and faculty. PMID: 18593100 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - April 1, 2008 Category: Medical Ethics Authors: Welsh RK, Lareau CR, Clevenger JK, Reger MA Tags: Account Res Source Type: journals

Scientific judgment and the limits of conflict-of-interest policies.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article argues that the three major elements of typical university conflict-of-interest (COI) policies (i.e., disclosure, management, and elimination of conflicts via divestiture or recusal) are likely to be insufficient for screening out many worrisome influences of financial COIs. Current psychological research challenges the effectiveness of disclosure, management plans are unlikely to address the wide range of ways that financial COIs can influence scientific judgment, and it is often impractical to eliminate conflicts. Identifying the limits of these policies highlights the importance of considering alternative s...
Source: Accountability in Research - January 1, 2008 Category: Medical Ethics Authors: Elliott KC Tags: Account Res Source Type: journals

Teaching and learning responsible research conduct: influences of prior experiences on acceptance of new ideas.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Despite requirements for Responsible Conduct of Research (RCR) training, little is known about how much this training actually influences the thinking and behaviors of participants. Interview-based qualitative research methods were used to study the reactions of Ph.D. students and postdoctoral fellows to what was taught in an RCR course. For trainees with limited prior RCR experience, or who agreed with what was taught, it was relatively easy to influence their attitudes and how they thought they would use the new information in the future. However, if their prior experiences or existing knowledge conflicted with what ...
Source: Accountability in Research - January 1, 2008 Category: Medical Ethics Authors: McGee R, Almquist J, Keller JL, Jacobsen SJ Tags: Account Res Source Type: journals

EPA's 2006 human-subjects rule for pesticide experiments.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Arguing that the 2006 Environmental Protection Agency (EPA) human-subjects rule allows use of unethical third-party research (on pregnant women and children) in setting pesticide regulations, this article first (a) provides a brief history of U.S. pesticide regulation, particularly regarding childhood safety. Next it (b) outlines ethical and scientific loopholes in the 2006 EPA rule; (c) shows how the Human Subjects Review Board, mandated by the 2006 rule, has been implemented in flawed ways; and (d) illustrates that one source of problems with the rule may be influence by those with conflicts of interest. PMID: 18...
Source: Accountability in Research - October 1, 2007 Category: Medical Ethics Authors: Shrader-Frechette K Tags: Account Res Source Type: journals

Offering results to research subjects: U.S. Institutional Review Board policy.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
CONCLUSIONS: Our findings demonstrate a marked lack of uniformity in IRB policy regarding the return of study results with over half providing no guidance. PMID: 18246944 [PubMed - in process] (Source: Accountability in Research)
Source: Accountability in Research - October 1, 2007 Category: Medical Ethics Authors: Kozanczyn C, Collins K, Fernandez CV Tags: Account Res Source Type: journals

Authorship and publication practices: evaluation of the effect of responsible conduct of research instruction to postdoctoral trainees.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
tiveness of responsible conduct of research (RCR) education in the areas of authorship and publication practices. We used a 3-wave telephone and on-line survey design, conducted over a period of two years, in order to test for individual change before and after completing RCR education. Overall the responses of the subjects suggested a clear awareness of standards and practices in publication. However, our results failed to suggest that RCR education in this group significantly increased the level of ethically appropriate behavioral responses measured in the study. Similarly we saw no significant effect on increasing aware...
Source: Accountability in Research - October 1, 2007 Category: Medical Ethics Authors: Authorship and publication practices: evaluation of the effect of responsible conduct of research instruction to postdoctoral trainees. Tags: Account Res Source Type: journals

Giving voice to research participants: should IRBs hear from research participant representatives?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article proposes a procedural mechanism that would ameliorate these systemic deficiencies by allowing "research participant representatives" to give voice to participants during the research review process. PMID: 17877106 [PubMed - indexed for MEDLINE] (Source: Accountability in Research)
Source: Accountability in Research - July 1, 2007 Category: Medical Ethics Authors: Hadskis MR Tags: Account Res Source Type: journals

Are risks and benefits of oncological research protocols both incommensurable and incompensable?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Institutional review boards (IRBs) are legally required to determine whether the balance between the risks and benefits (the risk-benefit ratio or RBR) of a proposed study is "reasonable" or "proportional". This obligation flows from their duty to protect the interests of research subjects. It has been argued that it is difficult, perhaps even impossible for IRBs to determine the RBR of studies, because the risks and benefits are not only heterogeneous, but also incommensurable. After arguing that the relevant meaning of incommensurability is incomparability, we discuss whether the risks of participating in a trial and...
Source: Accountability in Research - July 1, 2007 Category: Medical Ethics Authors: Musschenga AW, Van Luijn HE, Keus RB, Aaronson NK Tags: Account Res Source Type: journals

Limited relevance of the right not to know--reflections on a screening study.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article argues against giving the right not to know such a prominent position. It does so by questioning the ethical relevance of the concept for both theoretical and empirical reasons. The main focus of the article is on empirical data from a prospective population screeningfor Type I diabetes. Data indicate that research participants are not as autonomous as is generally assumed by the defenders of the right not to know. PMID: 17877108 [PubMed - indexed for MEDLINE] (Source: Accountability in Research)
Source: Accountability in Research - July 1, 2007 Category: Medical Ethics Authors: Helgesson G, Eriksson S, Swartling U Tags: Account Res Source Type: journals

A right to benefit from international research: a new approach to capacity building in less-developed countries.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article proposes a means by which benefits provided in international research collaborations might be employed to strengthen health care, research, and other capacities in less-developed countries. The Declaration of Helsinki and CIOMS Guidelines define certain expectations of benefits, but these requirements are ambiguous, logistically problematic, and studies suggest they are inconsistently upheld. Drawing on the principle of respect for persons, a right to benefit from hosting externally-sponsored research is proposed. This right guarantees host communities benefits of a certain value, the nature and use of which i...
Source: Accountability in Research - April 1, 2007 Category: Medical Ethics Authors: White MT Tags: Account Res Source Type: journals

The Research Environment Norm Inventory (RENI): a study of integrity in research administrative systems.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
University research administrators have been generally ignored in basic studies of research integrity. Hensley noted that research administrators are "essential... to the achievement of the specific missions of postsecondary institutions... and to science and the academic infrastructure". The following study sought to extend the scope of research on research integrity to research administrative structures with a new instrument called the Research Environment Norm Inventory or RENI. University research administrators and their professional association were targeted for data collection. Evidence suggested that research a...
Source: Accountability in Research - April 1, 2007 Category: Medical Ethics Authors: Atkinson TN, Gilleland DS, Pearson LC Tags: Account Res Source Type: journals

The ethical issues in uranium mining research in the Navajo Nation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We explore the experience of Navajo communities living under the shadow of nuclear age fallout who were subjects of five decades of research. In this historical analysis of public health (epidemiological) research conducted in the Navajo lands since the inception of uranium mining from the 1950s untill the end of the 20th century, we analyze the successes and failures in the research initiatives conducted on Navajo lands, the ethical breaches, and the harms and benefits that this research has brought about to the community. We discuss how scientific and moral uncertainty, lack of full stakeholder participation and comm...
Source: Accountability in Research - April 1, 2007 Category: Medical Ethics Authors: Panikkar B, Brugge D Tags: Account Res Source Type: journals

Real-time updates of meta-analyses of HIV treatments supported by a biomedical ontology.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Meta-analyses involve a systematic statistical explanation of available evidence and are a commonly used systematic reviewing strategy for addressing health related scientific research. Publication biases often delay reporting of meta-analyses and subsequent policy making. Ontologies have the capacity to provide real time meta-analyses that can reduce publication delay. The purpose of this study was to describe the meta-analytic process of a recently revised ontology. Three recently published meta-analyses were replicated using an ontology that extracts appropriate statistical "tags" from the originally reviewed publis...
Source: Accountability in Research - January 1, 2007 Category: Medical Ethics Authors: Cook C, Hannley M, Richardson JK, Michon J, Harker M, Pietrobon R Tags: Account Res Source Type: journals

Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: challenging 45 CFR 46.406.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article demonstrates that, even if the necessity and magnitude of benefit to society justify exposing children to increased risk, the decision to categorically restrict participation in such research to children with the disorder or condition under investigation (unless the study is federally reviewed and approved) is not justified. Subpart D should be revised. PMID: 17847605 [PubMed - indexed for MEDLINE] (Source: Accountability in Research)
Source: Accountability in Research - January 1, 2007 Category: Medical Ethics Authors: Iltis A Tags: Account Res Source Type: journals

Intentional exposure studies of environmental agents on human subjects: assessing benefits and risks.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and diseas...
Source: Accountability in Research - January 1, 2007 Category: Medical Ethics Authors: Resnik DB Tags: Account Res Source Type: journals

Research records and the resolution of misconduct allegations at research universities.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this study, we examined the role of research records in the resolution of misconduct allegations as a useful barometer for the incidence and types of problems that occur with records. We interviewed Research Integrity Officers (RIOs) at 90 major research universities and conducted focus groups with active research faculty. RIOs reported problems with research records in 38% of the 553 investigations they conducted. Severe problems with research records often prevented completion of investigations while problems that are more typical lengthened them by 2 to 3 weeks. Five types of poor record keeping practices accounted f...
Source: Accountability in Research - January 1, 2007 Category: Medical Ethics Authors: Wilson K, Schreier A, Griffin A, Resnik D Tags: Account Res Source Type: journals

The ethics of withdrawal from study participation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We investigated whether consent forms adhere to Federal Common Rule regulations pertaining to withdrawal from research, described the language of withdrawal provisions, and assessed differences in studies by withdrawal provisions. A random sample of 114 consent forms from a midwestern, academic medical center were examined for descriptive content of withdrawal parameters stated within consent forms. All consent forms included the required statement about withdrawal pursuant to the Code of Federal Regulations (CFR) 45 CFR (46.116(a)(8)), and all adhered to regulation 45 CFR (46.116(b)(4)) by including a statement that w...
Source: Accountability in Research - October 1, 2006 Category: Medical Ethics Authors: Gordon EJ, Prohaska TR Tags: Account Res Source Type: journals

Gender, racial, and ethnic disclosure in NIH K-Award funded diabetes and obesity clinical trials.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have "appropriate representation" of minority and women subjects. Our aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Using the CRISP search engine and PUBMED, we selected publications published by the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Ki...
Source: Accountability in Research - October 1, 2006 Category: Medical Ethics Authors: Guevara C, Cook C, Herback N, Pietrobon R, Jacobs DO, Vail TP Tags: Account Res Source Type: journals

Comparison of conflict of interest policies and reported practices in academic medical centers in the United States.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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 ...
Source: Accountability in Research - October 1, 2006 Category: Medical Ethics Authors: Dinan MA, Weinfurt KP, Friedman JY, Allsbrook JS, Gottlieb J, Schulman KA, Hall MA, Dhillon JK, Sugarman J Tags: Account Res Source Type: journals

Human embryonic stem cell research: an argument for national research review.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. AT the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In parti...
Source: Accountability in Research - July 1, 2006 Category: Medical Ethics Authors: Baylis F, Robert JS Tags: Account Res Source Type: journals

Research misconduct and the scientific process: continuing quality improvement.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The response to research misconduct involves the attempt to regulate behavior through (a) creating and enforcing a rule and (b) ethics education. The roles of each must be shaped by considerations of the nature of scientific practice. Given the nature of science, the role of (a) must be limited in scope: both in the types of behavior it covers and in the level of intent that must be present for an allegation of misconduct to be proven. Since one important role of ethics education is to fill the gaps that regulatory rules leave open, it is this limitation in scope and its source in theoretical concerns that better revea...
Source: Accountability in Research - July 1, 2006 Category: Medical Ethics Authors: Koppelman-White E Tags: Account Res Source Type: journals

Research misconduct policies of high impact biomedical journals.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Several national and international organizations have recommended policies regarding journal responsibilities about research misconduct in submitted or published manuscripts. A search of Web sites of the fifty highest impact journals in a cluster of biomedical fields and a limited survey of their editors shows that few journals have formally adopted standards for dealing with questions of research misconduct. Publicly available policies may have a deterrent effect and can prevent arbitrariness in handling cases. PMID: 17124760 [PubMed - indexed for MEDLINE] (Source: Accountability in Research)
Source: Accountability in Research - July 1, 2006 Category: Medical Ethics Authors: Redman BK, Merz JF Tags: Account Res Source Type: journals

Deception in psychology: moral costs and benefits of unsought self-knowledge.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Is it ethically permissible to use deception in psychological experiments? We argue that, provided some requirements are satisfied, it is possible to use deceptive methods without producing significant harm to research participants and without any significant violation of their autonomy. We also argue that methodological deception is at least at the moment the only effective means by which one can acquire morally significant information about certain behavioral tendencies. Individuals in general, and research participants in particular, gain self-knowledge which can help them improve their autonomous decision-making. T...
Source: Accountability in Research - July 1, 2006 Category: Medical Ethics Authors: Bortolotti L, Mameli M Tags: Account Res Source Type: journals

Two facets of peer review and the proper role of study sections.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The current National Institutes of Health study section system is under increasing criticism due to tight budgets and decreased levels of perceived competence. There is also an overemphasis on written critiques from the study section by unsuccessful applicants. It is argued that this arises from confusion between two different purposes of peer review. A system of universal participation in peer review by senior funded investigators is proposed to ameliorate these problems. PMID: 17124762 [PubMed - indexed for MEDLINE] (Source: Accountability in Research)
Source: Accountability in Research - July 1, 2006 Category: Medical Ethics Authors: Lenard J Tags: Account Res Source Type: journals

Are you sitting comfortably? Perspectives of the researchers and the researched on "being comfortable".Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In a study of volunteers in medical research, we found contrasting readings of "being comfortable" by the volunteer research subjects and the researchers. Although the experimental process (testing a new kind of diagnostic technology) involved some physical discomfort--and the researchers focused on this--the volunteers' concerns centred on feeling socially comfortable and managing feelings of embarrassment or isolation, and they generally made light of the physical aspects. The bias of volunteer concerns, which is understandable in terms of the different situations of researchers and volunteers and the different tensi...
Source: Accountability in Research - April 1, 2006 Category: Medical Ethics Authors: Morris N, Balmer B Tags: Account Res Source Type: journals