MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'Accountability in Research' source. Tue, 02 Mar 2010 17:42:29 +0100 http://www.medworm.com/index.php?rid=3201131&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20094927%26dopt%3DAbstract Authors: De Ville K PMID: 20094927 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=3201131 Fri, 01 Jan 2010 00:00:00 +0100 3201131 http://www.medworm.com/index.php?rid=3201130&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20094928%26dopt%3DAbstract This article will address the overall ethical issues associated with these new technologies. The report identifies the ethical and cultural challenges in conducting research on these new tools, explores the possibility of using current U.S. regulatory requirements regarding drugs and devices as a model for regulating these new technologies, and suggests approaches for the future. PMID: 20094928 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=3201130 Fri, 01 Jan 2010 00:00:00 +0100 3201130 http://www.medworm.com/index.php?rid=3201129&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D20094929%26dopt%3DAbstract This article undertakes an analysis and exploration of the potential liability that exists for DSMBs and their members under negligence theory and discusses the means by which DSMBs and their members may avoid litigation or defend themselves in the face of a lawsuit. Research accountability implications of imposing liability, or not, on DSMBs are also considered. It is suggested that legislation be contemplated requiring sponsors to indemnify DSMBs and their members in the face of litigation. PMID: 20094929 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=3201129 Fri, 01 Jan 2010 00:00:00 +0100 3201129 http://www.medworm.com/index.php?rid=2944354&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19866379%26dopt%3DAbstract Authors: Edwards SJ 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 standards of good science, whatever they may be. Weak science is unnecessary for educational purposes, and it is, in any case, unlikely to produce good resear... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2944354 Fri, 30 Oct 2009 22:44:10 +0100 2944354 http://www.medworm.com/index.php?rid=2944353&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19866380%26dopt%3DAbstract Authors: Kumar MN 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. There is no dearth of suggestions to improve the objectivity and fairness of investigations. What is needed is the willingness to test the various opt... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2944353 Fri, 30 Oct 2009 22:44:07 +0100 2944353 http://www.medworm.com/index.php?rid=2944352&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19866381%26dopt%3DAbstract Authors: Rivera H 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 integrity. PMID: 19866381 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2944352 Fri, 30 Oct 2009 22:44:04 +0100 2944352 http://www.medworm.com/index.php?rid=2804908&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19757230%26dopt%3DAbstract 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 journals, respectively, were explicit about the type of content covered by the policy; 20% and 29%, respectively, included a monetary threshold for reporting purposes; the... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2804908 Fri, 18 Sep 2009 08:38:02 +0100 2804908 http://www.medworm.com/index.php?rid=2804907&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19757231%26dopt%3DAbstract Authors: Resnik DB, Peddada S, Brunson W 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 journal, and 14.7% had a policy that was generated by another source, such as a professional association. We analyzed the relationship ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2804907 Fri, 18 Sep 2009 08:38:02 +0100 2804907 http://www.medworm.com/index.php?rid=2804906&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19757232%26dopt%3DAbstract Authors: Schmaling KB, Blume AW 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 of future research designed to improve RCR instruction. PMID: 19757232 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2804906 Fri, 18 Sep 2009 08:38:02 +0100 2804906 http://www.medworm.com/index.php?rid=2472634&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19353386%26dopt%3DAbstract Authors: Krimsky S PMID: 19353386 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2472634 Wed, 01 Apr 2009 04:00:00 +0100 2472634 http://www.medworm.com/index.php?rid=2472611&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19353387%26dopt%3DAbstract Authors: Tereskerz PM, Hamric AB, Guterbock TM, Moreno JD 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%) because of industry support. Financial relationships with industry were prevalent and considered important to cond... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2472611 Wed, 01 Apr 2009 04:00:00 +0100 2472611 http://www.medworm.com/index.php?rid=2472589&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19353388%26dopt%3DAbstract Authors: Macdonald C, Williams-Jones B 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 supervisors, and the other for institutions and policy-makers. PMID: 19353388 [PubMed - in process] (Source: Accountability in... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2472589 Wed, 01 Apr 2009 04:00:00 +0100 2472589 http://www.medworm.com/index.php?rid=2223834&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19247850%26dopt%3DAbstract 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 journals that publish longer turnover research. It is hoped that the approach can provide a comprehensive assessment of the quality of a journal regardless of the disciplinar... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2223834 Thu, 01 Jan 2009 05:00:00 +0100 2223834 http://www.medworm.com/index.php?rid=2223833&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19247851%26dopt%3DAbstract Authors: Gordon R, Poulin BJ 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 university hiring, promotion and tenure proceedings, journal reviews of submitted work, and the patent process, whose collective scrutiny far... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2223833 Thu, 01 Jan 2009 05:00:00 +0100 2223833 http://www.medworm.com/index.php?rid=2223832&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D19247852%26dopt%3DAbstract We present possible safeguards designed to protect the integrity of research. PMID: 19247852 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=2223832 Thu, 01 Jan 2009 05:00:00 +0100 2223832 http://www.medworm.com/index.php?rid=1921642&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972262%26dopt%3DAbstract Authors: Illes J, Pierce R PMID: 18972262 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921642 Wed, 01 Oct 2008 04:00:00 +0100 1921642 http://www.medworm.com/index.php?rid=1921641&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972263%26dopt%3DAbstract Authors: Carter A, Hall W 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 free and informed consent. PMID: 18972263 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921641 Wed, 01 Oct 2008 04:00:00 +0100 1921641 http://www.medworm.com/index.php?rid=1921640&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972264%26dopt%3DAbstract Authors: Parker LS, Kienholz ML 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 provisions for helping subjects make sense of the information to be disclosed. PMID: 18972264 [PubMed - in process] (Source: Accountabili... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921640 Wed, 01 Oct 2008 04:00:00 +0100 1921640 http://www.medworm.com/index.php?rid=1921639&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972265%26dopt%3DAbstract Authors: Tovino SA 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921639 Wed, 01 Oct 2008 04:00:00 +0100 1921639 http://www.medworm.com/index.php?rid=1921638&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972266%26dopt%3DAbstract Authors: Pierce R 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 condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolute... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921638 Wed, 01 Oct 2008 04:00:00 +0100 1921638 http://www.medworm.com/index.php?rid=1921637&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972267%26dopt%3DAbstract Authors: Secko DM, Burgess M, O'Doherty K 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 for public engagement in neuroscience. PMID: 18972267 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921637 Wed, 01 Oct 2008 04:00:00 +0100 1921637 http://www.medworm.com/index.php?rid=1921636&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18972268%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1921636 Wed, 01 Oct 2008 04:00:00 +0100 1921636 http://www.medworm.com/index.php?rid=1798813&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18792535%26dopt%3DAbstract 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. PMID: 18792535 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1798813 Tue, 01 Jul 2008 04:00:00 +0100 1798813 http://www.medworm.com/index.php?rid=1798812&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18792536%26dopt%3DAbstract Authors: McHenry LB, Jureidini JN 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1798812 Tue, 01 Jul 2008 04:00:00 +0100 1798812 http://www.medworm.com/index.php?rid=1798811&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18792537%26dopt%3DAbstract Authors: Amin SB, McDermott MP, Shamoo AE 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 research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1798811 Tue, 01 Jul 2008 04:00:00 +0100 1798811 http://www.medworm.com/index.php?rid=1798810&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18792538%26dopt%3DAbstract Authors: Borenstein J 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1798810 Tue, 01 Jul 2008 04:00:00 +0100 1798810 http://www.medworm.com/index.php?rid=1575945&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18593098%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1575945 Tue, 01 Apr 2008 04:00:00 +0100 1575945 http://www.medworm.com/index.php?rid=1575944&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18593099%26dopt%3DAbstract Authors: Wester KL, Willse JT, Davis MS 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1575944 Tue, 01 Apr 2008 04:00:00 +0100 1575944 http://www.medworm.com/index.php?rid=1575943&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18593100%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1575943 Tue, 01 Apr 2008 04:00:00 +0100 1575943 http://www.medworm.com/index.php?rid=1271629&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18298027%26dopt%3DAbstract 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 strategies, such as encouraging more independently funded esearch, in order to maintain the integrity of science. PMID: 18298027 [PubMed - in process] (Source: Account... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271629 Tue, 01 Jan 2008 05:00:00 +0100 1271629 http://www.medworm.com/index.php?rid=1271628&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18298028%26dopt%3DAbstract Authors: McGee R, Almquist J, Keller JL, Jacobsen SJ 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 was taught they resisted and often rejected new ideas that were presented. Interviews also revealed the tremendously ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271628 Tue, 01 Jan 2008 05:00:00 +0100 1271628 http://www.medworm.com/index.php?rid=1271632&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18246943%26dopt%3DAbstract Authors: Shrader-Frechette K 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: 18246943 [PubMed - in process] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271632 Mon, 01 Oct 2007 04:00:00 +0100 1271632 http://www.medworm.com/index.php?rid=1271631&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18246944%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271631 Mon, 01 Oct 2007 04:00:00 +0100 1271631 http://www.medworm.com/index.php?rid=1271630&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D18246945%26dopt%3DAbstract Authors: Funk CL, Barrett KA, Macrina FL We have studied postdoctoral trainees funded by NIH F32 fellowship awards in order to test the effectiveness 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 awareness of or attention to e... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271630 Mon, 01 Oct 2007 04:00:00 +0100 1271630 http://www.medworm.com/index.php?rid=1271635&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17877106%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271635 Sun, 01 Jul 2007 04:00:00 +0100 1271635 http://www.medworm.com/index.php?rid=1271634&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17877107%26dopt%3DAbstract Authors: Musschenga AW, Van Luijn HE, Keus RB, Aaronson NK 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 the benefits are comparable. We conclude that at least the risks and the benefits to participants are comparab... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271634 Sun, 01 Jul 2007 04:00:00 +0100 1271634 http://www.medworm.com/index.php?rid=1271633&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17877108%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271633 Sun, 01 Jul 2007 04:00:00 +0100 1271633 http://www.medworm.com/index.php?rid=1271645&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17844784%26dopt%3DAbstract 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 is controlled by indigenous personnel. Suggestions are made as to how implementation of this right, using structured incentives, may systematically promote capacity buildi... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271645 Sun, 01 Apr 2007 04:00:00 +0100 1271645 http://www.medworm.com/index.php?rid=1271644&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17844785%26dopt%3DAbstract Authors: Atkinson TN, Gilleland DS, Pearson LC 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 administration in the United States supports integrity in the research environment through: (1) respect for community; (2) r... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271644 Sun, 01 Apr 2007 04:00:00 +0100 1271644 http://www.medworm.com/index.php?rid=1271643&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17844786%26dopt%3DAbstract Authors: Panikkar B, Brugge D 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 community wide outreach and education can impact ethical decisions made in research. PMID: 17844786 [PubMed - indexed for MEDLINE] (Source: ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271643 Sun, 01 Apr 2007 04:00:00 +0100 1271643 http://www.medworm.com/index.php?rid=1271642&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17847604%26dopt%3DAbstract Authors: Cook C, Hannley M, Richardson JK, Michon J, Harker M, Pietrobon R 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 published manuscripts. The ontology was able to closely represent the findings of the original meta-a... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271642 Mon, 01 Jan 2007 05:00:00 +0100 1271642 http://www.medworm.com/index.php?rid=1271641&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17847605%26dopt%3DAbstract 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271641 Mon, 01 Jan 2007 05:00:00 +0100 1271641 http://www.medworm.com/index.php?rid=1271640&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17847606%26dopt%3DAbstract Authors: Resnik DB 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 disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as med... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271640 Mon, 01 Jan 2007 05:00:00 +0100 1271640 http://www.medworm.com/index.php?rid=1271639&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17847607%26dopt%3DAbstract 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 for 75 % of the problems with incomplete/inadequate records being the most common (30%). The focus groups concurred with the findings from the interviews with RIOs, stress... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271639 Mon, 01 Jan 2007 05:00:00 +0100 1271639 http://www.medworm.com/index.php?rid=1271638&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17849641%26dopt%3DAbstract Authors: Gordon EJ, Prohaska TR 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 withdrawal will have no affect on care provided. Of 114 studies, thirty (26%) studies explicitly requested subjects/participants to engage ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271638 Sun, 01 Oct 2006 04:00:00 +0100 1271638 http://www.medworm.com/index.php?rid=1271637&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17849642%26dopt%3DAbstract Authors: Guevara C, Cook C, Herback N, Pietrobon R, Jacobs DO, Vail TP 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 Kidney Diseases (NIDDK) K-grant recipients during 1989-2004, associated with all the diabetes and obe... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271637 Sun, 01 Oct 2006 04:00:00 +0100 1271637 http://www.medworm.com/index.php?rid=1271636&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17849643%26dopt%3DAbstract Authors: Dinan MA, Weinfurt KP, Friedman JY, Allsbrook JS, Gottlieb J, Schulman KA, Hall MA, Dhillon JK, Sugarman J 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 IR... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271636 Sun, 01 Oct 2006 04:00:00 +0100 1271636 http://www.medworm.com/index.php?rid=1271650&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17124758%26dopt%3DAbstract Authors: Baylis F, Robert JS 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 particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cel... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271650 Sat, 01 Jul 2006 04:00:00 +0100 1271650 http://www.medworm.com/index.php?rid=1271649&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17124759%26dopt%3DAbstract Authors: Koppelman-White E 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 reveals the type and kind of education needed. It is argued that much of the current ethics education falls short. Since the gaps left by the rule a... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271649 Sat, 01 Jul 2006 04:00:00 +0100 1271649 http://www.medworm.com/index.php?rid=1271648&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17124760%26dopt%3DAbstract Authors: Redman BK, Merz JF 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271648 Sat, 01 Jul 2006 04:00:00 +0100 1271648 http://www.medworm.com/index.php?rid=1271647&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17124761%26dopt%3DAbstract Authors: Bortolotti L, Mameli M 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. The community gains collective self-knowledge that, once shared, can play a role in shaping education, informing policies and in general cr... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271647 Sat, 01 Jul 2006 04:00:00 +0100 1271647 http://www.medworm.com/index.php?rid=1271646&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D17124762%26dopt%3DAbstract Authors: Lenard J 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) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271646 Sat, 01 Jul 2006 04:00:00 +0100 1271646 http://www.medworm.com/index.php?rid=1271654&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16827215%26dopt%3DAbstract Authors: Morris N, Balmer B 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 tensions they create, has potential implications for the engagement of researchers with their research subjects and prevailing standards for the et... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271654 Sat, 01 Apr 2006 05:00:00 +0100 1271654 http://www.medworm.com/index.php?rid=1271653&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16827216%26dopt%3DAbstract Authors: Anderson EE In addition to outlining criteria for the approval of human subjects research, federal regulations provide guidance regarding local institutional review boards (IRB) membership. IRBs are mandated to include "at least one member whose primary concerns are in nonscientific areas" and "at least one member who is not otherwise affiliated with the institution." Often a single individual serves both of these roles simultaneously. Although there have been calls for increased representation of lay community members in IRBs, little is known regarding their experiences or their perceptions of human subject protections and the IRB process. Using an ethnographic interview approach, this study seeks to gain a perspective from non-affiliated, non-scientist (NA/NS) IRB members ab... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271653 Sat, 01 Apr 2006 05:00:00 +0100 1271653 http://www.medworm.com/index.php?rid=1271652&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16830406%26dopt%3DAbstract Authors: Resnik DB, Jones CW In this article, we examine Institutional Review Board (IRB) policies, international guidelines, and federal regulations and guidance for dealing with Limited English Proficiency (LEP) research subjects. We show that federal and international guidance concerning this topic is insufficient, and there is considerable variation in IRB policies. While some IRBs have thorough and useful policies, others do not. Many IRBs do not provide researchers and IRB member with answers to several important questions relating to language barriers in research. We recommend that federal agencies, international organizations, IRBs, and researchers take steps to fill in the gaps in guidance and policy to help insure that LEP populations will receive equitable and ethical treatm... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271652 Sat, 01 Apr 2006 05:00:00 +0100 1271652 http://www.medworm.com/index.php?rid=1271651&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16830407%26dopt%3DAbstract Authors: Keranen L Federal and institutional policies recommend the criterion of "seriousness" as a guide for sanction assignment in cases where researchers have been found to have committed research misconduct. Discrepancies in assessments of seriousness for similar acts of misconduct suggest the need to clarify what might be meant by the seriousness of research misconduct and how the criterion can be used to assign sanctions. This essay demonstrates how determinations of seriousness can differ depending on the set of ethical appeals employed and argues that an expanded lexicon for talking about the seriousness of research misconduct would help to promote fairness and consistency in sanction assignment. It concludes with some policy recommendations for those charged with research misc... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271651 Sat, 01 Apr 2006 05:00:00 +0100 1271651 http://www.medworm.com/index.php?rid=1271660&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16770856%26dopt%3DAbstract Authors: Mann H, Shamoo AE PMID: 16770856 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271660 Sun, 01 Jan 2006 05:00:00 +0100 1271660 http://www.medworm.com/index.php?rid=1271659&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16770857%26dopt%3DAbstract Authors: Nowak KS, Bankert EA, Nelson RM The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems. Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet, a newly developed web-based program for coo... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271659 Sun, 01 Jan 2006 05:00:00 +0100 1271659 http://www.medworm.com/index.php?rid=1271658&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16770858%26dopt%3DAbstract Conclusions: The complicated ethical issues and science involved in much of current research warrant an expert review panel. Centralized review would enable expert review specific to the research at hand, ensure consistency in human subjects protection, reduce the burden on local IRBs, and may reduce time spent obtaining approval. A centralized virtual system would allow IRB members to remain at their institutions while providing unprecedented expert review through currently available technology, and make information regarding monitoring and adverse event reporting available online in real-time. PMID: 16770858 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271658 Sun, 01 Jan 2006 05:00:00 +0100 1271658 http://www.medworm.com/index.php?rid=1271657&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16770859%26dopt%3DAbstract Authors: Fitzgerald MH, Phillips PA The research ethics review process is now an inherent part of conducting research and a topic of much discussion. On the negative side it has been presented as cumbersome, expensive, time consuming, and potentially a system that does not adequately deal with the concerns it was set up to address. One common, but often controversial, proposal to address some of these concerns has been the institutionalization of centralized systems of review. This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralized review, to explore issues related to centralization of the review process. It suggests that there are at least three types of systems (fu... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271657 Sun, 01 Jan 2006 05:00:00 +0100 1271657 http://www.medworm.com/index.php?rid=1271656&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16770860%26dopt%3DAbstract Authors: Downie J 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, ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271656 Sun, 01 Jan 2006 05:00:00 +0100 1271656 http://www.medworm.com/index.php?rid=1271655&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16770863%26dopt%3DAbstract Authors: Resnik DB, Shamoo AE, Krimsky S PMID: 16770863 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271655 Sun, 01 Jan 2006 05:00:00 +0100 1271655 http://www.medworm.com/index.php?rid=1271669&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16578917%26dopt%3DAbstract Conclusion: The current effort demonstrated the usefulness of the SMQ-R in obtaining information from a national sample of experienced research coordinators about their perceptions of the prevalence of different types of scientific misconduct and of factors that influence the occurrence of misconduct. The psychometric evaluation of the SMQ-R suggests good internal consistency for most subscales and suggests adequate construct validity of the instrument as a whole. The analyses also suggest that further refinement of the instrument for future studies is warranted. PMID: 16578917 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271669 Sat, 01 Oct 2005 04:00:00 +0100 1271669 http://www.medworm.com/index.php?rid=1271668&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16578922%26dopt%3DAbstract This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been pr... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271668 Sat, 01 Oct 2005 04:00:00 +0100 1271668 http://www.medworm.com/index.php?rid=1271667&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16578923%26dopt%3DAbstract Authors: Moyer A, Finney JW Assessing methodological quality is considered essential in deciding what investigations to include in research syntheses and in detecting potential sources of bias in meta-analytic results. Quality assessment is also useful in characterizing the strengths and limitations of the research in an area of study. Although numerous instruments to measure research quality have been developed, they have lacked empirically-supported components. In addition, different summary quality scales have yielded different findings when they were used to weight treatment effect estimates for the same body of research. Suggestions for developing improved quality instruments include: distinguishing distinct domains of quality, such as internal validity, external validity, the com... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271667 Sat, 01 Oct 2005 04:00:00 +0100 1271667 http://www.medworm.com/index.php?rid=1271666&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16634167%26dopt%3DAbstract Authors: Redman BK, Merz JF The Office of Research Integrity has proposed a new definition of scientific misconduct that will substantively reduce the federal government's role of oversight of scientific practices. The standard is being changed despite the lack of evidence about the effects of current policies or understanding of why research misconduct occurs, how it can be detected and prevented, and the nature and effectiveness of sanctions. Given this lack of knowledge and the perception that the integrity of science is falling, we believe it would be unwise for the academic and scientific community to adopt this new standard. PMID: 16634167 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271666 Fri, 01 Jul 2005 04:00:00 +0100 1271666 http://www.medworm.com/index.php?rid=1271665&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16634168%26dopt%3DAbstract Authors: Mello MM, Clarridge BR, Studdert DM We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial invest... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271665 Fri, 01 Jul 2005 04:00:00 +0100 1271665 http://www.medworm.com/index.php?rid=1271664&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16634171%26dopt%3DAbstract Authors: Barrett KA, Funk CL, Macrina FL We have conducted a longitudinal survey of NIH-funded F32 postdoctoral fellows to determine if mandated instruction in the responsible conduct of research (RCR) has measurable effects on awareness of, attentiveness to, and behavioral judgments about research ethics and authorship and publication. Of 418 F32 fellows participating in the study, 50% were aware of and had referred to guidelines on authorship and publication practices while 50% were either unaware of or had not referred to guidelines. Groups were similar with regard to total number of peer-reviewed publications and total number of first author publications, years of research experience, years since completing their doctoral degree, and receipt of RCR training. The equal distribution ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271664 Fri, 01 Jul 2005 04:00:00 +0100 1271664 http://www.medworm.com/index.php?rid=1271663&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16634172%26dopt%3DAbstract Authors: Heitman E, Bulger RE To determine core content for RCR instruction, content analysis was conducted using key instructional resources for ORI's nine RCR "core instructional areas". Topics discussed in these key RCR resources were identified and their frequency across resources was tabulated. Topics covered most frequently were judged to be core content. Although key educational resources cited a variety of references, specific topics and issues addressed were generally consistent across the materials examined. Nonetheless, key resources varied in organization and depth of coverage for core instructional areas. Recent resources were more systematic and comprehensive than earlier works. This was particularly evident in materials about human participant research, conflicts of inte... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271663 Fri, 01 Jul 2005 04:00:00 +0100 1271663 http://www.medworm.com/index.php?rid=1271662&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16634173%26dopt%3DAbstract Authors: Adams D, Pimple KD For 200 years, criminologists theorized that delinquent and criminal acts arise from deviant psychological states (such as irrationality or immorality) and/or social conditions that produce these psychological states. This theoretical perspective, which is being duplicated in most efforts to understand and control research misconduct, has not been productive. More recently, criminological perspectives have emerged, emphasizing situational factors that enhance or restrict the opportunity for illegal or imprudent behavior. These so-called "opportunity" theories have been shown to have practical value in reducing crime rates. We explore the promise of these newer theories for the responsible conduct of research (RCR). PMID: 16634173 [PubMed - indexed for ME... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271662 Fri, 01 Jul 2005 04:00:00 +0100 1271662 http://www.medworm.com/index.php?rid=1271661&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16634174%26dopt%3DAbstract Authors: Lind RA 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). 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 ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271661 Fri, 01 Jul 2005 04:00:00 +0100 1271661 http://www.medworm.com/index.php?rid=1271673&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16220621%26dopt%3DAbstract This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects. PMID:... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271673 Fri, 01 Apr 2005 05:00:00 +0100 1271673 http://www.medworm.com/index.php?rid=1271672&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16220624%26dopt%3DAbstract Authors: Ngai S, Gold JL, Gill SS, Rochon PA Ghost authorship occurs when an individual who contributed substantially to a manuscript is not named in the byline or acknowledgments. Ghost authors may be employed by industry to prepare clinical trial results for publication. An expert is then "hired" as author so as to lend an air of credibility and neutrality to the manuscript. Ghost authorship is difficult to detect, and most articles that have been identified as ghostwritten were revealed as such only after investigative work by lawyers, journalists, or scientists. Ghost authorship is ethically questionable in that it may be used to mask conflicts of interest with industry. As it has been demonstrated that industry sponsorship of clinical trials may be associated with outcomes favorab... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271672 Fri, 01 Apr 2005 05:00:00 +0100 1271672 http://www.medworm.com/index.php?rid=1271671&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16220625%26dopt%3DAbstract Authors: Widom CS, Czaja SJ This paper describes the extent to which vulnerable individuals (defined by economic, social, psychological, physical health, and child maltreatment status) react to research participation. As part of an ongoing longitudinal study, participants (N=896) completed a lengthy and intrusive in-person interview and provided a small amount of blood through finger pricks. At the end of the interview, participants were asked eight questions about their reactions to the research experience. Vulnerable individuals in general agreed more strongly about having an emotional reaction, but were not less willing to continue to participate. In addition, psychologically vulnerable individuals more strongly agreed they would continue to participate, were treated with respect an... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271671 Fri, 01 Apr 2005 05:00:00 +0100 1271671 http://www.medworm.com/index.php?rid=1271670&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16220626%26dopt%3DAbstract Authors: Tereskerz PM, Moreno J Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and government entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified nationa... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271670 Fri, 01 Apr 2005 05:00:00 +0100 1271670 http://www.medworm.com/index.php?rid=1271677&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16021788%26dopt%3DAbstract Authors: Zlotnik Shaul R, Reid L, Essue B, Gibson J, Marzinotto V, Daneman D Recent articles have argued from principles of bioethics for the right of research subjects to receive the results of the studies in which they have participated. We argue that accountability is a powerful tool of meso-level analysis appropriate to reasoning about answerability in research ethics, and that it captures the responsibility of researchers to disseminate study results to research subjects. We offer the following features of the research situation as relevant to the manner of dissemination to study subject, in addition to factors already proposed in the literature (risk and impact on health outcome): (a) features of the research subject in relation to identity, personal investment, disease, and comm... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271677 Sat, 01 Jan 2005 05:00:00 +0100 1271677 http://www.medworm.com/index.php?rid=1271676&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16021789%26dopt%3DAbstract Conclusions: Most researchers report R/E and believe it is relevant to their research. Despite policies that reject R/E as explanatory variables, most researchers do not report or discuss the underlying social mechanisms that may explain R/E differences. PMID: 16021789 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271676 Sat, 01 Jan 2005 05:00:00 +0100 1271676 http://www.medworm.com/index.php?rid=1271675&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16021790%26dopt%3DAbstract Authors: Dickert N, Kass N, Paasche-Orlow M, Taylor H Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the co... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271675 Sat, 01 Jan 2005 05:00:00 +0100 1271675 http://www.medworm.com/index.php?rid=1271674&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D16021792%26dopt%3DAbstract Authors: Morreim EH Litigation involving human clinical research trials has escalated rapidly in the past few years. Whereas these suits raise many important theoretical questions, they also have important practical and human dimensions of which many people are unlikely to be aware until, by some unfortunate turn, they must live the reality. From the vantage of a fairly close view on one recent lawsuit, this article offers some ground-level observations and reflections that, it is hoped, may be of use to people in clinical research who might one day find themselves in a similar position. PMID: 16021792 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271674 Sat, 01 Jan 2005 05:00:00 +0100 1271674 http://www.medworm.com/index.php?rid=1271681&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15812961%26dopt%3DAbstract This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures). PMID: 15812961 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271681 Thu, 01 Jul 2004 04:00:00 +0100 1271681 http://www.medworm.com/index.php?rid=1271680&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15812964%26dopt%3DAbstract Authors: Cohen CB Two camps in bioethics with seemingly opposing world views have staked out conflicting positions regarding the ethics of human reproductive cloning. These camps do not appear to share common concepts or ways of reasoning through which to exchange views and come to a meeting of minds about uses of this technology. Yet analysis of their respective approaches to several issues surrounding reproductive cloning, such as where the ethical limits of individual reproductive choice lie, whether the use of this technology would violate human dignity, whether it would create risks to the resulting fetuses and children that would make its use intolerable, and whether it would challenge certain core social values, reveals that they are not wholly opposed to one another. Indeed, it... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271680 Thu, 01 Jul 2004 04:00:00 +0100 1271680 http://www.medworm.com/index.php?rid=1271679&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15812966%26dopt%3DAbstract Authors: Shamoo AE, Cole J PMID: 15812966 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271679 Thu, 01 Jul 2004 04:00:00 +0100 1271679 http://www.medworm.com/index.php?rid=1271678&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15812967%26dopt%3DAbstract Conclusion: Minority groups are currently under-represented in clinical trials. Information on the race and ethnicity of clinical trial participants is currently underreported in six leading medical journals. Reporting of minority group information was significantly better only in NIH funded trials, which also were more likely to include nonwhite participants. This suggests that mandatory reporting policies may have a positive effect on both reporting and representation. PMID: 15812967 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271678 Thu, 01 Jul 2004 04:00:00 +0100 1271678 http://www.medworm.com/index.php?rid=1271686&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15675049%26dopt%3DAbstract Authors: Krimsky S PMID: 15675049 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271686 Thu, 01 Apr 2004 05:00:00 +0100 1271686 http://www.medworm.com/index.php?rid=1271685&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15675050%26dopt%3DAbstract This study reports the results of a large-scale, cross-sectional survey of research faculty at the nine campuses of the University of California regarding their understandings of and attitudes toward campus conflict of interest policies. We gathered information on their general assessments of investigators with financial ties to industry sponsors and reactions to the process of implementing conflict of interest policies at their respective campuses. We surveyed 1,971 faculty members from the nine-campus University of California system and had 779 responses (39% response rate). The sampled faculty were in the ten departments with the most number of financial disclosures at each campus. We utilized the WebSurveyor software to create a secure, online, 21-item survey. Our study reveals faculty... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271685 Thu, 01 Apr 2004 05:00:00 +0100 1271685 http://www.medworm.com/index.php?rid=1271684&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15675051%26dopt%3DAbstract Authors: Campbell EG, Moy B, Feibelmann S, Weissman JS, Blumenthal D The purpose of this study was to explore qualitatively the nature, consequences and management of institutional academic industry relationships (IAIRs) in the life and health sciences. The results of our interviews suggest that in the institutions we visited IAIRs are common and deeply embedded in the academic enterprise both among institutional officials and the organization itself. Many believe these relationships have potential benefits for the research and education mission while creating the potential for conflicts of interest. Further tracking and study of the IAIRs is required to understand and anticipate the full effects of these relationships on the scientific enterprise in the United States. PMID: 156750... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271684 Thu, 01 Apr 2004 05:00:00 +0100 1271684 http://www.medworm.com/index.php?rid=1271683&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15675053%26dopt%3DAbstract Authors: Solyom AE Financial conflicts of interest arise when physician's judgment and decision making become compromised by financial gains or interests, and thus create risk of undo harm to research participants, to the integrity of research projects, and, ultimately to society at large. Such conflicts also violate the moral maxims of medicine, and thus damage the integrity of physicians and the medical profession. I submit that key remedies for this problem are the integrity (self-respect) of physicians and the respectful engagement of research participants (whether patients or nonpatient volunteers) as partners in research projects. Accordingly, I consider physicians the primary moral agents, research participants the secondary moral agents, and society the tertiary moral agent wit... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271683 Thu, 01 Apr 2004 05:00:00 +0100 1271683 http://www.medworm.com/index.php?rid=1271682&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15675055%26dopt%3DAbstract Authors: Resnik DB In this article, I examine the ethical and legal issues related to disclosure of conflicts of interest to research subjects, and discuss some empirical studies related to the topic. I argue that researchers have an ethical obligation to disclose conflicts of interest to research subjects, provided that they take steps to help subjects understand information about conflicts of interest and how to interpret it. Researchers also may have a legal duty to disclose conflicts of interests to subjects, depending on the facts of the case and the court's interpretation of the law. To reinforce and clarify the legal obligation to disclose conflicts of interest, the federal regulations should be amended to include disclosure of conflicts of interest as one of the informed consen... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271682 Thu, 01 Apr 2004 05:00:00 +0100 1271682 http://www.medworm.com/index.php?rid=1271690&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15341044%26dopt%3DAbstract This article reviews the growing literature on genetics research and ethics to describe some of the fundamental ethical issues in population-based genetics research, including research design, recruitment and informed consent, and dealing with research results. Its focus is on areas where consensus is forming and where future work is needed. PMID: 15341044 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271690 Thu, 01 Jan 2004 05:00:00 +0100 1271690 http://www.medworm.com/index.php?rid=1271689&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15341045%26dopt%3DAbstract This article reviews these selected major ethical issues arising in (1) the conduct of behavioral genetics research; and (2) the application of its research findings. While some of the ethical concerns in the latter category are likely to be of substantial importance and animate considerable popular concern, they currently fall outside the realm of traditional research review. Determining how to deal with these concerns should be a focus of future scholarly work. PMID: 15341045 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271689 Thu, 01 Jan 2004 05:00:00 +0100 1271689 http://www.medworm.com/index.php?rid=1271688&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15341046%26dopt%3DAbstract Authors: MacQueen KM, Shapiro K, Karim QA, Sugarman J Members of an HIV-prevention research network were asked to describe ethical challenges faced in their work. Major themes included acceptable standards of care for participants, defining research of relevance to host countries, reducing risks related to stigma, designing research that meets local needs without contributing to an inadequate status quo, and ensuring informed consent for complex research with potentially vulnerable participants. The challenges are interrelated and highlight the need for innovative, practical strategies to be incorporated into the planning, design, and conduct of HIV prevention trials. Research in applied ethics to support decision-making about HIV prevention research is needed, along with ethics traini... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271688 Thu, 01 Jan 2004 05:00:00 +0100 1271688 http://www.medworm.com/index.php?rid=1271687&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D15341047%26dopt%3DAbstract Authors: Farber NJ, Aboff BM, DeJoseph MR, Castellano J, Weiner J, Boyer EG We investigated physicians' attitudes about entering patients who cannot give informed consent or who are of a vulnerable population into clinical trials. A survey instrument asked a nationwide sample of practicing physicians about whether ten hypothetical patients could be enrolled in a phase I clinical trials. The impact of demographic variables on the number of scenarios viewed as completely or somewhat acceptable was analyzed via student's T tests or analysis of variance (ANOVA) as applicable. All significant (p<0.01) variables were entered into a multiple logistic regression model. Eighty-four percent of respondents indicated that at least one case scenario was acceptable. A majority of those who conduc... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271687 Thu, 01 Jan 2004 05:00:00 +0100 1271687 http://www.medworm.com/index.php?rid=1271692&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14989284%26dopt%3DAbstract Authors: Helton-Fauth W, Gaddis B, Scott G, Mumford M, Devenport L, Connelly S, Brown R The intent of the current article is to describe the development of a new approach to the study of ethical conduct in scientific research settings. The approach presented in this article has two main components. The first component entails the development of a taxonomy of ethical events as they occur across a broad range of scientific disciplines. The second involves the identification of proximate criteria that will allow systematic and objective evaluation of ethical behaviors through low-fidelity performance simulations. Two proposed measures based on the new approach are intended to identify and measure variations in the scientific environment that might predispose certain individuals to make un... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271692 Wed, 01 Oct 2003 04:00:00 +0100 1271692 http://www.medworm.com/index.php?rid=1271691&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14989285%26dopt%3DAbstract In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle." PMID: 14989285 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271691 Wed, 01 Oct 2003 04:00:00 +0100 1271691 http://www.medworm.com/index.php?rid=1271696&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14979317%26dopt%3DAbstract Authors: Tereskerz PM PMID: 14979317 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271696 Tue, 01 Jul 2003 04:00:00 +0100 1271696 http://www.medworm.com/index.php?rid=1271695&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14979318%26dopt%3DAbstract Authors: Neill KM In 2001, the National Center for Research Resources (NCRR) directed the 78 General Clinical Research Centers (GCRC) to develop a Research Subject Advocate (RSA) position. The RSA would report directly to the Principal Investigator (PI) of each GCRC and assure compliance of studies conducted on the GCRC with federal regulations and policies. Seven RSAs agreed to be interviewed about their new role. Website documents, electronic correspondence, and presentations at the first annual national meeting of RSAs were scrutinized using discursive analysis to shed light on this new organizational form and its potential for increased protection of human research participants. The RSA role actualizes the ethical principles of respect for persons, justice, and beneficence that are... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271695 Tue, 01 Jul 2003 04:00:00 +0100 1271695 http://www.medworm.com/index.php?rid=1271694&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14979319%26dopt%3DAbstract Authors: Davis JK Except in certain cases of unusual risk, self-experimentation should not be encouraged. It is usually scientifically inadequate for lack of proper controls and sufficient subjects to generate meaningful results. It is also inadequate as an ethical test because even if lay persons are also enrolled, self-experimentation is neither necessary nor sufficient to establish that they may participate. It is not necessary to establish that lay persons may participate because institutional ethics review and informed consent are better ways to determine this. It is not sufficient because the investigator may be more risk accepting or not medically typical. Moreover, because scientific research is now done in teams, self-experimentation may involve undue influence when junior inv... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271694 Tue, 01 Jul 2003 04:00:00 +0100 1271694 http://www.medworm.com/index.php?rid=1271693&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14979320%26dopt%3DAbstract Authors: Davis MS There seems to be a taboo against discussing the role culture or national origin might play in research misconduct. Still, some observers wonder why so many scientists representing foreign cultures are among those found guilty of misconduct. Even after examining the scant available data, whether foreign nationals are disproportionately represented among Office of Research Integrity (ORI) respondents remains unclear. The lack of data, however, does not negate culture as a possible explanatory variable in research misconduct. Applying theories from sociological criminology, the author posits that the culture some researchers bring may be at odds with the norms of academic science and may emphasize ends more than means. As such, culture simply may be one of several etiol... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271693 Tue, 01 Jul 2003 04:00:00 +0100 1271693 http://www.medworm.com/index.php?rid=1271700&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14577421%26dopt%3DAbstract Authors: Embrey E PMID: 14577421 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271700 Tue, 01 Apr 2003 05:00:00 +0100 1271700 http://www.medworm.com/index.php?rid=1271699&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14577422%26dopt%3DAbstract Authors: Hodge JG During the fall of 2001, public health law scholars at the Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities were asked by the Centers for Disease Control and Prevention (CDC) and a series of national partners to develop the Model State Emergency Health Powers Act (MSEHPA). The MSEHPA provides a series of modern powers for states to consider in responding to catastrophic public health emergencies, including bioterrorism events. Since December 2001, provisions based on the MSEHPA have been introduced in nearly 40 states and passed in 20. Underlying the development of the act is a long-standing debate between legal and ethical scholars and law- and policymakers as to the appropriate ways to balance individual and communal rights. The dr... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271699 Tue, 01 Apr 2003 05:00:00 +0100 1271699 http://www.medworm.com/index.php?rid=1271698&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14577423%26dopt%3DAbstract Authors: Trotter G PMID: 14577423 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271698 Tue, 01 Apr 2003 05:00:00 +0100 1271698 http://www.medworm.com/index.php?rid=1271697&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14577424%26dopt%3DAbstract Authors: Resnik DB This essay proposes a new definition of scientific "misconduct," which is broader than the definition recently adopted by the U.S. government. According to the proposed definition, misconduct is a serious and intentional violation of accepted scientific practices, commonsense ethical norms, or research regulations in proposing, designing, conducting, reviewing, or reporting research. Punishable misconduct includes fabrication of data or experiments, falsification of data, plagiarism, or interference with a misconduct investigation. Misconduct does not include honest errors, differences of opinion, or ethically questionable research practices. PMID: 14577424 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271697 Tue, 01 Apr 2003 05:00:00 +0100 1271697 http://www.medworm.com/index.php?rid=1271705&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14552298%26dopt%3DAbstract Authors: Lederer SE Experimentation involving children is not a new phenomenon. Children have been used as research subjects in a diverse set of experiments, including the trials of new vaccines and sera, in efforts to understand normal pediatric anatomy and physiology and in the development of new drugs and procedures. Concern about child participants in research is also not a new development. For more than a century, critics of medical research have called attention to the fact that children and other vulnerable populations--pregnant women, prisoners, the mentally ill--have too often served as the unwitting and unwilling subjects of medical experiments. This paper looks at several early cases in which children participated, including the first trial of cowpox vaccine, the first human... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271705 Wed, 01 Jan 2003 05:00:00 +0100 1271705 http://www.medworm.com/index.php?rid=1271704&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14552299%26dopt%3DAbstract Authors: Kodish E PMID: 14552299 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271704 Wed, 01 Jan 2003 05:00:00 +0100 1271704 http://www.medworm.com/index.php?rid=1271703&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14552300%26dopt%3DAbstract Authors: Moreno JD PMID: 14552300 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271703 Wed, 01 Jan 2003 05:00:00 +0100 1271703 http://www.medworm.com/index.php?rid=1271702&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14552301%26dopt%3DAbstract Authors: Kipnis K PMID: 14552301 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271702 Wed, 01 Jan 2003 05:00:00 +0100 1271702 http://www.medworm.com/index.php?rid=1271701&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D14552302%26dopt%3DAbstract Authors: Shamoo AE, Campbell JD PMID: 14552302 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271701 Wed, 01 Jan 2003 05:00:00 +0100 1271701 http://www.medworm.com/index.php?rid=1271711&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12816123%26dopt%3DAbstract Authors: Tauer CA We are obligated to protect individual child subjects of research, yet it is also necessary to investigate the safety and efficacy of medical treatments that benefit children as a class. The federal regulations on research with children have provided ethical guidance since 1983, but divergent interpretations persist. Since varying interpretations can lead to confusion and abuses, efforts are underway to clarify the criteria. Clarity is needed to protect individual child subjects from harm while enabling ethical research to proceed. The "pediatric rule" and the "pediatric exclusivity" incentive are important policy initiatives for promoting sound research on the medical treatment of children. PMID: 12816123 [PubMed - indexed for MEDLINE] (Source: Accountability in ... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271711 Mon, 01 Jul 2002 04:00:00 +0100 1271711 http://www.medworm.com/index.php?rid=1271710&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12816124%26dopt%3DAbstract Authors: Shamoo AE, Tauer CA PMID: 12816124 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271710 Mon, 01 Jul 2002 04:00:00 +0100 1271710 http://www.medworm.com/index.php?rid=1271709&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12816125%26dopt%3DAbstract Authors: Shamoo AE PMID: 12816125 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271709 Mon, 01 Jul 2002 04:00:00 +0100 1271709 http://www.medworm.com/index.php?rid=1271708&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12816126%26dopt%3DAbstract Authors: Kopelman LM The Maryland Court of Appeals in Grimes v. Kennedy Krieger Institute was sharply critical of the lead abatement study conducted by this Institute, an affiliate of Johns Hopkins University. Grimes ruled that investigators might, given the facts of the case, have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. This ruling has implications for pediatric research practices and long-standing disputes among informed people of good will about what pediatric studies should be permitted. PMID: 12816126 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271708 Mon, 01 Jul 2002 04:00:00 +0100 1271708 http://www.medworm.com/index.php?rid=1271707&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12816127%26dopt%3DAbstract Authors: Frader JE PMID: 12816127 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271707 Mon, 01 Jul 2002 04:00:00 +0100 1271707 http://www.medworm.com/index.php?rid=1271706&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12816128%26dopt%3DAbstract Authors: De Vries RG, Forsberg CP PMID: 12816128 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271706 Mon, 01 Jul 2002 04:00:00 +0100 1271706 http://www.medworm.com/index.php?rid=1271716&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12625352%26dopt%3DAbstract This article suggests lines of further research that could define the problem more explicitly and that might lead to additional corrective measures. PMID: 12625352 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271716 Mon, 01 Apr 2002 05:00:00 +0100 1271716 http://www.medworm.com/index.php?rid=1271715&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12625353%26dopt%3DAbstract Conclusions: I argue that in medical situations, the military is obligated to treat its troops as autonomous persons entitled to basic rights and protections. The DoD is currently using an approved drug, the anthrax vaccine, for an unapproved purpose and in an unapproved manner. In doing so, the DoD is not only violating the FDA's regulations against such practices, it is also violating an executive order which only allows the president to authorize the use of INDs on service members without their consent. PMID: 12625353 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271715 Mon, 01 Apr 2002 05:00:00 +0100 1271715 http://www.medworm.com/index.php?rid=1271714&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12705242%26dopt%3DAbstract This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Su... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271714 Tue, 01 Jan 2002 05:00:00 +0100 1271714 http://www.medworm.com/index.php?rid=1271713&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12705245%26dopt%3DAbstract This article argues that research litigation is not, and will probably never become, an effective means of ensuring retrospective accountability in regard to research injuries and ethical violations. Paradoxically though, the current wave of research litigation may serve an important and even key role in encouraging and ensuring prospective accountability. PMID: 12705245 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271713 Tue, 01 Jan 2002 05:00:00 +0100 1271713 http://www.medworm.com/index.php?rid=1271712&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12705246%26dopt%3DAbstract Authors: Resnik DB, Shamoo AE This essay provides an analysis of conflicts of interest (COIs) that arise in university relationships with private industry and articulates the concept of an "institutional" COI. It compares personal and institutional COIs in order to shed some light on the difficulties universities face in managing their own COIs. The essay discusses some proposed strategies for responding to institutional COIs, such as developing independent boards to monitor and oversee the university's COIs, building firewalls between various parts of the university to prevent financial interests from affecting university functions, creating independent research institutes, and prohibiting some types of university investments. PMID: 12705246 [PubMed - indexed for MEDLINE] (Source:... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271712 Tue, 01 Jan 2002 05:00:00 +0100 1271712 http://www.medworm.com/index.php?rid=1271726&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481762%26dopt%3DAbstract Authors: Beach JE When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted i... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271726 Mon, 01 Jan 2001 05:00:00 +0100 1271726 http://www.medworm.com/index.php?rid=1271725&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481767%26dopt%3DAbstract Authors: Zucker C PMID: 12481767 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271725 Mon, 01 Jan 2001 05:00:00 +0100 1271725 http://www.medworm.com/index.php?rid=1271724&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481768%26dopt%3DAbstract Authors: Fins JJ, Schachter M PMID: 12481768 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271724 Mon, 01 Jan 2001 05:00:00 +0100 1271724 http://www.medworm.com/index.php?rid=1271723&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481780%26dopt%3DAbstract Authors: Shamoo AE NIH data indicate that annually seven million human subjects are enrolled in research sponsored by NIH alone. In addition, there are sixteen federal agencies and numerous departments outside NIH conducting experiments with human subjects. Moreover, the pharmaceutical industry spends $26 billion on research (compared to $16 billion for NIH), thus, the total number of human subjects enrolled in research for both the public and private sectors can be estimated as high as nineteen million. I present data on the potential magnitude of adverse events in the United States among human subjects enrolled in research that appear to be unreported and unaccounted for. We obtained data from the Office for Human Research Protections (OHRP) through the Freedom of Information Act for... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271723 Mon, 01 Jan 2001 05:00:00 +0100 1271723 http://www.medworm.com/index.php?rid=1271722&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481786%26dopt%3DAbstract Authors: Angell M PMID: 12481786 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271722 Mon, 01 Jan 2001 05:00:00 +0100 1271722 http://www.medworm.com/index.php?rid=1271721&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481789%26dopt%3DAbstract Authors: Fried E In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects,... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271721 Mon, 01 Jan 2001 05:00:00 +0100 1271721 http://www.medworm.com/index.php?rid=1271720&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481794%26dopt%3DAbstract Authors: Fried E In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of "informational manipulation" that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disab... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271720 Mon, 01 Jan 2001 05:00:00 +0100 1271720 http://www.medworm.com/index.php?rid=1271719&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481796%26dopt%3DAbstract Authors: Newman E, Willard T, Sinclair R, Kaloupek D Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses inve... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271719 Mon, 01 Jan 2001 05:00:00 +0100 1271719 http://www.medworm.com/index.php?rid=1271718&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481797%26dopt%3DAbstract Authors: Kevles DJ PMID: 12481797 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271718 Mon, 01 Jan 2001 05:00:00 +0100 1271718 http://www.medworm.com/index.php?rid=1271717&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D12481798%26dopt%3DAbstract Authors: Goldhammer A 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 com... Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271717 Mon, 01 Jan 2001 05:00:00 +0100 1271717 http://www.medworm.com/index.php?rid=1271727&cid=s_36879_74_f&fid=36879&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fentrez%2Fquery.fcgi%3Ftmpl%3DNoSidebarfile%26db%3DPubMed%26cmd%3DRetrieve%26list_uids%3D11660591%26dopt%3DAbstract Authors: Egilman D, Wallace W, Stubbs C, Mora-Corrasco F PMID: 11660591 [PubMed - indexed for MEDLINE] (Source: Accountability in Research) Accountability in Research journals http://www.medworm.com/rss/comments.php?id=1271727 Thu, 01 Jan 1998 05:00:00 +0100 1271727