Research, ethics and conflicts of interest.
In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest. (+info)
Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.
OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. (+info)
Responses by four Local Research Ethics Committees to submitted proposals.
BACKGROUND: There is relatively little research concerning the processes whereby Local Research Ethics Committees discharge their responsibilities towards society, potential participants and investigators. OBJECTIVES: To examine the criteria used by LRECs in arriving at their decisions concerning approval of research protocols through an analysis of letters sent to investigators. DESIGN: Four LRECs each provided copies of 50 letters sent to investigators after their submitted proposals had been considered by the committees. These letters were subjected to a content analysis, in which specific comments and requests for additional information and changes in the protocols were recorded and compared. FINDINGS: Overall 24% of proposals were approved without request for changes or clarifications, but this varied by committee: one committee approved only 6% of proposals without change or clarification while the others ranged from 26% to 32%. The content analyses of responses indicated that they could be placed into four categories: (i) further information for the committee to aid in their deliberations; (ii) requests for changes to the design or justification for the design used; (iii) changes to the information sheets provided to potential participants; and (iv) changes to consent procedures. Of these, alterations to information sheets were the most common type of request. These four types of response could be seen as safeguarding the wellbeing of potential participants (the principle of non-maleficence), of promoting the scientific validity of the research (the principle of beneficence), and of enhancing the rights of potential participants (the principle of autonomy). CONCLUSIONS: The committees were consistent in the types of requests they made of investigators, which can be seen as attempts to protect participants' rights and ensure the scientific validity of studies. Without an analysis of the proposals sent to the committees, however, it is difficult to account for the variation in the requirements set by the committees before approval was given. (+info)
Effect of blinding and unmasking on the quality of peer review.
The objectives of this study were to see whether, in the opinion of authors, blinding or unmasking or a combination of the two affects the quality of reviews and to compare authors' and editors' assessments. In a trial conducted in the British Medical Journal, 527 consecutive manuscripts were randomized into one of three groups, and each was sent to two reviewers, who were randomized to receive a blinded or an unblinded copy of the manuscript. Review quality was assessed by two editors and the corresponding author. There was no significant difference in assessment between groups or between editors and authors. Reviews recommending publication were scored more highly than those recommending rejection. (+info)
Alternative tests make the grade.
Toxicity testing is absolutely necessary for assessing the safety of substances in food, air, and water, in the workplace and at home. Although there are several tried-and-true toxicity assays, the search is always on for methods that can even better predict toxic effects. As scientific understanding of the effects of environmental toxicants grows, new tests are needed to evaluate previously unexamined end points and to take advantage of advances in biotechnology and the growing knowledge of how toxicants work at the molecular and cellular levels. Another issue is how to develop tests that can reliably and accurately assess toxicity using less time, money, and materials, and with greater regard for animal welfare. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was established in 1997 to address these needs through the development, validation, acceptance, and harmonization of new and revised toxicological test methods throughout the federal government. (+info)
Croatian Medical Journal at the turn of the millennium.
The turn of the millennium coincided with the inclusion of the Croatian Medical Journal into the bibliographic databases MEDLINE (1998), and Current Contents/Clinical Medicine (1999), which greatly increased the number of submitted manuscripts. The increased pressure on the editorial office prompted us to modify the editorial procedure and sharpen our acceptance criteria. At the same time, we extended our author-friendly policy to all for global medicine and (2) medicine in translational and emerging countries. The Editorial Board and the Advisory Board were critical in developing and improving the Journal and setting the highest standards in all aspects of publication, especially in manuscript selection by high-quality peer review. In this editorial, we finally meet the members of the two Boards in person, or rather, in photographs and short biographies. (+info)
Biomedical publishing stands at a crossroads. The traditional print, peer-reviewed, subscription journal has served science well but is now being called into question. Because of spiraling print journal costs and the worldwide acceptance of the Internet as a valid publication medium, there is a compelling opportunity to re-examine our current paradigm and future options. This report illustrates the conflicts and restrictions inherent in the current publishing model and examines how the single act of permitting authors to retain copyright of their scholarly manuscripts may preserve the quality-control function of the current journal system while allowing PubMed Central, the Internet archiving system recently proposed by the director of the National Institutes of Health, to simplify and liberate access to the world's biomedical literature. (+info)
A randomized controlled study of reviewer bias against an unconventional therapy.
A study was designed to test the hypothesis that experts who review papers for publication are prejudiced against an unconventional form of therapy. Two versions were produced (A and B) of a 'short report' that related to treatments of obesity, identical except for the nature of the intervention. Version A related to an orthodox treatment, version B to an unconventional treatment. 398 reviewers were randomized to receive one or the other version for peer review. The primary outcomes were the reviewers' rating of 'importance' on a scale of 1-5 and their verdict regarding rejection or acceptance of the paper. Reviewers were unaware that they were taking part in a study. The overall response rate was 41.7%, and 141 assessment forms were suitable for statistical evaluation. After dichotomization of the rating scale, a significant difference in favour of the orthodox version with an odds ratio of 3.01 (95% confidence interval, 1.03 to 8.25), was found. This observation mirrored that of the visual analogue scale for which the respective medians and interquartile ranges were 67% (51% to 78.5%) for version A and 57% (29.7% to 72.6%) for version B. Reviewers showed a wide range of responses to both versions of the paper, with a significant bias in favour of the orthodox version. Authors of technically good unconventional papers may therefore be at a disadvantage in the peer review process. Yet the effect is probably too small to preclude publication of their work in peer-reviewed orthodox journals. (+info)