Can the written information to research subjects be improved?--an empirical study.
OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information. (+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)
Should Zelen pre-randomised consent designs be used in some neonatal trials?
My aim is to suggest that there is a case for using a randomised consent design in some neonatal trials. As an example I use the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. In some trials the process of obtaining consent has the potential to harm the subject, for example, by disappointing those who end in the control group and by creating additional anxiety at times of acute illness. An example of such were the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. Pre-randomised consent could avoid or lessen these harms. However, a number of ethical objections are made to these research designs. They involve denial of information, using people, denial of choice, and "overselling" of allocated treatment. Furthermore, they are the wrong response; better communication might be the answer, for example. I argue that these objections are not completely persuasive. However, they are enough to suggest caution in the use of such designs. (+info)
Parental consent to publicity.
The problems presented by the use of named child patients and their medical histories in television, radio and newspapers is discussed. It is suggested that it is not acceptable to regard this as comparable to their participation in non-therapeutic research, and that no one, not even the parent has the authority to give consent to such use. (+info)
The Council of Europe's first Symposium on Bioethics: Strasbourg, Dec 5-7 1989.
This symposium discussed bioethics teaching, research and documentation and also research ethics committees. An international convention for the protection of the integrity of the human body was called for, as was a new European Committee on Ethics. 'The genetic impact' was a major preoccupation of the symposium. (+info)
Health care directives for the elderly.
The treatment of incompetent older people presents physicians and family members with complex medical, ethical, moral, and legal problems. This article explores the use of advance health care directives in the decision-making process, the qualities of the "ideal" directive, practical and legal issues relating to directives, and the role of the family physician in their implementation. (+info)