Selecting subjects for participation in clinical research: one sphere of justice.
Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (+info)
How physician executives and clinicians perceive ethical issues in Saudi Arabian hospitals.
OBJECTIVES: To compare the perceptions of physician executives and clinicians regarding ethical issues in Saudi Arabian hospitals and the attributes that might lead to the existence of these ethical issues. DESIGN: Self-completion questionnaire administered from February to July 1997. SETTING: Different health regions in the Kingdom of Saudi Arabia. PARTICIPANTS: Random sample of 457 physicians (317 clinicians and 140 physician executives) from several hospitals in various regions across the kingdom. RESULTS: There were statistically significant differences in the perceptions of physician executives and clinicians regarding the existence of various ethical issues in their hospitals. The vast majority of physician executives did not perceive that seven of the eight issues addressed by the study were ethical concerns in their hospitals. However, the majority of the clinicians perceived that six of the same eight issues were ethical considerations in their hospitals. Statistically significant differences in the perceptions of physician executives and clinicians were observed in only three out of eight attributes that might possibly lead to the existence of ethical issues. The most significant attribute that was perceived to result in ethical issues was that of hospitals having a multinational staff. CONCLUSION: The study calls for the formulation of a code of ethics that will address specifically the physicians who work in the kingdom of Saudi Arabia. As a more immediate initiative, it is recommended that seminars and workshops be conducted to provide physicians with an opportunity to discuss the ethical dilemmas they face in their medical practice. (+info)
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)
The new system of review by multicentre research ethics committees: prospective study.
OBJECTIVE: To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. DESIGN: Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. SETTING: A single multicentre research ethics committee and 125 local ethics committees from six regions of England. MAIN OUTCOME MEASURES: Time to reply, time to approval, and number of non-local changes to the application requested. RESULTS: Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. CONCLUSIONS: The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims. (+info)
Ethics consultation on demand: concepts, practical experiences and a case study.
Despite the increasing interest in clinical ethics, ethics consultation as a professional service is still rare in Europe. In this paper I refer to examples in the United States. In Germany, university hospitals and medical faculties are still hesitant about establishing yet another "committee". One of the reasons for this hesitation lies in the ignorance that exists here about how to provide medical ethics services; another reason is that medical ethics itself is not yet institutionalised at many German universities. The most important obstacle, however, may be that medical ethics has not yet demonstrated its relevance to the needs of those caring for patients. The Centre for Ethics and Law, Freiburg, has therefore taken a different approach from that offered elsewhere: clinical ethics consultation is offered on demand, the consultation being available to clinician(s) in different forms. This paper describes our experiences with this approach; practical issues are illustrated by a case study. (+info)
Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees.
With the advent of multicentre research ethics committees in the UK, local research ethics committees (LRECs) are required to advise only on issues relating to the local acceptability of a project. We looked at the handling of two commercially sponsored studies, one initiated before the change and one after, confining the analysis to 21 LRECs approached in both. As judged by the amount of paper per application, the new system for LRECs is simpler and should be less costly. However, there was an increasing tendency for LRECs to charge for their services (30% study 1, 47% study 2) and these charges varied by more than 400%. If such fees must be levied, a common scale is desirable. (+info)