Informed consent in clinical research with drugs in Spain: Perspective of clinical trials committee members

Dal‐Ré, Rafael

doi:10.1007/bf00315568

Cited by 4 publications

(7 citation statements)

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“…Twenty studies examined the opinions of healthcare professionals (four studies examined both: Epstein and Lasagna, 1969;Marsden et al, unpublished;Oakley, 1990;Penman et al, 1984). Professionals' views were generally based on real trials, though five studies looked at views on clinical trials in general and two studies looked at the views of members of trial review committees (Dal-re, 1990;Kodish et al, 1992).…”

Section: Studies Under Reviewmentioning

confidence: 99%

“…One study hinged on a particular hypothetical trial of early versus delayed delivery for preterm foetuses (Lilford, 1994), while one study used an HRT pilot trial (Marsden et al, unpublished). Five studies looked at the views of committee members, academics or chairpersons when reviewing Phase 1 studies (Kodish et al, 1992), trials involving children (Mammel and Kaplan, 1995) or trials in general (Blum et al, 1987;Dal-re, 1990Dal-re, , 1993. Table 13 provides a summary of the reported attitudes to the various trials, the sample population, the method of assessing the attitudes and comments on the quality of the data.…”

Section: Views Of Healthcare Professionalsmentioning

confidence: 99%

“…Fourteen studies examined views on the informed consent process. Although informed consent was regarded as a necessary precursor to randomisation by over 91% of respondents (Benson et al, 1991;Dal-re, 1990Dal-re, , 1992e, 1993, up to 22% of respondents in the studies of Williams and Zwitter (1994) and Taylor and Kelner (1987b) regularly entered patients without obtaining informed consent. Approximately 60% of responding IRB members thought that parental consent was required for (hypothetical) trials involving children, though 85% thought that parental consent could be waived when the risk was minimal (Mammel and Kaplan, 1995).…”

Section: Views Of Healthcare Professionalsmentioning

confidence: 99%

“…Approximately 60% of responding IRB members thought that parental consent was required for (hypothetical) trials involving children, though 85% thought that parental consent could be waived when the risk was minimal (Mammel and Kaplan, 1995). Dal-re (1990) reported that nearly 70% of responding committee members thought it permissible for an investigator to administer trial drugs without informed consent but only under 'special circumstances', while 39% of respondents in the study of Blum et al (1987) agreed that the law should permit research under such circumstances. If the requirement of informed consent were abandoned, some physicians stated that they would enter more patients (Taylor and Kelner, 1987a,b).…”

Section: Views Of Healthcare Professionalsmentioning

confidence: 99%

See 3 more Smart Citations

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

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Health Technology Assessment is indexed in Index Medicus/MEDLINE and Excerpta Medica/ EMBASE. Copies of the Executive Summaries are available from the NCCHTA web site (see overleaf). NHS R&D HTA Programme T he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology assessment. Six advisory panels assist the Standing Group in identifying and prioritising projects. These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA). This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care. It was identified as a priority by the Methodology Panel and funded as project number 93/41/02. The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health. The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for the recommendations for policy contained herein. In particular, policy options in the area of screening will, in England, be considered by the National Screening Committee. This Committee, chaired by the Chief Medical Officer, will take into account the views expressed here, further available evidence and other relevant considerations. Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

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Section: Studies Under Reviewmentioning

confidence: 99%

Section: Views Of Healthcare Professionalsmentioning

confidence: 99%

Section: Views Of Healthcare Professionalsmentioning

confidence: 99%

Section: Views Of Healthcare Professionalsmentioning

confidence: 99%

See 2 more Smart Citations

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

View full text Add to dashboard Cite

show abstract

“…In three Spanish studies, over 90% of trialists agreed on a minimum dataset for all patients,7 – 9 and, in another study, a substantial proportion (58%) of doctors from the United Kingdom and eastern Europe said that they tried to give all information that might be pertinent 126 and about half the trialists doubted their capacity to judge what information to give patients 13…”

Section: Informed Consentmentioning

confidence: 99%

The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals

Edwards

Lilford²,

Hewison³

1998

BMJ

154

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Since the introduction of randomised controlled trials, professionals and lay people alike have worried over whether doing this sort of experiment in humans is ethical. It has been argued that participants may be called to sacrifice their own best interests for the benefit of future patients.1 The scientific rationale for conducting a trial rests in collective equipoise, which means that the medical community as a whole is genuinely uncertain over which treatment is best. The key point, however, is that future patients benefit at no cost to participants, provided that participants are in personal equipoise and give informed consent on this basis. In these circumstances, the trial arms are an equally good bet prospectively. 2 MethodsTo find out what patients, the general public, and healthcare professionals thought about trials, we undertook a review of the ethics of randomised controlled trials from these perspectives as part of a broader review relating to the ethics of designing and conducting clinical trials.1 We searched BIDS, Medline, and Psychlit (for strategy see the BMJ website). There were 61 studies on attitudes to trials, 54 based on quantitative methods and eight based on qualitative ones (one study used both). Twenty studies made use of hypothetical trial scenarios. Seven studies focused on early trials (phases I and II). Our search also identified three reviews that included views on clinical trials, [3][4][5] but only one was a systematic review and even this study gave only limited information about the quality of the composite studies. 4 In all three reviews, the number of studies cited was much lower than the number we found.Abstraction of results and quality assessment for all studies were carried out independently by SE and JH. We have chosen to focus here on the issues of informed consent, doctor-patient relationship, what motivates participants, equipoise, and restricting new treatments to trials. Other issues are summarised elsewhere.1 Quality assessment was difficult in many cases because insufficient information was given by the authorsperhaps itself an indicator of poor quality. The dimensions of methodological rigour used are listed in table 1. Our detailed findings are available in the form of a Health Technology Assessment monograph.1 Here, we discuss the salient findings in narrative style. The results were often surprising and sometimes even shocking.

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Offering patients entry in clinical trials: preliminary study of the views of prospective participants.

1996

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Objective-To ascertain attitudes to different methods of obtaining informed consent for randomised clinical trials (RCTs). Design Structured interviews with members of the public, medical secretaries and medical students. Setting The public were approached in a variety of public places. Medical secretaries and students were approached in their place of work. Subjects-Fifty members of the public, 25 secretaries and 25 students. Main outcome measures Views on RCTs were elicited, with particular emphasis on how subjects thought the concept of randomisation should be explained. Each participant was presented with descriptions ofproposed clinical trials and asked to select his or her preference from a range of options. Results-Written information was preferred over verbal information in 91 % of replies. Most respondents (860o) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour ofexplanations that were less explicit about the play of chance (ANOVA; p=0 0004). Eighty-three per cent of participants thought that randomised trials were morally acceptable when there was no prior medical preference between treatments. However, over half (55%) thought they would find it upsetting to be offered entry in such a trial and a quarter thought the outcome of treatment might be adversely affected. Conclusions Our results offer some support for the idea that "economy with truth" is less unsettling than a frank description of the stark reality of what randomisation means. It is a matter of debate as to whether, if we are correct, autonomy should have precedence over beneficence.

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Informed consent in clinical research with drugs in Spain: Perspective of clinical trials committee members

Cited by 4 publications

References 20 publications

Ethical issues in the design and conduct of randomised controlled trials.

Ethical issues in the design and conduct of randomised controlled trials.

The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals

Offering patients entry in clinical trials: preliminary study of the views of prospective participants.

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