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Based on extensive questionnaire data, this paper focuses on parents' views about children's right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings.

Introduction: The use of human samples in genomic research has increased ethical debate about informed consent (IC) requirements and the information that subjects should receive regarding the results of the research. However, there are no quantitative data regarding researchers' attitudes about these issues. Methods: We present the results of a survey of 104 US and 100 Spanish researchers who had published genomic epidemiology studies in 61 journals during 2006. Results: Researchers preferred a broader IC than the IC they had actually obtained in their published papers. US authors were more likely than their Spanish colleagues to support obtaining a broad IC, covering either any future research project or any projects related to a group of diseases (67.6% vs 43%; adjusted OR = 4.84, 95% CI, 2.32 to 10.12). A slight majority of researchers (55.8%) supported informing participants about individual genomic results only if the reliability and clinical validity of the information had been established. Men were more likely than women to believe that patients should be informed of research results even if these conditions were not met (adjusted OR = 2.89, 95% CI = 1.46 to 5.72). Conclusions: This study provides evidence of a wide range of views among scientists regarding some controversial ethical issues related to genomic research, suggesting the need for more study, debate and education. In the interim, journals might consider including the investigators' policies regarding these ethical issues in the papers they publish in the field of genomic epidemiology.

This article examines a key ethical concern that has arisen in the work of the international research consortium GenoMEL (http://www.genomel.org) and that has relevance to all genetic research in humans. The question is whether it is ethical to deny research participants the opportunity to receive individualised genetic results obtained from the biological samples they provide. Where those results are of clinical importance, a 'respect for persons' requirement would make the offering of those results imperative. However, where those results are of uncertain clinical value, the picture is less clear. This paper argues that researchers may not be ethically obliged to offer such results to their participants, because of competing ethical demands.

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association Declaration of Helsinki, and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health (formerly the British Paediatric Association), and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration.

Background: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. Method: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). Results: The mean Jadad score was 9.86 [+ or -] 1.117. The methodological quality was poor in 75 RCTs (Jadad score

Debate continues about the ethics of sham surgery controls. The most powerful argument for sham surgery controls is that rigorous experiments are needed to demonstrate safety and efficacy of surgical procedures. Without such experiments, there is danger of adopting worthless procedures in clinical practice. Opponents of sham surgery controls argue that sham surgery constitutes unacceptable violation of the rights of research subjects. Recent philosophical discussion has used two thought experiments-the transplant case and the trolley problem--to explore the circumstances under which individuals may be harmed to benefit a larger group. The transplant case is felt to exemplify circumstances that forbid harming some to benefit a larger group while the trolley problem exemplifies circumstances that permit harming some to benefit others. I argue that sham surgery controls satisfy criteria derived from the trolley problem and are morally permissible.

Background: Bronchoscopy with biopsy and BAL is being performed increasingly in patients with COPD as a research tool. Previous reports have shown these procedures to be safe in asthmatic patients, [...]

Objective: The authors' goal was to assess healthy individuals' attitudes toward five of the most prominent proposed safeguards regarding the consent process for research with adults unable to consent. Method: Telephone interviews were conducted with 246 individuals with a family history of Alzheimer's disease who had participated in clinical research. Results: The majority of respondents said that they were willing to participate in research if they lost the ability to consent. Few completed a research advance directive. Many had discussed their preferences with their families, and the majority would allow their families to make research decisions for them. Conclusions: Enrolling individuals who are unable to consent in research that offers no potential for medical benefit is consistent with the preferences of at least some individuals. This suggests that such research should not be prohibited, provided there is sufficient evidence that it is consistent with the preferences of individual subjects. Requiring that such evidence be provided in a formal research advance directive may be unnecessarily restrictive. More research is needed to assess whether the findings in this group of subjects generalize to other groups.

The rapid growth of clinical trials sponsored by the pharmaceutical industry and conducted by community physicians raises concerns about the scientific quality of this research and the adequacy of protections [...]

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ('equipoise'). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation. Keywords: Medical ethics; clinical trials; research design; random allocation; decision making; human experimentation

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 [...]

When consulting with nurses on potential research projects, we are often asked, 'Will I need to include an informed consent for the subjects of the study?' This is an excellent [...]

There is a sort of controversy machine, a social mechanism, that has helped to develop the system of ethical review of research on humans. It usually escapes notice. As scandals become public over years, ethical surveillance is increased. Some responses may not be the ones that would most effectively control underlying problems. A set of goals and paths to reach them should be developed. Then progress should be looked at. The system of ethical review in existence is at risk of becoming very adversarial. Researchers are seen as possible offenders. Reviewers are seen as protectors. A widespread discussion is needed. Recommendations have been made.

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make 'no legal commitment' to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. Key words: ABPI guidelines; negligence actions; LRECs; drug research; compensation; innovative therapy; research on patients; research on healthy volunteers; NHS indemnity.

Michael Lockwood has recently concluded that it can be morally permissible to perform potentially damaging non-therapeutic experiments on live human (pre)embryos. The masons he provides in support of this conclusion commit him inter alia to the following controversial theses: (I) an organism's potential for twinning bears critically on the identity conditions for that organism; and (ii) functionally intact mentality-mediating neurological structures play a critical role in establishing the identity conditions for human organisms. I argue that Lockwood has given us no good reason to endorse either of these theses and, hence, that he has given us no good reason to believe that it can be morally permissible to perform potentially damaging non-therapeutic experiments on live human (pre)embryos.

In clinical research the giving of consent by the patient often lies within the context of illness or the doctor/patient relationship. On exploration of these issues it would appear unlikely that the patient's consent is free of substantial influences, some of which may be strong enough to be controlling. Five categories of consent are suggested: voluntary, involuntary, coerced, enforced and partially voluntary. It is argued that consent in clinical research is substantially influenced and thus only partially voluntary. Several practical strategies are proposed to ensure adequately voluntary consent by reducing some circumstantial influences when consent to clinical research is obtained.

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 of proposed 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 (86%) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour of explanations 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. The offer of entry in a clinical trial is likely to affect the experience of care for many people, especially if the process of randomisation is described explicitly. Potential participants should be given a detailed written explanation of the rationale for the trial and be asked to sign a consent form if they agree to take part.

Hans Jonas, in his essay 'Philosophical Reflection on Experimenting with Human Subjects' asserts that people are not morally or socially obliged to volunteer as subjects for experiments in medicine. They must be allowed to volunteer only if they are committed to the project and give a free and uncoerced consent. However, requiring a commitment does not protect volunteers from their own emotionally motivated self-sacrifice.

Most randomised clinical trials require periodic monitoring of the accumulating data. While the efficiency of trial management is enhanced by data monitoring, ethical reasons should primarily dictate the need to [...]

The clinical trial is an essential part of the evaluation of novel drugs and treatment protocols. The randomized clinical trial, in which the patients are randomly assigned into the different treatment groups, is less susceptible to the introduction of bias, and is therefore often to be preferred. However, the random clinical trial, or RCT, is not without difficulties, and must be carefully designed in order to lead to reliable conclusions. Complicating the design of RCTs are important ethical considerations, which generally revolve around the need for control groups and the validity of informed consent. Ethically, it is difficult to withhold treatment known to be effective, and control groups must be designed with this in mind. The purely ''placebo'' control must be abandoned in many cases. In addition, especially with incurable diseases, the patient may agree to participate out of desperation; this is viewed by some as a form of coercion, rendering informed consent no longer valid. The authors suggest that enrolling patients in an RCT is ethical only if there is truly no reason to believe either treatment arm is to be preferred. This will relegate the RCT to situations where the experimental treatment and the traditional treatment are likely to yield very similar results. For treatments yielding well improved results, historical cases may be adequate for experimental control. The authors also suggest that the RCT be modified to take patient preference into account. Patients' treatment preferences should self-randomize; if they do not, that might be a clue into important perceived differences between the treatment groups. Although randomized clinical trials are often preferred by researchers, when alternative experimental designs are possible, ethics may demand that randomization not be used. (Consumer Summary produced by Reliance Medical Information, Inc.)

Numerous problems face the design and implementation of programs of clinical research, not the least of which is the general anti-intellectual attitude of our times. Often this attitude results in a ''double-bind,'' since the desires and fears of the public are often contradictory. This is most evident among patients with AIDS, who are afraid of being made ''guinea pigs,'' but who also insist that any drug which shows even the remotest chance of benefitting them be made available. Furthermore, they often demand that the fruits of research be made available in such a way that it is impossible to scientifically assess the results. Behind this general cultural orientation are more mundane but nevertheless difficult problems. How can clinical research be integrated into a health care system which itself is in chaos? How can the science of clinical trials be improved? How may more patients become involved in clinical trials without compromising the ethics of medical practice? And of course, questions must always be raised about the management of clinical research. Can clinical researchers, community physicians, and the National Cancer Institute cooperate effectively at the same time each is trying to maintain and expand power and control? Ultimately, all of these questions influence the care that is received by cancer patients, and the care that will be received by patients of the future. Although the questions are not easy, they must be resolved if the care of cancer patients is to continue to advance. (Consumer Summary produced by Reliance Medical Information, Inc.)

In 1798 Dr Edward Jenner published his famous account of 'vaccination'. Some claim that a Research Ethics Committee, had it existed in the 1790s, might have rejected his work. I provide the historical context of his work and argue that it addressed a major risk to the health of the community, and, given the devastating nature of smallpox and the significant risk of variolation, the only alternative preventative measure, Jenner's study had purpose, justification and a base in the practice of the day.

The latest revision to the Declaration of Helsinki was precipitated by concern about Northern researchers exploiting populations in poorer countries. (1) It is too soon for consumer groups to have [...]

Deliberately infecting volunteers with the malaria parasite poses ethical problems but is probably necessary in order to develop effective malaria drugs and vaccines. The malaria parasite typically enters the liver and reproduces for 5 to 10 days. Then tens of thousands of parasites are released into the bloodstream, where they can infect red blood cells. One type of vaccine attempts to block parasite reproduction in the liver, since infection of red blood cells causes most malaria symptoms. If the vaccine fails, the volunteers can be promptly treated. Reducing the mortality rate from malaria is more important than preventing infection.