What should authorities establish as the job of ethics committees and review boards? Two answers are: review of proposals for consistency with the duly established and applicable code and review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and (...) independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. (shrink)

What job should authorities give to review boards? We are grateful to Soren Holm, Rosamond Rhodes, Julian Savulescu and G Owen Schaefer for their thoughtful commentaries on our answer.1–4 Here we add to the discussion. Let us summarise the claims for which we argued.5 Relevant authorities can task boards with review for consistency with duly established code, thereby making code-consistent activities apt for approval and code-inconsistent activities apt for rejection. They can instead task boards with review for ethical acceptability, making (...) ethically acceptable activities apt for approval and ethically unacceptable activities apt for rejection. For every proposal a board might consider, these two different jobs establish different review bases, and their approvals and rejections also sometimes conflict. Some international and national statements require ECR, others instead require CCR, and others again seem either to require both or just to run the two together. Those responsible for these statements should make them clearer and better aligned here. For reasons of practicality, publicity and separation of powers, authorities do better to task boards with CCR and not ECR. These arguments also count against establishing any code with content that in effect collapses CCR into ECR. If our arguments withstand robust scrutiny, authorities should also remove ‘ethics’ and cognate terms from the names of these boards and their review activities and emphasise code expertise not ethics expertise in the required skill sets of boards. Our article noted that ‘ethical considerations informed the genesis of these boards and express their aspirations’. Rhodes similarly notes: ‘the authors and endorsers of research ethics codes, declarations and regulations … articulating the ethical standards for conducting human subject research’ and ‘This framework embeds the ethical parameters of human subject research into the moral missions of institutions’. Schaefer too …. (shrink)

Background: Medical decision making is based on patient autonomy and informed consent, which is an integral part of medical ethics, risk management and clinical governance. Consent to treatment has been extensively discussed, but the viewpoint of patients is not well represented. A new consent form was introduced by the Department of Health in 2001.Aims: To determine the information most important to patients, to facilitate evidence-based guidelines and to provide a valid and reliable consent-procedure-satisfaction questionnaire.Methods: An anonymous quantitative survey was carried (...) out, asking 100 patients 15 questions regarding procedures they may need to undergo, using a Visual Analogue Scale to test the importance of each question.Results and discussion: In total there were 77 respondents and the mean age was 48.8 years. There were 52% women and 48% men. Major complications, such as not undergoing the procedure, future management and long-term effect on work, all scored a median of 95%. Least concerns were related to technical details of the procedure and minor complications . All other questions were still considered important . No significant differences were observed between sex, age and professional groups, but a significant difference was observed between the education groups. Qualifications of the doctor did not correlate to any other question.Conclusions: This questionnaire is proposed as a basis for informed consent guidelines to health workers and for measures of satisfaction with the consent procedure. (shrink)

BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by (...) REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. (shrink)

Background: Obtaining patients’ informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient’s informed consent to treatment.Aims: To review four models of consent and analyse the way each model incorporates the (...) ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts.Methods: An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent.Results and discussion: All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients’ consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy.Conclusions: The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices. (shrink)

In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in (...) favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities’ respective approaches to interpretation and implementation of the Declarations’ placebo paragraph in the conduct of medical research. Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of “serious harm” and “methodological reasons” are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki’s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard. (shrink)