Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. MAIN TEXT: We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. CONCLUSION: Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

Australia's new digital health record created ethical dilemmas.

The last few months of 2018 saw a major battle over privacy, autonomy and use of health information in Australia as the basis for the national electronic health record changed from an opt-in system to one where every person had such a record unless they specifically requested to opt-out of the system. The debate was messy, involving both ethical and wider political concerns, with the ethical concerns partly heightened because of the political context. Canadian health leaders can learn from the mistakes and successes of this situation.

Acid Brothers: Henry Beecher, Timothy Leary, and the psychedelic of the century.

Henry Knowles Beecher, an icon of human research ethics, and Timothy Francis Leary, a guru of the counterculture, are bound together in history by the synthetic hallucinogen lysergic acid diethylamide (LSD). Both were associated with Harvard University during a critical period in their careers and of drastic social change. To all appearances the first was a paragon of the establishment and a constructive if complex hero, the second a rebel and a criminal, a rogue and a scoundrel. Although there is no evidence they ever met, Beecher's indirect struggle with Leary over control of the 20th century's most celebrated psychedelic was at the very heart of his views about the legitimate, responsible investigator. That struggle also proves to be a revealing bellwether of the increasingly formalized scrutiny of human experiments that was then taking shape.

Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain.

Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and objective account of these trials is lacking. The aim of this study was to describe and evaluate the clinical trials performed in the German Democratic Republic (GDR) based on archival material from the health system and the secret service. We found documents relating to 220 trials involving more than 14,000 patients and 68 Western companies. However, no record of patient information forms or systematic documentation regarding the provision of patient consent was discovered. There was no evidence to suggest that the trials systematically and intentionally damaged patients. The trials were conducted without the knowledge of the public. GDR legislation stipulated that patients must consent to the trials, but no evidence was found to suggest that patients were systematically informed. Documents suggest that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. The GDR agreed to the trials due to impending bankruptcy and Western pharmaceutical companies capitalised on this situation.

Governance of biomedical research in Singapore and the challenge of conflicts of interest.

This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee (BAC), which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this.

Public health accreditation and metrics for ethics: a case study on environmental health and community engagement.

As public health departments around the country undergo accreditation using the Public Health Accreditation Board standards, the process provides a new opportunity to integrate ethics metrics into day-to-day public health practice. While the accreditation standards do not explicitly address ethics, ethical tools and considerations can enrich the accreditation process by helping health departments and their communities understand what ethical principles underlie the accreditation standards and how to use metrics based on these ethical principles to support decision making in public health practice. We provide a crosswalk between a public health essential service, Public Health Accreditation Board community engagement domain standards, and the relevant ethical principles in the Public Health Code of Ethics (Code). A case study illustrates how the accreditation standards and the ethical principles in the Code together can enhance the practice of engaging the community in decision making in the local health department.

Ageism and equality.

This paper rebuts suggestions made by Littlejohns et al that NICE is not ageist by analysing the concept of ageism. It recognises the constraints that finite resources impose on decision making bodies such as NICE and then makes a number of positive suggestions as to how NICE might more effectively and more justly intervene in the allocation of scarce resources for health.

National Institute for Health and Clinical Excellence appraisal and ageism.

The requirements of the UK Equality Act 2010 and some high profile criticism for using a potentially ageist methodology have prompted the National Institute for Health and Clinical Excellence (NICE) to assess the processes and methodology it uses to make appraisal decisions. This paper argues that NICE has established rigorous systems to protect against ageist decisions, has no track record of ageism and is well placed to meet the requirements of new UK equality legislation.

Low organisational justice and heavy drinking: a prospective cohort study.

OBJECTIVES: To investigate whether low perceived organisational injustice predicts heavy drinking among employees. METHODS: Data from a prospective occupational cohort study, the 10-Town Study, on 15 290 Finnish public sector local government employees nested in 2432 work units, were used. Non-drinkers were excluded. Procedural, interactional and total organisational justice, heavy drinking (>/=210 g of absolute alcohol per week) and other psychosocial factors were determined by means of questionnaire in 2000-2001 (phase 1) and 2004 (phase 2). Multilevel logistic regression analyses taking into account the hierarchical structure of the data were conducted and adjustments were made for sex, age, socio-economic status, marital status, baseline heavy drinking, psychological distress and other psychosocial risk factors such as job strain and effort/reward imbalance. RESULTS: After adjustments, participants who reported low procedural justice at phase 1 were approximately 1.2 times more likely to be heavy drinkers at phase 2 compared with their counterparts reporting high justice. Low perceived justice in interpersonal treatment and low perceived total organisational justice were associated with increased prevalence of heavy drinking only in the model adjusted for sociodemographics. CONCLUSIONS: This is the first longitudinal study to show that low procedural justice is weakly associated with an increased likelihood of heavy drinking.

Indecent medicine: in defense of the absolute prohibition against physician participation in torture.

In a recent article, Gross (2004) argues that physicians in decent societies have a civic duty to aid in the torturing of suspected terrorists during emergency conditions. The argument presupposes a communitarian society in which considerations of common good override questions of individual rights, but it is also utilitarian. In the event that there is a ticking bomb and no other alternative available for defusing it, torture must be used, and physicians must play their part. In an earlier article, Jones (1980) also argues in favour of physician participation in torture, going so far as to enthusiastically endorse the allocation of research resources as well to ensure that the ability to meet emergency situations is as efficient as scientifically possible. I argue against both these views and defend the absolute prohibition against torture generally, and against any participation by physicians in particular. I show that these arguments are incompatible with liberal or decent societies, and that the institutional requirements for making torture effective would constitute an unacceptable degradation both of medical ethics and practice, as well as of political institutions in general.

Neurosciences and research on chemical weapons of mass destruction in Nazi Germany.

As a side-product of industrial research, new chemical nerve agents (Tabun, Sarin, Soman) superior to those available to the Allied Forces were discovered in Nazi Germany. These agents were never used by Germany, even though they were produced at a large scale. This article explores the toxicological and physiological research into the mechanisms of action of these novel nerve agents, and the emergence of military research objectives in neurophysiological and neurotoxicological research. Recently declassified Allied military intelligence files document secret nerve agent research, leading to intensified research on anticholinesterase agents in the peripheral and the central nervous system. The article discusses the involvement of IG Farben scientists, educational, medical and military institutions, and of Nobel Prize laureate Richard Kuhn, director of the Kaiser Wilhelm Institute for Medical Research.

Combined effects of uncertainty and organizational justice on employee health: testing the uncertainty management model of fairness judgments among Finnish public sector employees.

We examined whether the combination of uncertainty (lack of work-time control, and negative changes at work) and organizational justice (i.e., justice of decision-making procedures and interpersonal treatment at work) contributes to sickness absence. A total of 7083 male and 24,317 female Finnish public sector employees completed questionnaires designed to assess organizational justice, workload and other factors. Hierarchical regression showed that after adjustment for age, income, and health behaviors low procedural and interactional justice were related to long sickness absence spells. In accordance with the uncertainty management model, these associations were dependent on experienced work-time control and perceived changes at work.