The trinity of good research: distinguishing between research integrity, ethics and governance

The words integrity, ethics and governance are used interchangeably in relation to research. This masks important differences that must be understood when trying to address concerns regarding research culture. While progress has been made in identifying negative aspects of research culture (such as inequalities in hiring/promotion, perverse incentives etc.), and practical issues that lead to research waste (outcome reporting bias, reproducibility etc.), the responsibility for addressing these problems can be unclear due to the complexity of the research environment. One solution is to provide a clearer distinction between the perspectives of “Research Integrity,” “Research Ethics” and “Research Governance.” Here it is proposed that Research Integrity should be understood as focussed on the character of researchers, and consequently the primary responsibility for promoting it lies with researchers themselves. This is a different perspective from Research Ethics, which is focussed on judgments on the ethical acceptability of research, and should primarily be the focus of research ethics committees, often including input from the public as well as the research community. Finally Research Governance is a technical area focussing on legal and policy requirements. Although complementary to research integrity and ethics, Research Governance requires input from expert research support officers with the skills and experience to address technical compliance

Measuring inconsistency in research ethics committee review

Abstract Background The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes. Methods We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published “mystery shopper” exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise. Results Our analysis highlights qualitative differences between the ShED 19, ShED 20 and “mystery shopper” exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises. Conclusions ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be

Exempting low-risk health and medical research from ethics reviews: Comparing Australia, the United Kingdom, the United States and the Netherlands

Background: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. Methods: We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. Results: Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. Conclusions: Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales

Reshaping consent so we might improve participant choice (II) : helping people decide

All articles in Research Ethics are published as open access. There are no submission charges and no Article Processing Charges as these are fully funded by institutions through Knowledge Unlatched, resulting in no direct charge to authors. For more information about Knowledge Unlatched please see here: http://www.knowledgeunlatched.orgPeer reviewe

'The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back':a survey of views on human research ethics reviews

Background: We conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia. Methods: We surveyed Australian health/medical researchers and Human Research Ethics Committee (HREC) members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide (optional) comments. Qualitative data were analysed thematically; quantitative data in R. Results: We received 514 responses. Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review (to prioritise systematic review topics 84%, on software strengths/weaknesses 85%); scenarios involving surplus samples (82%) and N-of-1 (single case) studies (76%) were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively. Conclusions: Considerable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties - the same principle should apply to ethics reviews. </p