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

Abstract

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 categoriesevaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluationwere 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.

“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 researchers’ and ethics committee members’ views on research ethics reviews in Australia

“…This survey of researchers and members of research ethics committees in Australia revealed no unanimity about the circumstances in which research ethics review was needed. Based on exemptions listed in guidance in other countries,(10) we identified two particular scenarios (interviews of professional staff about systematic review topics, and evaluation of systematic review software) – for which we found that 84% and 85%, respectively, agreed that ethics review was not required. Conversely, there was no scenario for which over 80% agreed that ethics review was required.…”

“…Six of the eight hypothetical research scenarios in Part 3 were derived from an earlier project, comparing the types of research exempt from ethics review in Australia, the United States, the United Kingdom, and The Netherlands(10); two scenarios (Linked Data Sets and N-of-1 (single case) studies) were suggested for inclusion by colleagues who had previously experienced challenges with ethics reviews for those types of research.…”

“…For example, surveys of professional staff aimed at improving professional practice were exempt in some but not all countries, and three of the four countries exempt questionnaire or survey research, albeit subject to stipulated conditions such as minimal inconvenience. (10) A recent petition to the Australian government further highlighted the problems faced by Australian researchers when navigating research ethics processes. Many of the over 400 comments prompted by the petition emphasised that “the overburden of bureaucracy in research is harmful to patients” and that a better system “would mean more efficient and better quality outcomes for patients.”(11)…”

How to strengthen a health research system: WHO’s review, whose literature and who is providing leadership?

“…Articles on the main components of a NHRS were supplemented by some important papers on topics that are highly relevant but which feature less frequently in HARPS. These include a study aimed at reducing the research waste that arises from disproportionate regulation by examining the practices for exempting low-risk research from ethics review in four high-income countries [71], the Global Observatory's paper on research funding described earlier [29], a study on the governance of national health research funding institutions [72], and one on a more recent topic of growing significancean analysis of attempts to boost gender equality in health research [73]. Additionally, some of the papers on specific components, such as impact evaluation or use of evidence, are extending the analysis.…”

Exempting low-risk health research from ethics reviews to better serve the interests of the patients and public: a qualitative analysis of survey responses

“…In Australia, this review is provided by human research ethics committees (HRECs), which assess the proposed research for compliance both with the applicable laws and the National Statement on Ethical Conduct in Human Research . (1)…”